Achieving ISO-13485:2016 MDSAP Certification Affirms the Company’s Quality Management Systems Meet FDA, Health Canada and CE Mark Requirements
HAYWARD, Calif.--(BUSINESS WIRE)--Sep. 29, 2020--
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced the receipt of Medical Device Single Audit Program certification.
The Medical Device Single Audit Program (MDSAP) allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory jurisdictions or authorities to enable appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on the industry. The program was developed by the International Medical Device Regulators Forum and currently representatives from The Therapeutic Goods Administration in Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada; Canadian Medical Device Regulations, Japan’s Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency, and the U.S. Food and Drug Administration, Center for Devices and Radiological Health participate in the program.
“On the path to commercializing the CellFX® System, MDSAP and ISO-13485 certifications represent important milestones. Certification through these programs validate our ongoing commitment to maintaining the highest quality assurance standards within the medical device industry as required by regulatory authorities across the world,” said Darrin Uecker, President and CEO of Pulse Biosciences. “We are very proud of our teams for this significant accomplishment and for demonstrating the high standards we maintain as we prepare for commercial launch. The MDSAP certification is a significant and necessary step on the path to Health Canada Approval for the CellFX System and with this we remain on track for an approval in the first half of 2021.”
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. If cleared, the CellFX® System will be the first commercial product to harness the distinctive advantages of the Company’s proprietary Nano-Pulse Stimulation™ (NPS™) technology to treat a variety of applications for which an optimal solution remains unfulfilled. Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. Subject to regulatory approval, the initial commercial use of the CellFX System is expected to address a broad range of dermatologic conditions that share high demand among patients and practitioners for improved and durable aesthetic outcomes. Designed as a multi-application platform, the CellFX System is intended to offer customer value with a utilization-based revenue model across an expanding spectrum of clinical applications. To learn more please visit www.pulsebiosciences.com.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.
Caution: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation technology are for investigational use only.
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences’ expectations regarding regulatory clearance and the timing of regulatory filings or approvals, the ability of the Company to prepare and provide data to regulatory bodies, the CellFX System including the benefits of the CellFX System and commercialization of the CellFX System, the Company’s market opportunity and commercialization plans, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.
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Sandra Gardiner, EVP and CFO
Philip Trip Taylor
Nadine D. Tosk
Source: Pulse Biosciences, Inc.