(MENAFN- EIN Presswire)
BioVentrix, Inc.
Brings Extensive Leadership Experience to Senior Management Team
Steve brings strong executive management & clinical operations experience to BioVentrix. He will be instrumental building a financially successful, patient-focused company, dedicated to saving lives.” - David Richmond, Chair of the Board, MA, UNITED STATES, January 21, 2025 /EINPresswire / -- BioVentrix
®, Inc., a specialty medical device company serving cardiothoracic surgeons and their patients with lifesaving heart failure therapies, announced today the appointment of Steven Chartier as President and Co-Chief Executive Officer. Steve has also been named to the Company's Board of Directors. In this role, he will work with Co-CEO Dave Richmond to complete BioVentrix's pivotal RELIVE trial involving 90 treated and 45 control patients, recently authorized by the FDA. Upon expected approval, Steve and Dave will expand commercial reach from the 20+ clinical sites to serve cardiothoracic surgeons and their patients globally.
“Steve brings a wealth of executive management and clinical operations experience to BioVentrix,” said David Richmond, Chair of the Board.“He will be instrumental in building a financially successful, patient-focused medical device company, dedicated to saving lives.”
Mr. Chartier is an experienced leader in both large and small start-up medical device organizations. He most recently held the position of Vice President of Regulatory and Quality at Conformal Medical, Inc., a cardiovascular left atrial appendage company. Prior to that, Mr. Chartier was the Chief Operating Officer at BioVentrix. He has also held clinical, regulatory, and operations positions at Sirtex Medical, Anika Therapeutics, and InfraReDx. Mr. Chartier brings a history of operational excellence, regulatory experience, and clinical trial success to the company, including strong relationships with the US Food and Drug Administration and European regulatory agencies. His goal is to build a team to bring the company through its pivotal clinical trial and secure FDA approval for the Revivent system and procedure.
“I have worked with the BioVentrix technology since 2021,” commented Mr. Chartier.“We are excited to start our clinical trial which we have full confidence will lead to approval by the FDA. With both this approval and our current CE Mark, we will be in position to provide this novel technology to a patient population in dire need of new therapies.”
About the Revivent System
The BioVentrix Revivent System is designed to support a minimally invasive procedure to treat a dilated left ventricle of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and extensive left ventricular scar, who have a suboptimal response to guideline-directed medical therapy. The procedure uses myocardial micro-anchor implants to reconstruct the dilated left ventricle to produce a more efficient chamber. Prior trials showed statistical significance with a subpopulation for similar endpoints to those that will be assessed in the RELIVE Trial. The Revivent System received the CE Mark in 2016.
The company recently announced that it had received approval from the Food and Drug Administration (FDA) for the RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial, a prospective, randomized, multi-center, dual-arm pivotal study of the BioVentrix Revivent System. Enrollment in the RELIVE Trial is expected to begin in the second half of 2025.
About BioVentrix
BioVentrix, Inc. a specialty medical device company serving cardiothoracic surgeons and their patients with lifesaving heart failure therapies. BioVentrix technologies aim to improve cardiac function by directly addressing LV dilation. The Company markets the Revivent System in Europe.
The BioVentrix trademark is a federally registered trademark owned by BioVentrix. Any unauthorized use is expressly prohibited.
Investigational Device. Limited to Investigational Use Only in The United States.
# # #
Media Contact:
Steve Chartier
...
Steve Chartier
BioVentrix, Inc.
...
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability
for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this
article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
MENAFN21012025003118003196ID1109112949
Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.