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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2024
OR 
☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ____ to ____  
Commission File Number 001-33351
_________________________________________________ 
NEUROMETRIX, INC.
(Exact name of registrant as specified in its charter)
Delaware04-3308180
(State or other jurisdiction of(I.R.S. Employer Identification No.)
incorporation or organization) 
  
4B Gill Street Woburn, Massachusetts
01801
(Address of principal executive offices)(Zip Code)
(781) 890-9989
(Registrant’s telephone number, including area code) 
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of exchange on which registered
Common Stock, $0.0001 par value per shareNUROThe Nasdaq Stock Market LLC
Preferred Stock Purchase Rights
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes x     No ¨
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes x     No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer Accelerated filer Non-accelerated filer Smaller reporting companyEmerging growth company
☐☐
x
x
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐     No x
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 2,042,689 shares of common stock, par value $0.0001 per share, were outstanding as of November 4, 2024.




NeuroMetrix, Inc.
Form 10-Q
Quarterly Period Ended September 30, 2024
 
TABLE OF CONTENTS
 
 
   
Item 1. 
   
 Balance Sheets as of September 30, 2024 (unaudited) and December 31, 2023
   
 Statements of Operations (unaudited) for the Quarters and Nine Months Ended September 30, 2024 and 2023
Statements of Comprehensive Loss (unaudited) for the Quarters Ended September 30, 2024 and 20232
   
Statements of Changes in Stockholders' Equity (unaudited) for the Quarters and Nine Months Ended September 30, 2024 and 2023
 Statements of Cash Flows (unaudited) for the Nine Months Ended September 30, 2024 and 20234
   
 
   
Item 2.12
   
Item 3.19
   
Item 4.20
   
 
   
Item 1.21
   
Item 1A.21
   
Item 2.21
  
Item 3.21
   
Item 4.21
  
Item 5.21
   
Item 6.22
   
23

All share amounts in the Quarterly Report on Form 10-Q have been adjusted to reflect a 1-for-8 reverse stock split that was effected on November 21, 2023.
3


PART I – FINANCIAL INFORMATION
 
Item 1. Financial Statements
 
NeuroMetrix, Inc.
Balance Sheets
 
 September 30, 2024December 31, 2023
(Unaudited)
Assets  
Current assets:  
Cash and cash equivalents
$921,520 $1,731,946 
Available-for-sale securities13,913,080 16,265,205 
Accounts receivable, net
149,092 518,824 
Inventories
1,430,122 1,559,428 
Prepaid expenses and other current assets
381,876 779,039 
Total current assets
16,795,690 20,854,442 
Fixed assets, net219,106 293,449 
Right of use asset147,824 250,150 
Other long-term assets26,400 26,400 
Total assets
$17,189,020 $21,424,441 
Liabilities and Stockholders’ Equity  
Current liabilities:  
Accounts payable
$347,641 $215,509 
Accrued expenses and compensation
719,609 876,739 
Lease obligation, current
142,621 148,391 
Total current liabilities
1,209,871 1,240,639 
Lease obligation, net of current portion
— 92,485 
Total liabilities
1,209,871 1,333,124 
Commitments and contingencies
Stockholders’ equity:  
Preferred stock
— — 
Convertible preferred stock
1 1 
Common stock, $0.0001 par value; 25,000,000 shares authorized at September 30, 2024 and December 31, 2023; 2,033,306 and 1,524,939 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively
203 152 
Additional paid-in capital
232,030,177 229,960,346 
Accumulated other comprehensive income83,853 240,171 
Accumulated deficit
(216,135,085)(210,109,353)
Total stockholders’ equity
15,979,149 20,091,317 
Total liabilities and stockholders’ equity
$17,189,020 $21,424,441 

The accompanying notes are an integral part of these interim financial statements.
1


NeuroMetrix, Inc.
Statements of Operations
(Unaudited)
 
 Quarters Ended September 30,Nine Months Ended September 30,
 2024202320242023
Revenues$587,314 $1,203,164 $2,450,018 $4,583,679 
Cost of revenues275,357 421,382 1,129,125 1,484,240 
Gross profit
311,957 781,782 1,320,893 3,099,439 
Operating expenses:    
Research and development
299,739 592,654 1,510,223 2,045,588 
Sales and marketing
441,171 943,795 1,937,914 2,504,630 
General and administrative
1,313,095 1,206,231 4,697,450 3,843,643 
Total operating expenses
2,054,005 2,742,680 8,145,587 8,393,861 
Loss from operations
(1,742,048)(1,960,898)(6,824,694)(5,294,422)
Other income:
Interest income 8,412 25,378 40,579 247,699 
Other income 225,410 166,783 758,383 166,783 
Total other income233,822 192,161 798,962 414,482 
Net loss$(1,508,226)$(1,768,737)$(6,025,732)$(4,879,940)
Net loss per common share applicable to common stockholders, basic and diluted$(0.75)$(1.66)$(3.10)$(4.86)
Weighted average number of common shares outstanding, basic and diluted2,023,280 1,065,003 1,945,995 1,004,339 
 


Statements of Comprehensive Loss
(Unaudited)

 Quarters Ended September 30,Nine Months Ended September 30,
 2024202320242023
Net loss $(1,508,226)$(1,768,737)$(6,025,732)$(4,879,940)
Other comprehensive income:
Unrealized gain on available-for-sale securities, net197,092 204,931 602,065 373,652 
Reclassification of realized gain on available-for-sale securities to other income $(225,410)$(166,783)$(758,383)$(166,783)
Comprehensive loss$(1,536,544)$(1,730,589)$(6,182,050)$(4,673,071)

The accompanying notes are an integral part of these interim financial statements.
2


NeuroMetrix, Inc.
Statements of Changes in Stockholders' Equity
(Unaudited)
Series B Convertible Preferred StockCommon
Stock		Additional
Paid-In
Capital		Accumulated Other Comprehensive IncomeAccumulated
Deficit		Total
Number of
Shares		AmountNumber of
Shares		Amount
Balance at December 31, 2023200.00 $1 1,518,717 $152 $229,960,346 $240,171 $(210,109,353)$20,091,317 
Stock-based compensation expense— — — $— 216,164 — — 216,164 
Issuance of common stock under at the market offering — — 458,380 $46 1,471,053 — — 1,471,099 
Vesting of restricted stock under equity plan — — 6,699 $1 (1)— — — 
Other comprehensive income— — — $— — 7,006 — 7,006 
Net loss — — — $— — — (3,029,574)(3,029,574)
Balance at March 31, 2024200.00 1 1,983,796 199 231,647,562 247,177 (213,138,927)18,756,012 
Stock-based compensation expense— — — — 176,148 — — 176,148 
Issuance of common stock under employee stock purchase plan— — 850 — 2,601 — — 2,601 
Vesting of restricted stock under equity plan— — 29,453 3 (3)— — — 
Other comprehensive income— — — — — (135,006)— (135,006)
Net loss— — — — — — (1,487,932)(1,487,932)
Balance at June 30, 2024200 $1 2,014,099 $202 $231,826,308 $112,171 $(214,626,859)$17,311,823 
Stock-based compensation expense— — — 203,870 — — 203,870 
Vesting of restricted stock under equity plan— — 17,610 1 (1)— — — 
Other comprehensive income— — — — — (28,318)— (28,318)
Net loss— — — — — — (1,508,226)(1,508,226)
Balance at September 30, 2024200 1 2,031,709 203 232,030,177 83,853 (216,135,085)15,979,149 
Series B Convertible Preferred StockCommon
Stock		Additional
Paid-In
Capital		Accumulated Other Comprehensive IncomeAccumulated
Deficit		Total
Number of
Shares		AmountNumber of
Shares		Amount
Balance at December 31, 2022200.00 $1 959,460 $96 $226,935,456 $— $(203,579,866)$23,355,687 
Stock-based compensation expense— — — — 165,361 — — 165,361 
Vesting of restricted stock under equity plan— — 2,439 — — — — — 
Other comprehensive income— — — — — 65,874 — 65,874 
Net loss — — — — — — (1,574,174)(1,574,174)
Balance at March 31, 2023200.00 1 961,899 96 227,100,817 65,874 (205,154,040)22,012,748 
Stock-based compensation— — — — 132,745 — — 132,745 
Issuance of common stock under at the market offering — — 90,661 9 691,396 — — 691,405 
Issuance common stock under employee stock purchase plan — — 1,316 — 8,713 — — 8,713 
Vesting of restricted stock under equity plan— — 9,015 1 (1)— — — 
Other comprehensive income— — — — — 102,847 — 102,847 
Net loss— — — — — — (1,537,029)(1,537,029)
Balance at June 30, 2023200 $1 1,062,891 $106 $227,933,670 $168,721 $(206,691,069)$21,411,429 
Stock-based compensation— — — — 221,268 — — 221,268 
Issuance of common stock under at the market offering— — 184 — 1,426 — — 1,426 
Vesting of restricted stock under equity plan— — 2,820 — — — — — 
Other comprehensive income— — — — — 38,148 — 38,148 
Net loss— — — — — — (1,768,737)(1,768,737)
Balance at September 30, 2023200 $1 1,065,895 $106 $228,156,364 $206,869 $(208,459,806)$19,903,534 
The accompanying notes are an integral part of these interim financial statements.

3








NeuroMetrix, Inc.
Statements of Cash Flows
(Unaudited)
 Nine Months Ended September 30,
 20242023
Cash flows from operating activities:  
Net loss$(6,025,732)$(4,879,940)
Adjustments to reconcile net loss to net cash used in operating activities:
  
Depreciation
74,343 30,957 
Amortization of right-of-use assets, operating lease102,326 58,087 
Stock-based compensation
596,182 519,374 
Inventory reserve charged to cost of revenue74,209 63,420 
Amortization of premiums and discounts on held-to-maturity securities— (135,293)
Realized gain on available-for-sale securities(758,383)(166,783)
Changes in operating assets and liabilities:  
Accounts receivable369,732 32,390 
Inventories55,097 (115,042)
Prepaid expenses and other current and long-term assets363,183 (200,118)
Accounts payable132,132 (142,608)
Accrued expenses and compensation(157,130)356,562 
Operating lease liability (64,275)(55,373)
Net cash used in operating activities(5,238,316)(4,634,367)
Cash flows from investing activities:  
Purchases of available-for-sale securities(29,045,810)(22,898,470)
Proceeds from maturities of available-for-sale securities 32,000,000 7,095,000 
Proceeds from maturities of held-to-maturity securities— 17,000,000 
Purchases of fixed assets— (138,176)
Net cash provided by (used in) investing activities2,954,190 1,058,354 
Cash flows from financing activities:  
Net proceeds from issuance of stock 1,473,700 701,546 
Net cash provided by financing activities1,473,700 701,546 
Net decrease in cash and cash equivalents(810,426)(2,874,467)
Cash and cash equivalents, beginning of period1,731,946 4,335,020 
Cash and cash equivalents, end of period$921,520 $1,460,553 
 
The accompanying notes are an integral part of these interim financial statements.
 
4

NeuroMetrix, Inc.
Notes to Unaudited Financial Statements
September 30, 2024



1.Business and Basis of Presentation

Our Business-An Overview
 
NeuroMetrix, Inc. (the "Company" or "NeuroMetrix") develops and commercializes health care products that utilize non-invasive neurostimulation. Revenues are derived from the sale of medical devices and after-market consumable products and accessories. The Company’s products are sold in the United States and select overseas markets. They are cleared by the U.S. Food and Drug Administration ("FDA") and regulators in foreign jurisdictions where appropriate. The Company has two primary products. DPNCheck® is a point-of-care test for diabetic peripheral neuropathy, which is the most common long-term complication of Type 2 diabetes. Quell is an app-enabled, wearable device for lower extremity chronic pain and for the symptoms of fibromyalgia.

The Company held cash, cash equivalents and investment grade securities totaling $14.8 million as of September 30, 2024. The Company believes that its present balance of cash resources and securities coupled with cash inflows from product sales will enable the Company to fund its operations for at least the next twelve months from the date of issuance of the financial statements. Actual cash requirements could differ from management's projections for many reasons, including changes the Company may make to its business strategy, commercial challenges, regulatory developments, changes to research and development programs, supply chain issues, staffing challenges and other items affecting the Company's projected uses of cash.

During February 2024, the Company announced that it would undertake a review of its strategic options to maximize shareholder value. These options include changes in marketing strategies, the acquisition of new assets, potential sale of Company assets, and a merger or other strategic transaction. This review process remains ongoing. A timetable for completion of this process has not been established, and even if certain strategic alternatives may be available, the Company cannot provide any assurance that the strategic alternatives review process will result in the successful realization of any particular alternative, transaction or value. Accordingly, the unaudited financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.

