Tuesday, July 16, 2024

Clinical Data Request from FDA Halts Pulse’s 510(k) Submission for PFA Device

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Clinical data requirements have led Pulse Biosciences to announce its plan to switch from the 510(k) pathway to pursuing premarket approval (PMA) for its pulsed field ablation (PFA) device. This change stems from the Food and Drug Administration’s (FDA) request for human clinical data, which necessitates running a pivotal clinical trial. Consequently, analysts now predict the device will not reach the market before late 2026, providing a competitive edge to companies like Atricure and Medtronic.

Pulse Biosciences, a company specializing in innovative medical technology, initially filed for 510(k) clearance for its Cellfx cardiac clamp in January. The Cellfx device has received a breakthrough device designation, potentially accelerating parts of the regulatory process. However, the FDA’s request for human data has delayed the program, compelling Pulse to shift its strategy toward obtaining PMA, which involves conducting extensive clinical trials.

Clinical Advancements: Pulse’s Nanosecond Electrical Pulses for AFib Surgery Outpace Traditional Thermal Methods

Pulse’s technology uses nanosecond-duration pulses of electrical energy to treat atrial fibrillation (AFib), targeting a smaller market segment focused on cardiac clamps used in AFib surgery. In contrast, companies like Boston Scientific and Medtronic are utilizing catheters to deliver PFA. According to Pulse, their PFA technology can provide faster ablation through thicker tissue compared to existing surgical thermal technologies.

In 2022, Atricure and Medtronic dominated the $250 million AFib surgical market, with market shares of 55% and 30%, respectively. Analysts had initially expected Pulse’s device to be a potential threat to Atricure as early as the second half of 2024. However, the new timeline delays its market entry, extending the competitive advantage for Atricure and Medtronic by approximately two years.

The decision to pivot from the 510(k) pathway to PMA came after several interactions with the FDA. In March, Darrin Uecker, Pulse’s Chief Technology Officer, mentioned an additional information letter from the FDA during an earnings call, although the device was still under the 510(k) process at that time. By the following earnings call in May, Pulse’s CEO Kevin Danahy disclosed that the FDA required clinical data, but the 510(k) application was still active. At that stage, Pulse had only conducted preclinical studies in animals.

The significant shift occurred two months later when Pulse announced it would no longer pursue 510(k) clearance and instead focus on initiating a pivotal clinical trial in 2025 to seek PMA. This strategic move aims to fulfill the FDA’s requirements for human clinical data, which is crucial for demonstrating the device’s safety and efficacy.

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Clinical Data Delay for Cellfx PFA Device Benefits Atricure by Reducing Immediate Competition

The delay in the Cellfx PFA device’s market entry is seen as beneficial for Atricure, as it removes an immediate competitive threat to their open-heart ablation business. This delay provides Atricure with additional time to develop its own PFA clamp. During an earnings call in May, Atricure’s CEO Michael Carrel acknowledged the development of their PFA clamp, although no specific launch timeline was provided.

Needham analysts have speculated on the implications of this regulatory change, noting that the extended timeline for Pulse’s device allows existing competitors to strengthen their market positions and potentially develop and launch new technologies without the immediate pressure of Pulse’s entry into the market.

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Pulse Biosciences plans to provide more details regarding the regulatory and commercial implications of their strategic shift later this year. The company remains committed to advancing its PFA technology and aims to successfully navigate the clinical trial process to eventually secure PMA. This approach is intended to ensure the long-term success and adoption of their innovative AFib treatment.

The pursuit of PMA, while delaying the market entry, represents a critical step in addressing the FDA’s requirements and ensuring the device’s comprehensive evaluation. This thorough approach is anticipated to bolster the device’s credibility and acceptance once it finally reaches the market, albeit later than initially planned.

In conclusion, the FDA’s request for clinical data has significantly impacted Pulse Biosciences’ timeline for bringing their PFA device to market. While this delay offers a temporary reprieve for competitors like Atricure and Medtronic, Pulse’s commitment to rigorous clinical evaluation underscores their dedication to delivering a safe and effective treatment for AFib, ultimately aiming for a successful market entry by late 2026.

 

Resource: Pulse Bioscience, July 08, 2024

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