Soliton, Inc., announced that Sanmina, Corp., the Company’s global manufacturing partner has delivered the Company’s second generation rapid acoustic pulse (“Gen 2 RAP”) device for use in the upcoming pivotal trial targeting cellulite reduction.
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 Gen 2 RAP device will be used in Company’s upcoming pivotal registration clinical trial to submit to the FDA for 510(k) clearance of the device. This new device is designed to be capable of functioning both as the Gen 1 device does for the acceleration of tattoo removal, and as a stand-alone device for potential reduction of cellulite and other future indications. In this second model, the Gen 2 RAP is capable of delivering higher-powered acoustic pulses at greater depths, making it a platform device with a wide range of potential future uses. This new device has not been cleared by the FDA.
The treatment head accommodates a specific reflector design to allow for treatment depths that are optimized for addressing the fibrotic structures that contribute to cellulite.