Unaudited Interim Financial Statements
 
The accompanying unaudited balance sheet as of September 30, 2024, unaudited statements of operations, statements of comprehensive loss, changes in stockholders' equity and cash flows for the quarters ended September 30, 2024 and 2023 have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. The accompanying balance sheet as of December 31, 2023 has been derived from the audited balance sheet as of December 31, 2023 included in the Company's Form 10-K referenced below and does not include all disclosures required by U.S. GAAP. In the opinion of management, the financial statements include all normal and recurring adjustments considered necessary for a fair presentation of the Company’s financial position and operating results. Operating results for the nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024 or any other period. These financial statements and notes should be read in conjunction with the financial statements for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the "SEC"), on March 1, 2024 (File No. 001-33351).

Prior period reclassification

Certain items in the Statements of Cash Flows from the prior year were reclassified to conform with the current presentation.
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Revenues

Revenues include product sales, net of estimated returns. Revenue is measured as the amount of consideration the Company expects to receive in exchange for product transferred. Revenue is recognized at the point in time when contractual performance obligations have been satisfied and control of the product has been transferred to the customer. The Company has a single product delivery performance obligation. Accrued product returns using the most likely amount method are estimated based on historical data and evaluation of current information and variable consideration is not constrained. Revenue from product sales that occur via an online pharmacy agent are recognized on a gross basis and the related fulfillment fees are expensed within cost of revenues.

Accounts receivable are recorded in the amount the Company expects to collect, net of the allowance for credit losses. The allowance for credit losses is the Company’s best estimate of the amount of probable credit losses based on customer past payment history, product usage activity, and recent communications with the customer. Individual customer balances which are over 90 days past due are reviewed individually for collectability and written-off when recovery is not probable. The Company does not have any off-balance sheet credit exposure related to its customers. Allowance for credit losses was $25,000 as of September 30, 2024 and December 31, 2023.
 
Two customers accounted for 28% of total revenues in the quarter ended September 30, 2024 and two different customers accounted for 28% of total revenues in the quarter ended September 30, 2023. One customer accounted for 10% of total revenues for the nine months ended September 30, 2024 and two customers accounted for 26% of total revenues in the nine months ended September 30, 2023. Four customers accounted for 74% and three customers accounted for 74% of accounts receivable as of September 30, 2024 and December 31, 2023, respectively.

Cash and Cash Equivalents

Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in U.S. government securities.

Securities

The Company invests in highly liquid, marketable debt securities with high credit ratings and typically with maturities of two years or less. Individual securities are designated by the Company as either "held-to-maturity" ("HTM") or “available-for-sale” ("AFS") at the point of investment. Securities classified as short-term have maturities of less than one year. As of September 30, 2024, all marketable securities held by the Company are classified as AFS and had remaining contractual maturities of one year or less.

HTM securities are valued on an amortized cost basis and reviewed to determine if an allowance for credit losses should be recorded in the statements of operations. AFS securities are valued at fair value. Unrealized gains and losses on AFS securities are included as a component of accumulated other comprehensive income in the balance sheets and statements of stockholders’ equity and a component of total comprehensive loss in the statements of comprehensive loss. An AFS security may be impaired if its fair value is less than amortized cost. Unrealized losses are evaluated to determine if the impairment is credit-related or non-credit-related. Credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings, and a non-credit-related impairment is recognized in other comprehensive loss. For certain types of securities, such as U.S. Treasuries, the Company generally expects zero credit losses. No allowance for credit losses was recorded on its securities portfolio as of September 30, 2024 or December 31, 2023.

Fair Value

The Company follows the provisions of Financial Accounting Standards Board (the "FASB") Accounting Standards Codification ("ASC") Topic 820-10, Fair Value Measurements and Disclosures ("ASC 820-10"), which defines fair value, establishes a framework for measuring fair value in GAAP and requires certain disclosures about fair value measurements. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.

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As a basis for considering such assumptions, ASC 820-10 established a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value as follows: Level 1 observable inputs such as quoted prices in active markets; Level 2 inputs, other than quoted prices in active markets, that are observable either directly or indirectly; and Level 3 unobservable inputs for which there are little or no market data, which require the Company to develop its own assumptions. The hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value (See Note 5).

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make significant estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during reporting periods. Actual results could differ from those estimates.

Recent Accounting Pronouncements

Accounting Standards Updates ("ASUs") issued by the FASB are evaluated for their applicability. ASUs not included in the disclosures in this report were assessed and determined to be either not applicable or not expected to have a material impact on our financial statements.

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires enhanced disclosures on both an annual and interim basis about significant segment expenses, including for companies with only one reportable segment. This ASU is effective on a retrospective basis for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact of the adoption of this standard on the Company’s Financial Statements and disclosures.

In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosures of specific categories in the rate reconciliation, additional information for reconciling items that meet a quantitative threshold and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of this standard on the Company’s Financial Statements and disclosures.


 
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2.     Net Loss Per Common Share
 
Basic and diluted net loss per common share were as follows:
Quarters Ended September 30,Nine Months Ended September 30,
2024202320242023
Net loss applicable to common stockholders$(1,508,226)$(1,768,737)$(6,025,732)$(4,879,940)
Weighted average number of common shares outstanding, basic and diluted2,023,280 1,065,003 1,945,995 1,004,339 
Net loss per common share applicable to common stockholders, basic and diluted$(0.75)$(1.66)$(3.10)$(4.86)

Shares underlying the following potentially dilutive weighted average number of common stock equivalents were excluded from the calculation of diluted net loss per common share because their effect was anti-dilutive for each of the periods presented: 
September 30,
 20242023
Options62,898 65,037 
Unvested restricted stock awards1,597 7,662 
Unvested restricted stock units92,991 37,706 
Convertible preferred stock8 8 
Total157,494 110,413 

3. Securities

The Company's marketable debt securities are classified as either HTM or AFS pursuant to ASC 320 - Investments - Debt Securities. HTM securities are valued at amortized cost. The following table summarizes the valuations and unrealized gains and losses of AFS securities which are recorded at estimated fair value as of September 30, 2024 and December 31, 2023. The Company held no HTM securities as of September 30, 2024 and December 31, 2023.
    
 September 30, 2024
Gross Unrealized
Available-for-sale securities Cost GainsLossesCredit LossesEstimated Fair Value
U.S. government bonds$13,829,227 $84,435 $(582)$— $13,913,080 


 December 31, 2023
Gross Unrealized
Available-for-sale securities Cost GainsLossesCredit LossesEstimated Fair Value
U.S. government bonds$4,412,935 $5,665 $— $— $4,418,600 
Commercial paper11,612,099 234,506 — — $11,846,605 
Total $16,025,034 $240,171 $— $— $16,265,205 


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The Company evaluates all HTM and AFS securities for impairment at each reporting period. It determined that changes in the fair value of its securities at September 30, 2024 resulted primarily from interest rate fluctuations subsequent to the purchase date of the securities. There was no deterioration in the credit worthiness of the issuers and no credit losses were recorded as of September 30, 2024.

4. Fair Value Measurements

The following tables set forth the Company’s financial instruments that were measured at fair value:

 September 30, 2024
Total Level 1Level 2Level 3
Assets:
Money market funds$666,939 $666,939 $— $— 
U.S. government bonds13,913,080 13,913,080 — — 
Total $14,580,019 $14,580,019 $— $— 

 December 31, 2023
Total Level 1Level 2Level 3
Assets:
Money market funds$1,284,290 $1,284,290 $— $— 
U.S. government bonds4,418,600 4,418,600 — — 
Commercial paper11,846,605 — 11,846,605 — 
Total $17,549,495 $5,702,890 $11,846,605 $— 

The Company's accounts receivable, accounts payable, and accrued expenses are valued at cost which approximates fair value.

5.     Inventories
 
Inventories consist of the following: 

 September 30, 2024December 31, 2023
Purchased components$1,130,180 $1,151,381 
Finished goods299,943 408,047 
 $1,430,122 $1,559,428 

The Company recorded a charge of $74,209 in the nine months ended September 30, 2024 to write down the value of its discontinued ADVANCE inventory within cost of revenues on the Company's statements of operations. The Company also recorded a charge of $63,420 in the nine months ended September 30, 2023 to reduce the carrying value of inventory to net realizable value.

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6.     Accrued Expenses and Compensation
  
Accrued expenses and compensation consist of the following:
 September 30, 2024December 31, 2023
Professional services$376,840 $298,534 
Compensation99,312 346,245 
Severance54,000 — 
Clinical 39,782 39,000 
Warranty 8,000 9,400 
Sales tax 130,308 141,672 
Other11,367 41,888 
 $719,609 $876,739 
During the nine months ended September 30, 2024, the Company recorded severance costs of approximately $580,000 of which approximately $54,000 remained unpaid as of September 30, 2024. See Note 10 - Employee Headcount Reduction.

7.     Operating Leases
 
The Company's lease on its Woburn, Massachusetts corporate office and manufacturing facilities extends through mid-September 2025 at a monthly base rent of $13,846 and with a 5-year extension option.

Future minimum lease payments under this non-cancellable operating lease as of September 30, 2024 are as follows:
2024$41,446 
2025117,431 
Total minimum lease payments$158,877 
Interest, based on a 15% discount rate
$16,256 
Lease obligation, current portion142,621 
$158,877 

Total recorded rent expense was $50,377 and $49,232, for the quarters ended September 30, 2024 and 2023, respectively. Total recorded rent expense was $151,132 and $147,696 for the nine month periods ended September 30, 2024 and 2023, respectively. The Company records rent expense on its facility lease on a straight-line basis over the lease term. The remaining operating lease term was 11.5 months as of September 30, 2024.

8.     Stockholders’ Equity
 
Preferred stock and convertible preferred stock consist of the following: 
 September 30, 2024December 31, 2023
Preferred stock, $0.001 par value; 5,000,000 shares authorized at September 30, 2024 and December 31, 2023; no shares issued and outstanding at September 30, 2024 and December 31, 2023
$— $— 
Series B convertible preferred stock, $0.001 par value; 147,000 shares designated at September 30, 2024 and December 31, 2023; 200 shares issued and outstanding at September 30, 2024 and December 31, 2023
$1 $1 

2024 equity activity

In the first quarter of 2024, the Company issued 458,380 shares of its common stock, under its at-the-market ("ATM") program and realized net proceeds of $1,471,099. As of April 18, 2024, the Company terminated its ATM program.

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In March 2024, 1,015 unvested restricted stock awards and 5,912 unvested restricted stock units were forfeited due to the employee reduction described in Note 10.

In June 2024, the Company issued 850 shares of fully vested common stock with a value of $2,601 pursuant to the Company's Employee Stock Purchase Plan.

In the quarter ended June 30, 2024, the Company issued 91,577 restricted stock units under its 2022 Equity Incentive Plan with a value of $376,027.

As of September 30, 2024, the Company had outstanding 1,597 unvested restricted stock awards and 92,991 unvested restricted stock units. At December 31, 2023 the Company had outstanding 6,222 unvested restricted stock awards and 60,492 unvested restricted stock units.

2023 equity activity

In May 2023, the Company issued 1,563 restricted stock units under its 2022 Equity Incentive Plan with a value of $12,625.

In June 2023, the Company issued 90,661 shares of its common stock under its ATM program and realized net proceeds of $691,405. It also issued 1,316 shares of fully vested common stock with a value of $8,715 pursuant to the Company's Employee Stock Purchase Plan.

In July 2023, the Company issued 1,470 shares of its common stock, under ATM program for net proceeds of $1,426 and issued 24,500 restricted stock units under its 2004 Stock Option Plan with a value of $22,883.

In August 2023, the Company issued 172,660 restricted stock units with a value of $240,000 as long term incentives to its directors under its 2022 Equity Incentive Plan.
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9.     Employee Headcount Reduction

The Company incurred severance charges related to a reduction of 10 full time employees in the first quarter of 2024. This reduction was implemented in order to better align staffing with work responsibilities and to reduce operating expenses. Total severance related charges of approximately $580,000 were recorded in the quarter ended March 31, 2024 and cash payments of approximately $25,000 were made at that time. During the quarter ended June 30, 2024 and September 30, 2024, additional severance payments of approximately $334,000 and $167,000, respectively, were made and the remaining accrued severance obligation was approximately $54,000 which will be paid during the remainder of 2024 in accordance with employee contractual agreements.

The following table sets forth the quarterly activity in accrued severance.

Nine months ended September 30, 2024
Severance
Beginning balance$— 
Additions 580,427 
Amounts paid out (25,427)
Balance, March 31, 2024555,000 
Amounts paid out (334,000)
Balance, June 30, 2024221,000 
Amounts paid out(167,000)
Balance, September 30, 2024$54,000 

Within the Company's Statements of Operations for the nine months ended September 30, 2024, total severance charges of $580,427 were recorded in the first quarter as follows: $310,200 within research and development, $234,527 within sales and marketing, $4,200 within general and administrative and $31,500 within cost of revenues.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
 
You should read the following discussion of our financial condition and results of operations in conjunction with our financial statements and the accompanying notes to those financial statements included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements that involve risks and uncertainties. For a description of factors that may cause our actual results to differ materially from those anticipated in these forward-looking statements, please refer to the below section of this Quarterly Report on Form 10-Q titled “Cautionary Note Regarding Forward-Looking Statements.” Unless the context otherwise requires, all references to “we”, “us”, the “Company”, or “NeuroMetrix” in this Quarterly Report on Form 10-Q refer to NeuroMetrix, Inc.


