The study will be a US-based, single-center, prospective trial, examining a maximum of 25 patients.
The device is already indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients and this latest new application is for the temporary improvement of the appearance of cellulite.
The Generation II RAP device delivers the same tattoo-removal therapy as the Generation I device, but is slightly modified for improved ease of use in the physician's office.
Global Nasdaq Partner Sanmina Delivers RAP Device to More Effectively Target Cellulite Reduction for Pivotal Trial
The company previously announced the completion of final testing of the device by Sanmina, Corp. After completing safety testing, they have delivered the devices to the first clinical trial site for the pivotal trial.
The company expects this larger pivotal trial to form the basis for FDA clearance of their Rapid Acoustic Pulse (RAP) device.
Soliton will sell an aggregate of 675,000 shares of the Company's common stock at $14.00 per share. Each share will be sold together with a warrant to purchase 0.7 shares of common stock.
Soliton reports the study, conducted by Dr. Michael Kaminer at SkinCare Physicians in Boston, MA, in collaboration with Dr. Elizabeth Tanzi of Capital Laser and Skin Care, concluded evaluation of safety and efficacy for all patients through the initial 12-week time point. The study is designed to evaluate results at both the 12-week and 26-week timepoints from initial treatment in order to assess both near-term and long-term effects.