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TORONTO - Venus Concept Inc. received 510(k) clearance from the U.S. Food and Drug Administration for its Venus NOVA platform, the company announced Monday. The micro-cap company, currently valued at just $3.59 million and trading near its 52-week low of $1.85, is hoping this regulatory win will help reverse its recent stock performance, which has declined over 53% year-to-date.
The next-generation multi-application device integrates Adaptive Electrical Muscle Stimulation, proprietary technology combining Multi-Polar Radio Frequency with Pulsed Electromagnetic Fields, and Advanced VariPulse technology for body contouring, muscle conditioning, and skin treatments.
Key features of the Venus NOVA include FlexMAX EMS technology that delivers up to 100,000 muscle contractions per session, multiple applicators designed for different body areas, and Automatic Temperature Control for maintaining optimal treatment temperatures.
"The development and introduction of our new Venus NOVA is consistent with the turnaround strategy implemented in 2023 and our Venus AI strategic initiative," said Rajiv De Silva, Chief Executive Officer of Venus Concept.
Melissa Kang, Chief Product Officer, noted that the device is "uniquely positioned to enhance body transformation journeys, including for those taking GLP-1 medications and experiencing skin laxity, facial volume loss, and body contour irregularities."
The company will support the device with its Venus Jumpstart Program, which provides clinical education, marketing support, and implementation guidance for practices.
Venus NOVA will be available to U.S. customers in December 2025, with global rollouts planned throughout 2026 and beyond, according to the company's press release statement.
Venus Concept operates in over 60 countries and offers a portfolio of aesthetic and hair restoration technologies.
In other recent news, Venus Concept Inc. has successfully reduced its debt by 24% through a strategic note exchange. The company announced the completion of a transaction on September 30, where it exchanged $11.48 million in subordinated convertible notes for 545,335 shares of Series Y preferred stock held by affiliates of Madryn Asset Management. This move has brought Venus Concept's total debt obligations down to approximately $30.1 million, a notable decrease from the $39.7 million outstanding at the end of 2024. These developments reflect the company's efforts to improve its financial position. The exchange of notes into preferred stock is a significant step in managing the company's liabilities. This recent reduction in debt could be of interest to investors monitoring the company's financial health. The transaction highlights Venus Concept's ongoing financial strategies aimed at strengthening its balance sheet.
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