HOUSTON, Aug. 13, 2020 /PRNewswire/ -- Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary aesthetic platform technology, today announced it has completed the design process for an advanced handpiece and cartridge for its Rapid Acoustic Pulse (RAP) device.
The new design for the handpiece and cartridge includes several improved features providing ease of use, and a more user-friendly experience. Upgrades to the device include modifications to five circuit boards in the consoles, automatically inserting and ejecting cartridges, a system to detect counterfeit cartridges, a method of automatic adjustment of the electrode resulting in longer cartridge life, and RFID chip detection. The Company's engineering and design services partner has now assembled the new handpiece and cartridge and successfully tested its functionality.
The cartridge design will be handed off to the Company's manufacturing partner to execute appropriate design adjustments for manufacturability and begin preparing to manufacture the cartridges in mass for the upcoming product launch.
"Designing the improved cartridge was a strategic decision made to capitalize on the time afforded by the delay in our launch plan resulting from COVID-19," commented Christopher Capelli, MD, founder, President and CEO of Soliton. "We believe the single-use replaceable RAP cartridges will be a main driver of future revenue, and through this new design, we have not only improved the device's functionality and ease of use, but positioned ourselves for efficient manufacturing and production and the collection of important marketing data."
Dr. Capelli continued, "As we have previously discussed, we revised our launch plan for RAP, due to the current COVID-19 pandemic. As we give the markets an opportunity to recover from the pandemic, we are moving forward with design improvements that should enhance our initial launch. The extended timeline ahead of the initial launch has allowed us the opportunity to launch the RAP device incorporating both the tattoo removal indication as well as the cellulite indication, pending FDA approval of the latter."
Soliton's RAP technology has not yet been cleared by the FDA for cellulite reduction and is not available for sale in the United States for this indication.
About Soliton, Inc.
Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company's first FDA cleared commercial product will use rapid pulses of acoustic shockwaves as an accessory to lasers for the removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse ("RAP") device to the market. The Company believes this "Soliton" method has the potential to lower tattoo removal costs for patients, while increasing profitability to practitioners, compared to current laser removal methods. Soliton has completed a clinical study using the RAP device to improve the appearance of cellulite and is investigating potential additional capabilities of the RAP technology. The device is currently cleared in the United States only for use in tattoo removal and is not yet cleared for use to address cellulite.
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which statements involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, our ability to successfully manufacture and receive the required safety and regulatory approvals for the improved cartridges, to receive clearance of the cellulite indication, and to successfully launch our product. These statements relate to future events, future expectations, plans and prospects. Although Soliton believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, actual results or outcomes may prove to be materially different from the expectations expressed or implied by such forward-looking statements. Soliton has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' "would," ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed in our filings with the Securities and Exchange Commission ("SEC"), including under the heading " Risk Factors" in the Form 10-K for year ended December 31, 2019 filed with the SEC and as updated in our Form 10-Q filings and in our other filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. Soliton undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.