PULSE BIOSCIENCES (PLSE) Company Report

Pulse Biosciences (PLSE) announced FDA Investigational Device Exemption (IDE) approval to initiate its nPulse Cardiac Catheter Ablation System Study (NANOPULSE-AF).
This study will evaluate the nPulse Cardiac Catheter System for the treatment of recurrent drug-resistant symptomatic paroxysmal atrial fibrillation (PAF).
The single-arm, multicenter, prospective study plans to enroll up to 145 patients across up to 30 sites, including three outside the United States.
The nPulse Cardiac Catheter utilizes nanosecond Pulsed Field Ablation (nsPFA) technology, designed to deliver lower total energy and potentially reduce collateral injury compared to existing systems.

Dec 18, 2025, 12:00 PM

Press Release

Pulse Biosciences Provides Business Overview and Strategic Update

PLSE

Product Launch

New Projects/Investments

Guidance Update

Pulse Biosciences (PLSE) is developing and commercializing nanosecond Pulsed Field Ablation (nsPFA) technology, which uses extremely short, high-amplitude pulses to cause regulated cell death non-thermally, preserving nerves and blood vessels.
The company holds 215 issued patents and 100 pending for its nsPFA technology, which has seen approximately $400 million invested in its development over about 10 years.
Pulse Biosciences ended Q3 with $95 million in cash against a $36 million burn for 2024, with an anticipated increase in burn for 2025 to fund two IDEs and a commercial launch. The company states it has the balance sheet to execute its plan through 2026.
The company is targeting three markets (Thyroid, Cardiac Surgery, Electrophysiology) currently valued at $6 billion, projected to grow to over $16 billion. Commercialization has begun for thyroid, cardiac surgery is in an IDE phase with Breakthrough Device Designation, and an IDE has been filed for EP.

Dec 3, 2025, 2:50 PM

Transcript

Pulse Biosciences Provides Overview of Nanosecond PFA Technology and Market Strategy

PLSE

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Pulse Biosciences is advancing Nanosecond Pulsed Field Ablation (nsPFA) technology, a proprietary platform that induces non-thermal cell death without damaging nerves or blood vessels. The company has invested approximately $400 million over 10 years and holds 215 issued patents.
The company is targeting three large markets: Thyroid, Cardiac Surgery, and Electrophysiology (EP), which currently represent a $6 billion opportunity and are projected to grow to over $16 billion.
Commercialization has begun with a limited market release for benign thyroid nodules, a $1 billion opportunity with no current competition.
For Cardiac Surgery, an IDE is underway with a Breakthrough Device Designation, and an IDE has been filed for EP, with patient enrollment expected in the next couple of months.
Pulse Biosciences reported $95 million in cash at the end of Q3, with a $36 million burn for 2024, and expects to have sufficient capital to execute its plan through 2026.

Dec 3, 2025, 2:50 PM

Transcript

Pulse Biosciences Provides Update on Nanosecond Pulsed Field Ablation Technology and Market Opportunities

PLSE

Product Launch

New Projects/Investments

Pulse Biosciences is commercializing its proprietary nanosecond pulsed field ablation (nsPFA) technology, which delivers ultra-precise nanosecond pulsed electric fields and offers significant advantages over microsecond PFA, including non-thermal, faster, and deeper ablations.
The company reported a strong balance sheet with $95.2 million in cash at the end of Q3 and generated $86,000 in revenue during the quarter from the limited market release of its M-Pulse Vibrance percutaneous electrode system.
Pulse Biosciences is targeting three initial market opportunities with its M-Pulse technology: benign thyroid nodules (a $1 billion annual market), surgical cardiac ablation, and AFib ablation in electrophysiology (a $3 billion opportunity), totaling a $6 billion opportunity today.
Key clinical developments include the initiation of the PRECISE-BTN study for thyroid nodules (with over 40% enrollment to date) , the NANOCLAMP AF study for surgical cardiac ablation (with the first patient treated last month) , and plans to commence a pivotal trial for the M-Pulse Cardiac Catheter in EP in Q1 2026.
The company plans a hybrid commercialization strategy, pursuing direct entry for markets like thyroid and seeking partnerships for larger, established markets such as electrophysiology.

Nov 13, 2025, 7:40 PM

Transcript

Pulse Biosciences Provides Update on Nanosecond PFA Technology and Market Progress

PLSE

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Pulse Biosciences reported a strong balance sheet with $95.2 million in cash at the end of Q3 2025 and generated $86,000 in revenue during the quarter from the limited market release of its FDA-cleared M-Pulse Vibrance percutaneous electrode system for soft tissue ablation.
The company is commercializing its proprietary nanosecond pulsed field ablation (nsPFA) technology, which delivers higher amplitude, shorter duration pulses (nanoseconds) compared to microsecond PFA, enabling non-thermal, faster, and deeper ablations with remarkable clinical benefits.
Pulse Biosciences is targeting three initial markets: the $1 billion annual thyroid intervention market, the underpenetrated surgical cardiac ablation market, and the $3 billion electrophysiology (AFib) market, with a combined potential of $6 billion today.
Clinical studies are progressing, with the Precise BTN study for benign thyroid nodules over 40% enrolled (expected completion Q1 2026), the NanoClamp AF study for surgical cardiac ablation having treated its first patient, and the M-Pulse Cardiac Catheter IDE study for AFib expected to commence in Q1 2026.

