BioVentrix treats first two patients in Georgia in RELIVE trial

BioVentrix said the first two patients in the Republic of Georgia have been treated with its Revivent System as part of the pivotal RELIVE trial at Caucasus Medical Centre in Tbilisi. The milestone expands the study of the investigational heart-failure device as enrollment continues across new sites.

Why it matters: - BioVentrix is adding a new international site to a pivotal study of the Revivent System for patients with advanced heart failure. - The first treated patients in Georgia mark another step in a trial designed to test whether the device can improve outcomes for people with scarred, weakened left ventricles. - The study could help support broader adoption of a less invasive treatment option for a difficult-to-treat heart-failure population.

What happened: - BioVentrix announced the first two patients in the Republic of Georgia were treated with the Revivent System in the RELIVE trial. - The procedures took place at Caucasus Medical Centre in Tbilisi, Republic of Georgia. - Sulkhan Lominadze, MD, PhD, Head of the Cardiothoracic Surgery Centre and Medical Director of Caucasus Medical Centre, performed the procedures. - Sebastian Schulte-Eistrup, MD, served as the BioVentrix proctor surgeon. - Natia Nazghaidze, MD, and Keti Chikhladze, MD, provided post-operative care. - Both patients tolerated the procedure well. - Both patients were discharged within five days without complications.

The details: - The Revivent System is being studied in the RELIVE trial for patients with heart failure with reduced ejection fraction, or HFrEF, and extensive scarring of the left ventricle. - The device is designed to exclude scarred, non-functioning heart muscle from the main pumping chamber. - BioVentrix says the procedure can help restore a more normal left-ventricle shape and size and may improve pumping ability. - RELIVE is a prospective, multi-center randomized trial comparing Revivent System plus guideline-directed medical therapy with guideline-directed medical therapy alone. - The trial includes patients with symptomatic heart failure and anterior/apical left ventricular scar or aneurysm. - About 135 patients will be randomized in a 2:1 ratio. - The primary safety endpoint is assessed at 30 days. - The primary efficacy endpoint is assessed at one year. - More information is available on ClinicalTrials.gov under NCT06813820. - The Revivent System uses myocardial micro-anchor implants to reconstruct a dilated left ventricle. - Prior trials showed statistical significance in a subpopulation for similar endpoints to those in RELIVE. - The Revivent System received CE Mark approval in 2016. - The device also has Breakthrough Device Designation from the U.S. Food and Drug Administration. - In the United States, the Revivent System is limited to investigational use only and is not approved for commercial use.

Between the lines: - Expanding RELIVE into Georgia gives BioVentrix another site as it works to build enrollment momentum in the pivotal study. - The company is leaning on early procedural success and uncomplicated recoveries to reinforce investigator confidence as more centers come online. - The trial’s randomized design sets up a direct comparison against standard medical therapy, which matters for future regulatory review and clinical adoption.

What's next: - RELIVE will continue enrolling patients at additional sites as BioVentrix advances the pivotal study. - The next key readouts are the 30-day safety data and one-year efficacy results. - Those outcomes will help determine whether the Revivent System can advance further in the U.S. and broader markets.

The bottom line: - BioVentrix has moved its pivotal heart-failure trial into Georgia, and the first cases were completed without complications.