Business Overview

NeuroMetrix is a commercial stage neurotechnology company based in Woburn, Massachusetts. The Company’s mission is to improve individual and population health through innovative medical devices and technology solutions for pain syndromes and neurological disorders. Our core expertise in biomedical engineering has been refined over two decades of designing, building and marketing medical devices that stimulate nerves and analyze nerve response for diagnostic and therapeutic purposes. We are fully integrated with in-house capabilities spanning research and development, manufacturing, regulatory affairs and compliance, sales and marketing, product fulfillment and customer support. We hold extensive, proprietary intellectual property.

NeuroMetrix created the market for point-of-care nerve testing and introduced sophisticated wearable technology for chronic pain syndromes. Nearly five million patients have been served with our products. Revenue is derived from the sale of medical devices, after-market consumable products and accessories in the United States and select overseas markets. Products
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are authorized by the U.S. Food and Drug Administration ("FDA") and regulators in foreign jurisdictions where appropriate. We have two principal product categories:

•Therapeutic technology – wearable neuromodulation for chronic pain syndromes
•Diagnostic technology - point-of-care peripheral neuropathy assessment

Chronic pain is a significant public health problem. It is defined by the National Institutes of Health (the "NIH") as pain lasting more than 12 weeks. This contrasts with acute pain which is a normal bodily response to injury or trauma. Chronic pain conditions include low back pain, arthritis, fibromyalgia, neuropathic pain, and cancer pain, among many others. Chronic pain
may be triggered by an injury or there may be an ongoing cause such as disease or illness. There may also be no clear cause. Chronic pain can also lead to other health problems including fatigue, sleep disturbance and mood changes, which cause difficulty in carrying out important activities and contribute to disability and despair. In general, chronic pain cannot be cured. Treatment of chronic pain is focused on reducing pain and improving function. The goal is effective pain management.

Chronic pain affects nearly 100 million adults in the United States and more than 1.5 billion people worldwide. The estimated incremental impact of chronic pain on health care costs in the United States is over $250 billion per year, and lost productivity is estimated to exceed $300 billion per year. The most common approach to chronic pain management is pain medication. This includes over-the-counter internal and external analgesics as well as prescription pain medications, both non-opioid and opioids. The approach to treatment is individualized, drug combinations may be employed, and the results are often inadequate. Side effects, including the potential for addiction, are substantial. Reflecting the complexity of chronic pain and the difficulty in treating it, we believe that inadequate relief leads 25% to 50% of pain sufferers to seek alternatives to prescription pain medications. These alternatives include nutraceuticals, acupuncture, chiropractic care, non-prescription analgesics, electrical stimulators, braces, sleeves, pads and other items. In total, these pain relief products and services account for approximately $20 billion in annual out-of-pocket spending in the United States.

Nerve stimulation is a long-established category of treatment for chronic pain. This treatment approach is available through implantable devices which have both surgical and ongoing risks, such as migration of the implanted nerve stimulation leads. Non-invasive approaches involving transcutaneous electrical nerve stimulation ("TENS") have achieved limited efficacy in practice due to power limitations, inadequate dosing and low patient adherence. We believe that our Quell wearable technology for chronic pain is designed to address many of the limitations of traditional TENS.

Peripheral neuropathies, or polyneuropathies, are diseases of the peripheral nerves. They affect about 10% of adults in the United States, with the prevalence rising to over 30% among individuals 65 years and older. Peripheral neuropathies are associated with loss of sensation, pain, increased risk of falling, weakness, and other complications. People with peripheral neuropathies have a diminished quality of life, poor overall health and higher mortality. The most common specific cause of peripheral neuropathies, accounting for about one-third of cases, is diabetes. Diabetes is a worldwide epidemic with an estimated affected population of over 400 million people. Within the United States there are over 30 million people with diabetes and another 80 million with pre-diabetes. The annual direct cost of treating diabetes in the United States exceeds $100 billion. Although there are dangerous acute manifestations of diabetes, the primary burden of the disease is in its long-term complications, which include cardiovascular disease, nerve disease and resulting conditions such as foot ulcers which may require amputation, eye disease leading to blindness, and kidney failure. The most common long-term complication of diabetes, affecting over 50% of the diabetic population, is peripheral neuropathy. Diabetic peripheral neuropathy ("DPN") is the primary trigger for diabetic foot ulcers which may progress to the point of requiring amputation. People with diabetes have a 15 to 25% lifetime risk of foot ulcers and approximately 15% of foot ulcers lead to amputation. Foot ulcers are the most expensive complication of diabetes with a typical cost of $5,000 to $50,000 per episode. In addition, between 16% and 26% of people with diabetes suffer from chronic pain in their feet and lower legs.

Early detection of peripheral neuropathies, such as DPN, is important because there are no treatment options once the nerves have degenerated. Currently available diagnostic methods for peripheral neuropathies range from a simple monofilament test for lack of sensory perception in the feet to a nerve conduction study performed by a specialist. Our DPNCheck nerve conduction technology provides a rapid, low cost, quantitative test for peripheral neuropathies, including DPN. It addresses an important medical need and is particularly effective in screening large populations. DPNCheck has been validated in multiple clinical studies.

Business Strategy

Our leading commercial products, and the focus of our strategic attention, are Quell and DPNCheck.
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Quell is our wearable neuromodulation technology for chronic pain. It has been refined over the past seven years with feedback from over 200,000 chronic pain patients and is protected by over 20 U.S. utility patents. Patients control and personalize the technology with a mobile phone app, and their utilization of the devices and certain clinical metrics may be tracked in the Quell Health Cloud. The degree of technological sophistication, combined with our extensive consumer experience and the compelling results of clinical studies, gives us the opportunity to leverage this technology base into a portfolio of Quell-based prescription ("Rx") wearable neurotherapeutics.

Quell received Breakthrough Device Designation from the FDA for a fibromyalgia indication in 2021 leading to the FDA granting a De Novo marketing authorization for the use of Quell as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. This Rx product was introduced to the domestic market in late 2022 under a controlled, strategic commercial launch with the objectives to develop an effective Rx fulfillment process, identify the higher-potential market sectors and an efficient marketing approach, and implement a cost-effective sales model. This led to the engagement of Health Warehouse as our on-line pharmacy, the introduction of a telemedicine option to facilitate patient prescriptions, higher electrode refill pricing, a focus on Veterans Administration patients and a shift to variable cost contractor sales versus an employee sales force. Many of these commercial efforts are being implemented. The Company is considering the reactivation of its promotion of Quell OTC for lower extremity chronic pain during the fourth quarter of 2024 or early 2025.

Quell also received FDA Breakthrough Device Designation in early 2022 for the treatment of chronic Chemotherapy Induced Peripheral Neuropathy ("CIPN"). A CIPN double-blind, randomized, sham-controlled clinical study employing Quell, funded by the National Cancer Institute and the NIH, was completed in 2023. A 510(k) marketing application was submitted to FDA in late 2023; however, after evaluating the unique characteristics of the oncology market, the Company decided to follow the De Novo model that was used for Quell-fibromyalgia. A De Novo application for marketing Quell-CIPN to patients with moderate to severe neuropathic pain and cramps is planned for filing in late 2024 or early 2025. This would be the second product in our emerging portfolio of Quell-based Rx wearable therapeutics. We anticipate a similar approach to other disease indications involving chronic pain. These potentially include Fibromyalgia-like Long COVID, Chronic Low Back Pain, and Chronic Overlapping Pain Conditions.

DPNCheck is our well-established testing technology for peripheral neuropathies. This technology has been evaluated in multiple clinical studies and promoted both in the domestic Medicare Advantage ("MA") market and also in the Asian markets of Japan and China. MA has historically contributed the majority of DPNCheck revenue and been the driver of product-line growth.

During 2023, the Centers for Medicare and Medicaid ("CMS") implemented significant changes to its MA Hierarchical Condition Categories ("HCC") risk adjustment payments and to its MA Risk Adjustment Data Validation ("RADV") audit practices. The changes to HCC risk factor coding significantly reduced CMS payments for population screening for various conditions, including for neuropathy, and resulted in a significant reduction in our DPNCheck sales. As a result, we have reduced our commercial sales team while continuing to support our customer base and attract new accounts. It is unlikely that there will be a near-term recovery from the decline in revenue of the DPNCheck MA business. DPNCheck sales in Asian markets are not affected by the reimbursement changes in MA.

Production and marketing of ADVANCE, a legacy, point-of-care neurodiagnostic technology primarily used for the diagnosis and screening for carpal tunnel syndrome, was discontinued in 2012. Our support to an eroding customer base of ADVANCE was terminated on July 31, 2024.

Strategy Review

The Company has initiated a review of its strategic options to promote growth of Quell and DPNCheck and to maximize shareholder value. The review covers a wide range of options including potential changes in marketing strategies, the acquisition of new assets, potential sale of Company assets, and a merger or other strategic transaction. A timetable for completion of this process has not been set and the Company will continue to promote its commercial operations while the review is being conducted. The Company has utilized outside professional services in conducting its review, expanded its Board of Directors, curtailed its equity offerings, and implemented a reduction-in-force to reduce its operating costs. As of the date of this Quarterly Report on Form 10-Q, there have been no other material strategic transactions or decisions that would warrant disclosure.

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Results of Operations
 
Comparison of Quarters Ended September 30, 2024 and 2023
 
Quarter ended September 30,Increase (Decrease)
20242023Amount Percent
Revenues$587,314 $1,203,164 $(615,850)(51.2)%
Gross profit311,957 781,782 $(469,825)(60.1)%
–% of revenues
53.1 %65.0 %(11.9)%
Operating expenses2,054,005 2,742,680 $(688,675)(25.1)%
Other income, net233,822 192,161 $41,661 21.7 %
Net loss$(1,508,226)$(1,768,737)$(260,511)(14.7)%
Net loss per common share$(0.75)$(1.66)$(0.91)(54.8)%

Revenues

Revenues for the third quarter of 2024 decreased by $616 thousand or 51.2% from the third quarter of 2023. DPNCheck sales accounted for the majority of revenues in both quarters and were the primary contributor to the revenue decline in the third quarter of 2024. The DPNCheck sales decline was primarily attributable to adverse CMS reimbursement changes in the Medicare Advantage market initiated in 2023 and scheduled to be phased in over a three year period which have reduced patient screening by healthcare providers for various conditions, including neuropathy. International sales of DPNCheck also declined from the prior year quarter due to excess inventory at the Japan distributor. The Company believes this situation is transient, and these biosensor orders should resume in the first quarter of 2025. Quell sales made a small contribution to offsetting the DPNCheck sales reduction in the third quarter of 2024.

Gross Profit

Gross profit for the third quarter of 2024 decreased by $470 thousand or 60.1% from the third quarter of 2023. Gross profit reflected a 53.1% gross margin rate in comparison with 65.0% in the prior year quarter. The decline in revenue, particularly DPNCheck revenue, was the largest contributor to the reduction in gross profit. The gross profit rate contraction reflected reduced weighting by DPNCheck, the Company’s highest margin product line.

Operating Expenses

Operating expenses declined in the third quarter of 2024 by $689 thousand or 25.1% from the third quarter of 2023. The primary contributors were cost benefits from the reduction in employee headcount in the first quarter of 2024 partially offset by increased professional service fees related to the business strategy review. Research and development spending in the third quarter of 2024 of $300 thousand decreased by $293 thousand from 2023 due primarily to a reduction in personnel costs of $275 thousand. Sales and marketing spending of $441 thousand decreased by $503 thousand from 2023 due primarily to a reduction of personnel costs of $374 thousand from 2023. General and administrative costs of $1.3 million increased by $107 thousand from 2023 reflecting higher professional fees of $122 thousand largely attributable to the business strategy review (legal and banking fees).

Net loss

The net loss in the third quarter of 2024 of $1.5 million decreased by $261 thousand from the third quarter of 2023. Net loss per common share was ($0.75) versus ($1.66) per common share in the third quarter of 2024. Per share amounts reflect 2.0 million shares outstanding in the third quarter of 2024 versus 1.1 million shares outstanding in the third quarter of 2023.

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Comparison of Nine Months Ended September 30, 2024 and 2023
  
Nine months ended September 30,Increase (Decrease)
20242023Amount Percent
Revenues$2,450,018 $4,583,679 $(2,133,661)(46.5)%
Gross profit$1,320,893 $3,099,439 $(1,778,546)(57.4)%
–% of revenues
53.9 %67.6 %(13.7)%
Operating expenses$8,145,587 $8,393,861 $(248,274)(3.0)%
Other income, net$798,962 $414,482 $384,480 92.8 %
Net loss$(6,025,732)$(4,879,940)$1,145,792 23.5 %
Net loss per common share$(3.10)$(4.86)$(1.76)(36.2)%

Revenues

Revenues for the nine months ended September 30, 2024 decreased by $2.1 million or 46.5% compared to the nine months ended September 30, 2023. DPNCheck sales, primarily focused on MA, accounted for the majority of revenues in both quarters and the decline in DPNCheck sales was the primary contributor to the revenue decrease.

