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 12 international markets through our 10 direct offices in the United States, Canada, Japan, Mexico, Spain, Germany, Australia, China, Hong Kong, and Israel.
Recent Developments
Offering
On February 27, 2024, we sold 817,748 shares of Common Stock to certain institutional investors at a price of $1.465 per share in a registered direct offering. In connection with such offering, we issued (i) 817,748 Warrants to such institutional investors and (ii) 57,242 Warrants as consideration to the placement agent in such offering. See “Selling Stockholders – Description of Offering” beginning on page
9.
Exploration of Strategic Alternatives
On January 24, 2024, we announced that our Board of Directors is evaluating potential strategic alternatives to maximize shareholder value. As part of the process, our Board of Directors is considering a full range of strategic alternatives, which may include one or more financings, recapitalizations, mergers, reverse mergers, other business combinations, sales of assets, licensings or other transactions. We have retained Canaccord Genuity LLC as our financial advisor to assist in evaluating potential strategic alternatives. There can be no assurance that the evaluation of strategic alternatives will result in any transaction, nor can there be any assurance regarding any transaction’s timing or ultimate outcome. We have not set a timetable for completion of the process and do not intend to disclose developments related to the process unless and until we execute a definitive agreement with respect thereto, or our Board of Directors otherwise determines that further disclosure is appropriate or required.
Nasdaq Delisting Notice
As previously disclosed, on May 31, 2023, we received a notice from the Listing Qualifications Department of Nasdaq (the “Nasdaq Staff”) stating that our stockholders’ equity as reported in 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 the Nasdaq Staff a plan to regain compliance with the Minimum Equity Requirement (the “Plan”). On July 28, 2023, the 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 we had not regained compliance with the Minimum Equity Requirement within the Plan period. As a result, the Nasdaq Staff advised us that our securities would be delisted at the opening of business on December 7, 2023, unless we timely request a hearing before the Nasdaq Hearings Panel (the “Panel”).
On December 5, 2023, we timely requested a hearing before the Panel, which hearing was held on March 5, 2024. Pursuant to the Nasdaq Listing Rules, the Panel is authorized to grant an additional extension period to regain compliance with the Minimum Equity Requirement not to exceed May 28, 2024.
On March 20, 2024, we received a decision from the Panel granting our request for continued listing on the Nasdaq Capital Market, subject to the Company demonstrating compliance with Nasdaq Listing Rule 5550(b)(1) or any of the alternative requirements under Nasdaq Listing Rule 5550(b) on or before May 28, 2024, and certain other conditions.