Pi-Cardia Ltd.

ShortCut leaflet modification device offers a safe, simple and effective way to split valve leaflets and ease valve-in-valve Transcatheter Aortic Valve Replacement procedures in patients who are at risk of coronary obstruction US FDA grants breakthrough nod to Pi-Cardia’s ShortCut device. (Credit: jesse orrico on Unsplash) Israeli medical device start-up Pi-Cardia has received breakthrough device designation from the US Food and Drug Administration (FDA) for its ShortCut leaflet modification device. ShortCut is intended to ease valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients who are at risk of coronary obstruction. The device is claimed to be the world’s first dedicated device to offer a safe, simple and effective way to split valve leaflets. The latest announcement follows the completion of enrolment in the US and Europe for the ShortCut pivotal study in September last year. The device is part of Pi-Cardia’s leaflet modification product portfolio which already includes ShortCut Mitral and Leaflex. Pi-Cardia CEO Erez Golan said: “Breakthrough device designation is only awarded to technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversible debilitating diseases or conditions, and it may help accelerate our review process with the FDA this year and bring ShortCut to market for the benefit of patients.” ShortCut Mitral is designed to split anterior mitral leaflets in patients at risk for left ventricular outflow tract obstruction after TMVR. On the other hand, Leaflex is a stand-alone, non-implant-based mechanical scoring device for patients with calcified aortic stenosis. It aims to improve valve hemodynamics and restore leaflet flexibility by manually scoring valve calcification at numerous sites. The global clinical trials for Leaflex are currently ongoing. Morristown Medical Center MD Philippe Genereux said: “Lifetime management of aortic stenosis calls for leaflet modification solutions like ShortCut to ensure that we are carefully addressing the risk of coronary obstruction before implanting a valve. “From what we have seen regarding the ability to easily teach and perform the procedure, ShortCut could be easily adopted by every TAVR centre as a critical step pre-implantation, so that patients at risk of coronary obstruction will be safely treated, without disruption of TAVR work-flow.” The medical device company is also developing more leaflet modification technologies to increase treatment choices in difficult anatomy like bicuspid valves.

REHOVOT, Israel--( BUSINESS WIRE )--Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it received Breakthrough Device Designation from the US Food and Drug Administration for ShortCut™ - the world's first dedicated leaflet modification device facilitating valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction. This announcement comes after completion of enrollment in the ShortCut™ Pivotal Study in the US and Europe in September 2023. “ Having been part of Pi-Cardia’s rigorous clinical program, I am thrilled to see the recognition in the importance of ShortCut™,” said Philippe Genereux, MD from Morristown Medical Center in New Jersey. “ Lifetime management of aortic stenosis calls for leaflet modification solutions like ShortCut™ to ensure that we are carefully addressing the risk of coronary obstruction before implanting a valve. From what we have seen regarding the ability to easily teach and perform the procedure, ShortCut™ could be easily adopted by every TAVR center as a critical step pre-implantation, so that patients at risk of coronary obstruction will be safely treated, without disruption of TAVR work-flow.” “ We are excited to receive this important recognition by the FDA,” said Erez Golan, Pi-Cardia's Chief Executive Officer. “ Breakthrough Device Designation is only awarded to technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversible debilitating diseases or conditions, and it may help accelerate our review process with the FDA this year and bring ShortCut™ to market for the benefit of patients.” ShortCut™ is part of Pi-Cardia's leaflet modification product portfolio, which includes the ShortCut™ Mitral for splitting leaflets in patients at risk for left ventricular outflow tract obstruction following TMVR, and Leaflex™ - a standalone, non-implant-based mechanical scoring device to restore leaflet mobility and improve hemodynamics for patients with aortic stenosis. Leaflex™ global clinical trials are underway. About Pi-Cardia Pi-Cardia is a global leader in the development of a unique portfolio non-implant, catheter-based, leaflet modification solutions for treating heart valves. Pi-Cardia's ShortCut™ device is designed to provide a safe, simple and effective way to split valve leaflets: ShortCut™ Aortic is designed to split leaflets of a pre-existing valve prior to TAVR in patients at risk for coronary obstruction and may assist in preserving coronary access; ShortCut™ Mitral is designed to split the anterior mitral leaflet prior to TMVR in patients at risk for LVOT obstruction. Pi-Cardia's Leaflex™ device mechanically scores valve calcification at multiple locations, with the intention of restoring leaflet flexibility and improving valve hemodynamics. Leaflex™ is designed to be a cost-effective, durable standalone treatment for patients with calcified aortic stenosis. Additional leaflet modification technologies are being developed to further expand treatment options in challenging anatomies such as bicuspid valves. The ShortCut™ device and Leaflex™ device are investigational devices, limited by United States law for investigational use. For more information, please visit: www.pi-cardia.net

