MIAMI - Pulse Biosciences, Inc. (NASDAQ:PLSE), a bioelectric medicine company, has announced preliminary results from a feasibility study indicating its Nanosecond Pulsed Field Ablation (nano-PFA) technology effectively reduces the volume of benign thyroid nodules and provides symptomatic relief. The findings were presented at the 2024 American Thyroid Association Annual Meeting.
The study, involving 30 patients, showed an average reduction in nodule size of over 50% after treatment with the company's Percutaneous Electrode System, with no evidence of residual fibrosis or scarring. Symptomatic relief was reported within the first month post-treatment, suggesting a nonthermal and minimally invasive alternative to traditional thermal ablation or surgical removal.
Dr. Stefano Spiezia, the study's principal investigator, expressed optimism about the potential of nano-PFA to improve the standard of care for patients with benign thyroid nodules. The study's outcomes are anticipated to inform the design of a pivotal trial slated for mid-2025, aiming for a specific labeling indication for commercial use in the United States.
Pulse Biosciences' technology, which has received FDA 510(k) clearance for soft tissue ablation, utilizes nanosecond pulses of electrical energy to target cellular tissue while sparing adjacent structures. The company is also exploring its CellFX nsPFA technology for the treatment of atrial fibrillation and other conditions.
The press release statement emphasized these results as groundbreaking and indicative of the potential benefits of nano-PFA energy. However, it also contained forward-looking statements regarding the technology's safety, effectiveness, and potential regulatory approval, which are subject to various factors and uncertainties.
Investors and interested parties are advised that the information is based on a press release statement, and further research and clinical trials are necessary to validate the efficacy and safety of the nano-PFA technology for treating benign thyroid nodules.
In other recent news, Pulse Biosciences reported its Q3 2024 financial results and shared updates on its nano-Pulse Stimulation Technology (nano-PFA). Despite a GAAP net loss of $12.7 million, the company raised $60 million through a rights offering and ended the quarter with $79 million in cash and cash equivalents. Highlighting recent developments, the company treated its first Atrial Fibrillation (AF) patients in Europe using the nano-PFA Cardiac Surgical System. The system has also received U.S. FDA breakthrough device designation.
The company is planning pilot programs and pivotal clinical studies for various applications of nano-PFA in 2025. Looking ahead, Pulse Biosciences is preparing for three pivotal clinical studies in 2025 and is expanding its team to support anticipated growth. The company has made key hires in leadership positions to advance clinical and operational objectives.
While the GAAP net loss for Q3 2024 was $12.7 million, an increase from the $10.6 million loss in Q3 2023, the company's cash and cash equivalents were $79 million as of September 30, 2024, up from $44.4 million at the end of 2023. These are some of the recent developments in the company's journey.
InvestingPro Insights
Pulse Biosciences' promising preliminary results for its nano-PFA technology are reflected in its recent market performance. According to InvestingPro data, the company has seen a remarkable 292.04% price total return over the past year, with a particularly strong 140.43% return in the last six months. This surge aligns with the positive clinical outcomes reported and the potential market opportunity for their innovative thyroid nodule treatment.
Despite these encouraging developments, it's important to note that Pulse Biosciences is currently not profitable, with an adjusted operating income of -$46.13 million over the last twelve months. However, an InvestingPro Tip suggests that net income is expected to grow this year, which could be driven by the advancement of their nano-PFA technology towards commercialization.
Another relevant InvestingPro Tip indicates that the company's liquid assets exceed short-term obligations, potentially providing financial flexibility as they move towards their planned pivotal trial in mid-2025. This solid financial footing could be crucial for supporting ongoing research and development efforts.
For investors seeking a more comprehensive analysis, InvestingPro offers 12 additional tips for Pulse Biosciences, providing deeper insights into the company's financial health and market position.
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