Pulse Biosciences, Inc. (PLSE) Announces FDA Clearance for the CellFX System
- Boeing, travel stocks pull Wall Street lower as virus cases rise
- Kansas City Southern (KSU) Soars as Bidding War Brews After Canadian National Railway (CNI) Makes a $33.7 Billion Offer
- Analysts Positive, Raise PTs as IBM (IBM) Tops Market Estimates and Reaffirms Guidance
- Boeing (BA) Down 3% After CFO - Aged 54 - Retires, Seen as an 'Odd' Move
- Tesla (TSLA): Problems in China Mounting as Communist Party Officials Ask Company to 'Respect Chinese Consumers and Comply with Local Laws'
Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced U.S. Food and Drug Administration (FDA) clearance of the CellFX® System for dermatologic procedures requiring ablation and resurfacing of the skin. In the coming weeks a controlled commercial launch in the U.S. will begin with a group of selected Key Opinion Leaders (KOLs) in aesthetic dermatology.
“The CellFX System offers a unique non-thermal mechanism that in my experience can clear epidermal and mid-dermal cellular structures without damaging the non-cellular dermal collagen, which can lead to remarkable improvements in common skin problems that I see every day,” said Brian Zelickson, MD, Founder and Medical Director, Zel Skin and Laser Specialists in Edina, Minnesota. “We look forward to adding the CellFX System to our practice and foresee a promising future of new applications for this versatile technology platform.”
The CellFX System is a multi-application platform that harnesses the Company’s proprietary NPS technology delivering nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. NPS technology provides the ability to clear unwanted cellular structures while limiting collateral damage to the surrounding healthy skin, resulting in the potential to clear cellular skin structures with aesthetically pleasing outcomes.
“FDA clearance for the CellFX System is a tremendous achievement for Pulse Biosciences. We received the indication we were pursuing and believe this will be the first of many in this stepwise approach with FDA. This continued progress on our regulatory strategy, following the recent receipt of the CE mark, is another strong validation of the safety and efficacy of our technology. We are proud of our team and thankful to the investigators and FDA for their diligent efforts as part of this accomplishment,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. “We look forward to proceeding with our Controlled Launch program with KOLs in the United States. This measured approach to launching the CellFX System is our top priority for 2021 and will be key to long-term commercial success of the CellFX platform.”
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Johnson & Johnson (JNJ) COVID-19 Vaccine Roll-out to Resume in Europe Following EMA Review
- Diversey Holdings Ltd. (DSEY) Adds Selim Bassoul and Juan R. Figuereo to Board
- Vincerx Pharma (VINC) Announces FDA Clearance of IND for Phase 1b Study of VIP152 in Chronic Lymphocytic Leukemia and Richter Syndrome
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!