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Pulse Biosciences, Inc. (PLSE) is a pioneering clinical-stage electroceutical company focused on the commercial application of its proprietary Nano-Pulse Stimulation (NPS) technology. Headquartered in Hayward, CA, the company's core mission is to leverage this novel technology to improve and extend patient lives, addressing the distinct needs of patients and physicians alike.
Nano-Pulse Stimulation Technology
NPS is a cutting-edge, non-thermal, drug-free energy-based technology that utilizes ultra-short nanosecond electrical pulses to impact cell membranes and intracellular structures. This method promotes unique cellular behaviors and can induce specific immune responses, opening up a myriad of therapeutic possibilities. Unlike conventional treatments, NPS delivers electrical pulses in billionths of a second, providing targeted effects without damaging surrounding tissues.
Applications and Innovations
Pulse Biosciences is actively exploring the potential of its NPS technology across various medical fields. Key areas of investigation include immuno-oncology, where NPS may be used to treat cancer by modulating the immune system's response, and dermatology, for treatments that require precise, non-invasive interventions. The technology's unique biologic effects position it as a promising solution for conditions lacking optimal treatments.
Recent Achievements and Projects
The company has made significant strides in both preclinical and clinical studies, demonstrating the safety and efficacy of NPS technology. Recent projects have focused on refining device capabilities, enhancing treatment protocols, and expanding the scope of applications. Partnerships with leading medical institutions and ongoing collaborations with researchers underscore Pulse Biosciences' commitment to innovation.
Financial Condition
Pulse Biosciences generates substantial revenue primarily from the sale of its systems in North America. The company continues to invest in research and development to further advance its technology and explore new market opportunities.
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Pulse Biosciences, Inc. (Nasdaq: PLSE) has announced its participation in two upcoming virtual investor conferences. On March 10, 2021, management will engage in one-on-one meetings at the H.C. Wainwright Global Life Sciences Conference, with a presentation webcast available on March 9, 2021. Additionally, on March 17, 2021, the company will participate in an aesthetic dermatology panel discussion at the Maxim Emerging Growth Virtual Conference, featuring a live webcast at 2:00pm ET. Interested parties can access on-demand webcasts via the company’s website.
Pulse Biosciences (Nasdaq: PLSE) reported its fourth quarter and full-year financial results for 2020. The company secured FDA clearance and CE mark approval for its CellFX® System, enhancing its market position in aesthetic dermatology. As of December 31, 2020, cash and investments totaled $20.5 million, a decrease from $29.6 million in Q3 2020. Despite a net loss of $13.8 million for Q4 2020, the company maintained operational focus, with minimal pandemic impact on its processes. The launch of its Controlled Launch program for the CellFX System is expected to drive long-term growth.
Pulse Biosciences (Nasdaq: PLSE) has successfully completed the first CellFX procedures in the European Union, marking a critical milestone in its controlled launch program. The CellFX System, which utilizes Nano-Pulse Stimulation™ technology, is designed to non-thermally treat common benign lesions, enhancing patient satisfaction. A survey highlighted that patients prioritize treatment for skin lesions, with an average of 200 cases per month per aesthetic dermatologist. The company aims to establish best practices with leading specialists across Europe, while concurrently launching in the U.S.
Pulse Biosciences (Nasdaq: PLSE) has initiated the controlled launch of its CellFX® System, marking its first commercial use. This innovative technology utilizes Nano-Pulse Stimulation™ (NPS™) to treat skin conditions non-thermally, preserving healthy tissue. The launch is supported by positive clinical data and has received interest from leading dermatology professionals in the U.S. and Europe. Medical Director Dr. Munavalli reports a high demand for improved treatment options among patients, affirming the CellFX System's versatility in dermatological applications.
Pulse Biosciences, Inc. (Nasdaq: PLSE) will report financial results for Q4 and full year 2020 after market close on February 22, 2021. A conference call is scheduled for 1:30 PM PT, allowing investors to hear management discuss the results. The company is known for its innovative Nano-Pulse Stimulation™ (NPS™) technology, which powers its CellFX® System, aimed at improving dermatologic outcomes while sparing non-cellular tissue. This system represents a multi-application platform with a utilization-based revenue model.
Pulse Biosciences (Nasdaq: PLSE) has filed a prospectus supplement with the SEC for an offering of common stock totaling up to $60 million. The funds will be used for working capital, including further investment in clinical studies for its Nano-Pulse Stimulation technology and the development of its CellFX System. Shares will be sold through Stifel, Nicolaus & Company as the sales agent. Investors are advised to read the complete prospectus and the risks associated with the offering.
Pulse Biosciences (Nasdaq: PLSE) has received FDA clearance for its CellFX® System, designed for dermatologic procedures that require skin ablation and resurfacing. This marks a significant step in the company’s regulatory strategy, following its recent CE mark acquisition. The CellFX System utilizes innovative Nano-Pulse Stimulation™ (NPS™) technology, which non-thermally clears unwanted cellular structures while preserving surrounding tissue. A controlled commercial launch will commence shortly with selected Key Opinion Leaders in the U.S., aiming for long-term commercial success.
Pulse Biosciences (Nasdaq: PLSE) has received CE mark approval for its CellFX® System, validating its Nano-Pulse Stimulation™ (NPS™) technology for treating dermatologic conditions like sebaceous hyperplasia and seborrheic keratosis in the EU. This marks the system's first commercial regulatory clearance, enabling a controlled launch in top aesthetic centers across Europe. The technology offers a unique approach to removing lesions without damaging adjacent tissue, presenting a significant advancement in aesthetic dermatology. The commercial launch is set to occur this quarter.
Pulse Biosciences (Nasdaq: PLSE) announced significant regulatory progress for its CellFX System. The FDA has moved its 510(k) submission for a general dermatology indication to Interactive Review. The company successfully completed treatments in a pivotal comparison study for sebaceous hyperplasia, with a 510(k) submission expected soon. Additionally, an FDA Investigational Device Exemption has been granted for a study on cutaneous non-genital warts. The review for CE mark approval and Health Canada license is also on track, showcasing robust advancements despite prior challenges.
Pulse Biosciences announced a notice of redemption for all outstanding warrants to purchase shares of the Company’s common stock, effective February 5, 2021. The redemption price is set at $0.01 per warrant. The warrants were issued as part of a rights offering that occurred in June 2020, which raised $30 million. The conditions for redemption were met as the average stock price exceeded $14.02 for ten consecutive trading days prior to December 31, 2020. If all warrants are exercised, the Company could receive an additional $4.5 million.
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