03/26/2026 | Press release | Distributed by Public on 03/26/2026 05:57
Mansfield, MA - March 26, 2026 - BioVentrix, Inc. a private clinical-stage medical device company specializing in left ventricular function restoration following heart failure, today announced the German Institute for the Hospital Remuneration System ("InEK") has again awarded Revivent Therapy NUB Status 1a designation for 2026, the highest priority designation available in Germany. For 2026, 91 German hospitals applied, and can now negotiate full reimbursement coverage of Revivent Therapy.
New examination and treatment methods (NUBs) are comprised of novel and innovative medicines, medical products and procedures that can be utilized by hospitals before reaching full reimbursement eligibility. The NUB process opens the path for negotiations between hospitals and health insurers for the reimbursement of new medical treatments in the German healthcare system. InEK is responsible for prioritizing new therapies in Germany through the NUB process.
"Our team has successfully secured full reimbursement in Germany," commented Steve Chartier, President and Co-CEO, BioVentrix, Inc. "Obtaining NUB Status 1a again for 2026 from the German authorities is an important component of our strategy of making Revivent Therapy available to more patients suffering from severe heart failure, a condition that poses serious health challenges. We are pleased at significant number of hospitals applying for Revivent Therapy NUB."
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.
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.
The BioVentrix trademark is a federally registered trademark owned by BioVentrix. Any unauthorized use is expressly prohibited.
Investigational Device. The Revivent System is limited to Investigational Use Only in The United States.
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.
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