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Business Wire
12-08-2025
- Business
- Business Wire
Pulse Biosciences Reports Business Updates and Second Quarter 2025 Financial Results
HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) technology, today announced business updates and financial results for the second quarter ended June 30, 2025. Recent Business Highlights Soft Tissue Ablation Expanded the pilot program for the nsPFA Percutaneous Electrode for soft tissue ablation. Treated over 140 Benign Thyroid Nodule patients to date across multiple pilot program centers. Identified five sites to participate in a post-market study of the treatment of benign thyroid disease, with plans to commence enrollment in Q3 upon receipt of IRB approvals. Surgical AF Ablation Submitted FDA IDE application, including the pivotal study protocol, to support a premarket approval (PMA) application for the treatment of atrial fibrillation (AF) and remain on track to commence the IDE pivotal study in the next few months. Treated 40 patients to date and generated positive clinical outcomes, as indicated by follow up remapping procedures, as part of the nsPFA Cardiac Surgery System multi-center, first-in-human AF feasibility study in Europe. Endocardial Catheter AF Ablation Submitted FDA IDE application, including the pivotal study protocol, and remain on track to commence the IDE pivotal study in the next few months. Observed improved procedure times since last presented at the Heart Rhythm Society 2025 Meeting in April. Treated over 140 total patients with the nsPFA 360° catheter to date as part of the multi-center, first-in-human AF study in Europe. 'We are advancing the top priorities established at the beginning of 2025 for each of our three market development programs,' said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. 'I am delighted to announce that we have expanded the pilot program for the Percutaneous Electrode for soft tissue ablation, submitted our IDE for both the cardiac surgical clamp and nsPFA 360° catheter, all while continuing to treat more patients and generate positive clinical outcomes with our cardiac devices in their respective feasibility studies in Europe. These achievements further reinforce the transformational potential of nsPFA energy for treating benign thyroid disease, AF and additional diseases in the future.' Second Quarter 2025 Financial Results Total GAAP costs and expenses, representing research and development and general and administrative expenses, for the three months ended June 30, 2025, were $20.3 million, an increase of $8.5 million compared to $11.7 million in the prior year period. The increase was primarily driven by administrative expenses related to the expanding organization to support advancement of the nsPFA device clinical trials and commercialization, and non-cash stock-based compensation and other compensation. Non-GAAP costs and expenses for the three months ended June 30, 2025, were $14.8 million, an increase of $5.4 million compared to $9.4 million in the prior year period. GAAP net loss for the three months ended June 30, 2025 was ($19.2) million compared to ($11.4) million for the three months ended June 30, 2024. Non-GAAP net loss for the three months ended June 30, 2025 was ($13.7) million compared to ($9.0) million for the three months ended June 30, 2024. Cash and cash equivalents totaled $106.3 million as of June 30, 2025, compared to $26.2 million as of June 30, 2024 and $119.3 million as of March 31, 2025. Cash used in operating activities in the second quarter of 2025 totaled $12.8 million, compared to $8.4 million used in the same period in the prior year, and $13.5 million used in the first quarter of 2025. Reconciliations of GAAP to Non-GAAP cost and expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading 'Non-GAAP Financial Measures.' Webcast and Conference Call Information Pulse Biosciences' management will host a conference call today, August 12, 2025, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-800-715-9871 or 1-646-307-1963 and providing passcode 2036874. A live and recorded webcast of the event will be available at About Pulse Biosciences ® Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the intention as well as the potential to improve the quality of life for patients. The Company's proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The Company is actively pursuing the development of its CellFX nsPFA technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers, such as surgical soft tissue ablation. Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA, nanosecond PFA and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries. Non-GAAP Financial Measures In this press release, in order to supplement the Company's condensed consolidated financial statements presented in accordance with Generally Accepted Accounting Principles, or GAAP, management has disclosed certain non-GAAP financial measures for the statement of operations. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance. Company management uses these measurements as aids in monitoring the Company's ongoing financial performance from quarter to quarter, and year to year, on a regular basis and for financial and operational decision-making. Non-GAAP adjustments include stock-based compensation, depreciation and amortization, restructuring, severance, and a legal settlement. From time to time in the future, there may be other items that the Company may exclude if the Company believes that doing so is consistent with the goal of providing useful information to management and investors. The Company has provided a reconciliation of each non-GAAP financial measure used in this earnings release to the most directly comparable GAAP financial measure. Investors are cautioned that there are a number of limitations associated with the use of non-GAAP financial measures as analytical tools. Investors are encouraged to review these reconciliations, and not to rely on any single financial measure to evaluate the Company's business. Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies, which could reduce the usefulness of the Company's non-GAAP financial measures as tools for comparison. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Non-GAAP financial measures in this earnings release exclude non-cash expenses for stock-based compensation, depreciation and amortization, restructuring costs, severance expense and legal settlement expenses. Forward-Looking Statements All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the effectiveness of the Company's nsPFA technology and CellFX System to non-thermally clear cells while sparing adjacent non-cellular tissue, statements concerning the Company's future commercialization and product development efforts and whether those efforts will be successful, statements concerning early clinical successes and whether they are predictive of the safety and effectiveness of any medical device, such as the nsPFA 360° Cardiac Catheter System, the nsPFA Cardiac Surgical System, and the nsPFA Percutaneous Electrode System, and statements concerning the Company's future clinical and regulatory initiatives anywhere in the world, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences' current expectations, estimates, and projections regarding Pulse Biosciences' business, operations and other similar or related factors. Words such as 'may,' 'will,' 'could,' 'would,' 'should,' 'anticipate,' 'predict,' 'potential,' 'continue,' 'expects,' 'intends,' 'plans,' 'projects,' 'believes,' 'estimates,' and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences' control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences' filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available. PULSE BIOSCIENCES, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except per share amounts) (Unaudited) Three-Month Periods Ended Six-Month Periods Ended June 30, June 30, 2025 2024 2025 2024 Revenues: Product revenues $ — $ — $ — $ — Total revenues — — — — Cost and expenses: Research and development 12,088 7,230 22,401 13,971 General and administrative 8,187 4,496 15,918 8,370 Total cost and expenses 20,275 11,726 38,319 22,341 Loss from operations (20,275 ) (11,726 ) (38,319 ) (22,341 ) Other income: Interest income, net 1,107 343 2,356 821 Total other income 1,107 343 2,356 821 Net loss (19,168 ) (11,383 ) (35,963 ) (21,520 ) Comprehensive loss $ (19,168 ) $ (11,383 ) $ (35,963 ) $ (21,520 ) Net loss per share: Basic and diluted net loss per share $ (0.28 ) $ (0.20 ) $ (0.54 ) $ (0.38 ) Weighted average shares used to compute net loss per common share — basic and diluted 67,276 57,180 67,201 57,152 Expand Reconciliation of GAAP to Non-GAAP Financial Measures The following table presents the reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures: (In thousands) (Unaudited) Three-Month Periods Ended Six-Month Periods Ended June 30, June 30, 2025 2024 2025 2024 Reconciliation of GAAP to non-GAAP Research and development: GAAP Research and development $ 12,088 $ 7,230 $ 22,401 $ 13,971 Less: Stock-based compensation expense (2,335 ) (1,001 ) (5,097 ) (1,950 ) Less: Depreciation and amortization (44 ) (52 ) (90 ) (105 ) Non-GAAP Research and development $ 9,709 $ 6,177 $ 17,214 $ 11,916 Reconciliation of GAAP to non-GAAP General and administrative: GAAP General and administrative $ 8,187 $ 4,496 $ 15,918 $ 8,370 Less: Stock-based compensation expense (2,854 ) (1,051 ) (5,773 ) (1,861 ) Less: Depreciation and amortization (229 ) (246 ) (466 ) (492 ) Add: Legal settlement — — 590 — Non-GAAP General and administrative $ 5,104 $ 3,199 $ 10,269 $ 6,017 Reconciliation of GAAP to non-GAAP Cost and expenses: GAAP Cost and expenses $ 20,275 $ 11,726 $ 38,319 $ 22,341 Less: Stock-based compensation expense (5,189 ) (2,052 ) (10,870 ) (3,811 ) Less: Depreciation and amortization (273 ) (298 ) (556 ) (597 ) Add: Legal settlement — — 590 — Non-GAAP Cost and expenses $ 14,813 $ 9,376 $ 27,483 $ 17,933 Reconciliation of GAAP to non-GAAP Net loss: GAAP Net loss $ (19,168 ) $ (11,383 ) $ (35,963 ) $ (21,520 ) Add: Stock-based compensation expense 5,189 2,052 10,870 3,811 Add: Depreciation and amortization 273 298 556 597 Less: Legal settlement — — (590 ) — Non-GAAP Net loss $ (13,706 ) $ (9,033 ) $ (25,127 ) $ (17,112 ) Expand
