Pulse Biosciences Announces Positive Clinical Data on Nano-Pulse Stimulation Procedure for Low-Risk Basal Cell Carcinoma Lesions

Rhea-AI Summary

Pulse Biosciences (PLSE) has announced positive clinical results for its CellFX® System using Nano-Pulse Stimulation™ (NPS™) technology to treat low-risk basal cell carcinoma (BCC) lesions. An oral presentation at the 2022 American Society for Dermatologic Surgery Annual Meeting in Denver, from October 6-10, highlighted the technology's efficacy and favorable cosmetic outcomes. The study suggests NPS may provide a non-surgical and less scarring alternative to current treatment methods, potentially revolutionizing care for the 3.6 million U.S. patients affected by BCC annually.

Positive

• Positive clinical data from FDA approved study on NPS technology for BCC treatment.
• Demonstrated complete clearance of low-risk BCC lesions with minimal scarring.
• Potential to disrupt existing treatment methods like excisional surgery and Mohs surgery.

Negative

• None.

~ Oral video presentation at 2022 American Society for Dermatologic Surgery Annual Conference to highlight high efficacy and favorable cosmesis using NPS technology to clear superficial and nodular basal cell carcinoma (BCC) lesions

HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX® System powered by Nano-Pulse Stimulation™ (NPS™) technology, today announced positive clinical data from an FDA approved Investigational Device Exempt treat and resect study on the use of NPS for low-risk basal cell carcinoma (BCC) lesions. An oral video presentation on the favorable results of performing the CellFX procedure for low-risk superficial and nodular BCC lesion clearance will be delivered at the 2022 American Society for Dermatologic Surgery (ASDS) Annual Meeting, taking place on October 6-10, 2022 in Denver, Colorado.

“It is exciting and encouraging to see complete clearance of basal cell carcinoma lesions using NPS technology,” said Amy Ross, MD, medical director and founder of PHDermatology of Tampa, Florida, and study investigator. “The results shown in this study gives me a high degree of confidence in NPS technology as an effective and cosmetically acceptable treatment, and potential alternative to the current standard of care for these types of BCC lesions.”

Excisional surgery using electrodesiccation and curettage (ED&C) or Mohs micrographic surgery are the current standards of care for BCC lesions, both of which inevitably lead to scarring. Basal Cell Carcinoma is the most common form of skin cancer, accounting for 67% of all skin cancers and affecting more than 3.6 million patients annually. Nonsurgical NPS technology can potentially be a disruptive treatment option, due to its nonthermal energy to clear lesions with lower likelihood of scar formation.

“Showcasing this exciting new clinical data to dermatology thought leaders at ASDS is a major step towards demonstrating the applicability of NPS technology beyond benign dermatologic conditions,” said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences. “The ongoing body of clinical evidence in dermatology continues to prove that NPS technology is safe and effective and produces excellent outcomes.”

Oral Video Presentation:
Title: Nano-Pulse Stimulation (NPS) Technology for Treatment of Low-Risk Basal Cell Carcinoma (BCC) - Feasibility Study Using a Treat and Resect Design

Presented by: Dr. Amy Ross, Tampa, FL
Co-Authors: Amy S. Ross, MD; Todd Schlesinger, MD; Christopher Harmon, MD; Ronald Moy, MD; Thomas E. Rohrer, MD; Darius R. Mehregan, MD, PhD; Lauren M. Johnston, BS; William A. Knape, BS

Location: The video presentation will be available within the Education Session Room to those attending the 2022 American Society for Dermatologic Surgery (ASDS) Annual Meeting during open exhibit hours.

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 (NPS) 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 for the use of NPS technology 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 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.

To stay informed about the CellFX System, please visit CellFX.com and sign-up for updates.

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 such as superficial and nodular basal cell carcinoma (BCC), statements relating to the Company’s future product development in healthcare outside of dermatology, 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 the Company’s NPS technology will become a disruptive treatment option for BCC and whether future clinical studies will show the CellFX System is safe and effective to treat BCC or any other medical condition, 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/20221006005287/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 are the results of Pulse Biosciences' recent clinical study on BCC treatments?

Pulse Biosciences reported positive clinical results showing complete clearance of low-risk basal cell carcinoma lesions using their CellFX® System with Nano-Pulse Stimulation technology.

When and where will the presentation of the BCC study take place?

The oral video presentation will occur at the 2022 American Society for Dermatologic Surgery Annual Meeting in Denver, Colorado, from October 6-10, 2022.

What is the significance of NPS technology in treating BCC?

NPS technology offers a non-surgical option for treating BCC that may reduce scarring and improve cosmetic outcomes compared to traditional methods.

How common is basal cell carcinoma in the United States?

Basal cell carcinoma is the most prevalent form of skin cancer, affecting over 3.6 million patients annually in the U.S.

What are the next steps for Pulse Biosciences following the study?

Pulse Biosciences aims to continue showcasing the clinical effectiveness of NPS technology and explore its applications in various medical specialties.