CH Biomedical's BrioVAD® INNOVATE Trial Receives U.S. Medicare Coverage, Accelerating Global Commercialization
BrioHealth Solutions
Ventricular Assist Device Developer and Manufacturer
Recently,BrioHealth Solutions BrioVAD®Milestone Clinical Trial INNOVATE StudyApproved by the U.S. Centers for Medicare & Medicaid Services，The required medical equipment and its associated routine examinations and services will be covered by Medicare in the United States.。
The Centers for Medicare & Medicaid Services (CMS), a federal agency under the U.S. Department of Health and Human Services, is responsible for administering Medicare, Medicaid, and the Children's Health Insurance Program (CHIP) in the United States. Since 1995, CMS has established a collaborative framework with the FDA to promote Medicare coverage of Investigational Device Exemption (IDE) studies for clinical trials. Based on the risk level and clinical research foundation of relevant studies, Medicare may cover the associated costs required for IDE research. This initiative aims to ensure that patients do not miss the opportunity to participate in clinical trials due to financial burdens while supporting medical device innovation companies in generating revenue and encouraging continuous industry investment in medical device research and development. According to relevantRule: In the INNOVATE clinical trial, the device is covered by MS-DRG 001, including BrioVAD.®The implantable left ventricular assist system and its associated routine inspection and service fees average approximately $220,000.
BrioHealth Solutions BrioVAD®Implantable Left Ventricular Assist System
INNOVATE Study to Evaluate BrioVAD, a Novel Fully Magnetically Levitated Left Ventricular Assist System Independently Developed by BrioHealth Solutions®To evaluate the efficacy and safety in treating refractory heart failure, this study will adopt a randomized controlled trial design, utilizing BrioVAD.®Compare with previously FDA-approved products. BrioVAD®The left ventricular assist system can provide short-term or long-term circulatory support for patients with end-stage heart failure. This system is part of the existing product line, CiFu.®VAD (Model: CH-VAD) has achieved portability of external components through multiple technological innovations, while further enhancing the overall system performance, based on its excellent blood compatibility.
This study received FDA approval in the first quarter of 2024, becoming the first original active implantable medical device produced in China to be approved by the FDA for clinical trials in the United States. Currently, BrioHealth Solutions is accelerating the preparation for various aspects of the U.S. clinical trial.
INNOVATE Clinical Trial First Investigator Meeting
The United States is currently the largest single market globally for the VAD industry and also the first key overseas market for BrioHealth Solutions' international expansion strategy.This CMS reimbursement approval for the INNOVATE study will eliminate the financial barriers for patients to participate in the research, promoting enrollment in clinical trials; at the same time, it reaffirms the scientific rigor and feasibility of the clinical study. This breakthrough will accelerate the progress of clinical trials in the United States and drive rapid revenue growth., injecting strong momentum into the company's global commercial strategic layout.