Gross Profit

Gross profit for the nine months ended September 30, 2024 decreased by $1.8 million or 57.4% compared to the nine months ended September 30, 2023. The decline in revenue, particularly DPNCheck revenue, was the largest contributor to the reduction in gross profit.

Operating Expenses

Operating expenses for the nine months ended September 30, 2024 decreased by $248 thousand or 3.0% compared to the nine months ended September 30, 2023. Increased general and administrative spending of $854 thousand was offset by reduced research and development spending of $535 thousand and reduced sales and marketing spending of $567 thousand. Higher general and administrative spending was largely attributable to costs associated with the strategic review process.

Net loss

The net loss for the nine months ended September 30, 2024 increased by $1.1 million compared to 2023. Net loss per common share was ($3.10) in the nine months ended September 30, 2024 versus ($4.86) per common share in 2023. The increase in the number of common shares outstanding in the nine months ended September 30, 2024 (2.0 million) versus common shares outstanding in the nine months ended September 30, 2023 (1.0 million) offset the effect of a greater net loss in the current year period.

16




Liquidity and Capital Resources
 
September 30, December 31,
202420232023
 
Cash, cash equivalents and marketable securities$14,834,600 $17,637,675 $17,997,151 
Working capital $15,585,819 $19,445,277 $19,613,803 
Current ratio13.9 16.4 16.8 
Net debt position$(13,624,729)$(16,254,439)$(16,664,027)
Days sales outstanding32.9 50.9 35.6 
Inventory turnover0.8 1.0 1.2 

Our primary sources of liquidity are cash and cash equivalents, securities, revenues from the sales of our products, and net proceeds from equity sales. Our expected cash outlays relate to funding operations. We believe that our resources are sufficient to fund our cash requirements over at least the next twelve months from the date of issuance of the financial statements. As indicated above, we have initiated a review of our strategic options to maximize shareholder value. These options include changes in marketing strategies, the acquisition of new assets, potential sale of Company assets, and a merger or other strategic transaction, which could affect our future liquidity.

As of September 30, 2024, we had working capital of $15.6 million, including $14.8 million in cash, cash equivalents and marketable securities, and a current ratio of 13.9. We had no term debt or borrowings. Net debt, defined as short and long-term debts, less cash, cash equivalents and securities, continues to be negative.

Days sales outstanding ("DSO") reflect our customer payment terms which vary from payment on order to 60 days from shipment date. The decrease in DSO in 2024 in comparison with the prior year reflects a greater weighting during 2024 of cash sales as compared to credit sales. Inventory turnover rate declined during the quarter ended September 30, 2024 due to the lower DPNCheck sales.

Cash Flows
Nine months ended September 30,
 20242023Change
 
Net cash provided by (used in):
Operating activities
$(5,238,316)$(4,634,367)$(603,949)
Investing activities
2,954,190 1,058,354 1,895,836 
Financing activities
1,473,700 701,546 772,154 
Net change in cash and cash equivalents$(810,426)$(2,874,467)

Operating activities
Cash used in operating activities in the nine months ended September 30, 2024 increased by $604 thousand from the comparable period in 2023. This primarily reflects the increased net loss in the period.




Investing activities

Investing activities in the nine months ended September 30, 2024 reflect $29.0 million in purchases of AFS securities offset by proceeds from maturity of AFS securities of $32.0 million. During the comparable period in 2023, investing activities reflected $22.9 million in purchases of AFS securities offset by proceeds from maturity of AFS and HTM securities of $24.1
17




million. The differences in investing activities between the two periods are due to variations in duration and maturity of individual securities in the Company’s securities portfolio as well as shifts in portfolio assets to fund operating activities.

Financing activities

Equity sales in the nine months ended September 30, 2024 and 2023 contributed $1.5 million and $701 thousand, respectively. Shares of our common stock were sold to investors pursuant to the Company's at-the-market facility which was terminated during the second quarter of 2024.



18





Cautionary Note Regarding Forward-Looking Statements
 
The statements contained in this Quarterly Report on Form 10-Q, including under the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other sections of this Quarterly Report, include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), including, without limitation, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future, such as our estimates regarding anticipated operating losses, future revenues and projected expenses, our future liquidity and our expectations regarding our needs for and ability to raise additional capital; our plan to pursue strategic alternatives to maximize shareholder value and the outcome of such pursuant; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; our ability to manage our expenses effectively and raise the funds needed to continue our business; our belief that there are unmet needs and our estimates regarding the addressable market for the management of chronic pain and in the diagnosis and treatment of diabetic neuropathy; our expectations surrounding our commercialized neurostimulation and neuropathy diagnostic products; our expected timing and our plans to develop and commercialize our products; our ability to meet our proposed timelines for the commercial availability of our products; our ability to obtain and maintain regulatory approval of our existing products and any future products we may develop; regulatory and legislative developments in the United States and foreign countries; the performance of our third-party manufacturers; our ability to obtain and maintain intellectual property protection for our products; the successful development of our sales and marketing capabilities; the size and growth of the potential markets for our products and our ability to serve those markets; our estimate of our customer returns of our products; the rate and degree of market acceptance of any future products; our reliance on key scientific management or personnel; the payment and reimbursement methods used by private or government third party payers; and other factors discussed elsewhere in this Quarterly Report on Form 10-Q. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements contained in this quarterly report are based on our current expectations and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in the section titled “Risk Factors” in our Annual Report on Form 10-K. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
 
Item 3. Quantitative and Qualitative Disclosures About Market Risk
 
We do not use derivative financial instruments in our investment portfolio and have no foreign exchange contracts. Our financial instruments consist of cash and cash equivalents and available for sale debt securities. We consider investments that, when purchased, have a remaining maturity of 90 days or less to be cash equivalents. The primary objectives of our investment strategy are to preserve principal, maintain proper liquidity to meet operating needs, and maximize yields. To minimize our exposure to an adverse shift in interest rates, we invest mainly in cash equivalents and investments with a maturity of twelve months or less and we maintain an average maturity of twelve months or less. We do not believe that a notional or hypothetical 10% change in interest rate percentages would have a material impact on the fair value of our investment portfolio or our interest income.
 
19




Item 4. Controls and Procedures
 
(a) Evaluation of Disclosure Controls and Procedures. Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of September 30, 2024, have concluded that, based on such evaluation, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
 
(b) Changes in Internal Controls. There were no changes in our internal control over financial reporting identified in connection with the evaluation of such internal control that occurred during the quarter ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
.

20




PART II – OTHER INFORMATION
 
Item 1. Legal Proceedings
 
While we are not currently a party to any material legal proceedings, we could become subject to legal proceedings in the ordinary course of business. We are not aware of and do not expect any such potential issues. However, should they occur, we would not expect them to have a significant impact on our financial position.
 
Item 1A. Risk Factors
 
Please refer to the complete Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (the “SEC”) on March 1, 2024, and to Item 1A of the Company's Quarterly Report on Form 10-Q, for the quarter ended March 31, 2024, filed with the SEC on May 15, 2024, for risks and uncertainties facing the Company that may have a material adverse effect on the Company’s business prospects, financial condition and results of operations. As of September 30, 2024, the risk factors of the Company have not changed materially from those disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2024.

Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds
None.

Item 3.    Defaults Upon Senior Securities
 
None. 

Item 4.    Mine Safety Disclosures
 
Not applicable. 

Item 5.    Other Information

 During the third quarter of 2024, none of our directors or executive officers adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c), and none of our directors or executive officers adopted or terminated a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K).
21




Item 6.    Exhibits

Exhibit No. Description
 Certification of Principal Executive Officer Under Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended, and pursuant to Section 302(a) of the Sarbanes-Oxley Act of 2002. Filed herewith.
   
 Certification of Principal Financial Officer Required Under Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended, and pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith.
   
 Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350. Furnished herewith.
101.INSInline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document). Filed herewith.
101.SCHInline XBRL Taxonomy Extension Schema Document. Filed herewith.
101.CALInline XBRL Taxonomy Extension Calculation Linkbase Document. Filed herewith.
101.DEFInline XBRL Taxonomy Extension Definition Linkbase Document. Filed herewith.
101.LABInline XBRL Taxonomy Extension Label Linkbase Document. Filed herewith.
101.PREInline XBRL Taxonomy Extension Presentation Linkbase Document. Filed herewith.
104Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101). Filed herewith.
22



SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
  NEUROMETRIX, INC.
  
November 5, 2024/s/SHAI N. GOZANI, M.D., PH. D.
  Shai N. Gozani, M.D., Ph. D.
  Chairman, President and Chief Executive Officer
  
November 5, 2024/s/THOMAS T. HIGGINS
  Thomas T. Higgins
  Senior Vice President, Chief Financial Officer and Treasurer
 
23

EXHIBIT 31.1
 
CERTIFICATION
 
I, Shai N. Gozani, M.D., Ph.D., certify that:
 
1.I have reviewed this Quarterly Report on Form 10-Q of NeuroMetrix, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
a)all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
b)any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
 


Date:November 5, 2024/s/ SHAI N. GOZANI, M.D., PH. D.
 Shai N. Gozani, M.D., Ph.D.
 Chairman, President and Chief Executive Officer


EXHIBIT 31.2
 
CERTIFICATION
 
I, Thomas T. Higgins, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of NeuroMetrix, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
a)all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
b)any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
 



Date:November 5, 2024/s/ THOMAS T. HIGGINS
 Thomas T. Higgins
 Senior Vice President, Chief Financial Officer and Treasurer


EXHIBIT 32
 
CERTIFICATION
 
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of NeuroMetrix, Inc., a Delaware corporation (the "Company"), does hereby certify, to such officer's knowledge, that:
 
The Quarterly Report for the quarter ended September 30, 2024 (the "Form 10-Q") of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
 /s/ SHAI N. GOZANI, M.D., PH. D.
 Shai N. Gozani, M.D., Ph.D.
 Chairman, President and Chief Executive Officer
  
  
 /s/ THOMAS T. HIGGINS
 Thomas T. Higgins
 Senior Vice President, Chief Financial Officer and Treasurer
  
November 5, 2024
  
This certification is being furnished and not filed, and shall not be incorporated into any document for any purpose, under the Securities Exchange Act of 1934 or the Securities Act of 1933.

