Press Releases

Pulse Biosciences Announces Presentation of Clinical Results Using Nano-Pulse Stimulation Technology for the Clearance of Skin Lesions at the American Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting

~ Two oral abstracts highlight positive findings from pivotal studies for the treatment of sebaceous hyperplasia and cutaneous non-genital warts with the CellFX® System ~

~ Two posters showcase favorable results of the CellFX System for the treatment of plantar warts and basal cell carcinoma ~

HAYWARD, Calif.--(BUSINESS WIRE)--Oct. 7, 2020-- Pulse Biosciences, Inc. (Nasdaq: PLSE) a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced that clinical results from studies spanning the Company’s dermatologic application portfolio will be presented at the American Society for Dermatologic Surgery (ASDS) virtual annual meeting on October 9-11, 2020. Positive study results generated using the Company’s innovative cellular-specific Nano-Pulse Stimulation mechanism performed with its CellFX System for the treatment of sebaceous hyperplasia lesions, cutaneous non-genital warts, plantar warts, and basal cell carcinoma will be presented in two oral presentations and two e-posters.

These newest published results from NPS clinical studies provide further evidence of the unique CellFX cellular mechanism of action for multiple applications across the lesion treatment spectrum. These recent findings were also the basis for the recently initiated multicenter clinical study to compare NPS technology to RF electrodessication in clearing sebaceous hyperplasia lesions. Treatment of the first study patient was previously announced by the Company on October 1, 2020.

“The positive results being shared at this year’s ASDS meeting add to the growing body of evidence in support of using Nano-Pulse Stimulation technology delivered by the CellFX System to treat a broad range of dermatology applications for which targeted clearance of cellular lesions or structures is medically or cosmetically desirable,” said Darrin Uecker, President and CEO of Pulse Biosciences. “These data underscore our persistent dedication to providing dermatologists a highly differentiated non-thermal solution with vast opportunity.”

Highlights from this meeting of leading dermatologic surgeons demonstrate:

  • Successful use of lower NPS energy levels to maintain high levels of effectiveness in clearing sebaceous hyperplasia lesions with greatly improved cosmesis and high subject satisfaction
  • Favorable clearance rate for warts on the hands, leg, knee, neck; no plume detected in a subset of NPS procedures
  • Encouraging findings of biopsy-confirmed elimination of residual BCC in the known NPS treatment zone for 8 nodular BCCs and 21 superficial BCCs, indicating promising potential for NPS treatment of both BCC-subtypes
  • Strong clearance rate of difficult-to-treat, recalcitrant plantar warts in a single treatment session

Dr. Ted Lain, author of the non-genital cutaneous wart study, said: “We are pleased to present conclusive evidence of consistently high rates of clearance across a variety of anatomical areas in one to two NPS treatments. Compared to today’s standard wart treatments, which typically require two to four visits to clear common cutaneous warts, these NPS results represent a much more convenient approach for the patient and the physician.” Dr. Lain is Chief Medical Officer of Sanova Dermatology in Austin, TX.

Members of the dermatologic surgery community who have registered for the virtual meeting can gain access to accepted video presentations and posters at the ASDS meeting portal. The listed dates and times below are subject to change.

Title

  Lead Author   Session Information

A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation (NPS) for Treatment of Cutaneous Non-Genital Warts

  Edward (Ted) Lain, MD,

Chief Medical Officer of Sanova Dermatology, Austin, TX

  Oral Presentation

(narrated video slide set)

Friday, October 9th at

11:15am ET

General Derm Track

Nano-Pulse Stimulation (NPS) Procedure to Treat Sebaceous Hyperplasia – A Dose-Ranging, Multi-Center, Pivotal Study

  Girish (Gilly) Munavalli, MD,

Medical Director of Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC.

  Oral Presentation

(narrated video slide set)

Saturday, October 10th at

11:00 to 11:45am ET

Cosmetic Track

A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation (NPS) Technology for Cutaneous Warts on the Feet

  Brenda LaTowsky, MD,

Clear Dermatology& Aesthetics Center, Scottsdale, AZ

  Poster Presentation

A first human feasibility study of Nano-Pulse Stimulation (NPS) to evaluate the potential elimination of a biopsy-confirmed nodular or superficial BCC in a short-term treat and resect study design

  Christopher B. Harmon, MD,

Mohs surgeon and founder of Surgical Dermatology Group, Birmingham, AL

  Poster Presentation

“We are thrilled to showcase our latest research and congratulate the American Society for Dermatology Surgery for hosting this important scientific exchange with aesthetic and surgical dermatology professionals as we work toward commercial introduction of our CellFX System powered by Nano-Pulse Stimulation technology,” said Ed Ebbers, Pulse’s Executive Vice President and General Manager, Dermatology.

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.

Caution: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation technology are for investigational use only.

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 regarding regulatory clearance and the timing of FDA and other regulatory filings or approvals, including meetings with FDA and the ability of the Company to successfully complete a 510(k) submission for the CellFX System or for a specific indication for the treatment of sebaceous hyperplasia (SH) lesions, the ability of the Company to prepare and provide data to FDA and other regulatory bodies, NPS technology including the effectiveness of such technology and the effectiveness of related clinical studies in predicting outcomes resulting from the use of NPS technology, the CellFX System including the benefits of the CellFX System and commercialization of the CellFX System, current and planned future clinical studies and the ability of the Company to execute such studies and results of any such studies, other matters related to its pipeline of product candidates, the Company’s market opportunity and commercialization plans, including the market for the treatment of SH, future financial performance, the impact of COVID-19 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.

Investor Relations:
Pulse Biosciences, Inc.
Sandra Gardiner, EVP and CFO
510.241.1077
IR@pulsebiosciences.com
or
Gilmartin Group
Philip Trip Taylor
415.937.5406
philip@gilmartinir.com

Media:
Tosk Communications
Nadine D. Tosk
504.453.8344
nadinepr@gmail.com
Press@pulsebiosciences.com

Source: Pulse Biosciences, Inc.