Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia

Rhea-AI Summary

Pulse Biosciences (Nasdaq: PLSE) announced that it has received FDA 510(k) clearance for its CellFX System, expanding treatment indications to include sebaceous hyperplasia for Fitzpatrick skin types I-III. This clearance is backed by clinical data from an IDE approved study. Additionally, the company introduced larger treatment tips (7.5mm and 10mm), enhancing the device's application for larger benign lesions. CEO Kevin Danahy expressed confidence in the system's effectiveness and potential market adoption.

Positive

• FDA clearance for CellFX System to treat sebaceous hyperplasia enhances market potential.
• Introduction of larger treatment tips expands application scope for various lesion sizes.

Negative

• None.

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® 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 Biosciences’ expectations concerning customer adoption and future use of the CellFX System to address a range of dermatologic conditions, statements relating to the Company’s future product development in healthcare outside of dermatology and the Company’s other activities to develop and commercialize NPS technology to drive growth, statements about the Company’s 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’s NPS technology and the CellFX System to improve the quality of life for patients, and Pulse Biosciences’ 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’ 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220926005228/en/

Investors:

Pulse Biosciences

Kevin Danahy, CEO

510.241.1077

IR@pulsebiosciences.com

or

Gilmartin Group

Philip Trip Taylor

415.937.5406

philip@gilmartinir.com

Source: Pulse Biosciences, Inc.

FAQ

What recent FDA clearance did Pulse Biosciences receive for the CellFX System?

Pulse Biosciences received FDA 510(k) clearance to expand the CellFX System's indications to include the treatment of sebaceous hyperplasia.

Which skin types are now included in the CellFX System's treatment indications?

The CellFX System can now treat patients with Fitzpatrick skin types I-III.

What are the new treatment tip sizes introduced by Pulse Biosciences?

Pulse Biosciences introduced 7.5mm and 10mm treatment tips for the CellFX System.

How does the recent FDA clearance affect Pulse Biosciences' market strategy?

The FDA clearance enhances the CellFX System's marketability and supports clinics in promoting specific treatments, potentially increasing the company's growth.