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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 (PLSE) released its third-quarter financial results for 2022, reporting no revenue and a GAAP net loss of $18.0 million, up from a loss of $14.3 million in Q3 2021. Total expenses rose to $18.0 million, including a $7.2 million inventory reserve for dermatology. Cash reserves improved to $69.2 million, compared to $14.8 million in Q2 2022. The company is focusing on cardiac ablation for atrial fibrillation and anticipates a quarterly cash burn of approximately $8 million starting Q1 2023. A $65 million term loan was secured from the Executive Chairman to support product development.
Pulse Biosciences (Nasdaq: PLSE) will report its third quarter 2022 financial results on November 10, 2022, after market close. A conference call will follow at 1:30pm PT / 4:30pm ET, where management will discuss the results. Investors can join the call by dialing 1-877-704-4453 (domestic) or 1-201-389-0920 (international), and a webcast will be available at investors.pulsebiosciences.com.
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.
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.
Pulse Biosciences is focusing on advancing its core Nano-Pulse Stimulation (NPS) technology in the cardiac and oncology sectors while reducing its dermatology operations. Kevin Danahy has been appointed as the new CEO, with Darrin Uecker becoming Chief Technology Officer. The company has secured a $65 million loan from Robert Duggan, who now serves as Executive Chairman. Pulse aims to refine its strategic focus and expects to announce further progress in its healthcare initiatives within 60 days.
Pulse Biosciences, Inc. (Nasdaq: PLSE) reported Q2 2022 revenue of $265,000, a decrease from previous quarters, with notable activities including FDA clearance for expanded energy settings of the CellFX System. The company successfully completed two sales of the system and transitioned four clinics to commercial use, with 43 total conversions. Operating expenses saw a 23% reduction, totaling $14.3 million. The net loss was ($14.0 million) for the quarter. Cash reserves fell to $14.8 million from $47.4 million the previous year, signaling financial challenges.
Pulse Biosciences, Inc. (NASDAQ: PLSE) has received FDA 510(k) clearance for expanded energy settings for its CellFX System in dermatology. This allows U.S. clinicians to offer more customized treatment options for benign lesions. The FDA's expedited review took only 53 days, confirming the new settings' safety and efficacy. The CellFX System, powered by Nano-Pulse Stimulation technology, aims to improve dermatologic outcomes and deliver value through a utilization-based revenue model. The company remains committed to advancing its technology and expanding clinical applications.
Pulse Biosciences, Inc. (Nasdaq: PLSE) will release its second quarter 2022 financial results after market close on August 10, 2022. A conference call will follow at 1:30pm PT for investors to discuss the results. The company focuses on bioelectric medicine, offering the CellFX® System, which utilizes Nano-Pulse Stimulation™ technology for treating dermatologic conditions.
Pulse Biosciences (NASDAQ: PLSE) recently announced the granting of equity inducement awards to three new employees. The Compensation Committee approved stock options for a total of 108,500 shares at an exercise price of $2.05, matching the closing stock price on June 15, 2022. The awards are structured mostly with four-year time-based vesting and include performance criteria for one employee. This move aligns with Nasdaq Listing Rule 5635(c)(4) and aims to attract and retain talent within the company.
Pulse Biosciences, Inc. (NASDAQ: PLSE) announced the successful closing of its rights offering, raising $15 million by selling 7,317,072 units at $2.05 each. Each unit consists of one share of common stock and one warrant for an additional share. The rights offering attracted significant investor interest, exceeding the $15 million limit, leading to a proportionate allocation for over-subscriptions. The gross proceeds may increase to $30 million if all warrants are exercised. As of now, the company has 37,119,352 shares outstanding, effective from the offering.
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