v3.24.3
Document And Entity Information - shares
 9 Months Ended
Sep. 30, 2024
Nov. 04, 2024
Document Information [Line Items]    
Entity Central Index Key 0001289850  
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2024  
Document Fiscal Period Focus Q3  
Amendment Flag false  
Entity Common Stock, Shares Outstanding   2,042,689
Entity Emerging Growth Company false  
Entity Shell Company false  
Document Type 10-Q  
Entity Current Reporting Status Yes  
Entity Small Business true  
Entity Interactive Data Current Yes  
Document Quarterly Report true  
Document Period End Date Sep. 30, 2024  
Document Transition Report false  
Entity File Number 001-33351  
Entity Registrant Name NEUROMETRIX, INC.  
Entity Incorporation, State or Country Code DE  
Entity Address, Postal Zip Code 01801  
Local Phone Number 890-9989  
Entity Filer Category Non-accelerated Filer  
Entity Tax Identification Number 04-3308180  
Entity Address, Address Line One 4B Gill Street  
Entity Address, City or Town Woburn  
Entity Address, State or Province MA  
City Area Code 781  
Stockholders' Equity, Reverse Stock Split All share amounts in the Quarterly Report on Form 10-Q have been adjusted to reflect a 1-for-8 reverse stock split that was effected on November 21, 2023.  
Common Stock [Member]    
Document Information [Line Items]    
Security Exchange Name NASDAQ  
Trading Symbol NURO  
Title of 12(b) Security Common Stock, $0.0001 par value per share  
Preferred Stock    
Document Information [Line Items]    
Title of 12(b) Security Preferred Stock Purchase Rights  
v3.24.3
Balance Sheets - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Current assets:    
Cash and cash equivalents $ 921,520 $ 1,731,946
Debt Securities, Available-for-Sale 13,913,080 16,265,205
Accounts receivable, net 149,092 518,824
Inventories 1,430,122 1,559,428
Prepaid expenses and other current assets 381,876 779,039
Total current assets 16,795,690 20,854,442
Fixed assets, net 219,106 293,449
Operating Lease, Right-of-Use Asset 147,824 250,150
Other Assets, Noncurrent 26,400 26,400
Total assets 17,189,020 21,424,441
Current liabilities:    
Accounts payable 347,641 215,509
Accrued expenses and compensation 719,609 876,739
Operating Lease, Liability, Current 142,621 148,391
Total current liabilities 1,209,871 1,240,639
Operating Lease, Liability, Noncurrent 0 92,485
Total liabilities 1,209,871 1,333,124
Commitments and contingencies
Stockholders’ equity:    
Common Stock, Value, Issued 203 152
Additional paid-in capital 232,030,177 229,960,346
Accumulated Other Comprehensive Income (Loss), Net of Tax 83,853 240,171
Accumulated deficit (216,135,085) (210,109,353)
Total stockholders’ equity 15,979,149 20,091,317
Total liabilities and stockholders’ equity $ 17,189,020 $ 21,424,441
Common Stock, Par or Stated Value Per Share $ 0.0001 $ 0.0001
Common Stock, Shares Authorized 25,000,000 25,000,000
Common Stock, Shares, Issued 2,033,306 1,524,939
Common Stock, Shares, Outstanding 2,033,306 1,524,939
Convertible preferred stock    
Stockholders’ equity:    
Preferred stock $ 1 $ 1
Preferred Non-Convertible Stock    
Stockholders’ equity:    
Preferred stock $ 0 $ 0
v3.24.3
Statements of Operations (Unaudited) - USD ($)
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Revenue from Contract with Customer, Including Assessed Tax $ 587,314 $ 1,203,164 $ 2,450,018 $ 4,583,679
Cost of revenues 275,357 421,382 1,129,125 1,484,240
Gross profit 311,957 781,782 1,320,893 3,099,439
Loss from operations (1,742,048) (1,960,898) (6,824,694) (5,294,422)
Investment Income, Interest 8,412 25,378 40,579 247,699
Other Nonoperating Income 225,410 166,783 758,383 166,783
Nonoperating Income (Expense), Total 233,822 192,161 798,962 414,482
Net loss $ (1,508,226) $ (1,768,737) $ (6,025,732) $ (4,879,940)
Earnings Per Share, Basic $ (0.75) $ (1.66) $ (3.10) $ (4.86)
Earnings Per Share, Diluted $ (0.75) $ (1.66) $ (3.10) $ (4.86)
Operating expenses:        
Research and development $ 299,739 $ 592,654 $ 1,510,223 $ 2,045,588
Sales and marketing 441,171 943,795 1,937,914 2,504,630
General and administrative 1,313,095 1,206,231 4,697,450 3,843,643
Total operating expenses $ 2,054,005 $ 2,742,680 $ 8,145,587 $ 8,393,861
v3.24.3
Statement of Comprehensive Income (Statement) - USD ($)
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Net Income (Loss) Attributable to Parent $ (1,508,226) $ (1,768,737) $ (6,025,732) $ (4,879,940)
Other Comprehensive Income Realized Gain Adjustment (225,410) (166,783) (758,383) (166,783)
Comprehensive Income (Loss), Net of Tax, Attributable to Parent (1,536,544) (1,730,589) (6,182,050) (4,673,071)
OCI, Debt Securities, Available-for-Sale, Unrealized Holding Gain (Loss), before Adjustment and Tax $ 197,092 $ 204,931 $ 602,065 $ 373,652
v3.24.3
Equity Rollforward Statement - USD ($)
Total
Additional Paid-in Capital [Member]
Retained Earnings [Member]
Preferred Stock
Convertible Preferred Stock [Member]
Common Stock [Member]
AOCI Attributable to Parent
Stockholders' Equity Attributable to Parent $ 23,355,687 $ 226,935,456 $ (203,579,866) $ 1 $ 96  
Shares, Outstanding       200.00 959,460  
APIC, Share-based Payment Arrangement, Increase for Cost Recognition 165,361 165,361        
Stock Issued During Period, Shares, Restricted Stock Award, Gross         2,439  
Other Comprehensive Income (Loss), Net of Tax 65,874         $ 65,874
Net Income (Loss) Attributable to Parent (1,574,174)   (1,574,174)      
Other Comprehensive Income Realized Gain Adjustment (166,783)          
Net Income (Loss) Attributable to Parent (4,879,940)          
Stockholders' Equity Attributable to Parent 22,012,748 227,100,817 (205,154,040) $ 1 $ 96 65,874
Shares, Outstanding       200.00 961,899  
APIC, Share-based Payment Arrangement, Increase for Cost Recognition 132,745 132,745        
Stock Issued During Period, Shares, New Issues         90,661  
Stock Issued During Period, Value, New Issues 691,405 691,396     $ 9  
Stock Issued During Period, Shares, Employee Stock Purchase Plans         1,316  
Stock Issued During Period, Value, Employee Stock Purchase Plan 8,713 8,713        
Stock Issued During Period, Value, Restricted Stock Award, Gross   (1)     $ 1  
Stock Issued During Period, Shares, Restricted Stock Award, Gross         9,015  
Other Comprehensive Income (Loss), Net of Tax 102,847         102,847
Net Income (Loss) Attributable to Parent (1,537,029)   (1,537,029)      
Stockholders' Equity Attributable to Parent 21,411,429 227,933,670 (206,691,069) $ 1 $ 106 168,721
Shares, Outstanding       200 1,062,891  
APIC, Share-based Payment Arrangement, Increase for Cost Recognition 221,268 221,268        
Stock Issued During Period, Shares, New Issues         184  
Stock Issued During Period, Value, New Issues 1,426 1,426        
Stock Issued During Period, Shares, Restricted Stock Award, Gross         2,820  
Other Comprehensive Income (Loss), Net of Tax 38,148         38,148
Other Comprehensive Income Realized Gain Adjustment (166,783)          
Net Income (Loss) Attributable to Parent (1,768,737)   (1,768,737)      
Stockholders' Equity Attributable to Parent 19,903,534 228,156,364 (208,459,806) $ 1 $ 106 206,869
Shares, Outstanding       200 1,065,895  
Stockholders' Equity Attributable to Parent 20,091,317 229,960,346 (210,109,353) $ 1 $ 152 240,171
Shares, Outstanding       200.00 1,518,717  
APIC, Share-based Payment Arrangement, Increase for Cost Recognition 216,164 216,164        
Stock Issued During Period, Shares, New Issues         458,380  
Stock Issued During Period, Value, New Issues 1,471,099 1,471,053     $ 46  
Stock Issued During Period, Value, Restricted Stock Award, Gross   (1)     $ 1  
Stock Issued During Period, Shares, Restricted Stock Award, Gross         6,699  
Other Comprehensive Income (Loss), Net of Tax 7,006         7,006
Net Income (Loss) Attributable to Parent (3,029,574)   (3,029,574)      
Other Comprehensive Income Realized Gain Adjustment (758,383)          
Net Income (Loss) Attributable to Parent (6,025,732)          
Stockholders' Equity Attributable to Parent 18,756,012 231,647,562 (213,138,927) $ 1 $ 199 247,177
Shares, Outstanding       200.00 1,983,796  
APIC, Share-based Payment Arrangement, Increase for Cost Recognition 176,148 176,148        
Stock Issued During Period, Shares, Employee Stock Purchase Plans         850  
Stock Issued During Period, Value, Employee Stock Purchase Plan 2,601 2,601        
Stock Issued During Period, Value, Restricted Stock Award, Gross   (3)     $ 3  
Stock Issued During Period, Shares, Restricted Stock Award, Gross         29,453  
Other Comprehensive Income (Loss), Net of Tax (135,006)         (135,006)
Net Income (Loss) Attributable to Parent (1,487,932)   (1,487,932)      
Stockholders' Equity Attributable to Parent 17,311,823 231,826,308 (214,626,859) $ 1 $ 202 112,171
Shares, Outstanding       200 2,014,099  
APIC, Share-based Payment Arrangement, Increase for Cost Recognition 203,870 203,870        
Stock Issued During Period, Value, Restricted Stock Award, Gross   (1)     $ 1  
Stock Issued During Period, Shares, Restricted Stock Award, Gross         17,610  
Other Comprehensive Income (Loss), Net of Tax (28,318)         (28,318)
Other Comprehensive Income Realized Gain Adjustment (225,410)          
Net Income (Loss) Attributable to Parent (1,508,226)   (1,508,226)      
Stockholders' Equity Attributable to Parent $ 15,979,149 $ 232,030,177 $ (216,135,085) $ 1 $ 203 $ 83,853
Shares, Outstanding       200 2,031,709  
v3.24.3
Statements of Cash Flows (Unaudited) - USD ($)
 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Dec. 31, 2022
Statement of Cash Flows [Abstract]        
Net Income (Loss), Including Portion Attributable to Noncontrolling Interest $ (6,025,732) $ (4,879,940)    
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation 74,343 30,957    
Operating Lease, Right-of-Use Asset, Periodic Reduction 102,326 58,087    
Stock-based compensation 596,182 519,374    
Inventory Charge Cost Of Revenues 74,209 63,420    
Investment Income, Net, Amortization of Discount and Premium 0 135,293    
Debt Securities, Available-for-Sale, Realized Gain (758,383) (166,783)    
Changes in operating assets and liabilities:        
Accounts receivable 369,732 32,390    
Inventories 55,097 (115,042)    
Prepaid expenses and other current and long-term assets 363,183 (200,118)    
Accounts payable 132,132 (142,608)    
Accrued expenses and compensation (157,130) 356,562    
Increase (Decrease) in Operating Lease Liability (64,275) (55,373)    
Net Cash Provided by (Used in) Operating Activities (5,238,316) (4,634,367)    
Cash flows from investing activities:        
Net Cash Provided by (Used in) Investing Activities 2,954,190 1,058,354    
Cash flows from financing activities:        
Net proceeds from issuance of stock and warrants 1,473,700 701,546    
Net Cash Provided by (Used in) Financing Activities 1,473,700 701,546    
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect (810,426) (2,874,467)    
Cash and cash equivalents, end of period 921,520      
Supplemental disclosure of cash flow information:        
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents 921,520 1,460,553 $ 1,731,946 $ 4,335,020
Payments to Acquire Debt Securities, Available-for-Sale (29,045,810) (22,898,470)    
Proceeds from Sale and Maturity of Debt Securities, Available-for-Sale 32,000,000 7,095,000    
Proceeds from Maturities, Prepayments and Calls of Held-to-Maturity Securities 0 17,000,000    
Payments to Acquire Property, Plant, and Equipment $ 0 $ (138,176)    
v3.24.3
Business and Basis of Presentation
 9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
Business and Basis of Presentation Business and Basis of Presentation
Our Business-An Overview
 
NeuroMetrix, Inc. (the "Company" or "NeuroMetrix") develops and commercializes health care products that utilize non-invasive neurostimulation. Revenues are derived from the sale of medical devices and after-market consumable products and accessories. The Company’s products are sold in the United States and select overseas markets. They are cleared by the U.S. Food and Drug Administration ("FDA") and regulators in foreign jurisdictions where appropriate. The Company has two primary products. DPNCheck® is a point-of-care test for diabetic peripheral neuropathy, which is the most common long-term complication of Type 2 diabetes. Quell is an app-enabled, wearable device for lower extremity chronic pain and for the symptoms of fibromyalgia.

The Company held cash, cash equivalents and investment grade securities totaling $14.8 million as of September 30, 2024. The Company believes that its present balance of cash resources and securities coupled with cash inflows from product sales will enable the Company to fund its operations for at least the next twelve months from the date of issuance of the financial statements. Actual cash requirements could differ from management's projections for many reasons, including changes the Company may make to its business strategy, commercial challenges, regulatory developments, changes to research and development programs, supply chain issues, staffing challenges and other items affecting the Company's projected uses of cash.

During February 2024, the Company announced that it would undertake a review of its strategic options to maximize shareholder value. These options include changes in marketing strategies, the acquisition of new assets, potential sale of Company assets, and a merger or other strategic transaction. This review process remains ongoing. A timetable for completion of this process has not been established, and even if certain strategic alternatives may be available, the Company cannot provide any assurance that the strategic alternatives review process will result in the successful realization of any particular alternative, transaction or value. Accordingly, the unaudited financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.

Unaudited Interim Financial Statements
 
The accompanying unaudited balance sheet as of September 30, 2024, unaudited statements of operations, statements of comprehensive loss, changes in stockholders' equity and cash flows for the quarters ended September 30, 2024 and 2023 have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. The accompanying balance sheet as of December 31, 2023 has been derived from the audited balance sheet as of December 31, 2023 included in the Company's Form 10-K referenced below and does not include all disclosures required by U.S. GAAP. In the opinion of management, the financial statements include all normal and recurring adjustments considered necessary for a fair presentation of the Company’s financial position and operating results. Operating results for the nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024 or any other period. These financial statements and notes should be read in conjunction with the financial statements for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the "SEC"), on March 1, 2024 (File No. 001-33351).

Prior period reclassification

Certain items in the Statements of Cash Flows from the prior year were reclassified to conform with the current presentation.
Revenues

Revenues include product sales, net of estimated returns. Revenue is measured as the amount of consideration the Company expects to receive in exchange for product transferred. Revenue is recognized at the point in time when contractual performance obligations have been satisfied and control of the product has been transferred to the customer. The Company has a single product delivery performance obligation. Accrued product returns using the most likely amount method are estimated based on historical data and evaluation of current information and variable consideration is not constrained. Revenue from product sales that occur via an online pharmacy agent are recognized on a gross basis and the related fulfillment fees are expensed within cost of revenues.

