Pulse Biosciences (Nasdaq:PLSE) today announced the first completed cases in a first-in-human feasibility study of its pulsed field ablation system. Hayward, Calif.–based Pulse Biosciences’ study evaluates its novel Cardiac Surgery System for ablating cardiac tissue to treat AFib. The Cardiac Surgery System received FDA breakthrough device designation last month. The technology utilizes Pulse Biosciences’ CellFX […]
Pulse Biosciences
Pulse Biosciences wins FDA breakthrough nod for AFib-treating pulsed field ablation tech
Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted breakthrough device designation for its pulsed field ablation system. Shares of PLSE rose more than 20% in mid-morning trading on the back of this announcement. Hayward, California–based Pulse Biosciences’ technology utilizes its CellFX nanosecond pulsed field ablation (nsPFA) technology and percutaneous electrode system, which the FDA […]
Pulse Biosciences names a new CEO with former boss moving to CCO role
Pulse Biosciences (Nasdaq:PLSE) announced that it appointed Burke T. Barrett as its new president and CEO. Barrett takes over the corner office at the maker of nanosecond pulsed field ablation (nsPFA) technology from Kevin Danahy. With this change at the top, Danahy moves into the role of chief commercial officer (CCO). His focus now turns […]
Pulse Biosciences announces first U.S. procedure with pulsed field ablation electrode tech
Pulse Biosciences (Nasdaq:PLSE) today announced the first U.S. procedure with its CellFX nsPFA percutaneous electrode system. The CellFX nanosecond pulsed field ablation (nsPFA) system’s percutaneous electrode system enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures. It received FDA clearance for the ablation of soft tissue in March. CellFX nsPFA’s percutaneous electrode […]
Pulse Biosciences to raise $60M
Pulse Biosciences (Nasdaq:PLSE) announced that its board of directors approved plans to initiate a rights offering worth $60 million. The offering features up to $60 million in the form of “units” available to all holders of the company’s common stock. Each unit consists of one share of common stock and warrants to purchase a total […]
FDA clears pulsed field ablation electrode tech from 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 […]
Pulse Biosciences reports positive 60-day evaluations for AFib-treating pulsed field ablation
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 […]
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 […]
Pulse Biosciences announces first human use of pulsed-field ablation catheter
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 […]
Pulse Biosciences, CardioNXT to collab on pulsed-field ablation trial
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 […]
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 […]
