CroíValve Raises an €8M Series A Round to Support a Feasibility Clinical Study

Expands the Board of Directors and Leadership Team

DUBLIN--(BUSINESS WIRE)--CroíValve, a Dublin based medical device company developing a novel treatment for tricuspid regurgitation, has raised a Series A round to fund a Feasibility clinical study with its DUO Coaptation Valve system. This novel approach to treating tricuspid regurgitation combines the best of repair and replacement to provide the right solution for the right heart. Additionally, CroíValve welcomes Dr. Azin Parhizgar, Ph.D., a leading medical device entrepreneur in structural heart, to its Board of Directors. In addition, Helen Scotch has joined the Senior Leadership Team as Vice President of Clinical and Regulatory Affairs.

Tricuspid regurgitation (TR) is a severe heart condition that occurs when the tricuspid valve fails to close properly. This results in blood being pumped backwards into the right atrium and venous system causing debilitating symptoms. The DUO System consists of a coaptation valve implant that works in tandem with the native tricuspid valve to restore valve function. The device is delivered percutaneously and is secured using a novel anchor system which leaves the delicate right heart chamber and native valve apparatus untouched. It is designed to be implanted in a straightforward procedure using standard imaging and is suitable for a broad patient cohort, including those who are challenging to treat with other valve repair and replacement technologies. This innovative approach has already generated convincing pre-clinical and clinical data. Temporary clinical implants of the DUO Coaptation Valve have demonstrated the ability to significantly reduce TR in patients with torrential TR, large annuli and imaging difficulties.

The investment round was led by the HBAN (Halo Business Angel Network) MedTech and Irrus Syndicates, alongside existing investors Atlantic Bridge University Fund, Broadview Ventures, SOSV and Enterprise Ireland and new investors Elkstone, Ascentifi and DBIC. The funding will support a European Feasibility Study of the CroíValve Transcatheter Tricuspid DUO Coaptation Valve System.

Dr. Parhizgar is currently the Chairman of the Board of CVPath Institute, a Senior Venture Partner at 415 Capital and a Board member at Soundbite Medical Solutions, InnovHeart, Moray Medical, Vessl, and Women as One. She was CEO, President and Board Member at Claret Medical, an embolic protection device company acquired by Boston Scientific in 2018. Prior to Claret Medical, Dr. Parhizgar served as COO of Conor Medsystems, which was acquired by Johnson & Johnson in 2007 and EVP Regulatory and Clinical Affairs for Arterial Vascular Engineering (AVE), which was acquired by Medtronic in 2000. Dr. Parhizgar received both her Ph.D. in Cell, Gene and Tissue Engineering and her M.Sc. in Biomechanical Engineering and Artificial Organ Design from Brown University.

Helen Scotch is a highly experienced leader of Regulatory, Clinical and Quality. Helen previously served in leadership roles in both start-ups (TriFlo and Cephea) and multinationals (Boston Scientific) across the full product development lifecycle in the structural heart space. Helen holds a BSc. in Industrial Chemistry and spent time as a R&D chemist prior to moving into Regulatory Affairs roles of increasing responsibility with Boston Scientific.

Dr. Lucy O’Keeffe, CroíValve’s CEO, said: “The strong investor support from both existing and new investors highlights the value of the opportunity, technology and progress made to date. Azin and Helen bring a huge amount of experience to the team which will be invaluable as we validate the device through clinical studies and remove the limitations in successfully treating all patients in need with TR.” CroíValve spun-out of Trinity College Dublin in early 2019 and is headquartered in Dublin, Ireland.