FDA clears pulsed field ablation electrode tech from Pulse Biosciences

The CellFX nsPFA percutaneous electrode system. [Image courtesy of Pulse Biosciences]Pulse Biosciences (Nasdaq:PLSE) announced that the FDA granted 510(k) clearance for its CellFX nsPFA percutaneous electrode system.

The Hayward, California-based company develops the CellFX nanosecond pulsed field ablation (nsPFA) system. Its percutaneous electrode system enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures.

CellFX nsPFA’s percutaneous electrode system features a percutaneous needle electrode for use with the proprietary CellFX console. The company designed the novel electrode to harness and deliver the key advantages of nsPFA energy. It enables the precise, nonthermal removal of cellular tissue without damaging noncellular structures or inducing thermal necrosis.

Pulse Biosciences designed this percutaneous electrode for non-cardiac applications, unlike other PFA technology on the market. The likes of Medtronic a…

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Pulse Biosciences reports positive 60-day evaluations for AFib-treating pulsed field ablation

The CellFX nsPFA system with the CardioNXT iMap system. [Image courtesy of Pulse Biosciences/CardioNXT]Pulse Biosciences (Nasdaq:PLSE) today announced favorable findings from post-procedure evaluations of its CellFX pulsed field ablation system.

The 60-day post-procedure evaluations looked at four initial patients treated in the company’s first-in-human feasibility study. This study, which kicked off in December 2023, looks at Pulse’s novel, proprietary CellFX nanosecond PFA technology for treating AFib.

Dr. Vivek Reddy of Mount Sinai Hospital (New York) and Dr. Petr Neuzil of Na Homolce Hospital, Prague, and colleagues performed the first procedures. Reddy said in a news release today that the initial results reveal favorable durable pulmonary vein isolation data.

Using the CellFX nsPFA 360° cardiac catheter, doctors have successfully treated 14 patients with AFib to date at Na Homolce. Investigators have evaluations underway at regular interva…

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Pulse Biosciences seeks FDA nod for pulsed-field ablation cardiac clamp

Pulse Biosciences (Nasdaq:PLSE) announced today that it filed for FDA 510(k) clearance for its novel CellFX nsPFA Cardiac Clamp.

Hayward, California-based Pulse designed its CellFX nanosecond pulsed-field ablation (nsPFA) technology to treat AFib. The company utilized this technology with a catheter for the first time in humans last month.

Pulse’s Cardiac Clamp produces continuous linear transmural ablations during concomitant cardiac surgical procedures using CellFX. The bipolar clamp uses the proprietary nsPFA nonthermal ablation technology developed by Pulse.

According to a news release, preclinical data suggests this ablation method could offer safety and performance benefits over current thermal cardiac ablation technologies. Pulsed-field ablation competition has continued to heat up recently in general. Earlier this month, Medtronic became the first company to win an FDA nod for PFA to treat paroxysmal and persistent AFib. Boston Scientific j…

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Pulse Biosciences announces first human use of pulsed-field ablation catheter

The CellFX nsPFA system with the CardioNXT iMap system. [Image courtesy of Pulse Biosciences/CardioNXT]Pulse Biosciences (Nasdaq:PLSE) today announced the completion of the first-in-human procedures for its CellFX nsPFA cardiac catheter.

The Hayward, California-based company completed the first five procedures in its first-in-human feasibility study. Treating physicians successfully discharged all patients. They’ll continue to be monitored and evaluated over the coming months to assess safety and effectiveness. Pulse Biosciences plans to evaluate the primary safety endpoint at 30 days.

Dr. Vivek Reddy of Mount Sinai Hospital (New York) and Dr. Petr Neuzil of Na Homolce Hospital, Prague, and colleagues performed the procedures. They used the CellFX nxPFA (pulsed-field ablation) 360 catheter integrated with the CardioNXT iMap mapping and navigation. The doctors successfully treated five patients with AFib at the Czech Republic hospital.

“We have been co…

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Pulse Biosciences, CardioNXT to collab on pulsed-field ablation trial

[Image courtesy of Pulse Biosciences/CardioNXT]Pulse Biosciences (Nasdaq:PLSE) announced today that it entered into a collaboration with CardioNXT to support its AFib treatment.

The collaboration supports Pulse Biosciences’ planned first-in-human study of its pulsed-field ablation technology. Hayward, California-based Pulse develops a proprietary nanosecond pulsed-field ablation (nsPFA) cardiac catheter to treat AFib.

Pulse and CardioNXT plan for their partnership to integrate the nsPFA catheter and the CardioNXT iMap navigation and mapping system. This enables electrophysiologists to successfully visualize individual cardiac structures when using the integrated platforms. They can then place the catheter for circumferential ablations of targeted pulmonary veins in AFib treatment.

CardioNXT CEO Jerome Edwards said in a news release that Pulse’s nsPFA technology provides “a highly differentiated” solution. He said integrating systems …

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Pulse Biosciences enters $65M private placement for pulsed-field ablation tech

Pulse Biosciences (Nasdaq:PLSE) announced today that it entered into a stock purchase agreement to raise approximately $65 million.

Hayward, California-based Pulse Biosciences entered into the agreement with Robert Duggan, the company’s executive chair. Duggan agreed to purchase 10,022,937 shares of the company’s common stock at $6.51 per share. That marks a greater than 1% premium over the last reported sale price of Pulse common stock on April 28, 2023.

Upon the closing of the private placement, all indebtedness owed to Duggan will be canceled as consideration for the shares. That includes the principal balance of $65 million and accrued and unpaid interest of approximately $0.25 million.

Pulse Biosciences develops its novel and proprietary nanosecond pulsed field ablation (nsPFA) technology. It also develops the proprietary CellFX System for the treatment of AFib.

“Upon closing, this transaction eliminates our debt and this ca…

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FDA clears nano-pulse stimulation tech for treating hyperplasia from Pulse Biosciences

The CellFX system. [Image from Pulse Biosciences]Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted 510(k) clearance for its CellFx system with expanded indication.

The new indication covers the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. Clearance followed positive clinical data from an investigational device exemption (IDE) study of the system.

CellFX uses Pulse Biosciences’ proprietary nano-pulse stimulation (NPS) technology. NPS technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue.

Hayward, California-based Pulse Biosciences said CellFX represents the first commercial product to use NPS technology to treat a variety of conditions. The company is pursuing development in cardiology, oncology, gastroenterology, and other medical specialties.

Pulse Biosciences also received FDA clearance for two additional treatm…

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Pulse Biosciences names chief strategy officer

Pulse Biosciences (NSDQ:PLSE) announced today that it appointed Mitchell E. Levinson to its newly created chief strategy officer role.

Hayward, Calif.-based Pulse Biosciences said in a news release that Levinson’s new role, which begins effective immediately, will be held in addition to his position as a member of the company’s board of directors.

Pulse Biosciences develops the CellFX system, powered by nano-pulse stimulation, for the delivery of nanosecond pulses of electrical energy designed to clear cells while sparing adjacent non-cellular tissue.

“As a board member and medical device industry veteran with a track record of successfully bringing new technologies and products to market across a variety of medical specialties, Mitch’s insights have benefitted Pulse Biosciences for over five years,” Pulse Biosciences president & CEO Darrin Uecker said in the release. “We are thrilled to add him to the executive leadership team at this cr…

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