{"id":688682,"date":"2022-09-26T08:17:52","date_gmt":"2022-09-26T12:17:52","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/pulse-biosciences-announces-fda-510k-clearance-for-the-treatment-of-sebaceous-hyperplasia\/"},"modified":"2022-09-26T08:17:52","modified_gmt":"2022-09-26T12:17:52","slug":"pulse-biosciences-announces-fda-510k-clearance-for-the-treatment-of-sebaceous-hyperplasia","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/pulse-biosciences-announces-fda-510k-clearance-for-the-treatment-of-sebaceous-hyperplasia\/","title":{"rendered":"Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia"},"content":{"rendered":"

<\/p>\n

Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia<\/b><\/p>\n

Additional 510(k) clearance recently received for use of larger spot size treatment tips <\/i>with the CellFX System<\/i><\/p>\n

HAYWARD, Calif.–(BUSINESS WIRE<\/a>)–
\nPulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX\u00ae System powered by Nano-Pulse Stimulation\u2122 (NPS\u2122) 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\u2019s 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\u2019s IDE approved study for the treatment of sebaceous hyperplasia.\n<\/p>\n

\nThe 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.\n<\/p>\n

\n\u201cWe 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\u2019s strong safety and effectiveness profile,\u201d said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences. \u201cWe 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.\u201d\n<\/p>\n

About Pulse Biosciences<\/b>\u00ae\n<\/p>\n

\nPulse 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\u2019s 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\u00ae 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<\/a> to learn more.\n<\/p>\n

\nPulse 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.\n<\/p>\n

Forward-Looking Statements<\/b><\/p>\n

\nAll statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences\u2019 expectations concerning customer adoption and future use of the CellFX System to address a range of dermatologic conditions, statements relating to the Company\u2019s future product development in healthcare outside of dermatology and the Company\u2019s other activities to develop and commercialize NPS technology to drive growth, statements about the Company\u2019s ability to pursue and complete strategic transactions and its prospects to partner any of its programs, whether in dermatology or otherwise, statements relating to the effectiveness of the Company\u2019s NPS technology and the CellFX System to improve the quality of life for patients, and Pulse Biosciences\u2019 expectations, whether stated or implied, regarding whether any regulatory clearances will enhance the value proposition of the CellFX System for patients, clinicians or others, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences\u2019 current expectations, estimates, and projections regarding Pulse Biosciences\u2019 business, operations and other similar or related factors. Words such as \u201cmay,\u201d \u201cwill,\u201d \u201ccould,\u201d \u201cwould,\u201d \u201cshould,\u201d \u201canticipate,\u201d \u201cpredict,\u201d \u201cpotential,\u201d \u201ccontinue,\u201d \u201cexpects,\u201d \u201cintends,\u201d \u201cplans,\u201d \u201cprojects,\u201d \u201cbelieves,\u201d \u201cestimates,\u201d 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\u2019 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\u2019 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.\n<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20220926005228\/en\/<\/a><\/span><\/p>\n

Investors:
\n<\/b>
Pulse Biosciences
\n
Kevin Danahy, CEO
\n
510.241.1077
\n
IR@pulsebiosciences.com
\n<\/a>
or
\n
Gilmartin Group
\n
Philip Trip Taylor
\n
415.937.5406
\n
philip@gilmartinir.com<\/a><\/p>\n

KEYWORDS:<\/b> California United States North America<\/p>\n

INDUSTRY KEYWORDS:<\/b> Biotechnology FDA Health Medical Devices<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
<\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia Additional 510(k) clearance recently received for use of larger spot size treatment tips with the CellFX System HAYWARD, Calif.–(BUSINESS WIRE)– Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX\u00ae System powered by Nano-Pulse Stimulation\u2122 (NPS\u2122) 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\u2019s 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 … <\/p>\n

Continue reading “Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-688682","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nPulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/pulse-biosciences-announces-fda-510k-clearance-for-the-treatment-of-sebaceous-hyperplasia\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia Additional 510(k) clearance recently received for use of larger spot size treatment tips with the CellFX System HAYWARD, Calif.–(BUSINESS WIRE)– Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX\u00ae System powered by Nano-Pulse Stimulation\u2122 (NPS\u2122) 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\u2019s general indication FDA clearance and enables the Company to support clinics in marketing and promoting CellFX treatments specifically for patients with sebaceous hyperplasia. 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