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Pulse Biosciences(PLSE) - 2024 Q3 - Earnings Call Transcript
PLSEPulse Biosciences(PLSE)2024-10-31 01:42
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Financial Data and Key Metrics Changes - In Q3 2024, total GAAP costs and expenses increased by 2.4millionto2.4 million to 13.7 million compared to 11.3millionintheprioryearperiod[50]−GAAPnetlossinQ32024was11.3 million in the prior year period [50] - GAAP net loss in Q3 2024 was 12.7 million compared to 10.6millionintheprioryearperiod[52]−Cashandcashequivalentstotaled10.6 million in the prior year period [52] - Cash and cash equivalents totaled 79 million as of September 30, 2024, compared to 44.4millionasofDecember31,2023[53]BusinessLineDataandKeyMetricsChanges−ThecompanytreatedthefirstpatientswithAtrialFibrillation(AF)usingitsnano−PFACardiacSurgicalSysteminEurope[13]−TheCellFXPercutaneousElectrodeSystemreceivedFDA510(k)clearanceforsofttissueablation[21]−Theinitialclinicalexperienceswiththenano−PFAneedleablationdeviceinbenignthyroidnoduleshavebeenpositive,withpatientsexperiencingsymptomaticrelief[31]MarketDataandKeyMetricsChanges−TheincidenceofpalpablebenignthyroidnodulesintheU.S.isabout0.144.4 million as of December 31, 2023 [53] Business Line Data and Key Metrics Changes - The company treated the first patients with Atrial Fibrillation (AF) using its nano-PFA Cardiac Surgical System in Europe [13] - The CellFX Percutaneous Electrode System received FDA 510(k) clearance for soft tissue ablation [21] - The initial clinical experiences with the nano-PFA needle ablation device in benign thyroid nodules have been positive, with patients experiencing symptomatic relief [31] Market Data and Key Metrics Changes - The incidence of palpable benign thyroid nodules in the U.S. is about 0.1% per year, with an estimated 250,000 patients diagnosed annually [24] - The treatment of benign thyroid nodules represents a potential market in excess of 1 billion per year for the company [30] Company Strategy and Development Direction - The company is focused on producing compelling clinical data to demonstrate the safety and effectiveness of its applications [19] - Plans to initiate pivotal clinical studies for its three products in mid-2025 [40][45] - The strategy includes seeking specific indications for the use of devices to drive faster clinician adoption and market penetration [20] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about continuing clinical experiences with three products throughout 2024 and into 2025 [55] - The company is building its team and infrastructure to support anticipated growth and conduct pivotal clinical studies [56] Other Important Information - The company completed a rights offering, raising 60millioningrossproceedswiththepotentialtoraiseanadditional60 million in gross proceeds with the potential to raise an additional 66 million through the exercise of warrants [14] - The differentiated mechanism of action of nano-PFA technology has the potential to destroy cells more effectively than traditional methods [17] Q&A Session Summary Question: Are there any questions from participants? - There were no questions during the Q&A session [57]