Accounts receivable are recorded in the amount the Company expects to collect, net of the allowance for credit losses. The allowance for credit losses is the Company’s best estimate of the amount of probable credit losses based on customer past payment history, product usage activity, and recent communications with the customer. Individual customer balances which are over 90 days past due are reviewed individually for collectability and written-off when recovery is not probable. The Company does not have any off-balance sheet credit exposure related to its customers. Allowance for credit losses was $25,000 as of September 30, 2024 and December 31, 2023.
 
Two customers accounted for 28% of total revenues in the quarter ended September 30, 2024 and two different customers accounted for 28% of total revenues in the quarter ended September 30, 2023. One customer accounted for 10% of total revenues for the nine months ended September 30, 2024 and two customers accounted for 26% of total revenues in the nine months ended September 30, 2023. Four customers accounted for 74% and three customers accounted for 74% of accounts receivable as of September 30, 2024 and December 31, 2023, respectively.

Cash and Cash Equivalents

Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in U.S. government securities.

Securities

The Company invests in highly liquid, marketable debt securities with high credit ratings and typically with maturities of two years or less. Individual securities are designated by the Company as either "held-to-maturity" ("HTM") or “available-for-sale” ("AFS") at the point of investment. Securities classified as short-term have maturities of less than one year. As of September 30, 2024, all marketable securities held by the Company are classified as AFS and had remaining contractual maturities of one year or less.

HTM securities are valued on an amortized cost basis and reviewed to determine if an allowance for credit losses should be recorded in the statements of operations. AFS securities are valued at fair value. Unrealized gains and losses on AFS securities are included as a component of accumulated other comprehensive income in the balance sheets and statements of stockholders’ equity and a component of total comprehensive loss in the statements of comprehensive loss. An AFS security may be impaired if its fair value is less than amortized cost. Unrealized losses are evaluated to determine if the impairment is credit-related or non-credit-related. Credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings, and a non-credit-related impairment is recognized in other comprehensive loss. For certain types of securities, such as U.S. Treasuries, the Company generally expects zero credit losses. No allowance for credit losses was recorded on its securities portfolio as of September 30, 2024 or December 31, 2023.

Fair Value

The Company follows the provisions of Financial Accounting Standards Board (the "FASB") Accounting Standards Codification ("ASC") Topic 820-10, Fair Value Measurements and Disclosures ("ASC 820-10"), which defines fair value, establishes a framework for measuring fair value in GAAP and requires certain disclosures about fair value measurements. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.
As a basis for considering such assumptions, ASC 820-10 established a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value as follows: Level 1 observable inputs such as quoted prices in active markets; Level 2 inputs, other than quoted prices in active markets, that are observable either directly or indirectly; and Level 3 unobservable inputs for which there are little or no market data, which require the Company to develop its own assumptions. The hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value (See Note 5).

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make significant estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during reporting periods. Actual results could differ from those estimates.

Recent Accounting Pronouncements

Accounting Standards Updates ("ASUs") issued by the FASB are evaluated for their applicability. ASUs not included in the disclosures in this report were assessed and determined to be either not applicable or not expected to have a material impact on our financial statements.

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires enhanced disclosures on both an annual and interim basis about significant segment expenses, including for companies with only one reportable segment. This ASU is effective on a retrospective basis for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact of the adoption of this standard on the Company’s Financial Statements and disclosures.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosures of specific categories in the rate reconciliation, additional information for reconciling items that meet a quantitative threshold and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of this standard on the Company’s Financial Statements and disclosures.
v3.24.3
Net Loss Per Common Share
 9 Months Ended
Sep. 30, 2024
Earnings Per Share [Abstract]  
Net Loss Per Common Share Net Loss Per Common Share
 
Basic and diluted net loss per common share were as follows:
Quarters Ended September 30,Nine Months Ended September 30,
2024202320242023
Net loss applicable to common stockholders$(1,508,226)$(1,768,737)$(6,025,732)$(4,879,940)
Weighted average number of common shares outstanding, basic and diluted2,023,280 1,065,003 1,945,995 1,004,339 
Net loss per common share applicable to common stockholders, basic and diluted$(0.75)$(1.66)$(3.10)$(4.86)

Shares underlying the following potentially dilutive weighted average number of common stock equivalents were excluded from the calculation of diluted net loss per common share because their effect was anti-dilutive for each of the periods presented: 
September 30,
 20242023
Options62,898 65,037 
Unvested restricted stock awards1,597 7,662 
Unvested restricted stock units92,991 37,706 
Convertible preferred stock8 8 
Total157,494 110,413 
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]
Quarters Ended September 30,Nine Months Ended September 30,
2024202320242023
Net loss applicable to common stockholders$(1,508,226)$(1,768,737)$(6,025,732)$(4,879,940)
Weighted average number of common shares outstanding, basic and diluted2,023,280 1,065,003 1,945,995 1,004,339 
Net loss per common share applicable to common stockholders, basic and diluted$(0.75)$(1.66)$(3.10)$(4.86)
v3.24.3
Investments, Debt and Equity Securities
 9 Months Ended
Sep. 30, 2024
Investments, Debt and Equity Securities [Abstract]  
Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure Securities
The Company's marketable debt securities are classified as either HTM or AFS pursuant to ASC 320 - Investments - Debt Securities. HTM securities are valued at amortized cost. The following table summarizes the valuations and unrealized gains and losses of AFS securities which are recorded at estimated fair value as of September 30, 2024 and December 31, 2023. The Company held no HTM securities as of September 30, 2024 and December 31, 2023.
    
 September 30, 2024
Gross Unrealized
Available-for-sale securities Cost GainsLossesCredit LossesEstimated Fair Value
U.S. government bonds$13,829,227 $84,435 $(582)$— $13,913,080 


 December 31, 2023
Gross Unrealized
Available-for-sale securities Cost GainsLossesCredit LossesEstimated Fair Value
U.S. government bonds$4,412,935 $5,665 $— $— $4,418,600 
Commercial paper11,612,099 234,506 — — $11,846,605 
Total $16,025,034 $240,171 $— $— $16,265,205 
The Company evaluates all HTM and AFS securities for impairment at each reporting period. It determined that changes in the fair value of its securities at September 30, 2024 resulted primarily from interest rate fluctuations subsequent to the purchase date of the securities. There was no deterioration in the credit worthiness of the issuers and no credit losses were recorded as of September 30, 2024.
v3.24.3
Fair Value Measurements
 9 Months Ended
Sep. 30, 2024
Fair Value Disclosures [Abstract]  
Fair Value Measurements Fair Value Measurements
The following tables set forth the Company’s financial instruments that were measured at fair value:

 September 30, 2024
Total Level 1Level 2Level 3
Assets:
Money market funds$666,939 $666,939 $— $— 
U.S. government bonds13,913,080 13,913,080 — — 
Total $14,580,019 $14,580,019 $— $— 

 December 31, 2023
Total Level 1Level 2Level 3
Assets:
Money market funds$1,284,290 $1,284,290 $— $— 
U.S. government bonds4,418,600 4,418,600 — — 
Commercial paper11,846,605 — 11,846,605 — 
Total $17,549,495 $5,702,890 $11,846,605 $— 
The Company's accounts receivable, accounts payable, and accrued expenses are valued at cost which approximates fair value.
v3.24.3
Inventories
 9 Months Ended
Sep. 30, 2024
Inventory Disclosure [Abstract]  
Inventories Inventories
 
Inventories consist of the following: 

 September 30, 2024December 31, 2023
Purchased components$1,130,180 $1,151,381 
Finished goods299,943 408,047 
 $1,430,122 $1,559,428 
The Company recorded a charge of $74,209 in the nine months ended September 30, 2024 to write down the value of its discontinued ADVANCE inventory within cost of revenues on the Company's statements of operations. The Company also recorded a charge of $63,420 in the nine months ended September 30, 2023 to reduce the carrying value of inventory to net realizable value.
Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure Securities
The Company's marketable debt securities are classified as either HTM or AFS pursuant to ASC 320 - Investments - Debt Securities. HTM securities are valued at amortized cost. The following table summarizes the valuations and unrealized gains and losses of AFS securities which are recorded at estimated fair value as of September 30, 2024 and December 31, 2023. The Company held no HTM securities as of September 30, 2024 and December 31, 2023.
    
 September 30, 2024
Gross Unrealized
Available-for-sale securities Cost GainsLossesCredit LossesEstimated Fair Value
U.S. government bonds$13,829,227 $84,435 $(582)$— $13,913,080 


 December 31, 2023
Gross Unrealized
Available-for-sale securities Cost GainsLossesCredit LossesEstimated Fair Value
U.S. government bonds$4,412,935 $5,665 $— $— $4,418,600 
Commercial paper11,612,099 234,506 — — $11,846,605 
Total $16,025,034 $240,171 $— $— $16,265,205 
The Company evaluates all HTM and AFS securities for impairment at each reporting period. It determined that changes in the fair value of its securities at September 30, 2024 resulted primarily from interest rate fluctuations subsequent to the purchase date of the securities. There was no deterioration in the credit worthiness of the issuers and no credit losses were recorded as of September 30, 2024.
v3.24.3
Accrued Expenses
 9 Months Ended
Sep. 30, 2024
Payables and Accruals [Abstract]  
Accrued Expenses Accrued Expenses and Compensation
  
Accrued expenses and compensation consist of the following:
 September 30, 2024December 31, 2023
Professional services$376,840 $298,534 
Compensation99,312 346,245 
Severance54,000 — 
Clinical 39,782 39,000 
Warranty 8,000 9,400 
Sales tax 130,308 141,672 
Other11,367 41,888 
 $719,609 $876,739 
During the nine months ended September 30, 2024, the Company recorded severance costs of approximately $580,000 of which approximately $54,000 remained unpaid as of September 30, 2024. See Note 10 - Employee Headcount Reduction.
v3.24.3
Leases Leases (Notes)
 9 Months Ended
Sep. 30, 2024
Leases [Abstract]  
Lessee, Operating Leases [Text Block] Operating Leases
 
The Company's lease on its Woburn, Massachusetts corporate office and manufacturing facilities extends through mid-September 2025 at a monthly base rent of $13,846 and with a 5-year extension option.

Future minimum lease payments under this non-cancellable operating lease as of September 30, 2024 are as follows:
2024$41,446 
2025117,431 
Total minimum lease payments$158,877 
Interest, based on a 15% discount rate
$16,256 
Lease obligation, current portion142,621 
$158,877 

Total recorded rent expense was $50,377 and $49,232, for the quarters ended September 30, 2024 and 2023, respectively. Total recorded rent expense was $151,132 and $147,696 for the nine month periods ended September 30, 2024 and 2023, respectively. The Company records rent expense on its facility lease on a straight-line basis over the lease term. The remaining operating lease term was 11.5 months as of September 30, 2024.
v3.24.3
Stockholders' Equity
 9 Months Ended
Sep. 30, 2024
Equity [Abstract]  
Stockholders' Equity Stockholders’ Equity
 
Preferred stock and convertible preferred stock consist of the following: 
 September 30, 2024December 31, 2023
Preferred stock, $0.001 par value; 5,000,000 shares authorized at September 30, 2024 and December 31, 2023; no shares issued and outstanding at September 30, 2024 and December 31, 2023
$— $— 
Series B convertible preferred stock, $0.001 par value; 147,000 shares designated at September 30, 2024 and December 31, 2023; 200 shares issued and outstanding at September 30, 2024 and December 31, 2023
$1 $1 

2024 equity activity

In the first quarter of 2024, the Company issued 458,380 shares of its common stock, under its at-the-market ("ATM") program and realized net proceeds of $1,471,099. As of April 18, 2024, the Company terminated its ATM program.
In March 2024, 1,015 unvested restricted stock awards and 5,912 unvested restricted stock units were forfeited due to the employee reduction described in Note 10.

In June 2024, the Company issued 850 shares of fully vested common stock with a value of $2,601 pursuant to the Company's Employee Stock Purchase Plan.

In the quarter ended June 30, 2024, the Company issued 91,577 restricted stock units under its 2022 Equity Incentive Plan with a value of $376,027.

As of September 30, 2024, the Company had outstanding 1,597 unvested restricted stock awards and 92,991 unvested restricted stock units. At December 31, 2023 the Company had outstanding 6,222 unvested restricted stock awards and 60,492 unvested restricted stock units.

2023 equity activity

In May 2023, the Company issued 1,563 restricted stock units under its 2022 Equity Incentive Plan with a value of $12,625.

In June 2023, the Company issued 90,661 shares of its common stock under its ATM program and realized net proceeds of $691,405. It also issued 1,316 shares of fully vested common stock with a value of $8,715 pursuant to the Company's Employee Stock Purchase Plan.

