(lipolysis) in the abdomen and flanks for certain body types and relief of minor muscle aches and pains in jurisdictions around the world. In addition, our technology pipeline is focused on the development of robotically assisted minimally invasive solutions for aesthetic procedures that are primarily treated by surgical intervention, including the AI.ME platform for which we received FDA 510(k) clearance for fractional skin resurfacing in December 2022.
In the United States, we have obtained 510(k) clearance from the FDA for our Venus Viva, Venus Viva MD, Venus Legacy, Venus Versa, Venus Versa Pro, Venus Velocity, Venus Bliss, Venus Bliss Max, Venus Epileve, Venus Fiore, ARTAS, ARTAS iX and AI.ME systems. Outside the United States, we market our technologies in over 60 countries across Europe, the Middle East, Africa, Asia-Pacific and Latin America. Because each country has its own regulatory scheme and clearance process, not every device is cleared or authorized for the same indications in each market in which a particular system is marketed.
As of the date of this prospectus, we operate directly in 14 international markets through our 11 direct offices in the United States, Canada, United Kingdom, Japan, Mexico, Spain, Germany, Australia, China, Hong Kong, and Israel.
Recent Developments
Exchange Agreement
On October 4, 2023, we entered into an exchange agreement, referred to herein as the “Exchange Agreement,” with Madryn Health Partners, LP, and Madryn Health Partners (Cayman Master), LP, collectively referred to herein as the “holders.” Under the Exchange Agreement, the holders agreed to exchange, referred to herein as the “Exchange,” $26,695,110.58 in aggregate principal amount of outstanding secured convertible notes of the Company, for (i) $22,791,748.32 in aggregate principal amount of new secured convertible notes of the Company, and (ii) 248,755 shares of newly-created convertible preferred stock of the company, par value $0.0001 per share, designated as “Series X Convertible Preferred Stock,” referred to herein as our “Series X preferred stock.” The Exchange closed on October 4, 2023.
See “Selling Stockholders – Description of Exchange” beginning on page
9.
Nasdaq Delisting Notice
As previously disclosed, on May 31, 2023, we received a notice (the “Notice”) from the Listing Qualifications Department of Nasdaq (“Nasdaq Staff”) stating that the stockholders’ equity as reported in the our Quarterly Report on Form 10-Q for the period ended March 31, 2023 was below the minimum $2,500,000 required for continued listing under Listing Rule 5550(b)(1) (“Minimum Equity Requirement”). The Notice had no immediate effect on the listing of our common stock.
On July 17, 2023, we submitted to Nasdaq Staff a plan to regain compliance with the Minimum Equity Requirement (the “Plan”). On July 28, 2023, Nasdaq Staff granted an extension until November 27, 2023 to evidence compliance with the Minimum Equity Requirement, conditioned upon our achievement of certain milestones as set forth in the Plan.
On November 28, 2023, we received a written notice from the Nasdaq Staff which described its determination that the Company had not regained compliance with the Minimum Equity Requirement within the Plan period. As a result, the Nasdaq Staff advised the Company that its securities will be delisted at the opening of business on December 7, 2023, unless the Company timely requests a hearing before a Nasdaq Hearings Panel (the “Panel”). Accordingly, the Company intends to timely request a hearing before the Panel. The hearing request will automatically stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. Pursuant to the Nasdaq Listing Rules, the Panel is authorized to grant, where it deems appropriate an additional extension period not to exceed May 28, 2024.
Risk Factors
Our operations and financial results are subject to various risk and uncertainties. Before deciding to invest in our securities, you should carefully consider the factors described under “Risk Factors” beginning on page
6 of this prospectus, as well as the other information included elsewhere in this prospectus, and the risk factors described under “Part I, Item 1A. Risk Factors” in our most recent Annual Report on Form 10-K and in any subsequently-filed Quarterly Reports on Form 10-Q, and those contained in our other filings with the SEC that