PLSE 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-14

• In March 2026, we announced a strategic realignment (“the 2026 Realignment”) to prioritize and accelerate the development of our nsPFA electrophysiology catheters and other cardiac devices for the treatment of AF. This initiative followed the release of our positive clinical data in February 2026 fr…

• Atrial fibrillation is a type of heart arrythmia, or irregular heartbeat, caused by faulty electrical signals in the heart. AF is a highly prevalent condition and is growing significantly with an ageing population. It is estimated that 43 million people worldwide are affected by AF. Treatment requir…

• The results of preclinical and clinical testing of our most advanced nPulse cardiac products, namely our endocardial ablation catheter and surgical ablation clamp, have exceeded our expectations and initial data have been presented at physician and industry conferences. While these devices serve dif…

• Our nPulse Cardiac Catheter System is uniquely designed to provide a circumferential, or circular, ablation in a single treatment cycle. We believe this will enable faster treatment times compared to what is currently performed with thermal modalities, especially when ablating around the pulmonary v…

• In recent years, Pulsed Field Ablation (“PFA”) has gained attention in electrophysiology for the treatment of AF because of its safety profile and speed. However, current clinical products employing PFA in AF treatment differ from nsPFA technology in that the pulse widths are longer, typically in th…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• Our first product for soft tissue ablation in a surgical setting, the Vybrance Percutaneous Electrode System, consists of a disposable, percutaneous, needle electrode for use with our proprietary nPulse Console. This novel electrode is designed to harness and deliver the key advantages of nsPFA ener…

• After years of preclinical development and testing, in June 2023, we initiated a first-in-human study using our proprietary nsPFA-enabled percutaneous electrode. This study was conducted by Professor Stefano Spiezia at the Ospedale del Mare in Naples, Italy, to help us better understand and confirm …

• In parallel, in November 2023, we filed a premarket notification 510(k) with the FDA for clearance to commercialize our novel Vybrance Percutaneous Electrode System in the United States. In March 2024, we received FDA 510(k) clearance for our Vybrance Percutaneous Electrode System for use in the abl…

• Having secured 510(k) clearance to market and sell the Vybrance Percutaneous Electrode System in the United States with different sizes of percutaneous electrode needles, we have engaged with experts in the field of soft tissue ablation to gather information that will help shape our future commercia…

• More recently, in September 2025, we commenced a clinical trial (PRECISE BTN) to generate clinical evidence to demonstrate the safety and effectiveness of this less-invasive thyroid preserving procedure and support planned commercialization of the Vybrance Percutaneous Electrode System in the United…

相对上期新增的文字 · 来源:10-Q · 2026-05-14

• lack of clinical data showing longer-term patient benefits; and

• Additionally, we may face pricing pressure that could reduce our revenues and margins, failure to achieve expected procedure volumes could adversely affect our revenue growth and gross margins, and our limited commercial history makes it difficult to forecast revenue growth. The cumulative effects o…

• The medical technology, medical device, biotechnology, and pharmaceutical industries are characterized by intense and dynamic competition to develop new technologies and proprietary therapies. We face competition from several sources, such as pharmaceutical companies, medical device companies, gener…

• We will find ourselves in competition with one or more of these companies, all of which may have competitive advantages over us, such as:

• Additionally, the market for the treatment of benign thyroid nodules is characterized by competition from established surgical procedures and minimally invasive thermal therapies. We compete primarily against the traditional surgical standard of care, including thyroid lobectomy and total thyroidect…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• We will need to raise additional capital, which may result in further dilution to our investors, or incur indebtedness. The servicing of future debt may impair our liquidity position.

• We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations of these laws and regulations.

• the possible introduction of new technologies competitive to our products; and

• The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indicatio…

• The medical technology, medical device, biotechnology, and pharmaceutical industries are characterized by intense and dynamic competition to develop new technologies and proprietary therapies. We face competition from several sources, such as pharmaceutical companies, medical device companies, gener…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• On May 14, 2025, Kevin Danahy, the Company’s Chief Commercial Officer, adopted a Rule 10b5‑1 trading arrangement intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act for the exercise of vested options and the sale of up to 150,000 shares of common stock between August…

• On June 12, 2025, Darrin Uecker, the Company’s Chief Technology Officer and a Director, adopted a Rule 10b5‑1 trading arrangement intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act for the exercise of expiring options and the sale of up to 120,000 shares of common s…