BioVentrix® Announces 1st Patients Treated with Revivent in RELIVE Trial at Caucasus Medical Centre, Republic of Georgia

Pivotal RELIVE Trial Is Evaluating the Safety and Efficacy of BioVentrix’s Revivent System in the Treatment of Patients Who Have Experienced Heart Failure

MANSFIELD, MA, UNITED STATES, October 6, 2026 /EINPresswire.com/ -- BioVentrix, Inc., a private clinical-stage medical device company specializing in left ventricular function restoration following heart failure, today announced the completion of treatment of its first two patients in the Republic of Georgia with the Revivent System as part of the company's pivotal RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) clinical trial.

BioVentrix’s proprietary Revivent System, currently being evaluated in the RELIVE pivotal trial, is designed to treat patients with heart failure with reduced ejection fraction (HFrEF) who have extensive scarring of the left ventricle. The less invasive therapy is designed to exclude the scarred, non-functioning portion of the heart muscle from the main pumping chamber, helping restore a more normal shape and size of the left ventricle and potentially improve its ability to pump blood.

The procedures were performed at Caucasus Medical Centre, Tbilisi, Republic of Georgia, by Sulkhan Lominadze, MD, PhD, Head of the Cardiothoracic Surgery Centre and Medical Director of Caucasus Medical Centre. Sebastian Schulte-Eistrup, MD, served as the BioVentrix proctor surgeon. Natia Nazghaidze, MD, Head of Cardiology and Keti Chikhladze, MD, Cardiologist and Heart Rhythm Specialist provided post-operative care. Both patients tolerated the procedure well and were discharged without complications within five days.

"We were very pleased with the execution of the procedures," said Dr. Lominadze. "Heart failure after a significant heart attack is a serious problem for many of our patients, and we are thrilled to be able to include them in a carefully designed international clinical trial of a less invasive surgical treatment option."

"Expanding RELIVE into the Republic of Georgia is an important step in advancing the RELIVE trial," said Steve Chartier, President and Co-CEO of BioVentrix. "The trial is progressing well, and we are building momentum as new sites come online. Strong cases like the ones in Tbilisi help build confidence among our investigators and site teams as enrollment continues. We are grateful to Dr. Lominadze and the team at Caucasus Medical Center, and to the patients who are participating in this study."

About the RELIVE Trial
RELIVE is a prospective, multi-center randomized trial comparing the Revivent System plus guideline-directed medical therapy (GDMT) with GDMT alone in patients with symptomatic heart failure and anterior/apical left ventricular scar or aneurysm. Approximately 135 patients will be randomized 2:1. The primary safety endpoint is evaluated at 30 days, and the primary efficacy endpoint is evaluated at one year. More information is available at ClinicalTrials.gov (NCT06813820).

About the Revivent System
The BioVentrix Revivent System is designed to support a less 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 Revivent System has received Breakthrough Device Designation from the US Food and Drug Administration.

About BioVentrix
BioVentrix, Inc. is a medical device company focused on developing innovative therapies to restore heart function and enhance the quality of life for patients suffering from advanced heart failure. Its solutions offer heart failure specialists new treatment options aimed at improving left ventricular function which may increase cardiac ejection fraction. The company’s flagship product, the Revivent System, is currently undergoing evaluation in the RELIVE Study, a pivotal clinical trial in the United States, and is in the early stages of commercialization across Europe.

BioVentrix and The Heart Logo are federally registered trademarks of BioVentrix, Inc. Any unauthorized use is expressly prohibited.

Investigational Device. The Revivent System is not approved for commercial use in the United States. In the United States, the Revivent System is limited to investigational use only.

Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release are forward-looking, which may be identified by the use of words such as “anticipate,” “expect,” “believe,” “forecast,” “aim,” “estimate” and “intend,” among other similar words. These forward-looking statements are based on BioVentrix’s current expectations. and actual results could differ materially and adversely from what is contemplated by the forward-looking statements. There are a number of risks and uncertainties that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing for enrollment in and outcomes from our clinical trials and ongoing FDA and other regulatory requirements, and interpretation of trial data by the FDA. As with any medical device under development, there are significant risks in the development, testing, regulatory approval, and commercialization of new products. Except as expressly required by law, BioVentrix does not undertake an obligation to update or revise any forward-looking statement. All of BioVentrix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

Steve Chartier
BioVentrix, Inc.
+1 925-830-1000
schartier@bioventrix.com