Milestone Brings the Company Closer to Commercializing the First-Ever Dedicated Leaflet Modification Solution to Facilitate TAVR REHOVOT, Israel--(BUSINESS WIRE)-- Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today the successful completion of its ShortCut™ Pivotal Study enrollment. ShortCut™ is the world's first dedicated device designed to split the leaflets of pre-existing valves to enable safe Transcatheter Aortic Valve Replacement (TAVR) in patients at risk of coronary obstruction. The study was conducted across 20 of the world’s leading TAVR centers in the US and Europe and was led by Drs. Susheel Kodali (New York Presbyterian/Columbia University, New York, USA), Didier Tchétché (Clinique Pasteur, Toulouse, France) and Danny Dvir (Sha’are Zedek, Jerusalem, Israel). It included 60 patients undergoing valve-in-valve procedures, in whom ShortCut™ was used as a preceding step to TAVR implantation. Data was independently analyzed by central echo and CT core-labs and baseline data will be presented at the upcoming TCT meeting. The TAVR market, currently estimated at $6 billion, is projected to double over the next five years, with expansion into low-risk younger patients. However, this growth may be hindered by a fundamental challenge: during TAVR implantation, the leaflets of pre-existing valves are pushed sideways, compromising normal flow in the sinuses and hindering coronary access. This can turn into a life-threatening complication of complete coronary obstruction in a significant number of patients, especially those who undergoing TAVR to treat a failing bioprosthetic valve. ShortCut™ offers a promising solution by enabling the pre-existing valve leaflets to be split, facilitating a safer valve-in-valve procedure and potentially broadening the TAVR market’s reach to younger patients. "We are excited to have been able to complete enrollment in such a groundbreaking study so efficiently,” said Dr. Kodali. “It clearly demonstrates the unmet need for ShortCut™ and how excited the sites were to learn and perform the procedure. I look forward to the commercial launch of ShortCut™ in the US in the near future.” “We’ve spent years looking for techniques to overcome the life-threatening complication of coronary obstruction,” said Dr. Dvir. “Having performed multiple ShortCut™ cases, I can clearly say we’ve found a simple, controlled and teachable solution that integrates well into the workflow of every TAVR center.” "I can see ShortCut™ becoming instrumental, not only in facilitating safe valve-in-valve procedures, but also for ensuring future coronary access in patients receiving their first TAVR or optimizing TAVR in bicuspid valves,” said Dr. Tchétché. “Lifetime management for patients with aortic stenosis is increasingly important as we treat younger patients. ShortCut™ holds the key for TAVR to safely expand to these large populations.” ShortCut™ is part of Pi-Cardia's leaflet modification product portfolio, which includes the ShortCut™ Mitral for splitting leaflets in patients at risk for left ventricular outflow tract obstruction following TMVR, and Leaflex™ - a standalone, non-implant-based mechanical scoring device to restore leaflet mobility and improve hemodynamics for patients with aortic stenosis. Leaflex™ global clinical trials are underway. "We are thrilled having completed enrollment months ahead of schedule,” said Erez Golan, Pi-Cardia's Chief Executive Officer. “This milestone not only validates our market models predicting a significant percentage of TAVR patients in need for leaflet modification, but it also means we should be able to commercialize ShortCut™ in the US and Europe as soon as 2024." About Pi-Cardia Pi-Cardia is a global leader in the development of a unique portfolio non-implant, catheter-based, leaflet modification solutions for treating heart valves. Pi-Cardia's ShortCut™ device is designed to provide a safe, simple and effective way to split valve leaflets: ShortCut™ Aortic is designed to split leaflets of a pre-existing valve prior to TAVR in patients at risk for coronary obstruction and assist in preserving coronary access; ShortCut™ Mitral is designed to split the anterior mitral leaflet prior to TMVR in patients at risk for LVOT obstruction. Pi-Cardia's Leaflex™ device mechanically scores valve calcification at multiple locations, with the intention of restoring leaflet flexibility and improving valve hemodynamics. Leaflex™ is designed to be a cost-effective, durable standalone treatment for patients with calcified aortic stenosis. Additional leaflet modification technologies are being developed to further expand treatment options in challenging anatomies such as bicuspid valves. The ShortCut™ device and Leaflex™ device are investigational devices, limited by United States law for investigational use. For more information: info@pi-cardia.net SOURCE: Pi-Cardia Ltd.