In July 2023, the Company issued 1,470 shares of its common stock, under ATM program for net proceeds of $1,426 and issued 24,500 restricted stock units under its 2004 Stock Option Plan with a value of $22,883.
In August 2023, the Company issued 172,660 restricted stock units with a value of $240,000 as long term incentives to its directors under its 2022 Equity Incentive Plan.
v3.24.3
Restructuring and Related Activities
 9 Months Ended
Sep. 30, 2024
Restructuring and Related Activities [Abstract]  
Restructuring and Related Activities Disclosure [Text Block] .     Employee Headcount Reduction
The Company incurred severance charges related to a reduction of 10 full time employees in the first quarter of 2024. This reduction was implemented in order to better align staffing with work responsibilities and to reduce operating expenses. Total severance related charges of approximately $580,000 were recorded in the quarter ended March 31, 2024 and cash payments of approximately $25,000 were made at that time. During the quarter ended June 30, 2024 and September 30, 2024, additional severance payments of approximately $334,000 and $167,000, respectively, were made and the remaining accrued severance obligation was approximately $54,000 which will be paid during the remainder of 2024 in accordance with employee contractual agreements.

The following table sets forth the quarterly activity in accrued severance.

Nine months ended September 30, 2024
Severance
Beginning balance$— 
Additions 580,427 
Amounts paid out (25,427)
Balance, March 31, 2024555,000 
Amounts paid out (334,000)
Balance, June 30, 2024221,000 
Amounts paid out(167,000)
Balance, September 30, 2024$54,000 
Within the Company's Statements of Operations for the nine months ended September 30, 2024, total severance charges of $580,427 were recorded in the first quarter as follows: $310,200 within research and development, $234,527 within sales and marketing, $4,200 within general and administrative and $31,500 within cost of revenues.
v3.24.3
Pay vs Performance Disclosure - USD ($)
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Jun. 30, 2024
Mar. 31, 2024
Sep. 30, 2023
Jun. 30, 2023
Mar. 31, 2023
Sep. 30, 2024
Sep. 30, 2023
Pay vs Performance Disclosure                
Net Income (Loss) Attributable to Parent $ (1,508,226) $ (1,487,932) $ (3,029,574) $ (1,768,737) $ (1,537,029) $ (1,574,174) $ (6,025,732) $ (4,879,940)
v3.24.3
Insider Trading Arrangements
 3 Months Ended
Sep. 30, 2024
Trading Arrangements, by Individual  
Material Terms of Trading Arrangement During the third quarter of 2024, none of our directors or executive officers adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c), and none of our directors or executive officers adopted or terminated a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K).
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
v3.24.3
Business and Basis of Presentation (Policies)
 9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
Unaudited Interim Financial Statements
Unaudited Interim Financial Statements
 
The accompanying unaudited balance sheet as of September 30, 2024, unaudited statements of operations, statements of comprehensive loss, changes in stockholders' equity and cash flows for the quarters ended September 30, 2024 and 2023 have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. The accompanying balance sheet as of December 31, 2023 has been derived from the audited balance sheet as of December 31, 2023 included in the Company's Form 10-K referenced below and does not include all disclosures required by U.S. GAAP. In the opinion of management, the financial statements include all normal and recurring adjustments considered necessary for a fair presentation of the Company’s financial position and operating results. Operating results for the nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024 or any other period. These financial statements and notes should be read in conjunction with the financial statements for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the "SEC"), on March 1, 2024 (File No. 001-33351).

Prior period reclassification
Certain items in the Statements of Cash Flows from the prior year were reclassified to conform with the current presentation.
Revenues
Revenues

Revenues include product sales, net of estimated returns. Revenue is measured as the amount of consideration the Company expects to receive in exchange for product transferred. Revenue is recognized at the point in time when contractual performance obligations have been satisfied and control of the product has been transferred to the customer. The Company has a single product delivery performance obligation. Accrued product returns using the most likely amount method are estimated based on historical data and evaluation of current information and variable consideration is not constrained. Revenue from product sales that occur via an online pharmacy agent are recognized on a gross basis and the related fulfillment fees are expensed within cost of revenues.

Accounts receivable are recorded in the amount the Company expects to collect, net of the allowance for credit losses. The allowance for credit losses is the Company’s best estimate of the amount of probable credit losses based on customer past payment history, product usage activity, and recent communications with the customer. Individual customer balances which are over 90 days past due are reviewed individually for collectability and written-off when recovery is not probable. The Company does not have any off-balance sheet credit exposure related to its customers. Allowance for credit losses was $25,000 as of September 30, 2024 and December 31, 2023.
 
Two customers accounted for 28% of total revenues in the quarter ended September 30, 2024 and two different customers accounted for 28% of total revenues in the quarter ended September 30, 2023. One customer accounted for 10% of total revenues for the nine months ended September 30, 2024 and two customers accounted for 26% of total revenues in the nine months ended September 30, 2023. Four customers accounted for 74% and three customers accounted for 74% of accounts receivable as of September 30, 2024 and December 31, 2023, respectively.
Cash and Cash Equivalents, Policy
Cash and Cash Equivalents

Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in U.S. government securities.
Marketable Securities, Policy
Securities

The Company invests in highly liquid, marketable debt securities with high credit ratings and typically with maturities of two years or less. Individual securities are designated by the Company as either "held-to-maturity" ("HTM") or “available-for-sale” ("AFS") at the point of investment. Securities classified as short-term have maturities of less than one year. As of September 30, 2024, all marketable securities held by the Company are classified as AFS and had remaining contractual maturities of one year or less.
HTM securities are valued on an amortized cost basis and reviewed to determine if an allowance for credit losses should be recorded in the statements of operations. AFS securities are valued at fair value. Unrealized gains and losses on AFS securities are included as a component of accumulated other comprehensive income in the balance sheets and statements of stockholders’ equity and a component of total comprehensive loss in the statements of comprehensive loss. An AFS security may be impaired if its fair value is less than amortized cost. Unrealized losses are evaluated to determine if the impairment is credit-related or non-credit-related. Credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings, and a non-credit-related impairment is recognized in other comprehensive loss. For certain types of securities, such as U.S. Treasuries, the Company generally expects zero credit losses. No allowance for credit losses was recorded on its securities portfolio as of September 30, 2024 or December 31, 2023.
Fair Value Measurement, Policy
Fair Value

The Company follows the provisions of Financial Accounting Standards Board (the "FASB") Accounting Standards Codification ("ASC") Topic 820-10, Fair Value Measurements and Disclosures ("ASC 820-10"), which defines fair value, establishes a framework for measuring fair value in GAAP and requires certain disclosures about fair value measurements. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.
As a basis for considering such assumptions, ASC 820-10 established a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value as follows: Level 1 observable inputs such as quoted prices in active markets; Level 2 inputs, other than quoted prices in active markets, that are observable either directly or indirectly; and Level 3 unobservable inputs for which there are little or no market data, which require the Company to develop its own assumptions. The hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value (See Note 5).
Use of Estimates
Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make significant estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during reporting periods. Actual results could differ from those estimates.
New Accounting Pronouncements, Policy
Recent Accounting Pronouncements

Accounting Standards Updates ("ASUs") issued by the FASB are evaluated for their applicability. ASUs not included in the disclosures in this report were assessed and determined to be either not applicable or not expected to have a material impact on our financial statements.

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires enhanced disclosures on both an annual and interim basis about significant segment expenses, including for companies with only one reportable segment. This ASU is effective on a retrospective basis for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact of the adoption of this standard on the Company’s Financial Statements and disclosures.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosures of specific categories in the rate reconciliation, additional information for reconciling items that meet a quantitative threshold and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of this standard on the Company’s Financial Statements and disclosures.
v3.24.3
Net Loss Per Common Share (Tables)
 9 Months Ended
Sep. 30, 2024
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items]  
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]
Quarters Ended September 30,Nine Months Ended September 30,
2024202320242023
Net loss applicable to common stockholders$(1,508,226)$(1,768,737)$(6,025,732)$(4,879,940)
Weighted average number of common shares outstanding, basic and diluted2,023,280 1,065,003 1,945,995 1,004,339 
Net loss per common share applicable to common stockholders, basic and diluted$(0.75)$(1.66)$(3.10)$(4.86)
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share
September 30,
 20242023
Options62,898 65,037 
Unvested restricted stock awards1,597 7,662 
Unvested restricted stock units92,991 37,706 
Convertible preferred stock8 8 
Total157,494 110,413 
v3.24.3
Investments, Debt and Equity Securities (Tables)
 9 Months Ended
Sep. 30, 2024
Investments, Debt and Equity Securities [Abstract]  
Schedule of Available-for-Sale Securities Reconciliation
 September 30, 2024
Gross Unrealized
Available-for-sale securities Cost GainsLossesCredit LossesEstimated Fair Value
U.S. government bonds$13,829,227 $84,435 $(582)$— $13,913,080 


 December 31, 2023
Gross Unrealized
Available-for-sale securities Cost GainsLossesCredit LossesEstimated Fair Value
U.S. government bonds$4,412,935 $5,665 $— $— $4,418,600 
Commercial paper11,612,099 234,506 — — $11,846,605 
Total $16,025,034 $240,171 $— $— $16,265,205 
v3.24.3
Fair Value Measurements (Tables)
 9 Months Ended
Sep. 30, 2024
Fair Value Disclosures [Abstract]  
Fair Value, Assets Measured on Recurring and Nonrecurring Basis
The following tables set forth the Company’s financial instruments that were measured at fair value:

 September 30, 2024
Total Level 1Level 2Level 3
Assets:
Money market funds$666,939 $666,939 $— $— 
U.S. government bonds13,913,080 13,913,080 — — 
Total $14,580,019 $14,580,019 $— $— 

 December 31, 2023
Total Level 1Level 2Level 3
Assets:
Money market funds$1,284,290 $1,284,290 $— $— 
U.S. government bonds4,418,600 4,418,600 — — 
Commercial paper11,846,605 — 11,846,605 — 
Total $17,549,495 $5,702,890 $11,846,605 $— 
v3.24.3
Inventories (Tables)
 9 Months Ended
Sep. 30, 2024
Inventory Disclosure [Abstract]  
Schedule of Inventory
Inventories consist of the following: 

 September 30, 2024December 31, 2023
Purchased components$1,130,180 $1,151,381 
Finished goods299,943 408,047 
 $1,430,122 $1,559,428 
Schedule of Available-for-Sale Securities Reconciliation
 September 30, 2024
Gross Unrealized
Available-for-sale securities Cost GainsLossesCredit LossesEstimated Fair Value
U.S. government bonds$13,829,227 $84,435 $(582)$— $13,913,080 


 December 31, 2023
Gross Unrealized
Available-for-sale securities Cost GainsLossesCredit LossesEstimated Fair Value
U.S. government bonds$4,412,935 $5,665 $— $— $4,418,600 
Commercial paper11,612,099 234,506 — — $11,846,605 
Total $16,025,034 $240,171 $— $— $16,265,205 
v3.24.3
Accrued Expenses (Tables)
 9 Months Ended
Sep. 30, 2024
Payables and Accruals [Abstract]  
Schedule of Accrued Expenses
Accrued expenses and compensation consist of the following:
 September 30, 2024December 31, 2023
Professional services$376,840 $298,534 
Compensation99,312 346,245 
Severance54,000 — 
Clinical 39,782 39,000 
Warranty 8,000 9,400 
Sales tax 130,308 141,672 
Other11,367 41,888 
 $719,609 $876,739 
D
v3.24.3
Leases Leases (Tables)
 9 Months Ended
Sep. 30, 2024
Leases [Abstract]  
Lessee, Operating Lease, Liability, Maturity [Table Text Block]
2024$41,446 
2025117,431 
Total minimum lease payments$158,877 
Interest, based on a 15% discount rate
$16,256 
Lease obligation, current portion142,621 
$158,877 
v3.24.3
Statement of Shareholders' Equity (Tables)
 9 Months Ended
Sep. 30, 2024
Equity [Abstract]  
Schedule of Stock by Class [Table Text Block]
Preferred stock and convertible preferred stock consist of the following: 
 September 30, 2024December 31, 2023
Preferred stock, $0.001 par value; 5,000,000 shares authorized at September 30, 2024 and December 31, 2023; no shares issued and outstanding at September 30, 2024 and December 31, 2023
$— $— 
Series B convertible preferred stock, $0.001 par value; 147,000 shares designated at September 30, 2024 and December 31, 2023; 200 shares issued and outstanding at September 30, 2024 and December 31, 2023
$1 $1 
v3.24.3
Restructuring and Related Activities (Tables)
 9 Months Ended
Sep. 30, 2024
Restructuring and Related Activities [Abstract]  
Schedule of Restructuring Reserve by Type of Cost
The following table sets forth the quarterly activity in accrued severance.

