BrioHealth Solutions Successfully Completes INNOVATE Clinical Trial Training Series for BrioVAD™ System in the U.S.

From September 30 to October 4, BrioHealth Solutions, Inc. ("BHS"), the U.S. subsidiary of BrioHealth Technologies, Inc. (formerly known as 同心医疗), successfully conducted the company's new fully magnetically levitated implantable left ventricular assist system, BrioVAD, at the University of Michigan.^TMMultiple training sessions of the INNOVATE clinical trial in the United States. Principal investigators and core team members from eight institutions, including the University of Michigan Medical Center, Cleveland Clinic, University of Chicago Medical Center, Duke University Medical Center, Montefiore Medical Center, Henry Ford Health System, University of Utah Medical Center, and Emory University Medical Center, participated in this round of activities. Also attending were Dr. Chen Chen, founder of BrioHealth Solutions, Mr. Karl Nelson, Senior Vice President of Clinical Operations, and Mr. Justin Callaway, Chief Operating Officer and Senior Vice President of R&D at BHS.

This round of training work is an important part of the preparation for the INNOVATE clinical trial.After months of meticulous organization by the team,Established a complete BrioVAD^TMProduct Training System and Standardized Operating Procedures。During this round of activities, Dr. Chen Chen, the founder of the company, shared the development history of BrioHealth Solutions, the product development process, and the technical features of the product; Mr. Pranesh Thirukkonda, Vice President of Clinical Affairs and Services at BHS, introduced the design, timeline, and specific implementation plans and publication strategy for the U.S. clinical trials; Mr. Ed Burke, Vice President of Marketing at BHS, introduced BrioVAD.^TMsystem composition and described the overall differences between this product and existing market products; Dawn Christensen, Ph.D., Director of Education and Training at BHS, provided a detailed introduction to BrioVAD.^TMThe entire process of system implantation and operation management of external components; Mr. Robert Ezzell, BHS Clinical Support Director, introduced the surgical and perioperative preparation for the product as well as related key considerations.

Dr. Chen Chen Shares the Company's Development History and Product Technology Features

Mr. Robert Ezzell Introduced Product Surgery and Perioperative Preparation

Francis Pagani, MD, PhD, Chief Investigator of the INNOVATE clinical trial, current Chairman of INTERMACS, and Otto Gago Endowed Professor at the University of Michigan, highlighted BrioVAD.^TMThe surgical implantation steps, and for BrioVAD^TMKey points related to product design features in the implantation process were explained in detail; Urich Jorde, professor at Montefiore Medical Center and member of the INNOVATE Clinical Trial Oversight Committee, along with Geetha Bhat, professor at Christ Hospital, provided a detailed introduction to BrioVAD.^TMKey points in patient medical management, with detailed explanations and emphasis on patient assessment, perioperative management, and related issues.

Professor Pagani Introduces Surgical Implantation Steps

Professor Urich Jorde Introduces Patient Medical Management

Professor Geetha Bhat Introduces Patient Medical Management

This round of training also organized multiple product simulation operation drills, including simulated training for surgical implantation procedures and training related to the management of external components, with lively on-site interactions.

Surgical Implant Simulation Operation

The INNOVATE clinical trial received FDA approval in February 2024. This study will evaluate the efficacy and safety of BrioVAD™, a novel fully magnetically levitated implantable left ventricular assist system independently developed by BrioHealth Solutions, for treating refractory heart failure, marking a historical precedent as the first active implantable medical device from China to be approved for clinical trials in the U.S. In April 2024, BrioHealth Solutions held its first investigator meeting and initiated a series of advancement efforts. In July 2024, the clinical study received approval from the U.S. Centers for Medicare & Medicaid Services, with the required medical devices and associated routine examinations and services to be covered by U.S. Medicare.The establishment of preclinical standardized training is an important part of this research. The successful implementation of this round of activities not only lays a solid foundation for the high-quality success of the INNOVATE clinical trial but also represents a significant milestone in the development of BrioHealth Solutions' international training system.