Pulse Biosciences Wins Health Canada Approval for CellFX System

Pulse Biosciences Inc., a novel bioelectric medicine company progressing Nano-Pulse Stimulation (NPS) technology, said its CellFX System has been approved by Health Canada for a Medical Device License for use in dermatological procedures requiring ablation and resurfacing of the skin for the reduction, removal, and/or clearance of cellular-based benign lesions. Pulse Biosciences will now expand its controlled commercial launch of the CellFX System to select medical practices in Canada for the treatment of general dermatologic conditions, including sebaceous hyperplasia, seborrheic keratosis and cutaneous non-genital warts.
 
Dermatologist Sheetal Sapra, M.D. of Toronto has begun participation in the CellFX System Controlled Launch program. “I am thrilled to be the first dermatologist in Canada to provide the clinical advantages of the CellFX System using NPS technology. I’m constantly seeking innovative ways to help my patients and I see an unmet need that the CellFX procedure can address in clearing challenging skin lesions like sebaceous hyperplasia, common warts and seborrheic keratosis,” she said. Sapra is co-founder and director of the Institute of Cosmetic and Laser Surgery and Centre for Clinical Trials.
 
“Health Canada approval marks an important corporate milestone in our regulatory strategy and enables the planned expansion of our CellFX System Controlled Launch program in Canada. This third regulatory approval, following FDA clearance and CE mark approval earlier this year, further validates our NPS technology and we are excited to bring our novel CellFX procedure to patients in Canada,” said Darrin Uecker, president and CEO of Pulse Biosciences. “We look forward to initiating our controlled launch program with leading aesthetic dermatologists in Canada, expanding to an estimated 80 practices participating across the U.S., EU and Canada.”
 
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. The distinct advantages of the NPS mechanism have the potential to improve clinical and aesthetic outcomes by clearing benign lesions where important treatment gaps exist.
 
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The company’s proprietary NPS technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The CellFX System is the first commercial product to harness the distinctive advantages of NPS technology to treat a variety of applications for which an optimal solution remains unfulfilled. The initial commercial use of the CellFX System is to address a range of dermatologic conditions that share high demand among patients and practitioners for improved dermatologic outcomes. Designed as a multi-application platform, the CellFX System offers customer value with a utilization-based revenue model.