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Pulse Biosciences [NASDAQ: PLSE] is a medical device company with one product – the CellFX system. PLSE’s history is full of failure and wasted investors’ money trying to sell its technology for skin treatments. With the same team and approach, failure is going to repeat in the company’s pivot to cardiac ablation, or the Pulsed Field Ablation (PFA) market.
PLSE is years behind Boston Scientific (Farapulse) and Medtronic (Affera and PulseSelect) in the clinical studies/FDA approval process for PFA. Farapulse’s first clinical study was launched in 2018, over five years ago.
While nano pulse PFA technology was patented by Farapulse, Farapulse does not use nano pulse. PLSE is developing nano pulse PFA technology, and could be infringing on Farapulse’s patents. Medtronic and Abbott also choose to not develop nano pulse because evidence shows it’s inferior to micro pulse.
PLSE is desperately trying to deceive investors that they are close to commercial revenue with their ablation clamp by failing to disclose that comparable clamps had to receive PMA approval from the FDA with large clinical s
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