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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): August 14, 2024

 

AVALON GLOBOCARE CORP.

(Exact name of registrant as specified in its charter)

 

Delaware   001-38728   47-1685128

(State or other jurisdiction
of incorporation)

 

(Commission File Number)

 

(I.R.S. Employer
Identification Number)

 

4400 Route 9 South, Suite 3100, Freehold, NJ 07728

(Address of principal executive offices)

 

(732) 780-4400

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.)

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.0001 per share   ALBT   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

Emerging growth company

 

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. ☐

 

 

 

 

 

Item 7.01. Regulation FD Disclosure.

 

On August 14, 2024, Avalon GloboCare Corp., a Delaware corporation (the “Company”), issued a press release announcing the anticipated launch of sales of the GeeWhiz External Condom Catheter by Laboratory Services MSO, LLC.

 

The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. The information included in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. The information set forth under this Item 7.01 shall not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is required to be disclosed solely to satisfy the requirements of Regulation FD.

 

Item 9.01. Financial Statement and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press release of the Company dated August 14, 2024
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

1

 

 

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 hereunto duly authorized.

 

  AVALON GLOBOCARE CORP.  
     
Dated: August 14, 2024 By: /s/ Luisa Ingargiola
  Name: Luisa Ingargiola
  Title: Chief Financial Officer

 

 

2

 

 

Exhibit 99.1

 

 

 

Avalon’s Laboratory Services MSO to Launch Sales of Proprietary FDA-Registered External Male Catheter Device

 

Device is Approved for Reimbursement by Medicare and is Supported by Several Private Insurance Providers

 

FREEHOLD, N.J., August 14, 2024 (GLOBE NEWSWIRE) – Avalon GloboCare Corp. (“Avalon” or the “Company”) (NASDAQ: ALBT), a developer of innovative cell-based technology, cellular therapy and precision diagnostics, today announced that Laboratory Services MSO, LLC (“LSM”) has begun manufacturing the GeeWhiz External Condom Catheter, a patented, FDA-registered, in-market, male incontinence device. LSM plans to launch its sales of the GeeWhiz External Condom Catheter in the third quarter of 2024. Avalon owns a 40% interest in LSM.

 

According to Grand View Research, the global male urinary incontinence market size was valued at $6.37 billion in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 5.87% from 2023 to 2030. The market is expected to grow steadily due to the increasing prevalence of incontinence, an aging population, and advancements in product technology. This growth reflects a broader awareness and demand for effective management solutions for urinary incontinence among men.

 

“We are thrilled to introduce the GeeWhiz External Condom Catheter to the market in the anticipated upcoming launch,” stated David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon GloboCare. “The GeeWhiz External Condom Catheter represents a significant advancement in managing male incontinence. Not only is this device FDA-registered and approved for reimbursement by Medicare, but it is also supported by several private insurance providers.”

 

“The GeeWhiz External Condom Catheter is meticulously engineered to address the needs of men with urinary incontinence and bladder control issues. Its innovative design aims to provide enhanced comfort, security, and ease of use, ultimately improving the quality of life for users. We are confident that this product will meet a critical need in the market and deliver substantial benefits to patients and healthcare providers alike. The anticipated upcoming launch of GeeWhiz underscores our commitment to advancing healthcare solutions and expanding our impact in the medical device industry,” concluded Dr. Jin.

 

About Avalon GloboCare Corp.


Avalon GloboCare Corp. (NASDAQ: ALBT) is a commercial stage company dedicated to developing and delivering innovative, transformative, precision diagnostics and clinical laboratory services. Avalon is working to establish a leading role in the innovation of diagnostic testing, utilizing proprietary technology to deliver precise, genetics-driven results. The Company also provides laboratory services, offering a broad portfolio of diagnostic tests, including drug testing, toxicology, and a broad array of test services, from general bloodwork to anatomic pathology, and urine toxicology. For more information about Avalon GloboCare, please visit www.avalon-globocare.com.

 

For the latest updates on Avalon GloboCare’s developments, please follow our twitter at @avalongc_avco

 

 

 

 

Forward-Looking Statements


Certain statements contained in this press release are “forward-looking statements” within the meaning of the federal securities laws. Forward-looking statements are made based on our expectations and beliefs concerning future events impacting the Company and therefore involve several risks and uncertainties. You can identify these statements by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “should”, “may”, and other words and terms of similar meaning or use of future dates, however, the absence of these words or similar expressions does not mean that a statement is not forward-looking. Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact, including statements regarding the ability to enter into a definitive agreement, as well as the Company’s commercialization, distribution and sales of its products and the ability to compete with other similar products. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (http://www.sec.gov), including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Form 8-Ks filed or furnished with the SEC. In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, and governmental and public policy changes. The forward-looking statements included in this press release represent the Company’s views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of the press release.

 

Contact Information:

 

Avalon GloboCare Corp.

4400 Route 9, Suite 3100

Freehold, NJ 07728

PR@Avalon-GloboCare.com

 

Investor Relations:

 

Crescendo Communications, LLC

Tel: (212) 671-1020 Ext. 304

albt@crescendo-ir.com

 

 

 

 

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