Latest news with #GeorgeFazio
Yahoo
9 hours ago
- 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
11 hours ago
- 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
Yahoo
11 hours ago
- Business
- Yahoo
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 /PRNewswire/ -- 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 About Corvia Medical, Inc. 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 MEDIA CONTACT:Lisa Ensz+1 978-654-6120lensz@ View original content: SOURCE Corvia Medical, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
