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
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 […]
FDA clears nano-pulse stimulation tech for treating hyperplasia 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 […]
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 […]
Pulse plans to seek $30m from investors
Pulse Biosciences (NSDQ:PLSE) announced it has filed a registration statement to raise approximately $30 million from existing shareholders. The rights offering will be made through the distribution of non-transferable subscription rights to purchase shares of the Hayward, Calif-based company’s common stock. The final price has not been set. Pulse Biosciences said it will use the proceeds […]
Pulse Biosciences announces $30m offering
Pulse Biosciences (NSDQ:PLSE) announced today that it filed a rights offering of its common stock for gross proceeds of approximately $30 million. According to a news release, the offering includes non-transferable subscription rights to purchase shares of common stock at par value of $0.001 per share at a subscription price to be determined. All of Pulse […]
Pulse Biosciences slides on FDA setback, Q1 miss
Pulse Biosciences (NSDQ:PLSE) said yesterday that the FDA asked for more data on the 510(k) application for its CellFX dermatology device and reported higher-than-expected first-quarter losses, sending its share price down. Hayward, Calif.-based Pulse is seeking an indication for treating general benign lesions including sebaceous hyperplasia and seborrheic keratosis. The company said it received a letter […]