Yahoo
17-06-2025
- Business
- Yahoo
Corvia Medical raises $55m to complete confirmatory heart shunt trial
Corvia Medical has raised $55m to complete an ongoing clinical trial of its atrial shunt system for heart failure. The US-based company's trial began in 2022 and is currently underway at more than 65 institutions across three continents with 750 patients enrolled, according to the trial's listing on Increasing Corvia's current funding to around $150m, the latest set of funds originated from the company's existing investment syndicate of Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, along with two strategic investors. Corvia anticipates the double-blind, randomised, sham-controlled confirmatory RESPONDER-HF (NCT05425459) trial of the Corvia atrial shunt system, which is being evaluated to treat heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF), to generate the final clinical data required to support a regulatory filing with the US Food and Drug Administration (FDA). The atrial shunt works by creating a small passage between the heart's left and right atria, enabling blood to flow from the high-pressure left side to the lower-pressure right side. Trial patients randomised to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transoesophageal echocardiography (TEE) guided trans-septal puncture and with the Corvia atrial shunt implant procedure. In addition, patients randomised to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium. Upon completion, patients will be evaluated at pre-specified time intervals and followed for five years. Corvia CEO George Fazio said: "We are profoundly grateful for the unwavering support of our longstanding investors as we advance toward FDA submission of the Corvia atrial shunt. "Their commitment furthers our mission to bring this transformative heart failure treatment to millions of patients worldwide." The funding will provide Corvia with the resources needed to navigate the approval process for the Corvia shunt system and introduce the therapy to the market, added Corvia board chair Paul LaViolette. Research indicates that around 65 million people worldwide have heart failure, with a majority affected by HFpEF. In October 2023, Corvia announced positive safety and efficacy results from its REDUCE LAP-HF II (NCT03088033) randomised Phase III trial of its atrial shunt. In comparison to the sham control, patients showed a 50% reduction in the rate of heart failure events and a sustained improvement in quality of life as measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ). "Corvia Medical raises $55m to complete confirmatory heart shunt trial" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Cision Canada
17-06-2025
- Business
- Cision Canada
Corvia Medical closes $55 million funding round to complete confirmatory trial and pursue FDA approval of Corvia Atrial Shunt
Existing investors provide funding to finish international RESPONDER-HF trial TEWKSBURY, Mass., June 17, 2025 /CNW/ -- Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced the successful closure of a $55 million funding round from the company's existing investment syndicate of Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, and two strategic investors. The funds will be used to complete the ongoing RESPONDER-HF trial, a double-blinded, randomized, sham-controlled, confirmatory trial of the Corvia ® Atrial Shunt currently underway at more than 65 institutions on three continents. The study is expected to generate the final supportive clinical data required for FDA approval of the shunt as a breakthrough treatment for heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF). "We are profoundly grateful for the unwavering support of our longstanding investors as we advance toward FDA submission of the Corvia Atrial Shunt," said George Fazio, CEO of Corvia Medical. "Their commitment furthers our mission to bring this transformative heart failure treatment to millions of patients worldwide." Paul LaViolette, Board Chair of Corvia Medical, added, "We firmly believe Corvia has the potential to fundamentally alter the landscape of heart failure treatment, and our investors share that vision. With these resources, we are well-equipped to drive the company through the approval process and introduce this groundbreaking therapy to the market." About heart failure (HF) and the Corvia Atrial Shunt More than 26 million people worldwide have HF, and the majority have HFpEF, making it the largest unmet clinical need in cardiovascular medicine. The Corvia Atrial Shunt is designed to reduce elevated left atrial pressure (LAP), the primary contributor to HF symptoms, by creating a passage between the left and right atria, reducing HF events and improving quality of life. The Corvia Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019. For information regarding RESPONDER-HF study eligibility, please visit Corvia Medical, Inc. is revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, MA, privately-held Corvia is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. Visit
