The CellFX System is a multi-application platform that uses Nano-Pulse Stimulation (NPS) technology to deliver nano-second pulses of electrical energy to nonthermally clear cells while sparing adjacent noncellular tissue.
The approval was 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.
With this approval, the company can now expand its commercial launch of the CellFX System to select medical practices in Canada to treat general dermatologic conditions, including sebaceous hyperplasia, seborrheic keratosis and cutaneous non-genital warts.
“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 quarter. This third regulatory approval, following FDA clearance and CE mark approval earlier this year, further validates our NPS technology. We are excited to bring our novel CellFX procedure to patients in Canada,” said Darrin Uecker, president and CEO of Pulse Biosciences.