subslover
2年前
Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia
September 26 2022 - 08:00AM
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Additional 510(k) clearance recently received for use of larger spot size treatment tips with the CellFX System
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX® System powered by Nano-Pulse Stimulation™ (NPS™) technology, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. This specific indication clearance enhances the CellFX System’s general indication FDA clearance and enables the Company to support clinics in marketing and promoting CellFX treatments specifically for patients with sebaceous hyperplasia. The clearance was based on clinical data from the Company’s IDE approved study for the treatment of sebaceous hyperplasia.
The Company also recently received FDA 510(k) clearance of two additional treatment tips with larger spot sizes, specifically 7.5mm and 10mm tip sizes, for treating larger benign lesions. These treatment tips broaden the portfolio of previously available 1.5mm, 2.5mm and 5.0mm treatment tip sizes.
“We are pleased with the continued advancement of the CellFX System and its capabilities to enhance its value proposition for patients, clinicians and any potential commercial partner. These clearances provide further validation of the system’s strong safety and effectiveness profile,” said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences. “We would like to thank all of the investigators, the staff at their clinics and the patients who participated in these trials, as well as the FDA for their ongoing collaboration as we endeavor to offer the benefits of NPS technology to more patients.”
About Pulse Biosciences®
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 Nano-Pulse Stimulation 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 conditions for which an optimal solution remains unfulfilled. The Company is actively pursuing application development in cardiology, oncology, gastroenterology, and other medical specialties. Designed as a multi-application platform, the CellFX System offers customer value with a utilization-based revenue model. Visit www.pulsebiosciences.com to learn more.
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.
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse
sokol
7年前
Insider buying.
Pulse Biosciences, Inc (NASDAQ:PLSE) Director Maky Zanganeh acquired 28,790 shares of the business's stock in a transaction dated Thursday, August 3rd. The shares were bought at an average price of $23.96 per share, for a total transaction of $689,808.40. Following the completion of the acquisition, the director now owns 287,225 shares in the company, valued at $6,881,911. The acquisition was disclosed in a legal filing with the SEC.
Director Maky Zanganeh bought 8,290 shares of Pulse Biosciences stock in a transaction dated Wednesday, August 2nd.
Pulse Biosciences, Inc (NASDAQ:PLSE) major shareholder Robert W. Duggan acquired 277,450 shares of Pulse Biosciences stock in a transaction on Thursday, August 3rd. The stock was acquired at an average price of $23.14 per share, with a total value of $6,420,193.00. Following the purchase, the insider now directly owns 3,153,234 shares in the company, valued at $72,965,834.76. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is available through the SEC website. Major shareholders that own at least 10% of a company's stock are required to disclose their transactions with the SEC.
sokol
7年前
Insider buying.
Pulse Biosciences, Inc (NASDAQ:PLSE) Director Maky Zanganeh acquired 28,790 shares of the business's stock in a transaction dated Thursday, August 3rd. The shares were bought at an average price of $23.96 per share, for a total transaction of $689,808.40. Following the completion of the acquisition, the director now owns 287,225 shares in the company, valued at $6,881,911. The acquisition was disclosed in a legal filing with the SEC.
Director Maky Zanganeh bought 8,290 shares of Pulse Biosciences stock in a transaction dated Wednesday, August 2nd.
Pulse Biosciences, Inc (NASDAQ:PLSE) major shareholder Robert W. Duggan acquired 277,450 shares of Pulse Biosciences stock in a transaction on Thursday, August 3rd. The stock was acquired at an average price of $23.14 per share, with a total value of $6,420,193.00. Following the purchase, the insider now directly owns 3,153,234 shares in the company, valued at $72,965,834.76. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is available through the SEC website. Major shareholders that own at least 10% of a company's stock are required to disclose their transactions with the SEC.