Nov 13, 2025, 7:40 PM

Transcript

Pulse Biosciences Discusses Nanopulse Stimulation Technology and Market Opportunities

PLSE

Product Launch

New Projects/Investments

Pulse Biosciences is advancing its proprietary nanosecond pulsed field ablation (nsPFA) technology, M-Pulse, for tissue ablation, highlighting its advantages over microsecond PFA.
The company reported a strong balance sheet with $95.2 million in cash at the end of Q3 and generated $86,000 in revenue in Q3 from the limited market release of its FDA-cleared M-Pulse Vibrance percutaneous electrode system.
Pulse Biosciences is pursuing three significant market opportunities: thyroid intervention (a $1 billion annual market), cardiac surgery for AFib, and electrophysiology for AFib (a $3 billion opportunity), utilizing a hybrid direct and partnership strategy.
Key clinical developments include the ongoing Precise BTN study for benign thyroid nodules (over 40% enrolled), the initiated NanoClamp AF study for surgical cardiac ablation, and the planned commencement of the pivotal trial for the M-Pulse Cardiac Catheter in Q1 2026.

Nov 13, 2025, 7:40 PM

Transcript

Pulse Biosciences Reports Q3 2025 Financial Results and Advances Clinical Programs

PLSE

Earnings

Product Launch

New Projects/Investments

Pulse Biosciences reported total revenue of $86,000 for Q3 2025, marking initial revenues from the limited market release of its M-Pulse Vibrance percutaneous electrode system. The company recorded a GAAP net loss of $19.4 million and a non-GAAP net loss of $13.5 million for the quarter.
As of September 30, 2025, cash and cash equivalents totaled $95.2 million. Cash used in operating activities during Q3 2025 was $13 million.
The company received FDA investigational device exemption (IDE) approval for the M-Pulse cardiac surgical system (NanoClamp AF) for atrial fibrillation, with the first patient successfully enrolled and treated in the IDE study.
Progress continues on the M-Pulse 360 catheter IDE submission for AF ablation, with the company expecting to resolve open items and commence the study in Q1. The PRECISE BTN clinical study for benign thyroid nodules is over 40% enrolled.

Nov 5, 2025, 9:30 PM

Transcript

Pulse Biosciences Reports Q3 2025 Financial Results and Business Updates

PLSE

Earnings

Product Launch

New Projects/Investments

Pulse Biosciences generated $86 thousand in total revenue for the third quarter ended September 30, 2025, primarily from the limited market release of its nPulse Vybrance percutaneous electrode system.
For Q3 2025, the company reported a GAAP net loss of ($19.4) million and a Non-GAAP net loss of ($13.5) million.
Cash and cash equivalents totaled $95.2 million as of September 30, 2025.
Significant clinical and regulatory advancements include 40% enrollment in the PRECISE-BTN study for benign thyroid nodules, FDA IDE approval and initial subject enrollment for the nPulse Cardiac Surgery System Study (NANOCLAMP AF), and the submission of an FDA IDE application for endocardial catheter AF ablation, with a study commencing in Q1 2026.

Nov 5, 2025, 9:11 PM

8-K

Pulse Biosciences Reports Third Quarter 2025 Financial Results and Business Updates

PLSE

Earnings

New Projects/Investments

Product Launch

Pulse Biosciences reported total revenue of $86 thousand for the third quarter ended September 30, 2025.
For the third quarter ended September 30, 2025, the company recorded a GAAP net loss of ($19.4) million and a Non-GAAP net loss of ($13.5) million.
As of September 30, 2025, cash and cash equivalents totaled $95.2 million, with $13.0 million used in operating activities during the third quarter of 2025.
The company initiated the PRECISE-BTN multi-center clinical study for benign thyroid nodules, enrolling 40% of study subjects, and received FDA IDE approval for the NANOCLAMP AF study for surgical AF ablation.
Pulse Biosciences also submitted an FDA IDE application for its nPulse 360° catheter for endocardial AF ablation, with plans to commence an IDE study in Q1 2026.

Nov 5, 2025, 9:05 PM

Press Release

Pulse Biosciences Begins NANOCLAMP AF Study with First Patient Enrollment

PLSE

Product Launch

New Projects/Investments

Pulse Biosciences has begun its NANOCLAMP AF clinical trial with the enrollment of the first patient, utilizing the FDA-approved nPulse Cardiac Surgical System for treating atrial fibrillation.
The nPulse system, which received FDA breakthrough device status in July 2024, employs a novel nanosecond pulsed field ablation (nsPFA) technology designed to offer a nonthermal, precise, and efficient cardiac ablation method.
Despite this clinical milestone, the company faces significant financial challenges, reporting no revenue or profitability, negative earnings per share, and negative operating margins.
Pulse Biosciences has a market capitalization of approximately $1.17 billion with 67.3 million shares outstanding, leading analysts to maintain a cautious stance due to ongoing operational costs and lack of revenue.