Nine months ended September 30, 2024
Severance
Beginning balance$— 
Additions 580,427 
Amounts paid out (25,427)
Balance, March 31, 2024555,000 
Amounts paid out (334,000)
Balance, June 30, 2024221,000 
Amounts paid out(167,000)
Balance, September 30, 2024$54,000 
v3.24.3
Business and Basis of Presentation (Detail) - USD ($)
 3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Jun. 30, 2024
Mar. 31, 2024
Jun. 30, 2023
Mar. 31, 2023
Dec. 31, 2022
Organization And Basis Of Presentation [Line Items]                    
Accounts receivable, net $ 149,092   $ 149,092   $ 518,824          
Net proceeds from issuance of stock and warrants     1,473,700 $ 701,546            
Accumulated deficit 216,135,085   216,135,085   210,109,353          
Cash and cash equivalents 921,520   921,520   1,731,946          
Prepaid expenses and other current assets (381,876)   (381,876)   (779,039)          
Assets, Current (16,795,690)   (16,795,690)   (20,854,442)          
Liabilities, Current (1,209,871)   (1,209,871)   (1,240,639)          
Operating Lease, Liability, Noncurrent 0   0   (92,485)          
Stockholders' Equity Attributable to Parent 15,979,149 $ 19,903,534 15,979,149 19,903,534 20,091,317 $ 17,311,823 $ 18,756,012 $ 21,411,429 $ 22,012,748 $ 23,355,687
Cost of revenues 275,357 421,382 1,129,125 1,484,240            
Gross Profit 311,957 $ 781,782 1,320,893 $ 3,099,439            
Operating Lease, Right-of-Use Asset (147,824)   (147,824)   (250,150)          
Assets (17,189,020)   (17,189,020)   (21,424,441)          
Accrued Liabilities, Current (719,609)   (719,609)   (876,739)          
Liabilities (1,209,871)   (1,209,871)   (1,333,124)          
Allowance for doubtful accounts 25,000   25,000   25,000          
Cash, Cash Equivalents, and Short-term Investments 14,800,000   14,800,000              
Debt Securities, Available-for-Sale, Allowance for Credit Loss 0   0   0          
Debt Securities, Held-to-Maturity, Allowance for Credit Loss $ 0   $ 0   $ 0          
One Customer | Revenue | Customer Concentration Risk                    
Organization And Basis Of Presentation [Line Items]                    
Concentration risk, percentage     10.00%              
Three Customers [Member] | Accounts Receivable | Customer Concentration Risk                    
Organization And Basis Of Presentation [Line Items]                    
Concentration risk, percentage         74.00%          
Two Customers | Revenue | Customer Concentration Risk                    
Organization And Basis Of Presentation [Line Items]                    
Concentration risk, percentage 28.00% 28.00%   26.00%            
Four Customers | Accounts Receivable | Customer Concentration Risk                    
Organization And Basis Of Presentation [Line Items]                    
Concentration risk, percentage     74.00%              
v3.24.3
Net Loss Per Common Share - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Detail) - shares
 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total antidilutive securities excluded from the computation of earnings per share (in shares) 157,494 110,413
Convertible preferred stock    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total antidilutive securities excluded from the computation of earnings per share (in shares) 8 8
Options    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total antidilutive securities excluded from the computation of earnings per share (in shares) 62,898 65,037
Restricted Stock    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total antidilutive securities excluded from the computation of earnings per share (in shares) 1,597 7,662
Restricted Stock Units (RSUs)    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total antidilutive securities excluded from the computation of earnings per share (in shares) 92,991 37,706
v3.24.3
Net Loss Per Common Share Schedule of Earnings Per Share, Basic and Diluted (Details) - USD ($)
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Jun. 30, 2024
Mar. 31, 2024
Sep. 30, 2023
Jun. 30, 2023
Mar. 31, 2023
Sep. 30, 2024
Sep. 30, 2023
Earnings Per Share [Abstract]                
Net Income (Loss) Attributable to Parent $ (1,508,226) $ (1,487,932) $ (3,029,574) $ (1,768,737) $ (1,537,029) $ (1,574,174) $ (6,025,732) $ (4,879,940)
Weighted Average Number of Shares Outstanding, Basic 2,023,280     1,065,003     1,945,995 1,004,339
Weighted Average Number of Shares Outstanding, Diluted 2,023,280     1,065,003     1,945,995 1,004,339
Earnings Per Share, Diluted $ (0.75)     $ (1.66)     $ (3.10) $ (4.86)
Earnings Per Share, Basic $ (0.75)     $ (1.66)     $ (3.10) $ (4.86)
v3.24.3
Investments, Debt and Equity Securities (Details) - AFS - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Debt Securities, Available-for-Sale [Line Items]    
Debt Securities, Available-for-Sale, Amortized Cost   $ 16,025,034
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax   240,171
Debt Securities, Available-for-Sale $ 13,913,080 16,265,205
Debt Securities, Available-for-Sale, Allowance for Credit Loss 0 0
Debt Securities, Held-to-Maturity, Amortized Cost, before Allowance for Credit Loss 0 0
Commercial Paper    
Debt Securities, Available-for-Sale [Line Items]    
Debt Securities, Available-for-Sale, Amortized Cost   11,612,099
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax   234,506
Debt Securities, Available-for-Sale   11,846,605
US Government Agencies Debt Securities    
Debt Securities, Available-for-Sale [Line Items]    
Debt Securities, Available-for-Sale, Amortized Cost 13,829,227 4,412,935
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax 84,435 5,665
Debt Securities, Available-for-Sale 13,913,080 $ 4,418,600
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, before Tax $ (582)  
v3.24.3
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Assets    
Debt Securities, Available-for-Sale $ 13,913,080 $ 16,265,205
Assets, Fair Value Disclosure 14,580,019 17,549,495
Money Market Funds [Member]    
Assets    
Cash and Cash Equivalents, Fair Value Disclosure 666,939 1,284,290
US Government Agencies Debt Securities    
Assets    
Debt Securities, Available-for-Sale 13,913,080 4,418,600
Commercial Paper    
Assets    
Debt Securities, Available-for-Sale   11,846,605
Level 1    
Assets    
Assets, Fair Value Disclosure 14,580,019 5,702,890
Level 1 | Money Market Funds [Member]    
Assets    
Cash and Cash Equivalents, Fair Value Disclosure 666,939 1,284,290
Level 1 | US Government Agencies Debt Securities    
Assets    
Debt Securities, Available-for-Sale 13,913,080 4,418,600
Level 2    
Assets    
Assets, Fair Value Disclosure $ 0 11,846,605
Level 2 | Commercial Paper    
Assets    
Debt Securities, Available-for-Sale   $ 11,846,605
v3.24.3
Inventories (Detail) - USD ($)
 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Inventory [Line Items]      
Purchased components $ 1,130,180   $ 1,151,381
Finished goods 299,943   408,047
Inventories 1,430,122   $ 1,559,428
Inventory Charge Cost Of Revenues $ 74,209 $ 63,420  
v3.24.3
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($)
 3 Months Ended 9 Months Ended
Mar. 31, 2024
Sep. 30, 2024
Jun. 30, 2024
Dec. 31, 2023
Payables and Accruals [Abstract]        
Professional services   $ 376,840   $ 298,534
Accrued Salaries, Current   99,312   346,245
Restructuring Reserve   54,000   0
Accrued Clinical Current   39,782   39,000
Warranty reserve   8,000   9,400
Other   11,367   41,888
Sales and Excise Tax Payable, Current   130,308   141,672
Accrued expenses   719,609   876,739
Product Liability Contingency [Line Items]        
Other   11,367   41,888
Employee Severance [Member]        
Payables and Accruals [Abstract]        
Restructuring Reserve $ 555,000 54,000 $ 221,000 $ 0
Product Liability Contingency [Line Items]        
Restructuring Charges $ 580,427 $ 580,000    
v3.24.3
Leases Leases (Details) - USD ($)
 3 Months Ended 9 Months Ended
Jun. 01, 2018
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Operating Leased Assets [Line Items]            
Operating Lease, Weighted Average Discount Rate, Percent   15.00%   15.00%    
Operating Lease, Expense   $ 50,377 $ 49,232 $ 151,132 $ 147,696  
Operating Lease, Right-of-Use Asset   $ 147,824   $ 147,824   $ 250,150
Lessee, Operating Lease, Remaining Lease Term   11 months 15 days   11 months 15 days    
Lessee, Operating Lease, Liability, to be Paid, Year One   $ 41,446   $ 41,446    
Lessee, Operating Lease, Liability, to be Paid, Year Two   117,431   117,431    
Lessee, Operating Lease, Liability, to be Paid   158,877   158,877    
Operating Lease Discount   16,256   16,256    
Operating Lease, Liability, Current   142,621   142,621   148,391
Operating Lease, Liability, Noncurrent   $ 0   $ 0   $ 92,485
Woburn Lease [Member]            
Operating Leased Assets [Line Items]            
Lessee, Operating Lease, Renewal Term 5 years          
Woburn Lease [Member] | MonthlyRent [Member]            
Operating Leased Assets [Line Items]            
Operating Lease, Payments $ 13,846          
v3.24.3
Stockholders' Equity - Additional Information (Detail) - USD ($)
 1 Months Ended 3 Months Ended 9 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Aug. 31, 2023
Jul. 31, 2023
Jun. 30, 2023
May 31, 2023
Sep. 30, 2024
Jun. 30, 2024
Mar. 31, 2024
Sep. 30, 2023
Jun. 30, 2023
Mar. 31, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Class of Stock [Line Items]                              
Stock Issued During Period, Value, Employee Stock Purchase Plan               $ 2,601     $ 8,713        
Net proceeds from issuance of stock and warrants                         $ 1,473,700 $ 701,546  
Common stock, par value (in dollars per share)             $ 0.0001           $ 0.0001   $ 0.0001
Stock Issued During Period, Value, New Issues                 $ 1,471,099 $ 1,426 $ 691,405        
Common Stock [Member]                              
Class of Stock [Line Items]                              
Stock Issued During Period, Shares, Employee Stock Purchase Plans 850       1,316                    
Stock Issued During Period, Value, Employee Stock Purchase Plan $ 2,601       $ 8,715                    
Common Stock [Member]                              
Class of Stock [Line Items]                              
Stock Issued During Period, Shares, Employee Stock Purchase Plans               850     1,316        
Stock Issued During Period, Shares, New Issues                 458,380 184 90,661        
Stock Issued During Period, Shares, Restricted Stock Award, Gross             17,610 29,453 6,699 2,820 9,015 2,439      
Stock Issued During Period, Value, Restricted Stock Award, Gross             $ 1 $ 3 $ 1   $ 1        
Stock Issued During Period, Value, New Issues                 $ 46   $ 9        
Restricted Stock                              
Class of Stock [Line Items]                              
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number             1,597           1,597   6,222
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Forfeited in Period   1,015                          
Restricted Stock Units (RSUs)                              
Class of Stock [Line Items]                              
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number             92,991           92,991   60,492
Stock Issued During Period, Shares, Restricted Stock Award, Gross     172,660 24,500   1,563   91,577              
Stock Issued During Period, Value, Restricted Stock Award, Gross     $ 240,000 $ 22,883   $ 12,625   $ 376,027              
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Forfeited in Period   5,912                          
At The Market Offering Program [Member] | Common Stock [Member]                              
Class of Stock [Line Items]                              
Stock Issued During Period, Shares, New Issues       1,470 90,661       458,380            
Proceeds from Issuance of Common Stock       $ 1,426 $ 691,405       $ 1,471,099            
v3.24.3
Preferred Stock and Convertible Preferred Stock (Details) - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Preferred Non-Convertible Stock    
Class of Stock [Line Items]    
Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
Preferred stock, shares authorized (in shares) 5,000,000 5,000,000
Preferred stock, shares issued (in shares) 0 0
Value of preferred stock issued $ 0 $ 0
Preferred stock, shares outstanding (in shares) 0 0
Series B Preferred Stock | Preferred Stock    
Class of Stock [Line Items]    
Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
Preferred stock, shares authorized (in shares) 147,000 147,000
Preferred stock, shares issued (in shares) 200 200
Value of preferred stock issued $ 1 $ 1
Preferred stock, shares outstanding (in shares) 200 200
v3.24.3
Restructuring and Related Activities (Details)
 3 Months Ended 9 Months Ended
Sep. 30, 2024
USD ($)
Jun. 30, 2024
USD ($)
Mar. 31, 2024
USD ($)
Sep. 30, 2024
USD ($)
Dec. 31, 2023
USD ($)
Restructuring Cost and Reserve [Line Items]          
Restructuring and Related Cost, Number of Positions Eliminated     10    
Restructuring Reserve $ 54,000     $ 54,000 $ 0
Employee Severance [Member]          
Restructuring Cost and Reserve [Line Items]          
Restructuring Reserve 54,000 $ 221,000 $ 555,000 54,000 $ 0
Restructuring Charges     580,427 $ 580,000  
Payments for Restructuring $ 167,000 $ 334,000 25,427    
Employee Severance [Member] | Research and Development Expense [Member]          
Restructuring Cost and Reserve [Line Items]          
Restructuring Charges     310,200    
Employee Severance [Member] | Selling and Marketing Expense [Member]          
Restructuring Cost and Reserve [Line Items]          
Restructuring Charges     234,527    
Employee Severance [Member] | General and Administrative Expense [Member]          
Restructuring Cost and Reserve [Line Items]          
Restructuring Charges     4,200    
Employee Severance [Member] | Cost of Sales          
Restructuring Cost and Reserve [Line Items]          
Restructuring Charges     $ 31,500    
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