Soliton files 510(k) with FDA for RAP device for reduction of cellulite » 08:0507/0107/01/20
Soliton announced that it…
Soliton announced that it filed for 510(k) premarket clearance with the U.S. FDA of its second generation Rapid Acoustic Pulse device for the reduction in the appearance of cellulite on June 30. The RAP device was previously cleared by the FDA as an accessory to a 1064 nm Q-switched laser for tattoo removal of black ink on patients with skin tones on the Fitzpatrick scale between I and III.
|Over a week ago|
Soliton 4.22M share Spot Secondary priced at $8.30 » 09:4106/2606/26/20
Soliton 4.22M share Spot…
Soliton 4.22M share Spot Secondary priced at $8.30 Cantor Fitzgerald is acting as sole book running manager for the offering.
Fly Intel: Pre-market Movers » 09:0306/2606/26/20
GPS, ZGNX, AXSM, EKSO, VXRT, BIG, NKE, APOG, DBVT, SOLY, IDEX
Check out this morning's…
Fly Intel: After-Hours Movers » 19:0906/2506/25/20
CAMP, SNX, PRGS, DKNG, INO, NKE, SOLY, MTCH
Soliton files to sell common stock, no amount given » 16:0206/2506/25/20
Cantor Fitzgerald &…
Cantor Fitzgerald & Co. is acting as the sole book-running manager for the proposed offering.
Soliton price target raised to $16 from $14 at Roth Capital » 09:5606/1606/16/20
Roth Capital analyst…
Roth Capital analyst Scott Henry raised the firm's price target on Soliton to $16 from $14 and keeps a Buy rating on the shares citing the "robust" pivotal results for the company's developmental non-invasive cellulite treatment. The data matched already high expectations as ~92% of patients believed that they had improvement after only one treatment, Henry tells investors in a research note. Soliton expects to file a 510K in June with potential approval in late 2020/early 2021, the analyst adds.
Soliton reports 'positive' pivotal cellulite clinical trial results » 08:0206/1506/15/20
Soliton announced that…
Soliton announced that new positive data from the company's pivotal cellulite clinical trial was presented in an oral presentation via the American Academy of Dermatology 2020 VMX Virtual Conference on June 12. "We are pleased that our pivotal cellulite study demonstrated positive results and appreciate the opportunity to have our findings presented through this prestigious dermatology organization," stated Christopher Capelli, MD, founder, President and CEO of Soliton. "In addition to demonstrating an average 32.5% improvement in the Cellulite Severity Score in our subjects, patient satisfaction was strong with 91.9% of subjects agreeing or strongly agreeing that their cellulite appeared improved. Further, there were no unexpected or serious adverse events and the average pain scores were 2.4 on a 10-point scale."
|Over a month ago|
Soliton reports Q1 EPS (19c), consensus (25c) » 07:3205/1405/14/20
Total cash was $7.7M as…
Total cash was $7.7M as of March 31, vs. $12.1M as of December 31, 2019. Cash, cash equivalents and restricted cash on hand is sufficient to fund operations into December but not beyond. CEO Chris Capelli commented, "Although Q1 was largely governed by the unprecedented COVID-19 pandemic, Soliton continued to achieve a number of significant milestones, including FDA clearance of the Special 510(k) premarket notification for the Generation II RAP device and the completion of both the 12-week keloid and hypertrophic scar proof-of-concept study and the pivotal cellulite clinical trial. We plan to present the results of the cellulite trial at the virtual AAD Conference expected to be held in mid-June 2020. The results of this study will support our anticipated 510(k) filing with the FDA for the treatment of cellulite during Q2. Our focus remains on executing our revised U.S. commercialization plans, adapted as a result of the COVID-19 crisis and now strategically incorporating both tattoo removal and cellulite treatment into a Generation II RAP device. We remain optimistic the aesthetic and financial markets will recover and look forward to providing details of our future U.S. commercial launch once conditions have stabilized for our dermatology customers."
Soliton granted patent for FDA cleared RAP technology » 08:0304/0804/08/20
Soliton has been issued a…
Soliton has been issued a patent by the USPTO titled "Rapid Pulse Electrohydraulic Shockwave Generator Apparatus and Methods for Medical and Cosmetic Treatments". The company's first planned commercial product is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to accelerate the removal of unwanted tattoos - RAP device -. In addition, higher energy versions of acoustic pulse devices are in early stages of development for potential stand-alone treatment of cellulite and other indications. The RAP device uses electrohydraulics to generate the designed acoustic shockwaves at a rate of up to 100 per second to effectively target differences in density at the cellular level.
|Over a quarter ago|
Soliton postpones launch of RAP tattoo removal device » 08:0704/0104/01/20
Soliton provided an…
Soliton provided an update on its business strategy and financial position in light of the current COVID-19 situation. CEO Christopher Capelli commented, "(...) Instead of launching our RAP device focused solely on tattoo removal in mid-2020, we are electing to delay that launch until the aesthetic and financial markets are demonstrating more stability. In the meantime, we will remain highly focused on our regulatory pathway for cellulite reduction. We now believe our initial launch could be timed appropriately to incorporate both tattoo and cellulite indications, subject to FDA clearance of the latter. (...)" At this time, Soliton does not anticipate a delay in its regulatory plans for the cellulite indication and plan to file its 510(k) in Q2. Follow-up visit cancellations in the ongoing 26-week cellulite assessment and increased difficulty in executing the initiation of further clinical trials at sites around the country will impact the timing of Soliton's planned additional hypertrophic scar proof-of-concept study and the longer-term 26-week follow-up visits in its cellulite pivotal study. Furthermore, it is possible this may extend the time required to file for additional, improved cellulite reduction claims with the FDA. Soliton now expects cash on hand to finance operations to December 2020.