Mitre Medical Corp. Accepted into the Harmonization by Doing (HBD) Program

October 9, 2020 – Morgan Hill, CA – Mitre Medical Corp. (“Mitre” or “company”) is an early-stage medical device company developing the Mitral Touch®, a less invasive and safer approach to treat functional mitral valve regurgitation (FMR) and remodel the left ventricle (LV).  The company’s lead product, Mitral Touch, became the first cardiac surgery device to be accepted into the Proof of Concept program for the US-Japan Regulatory initiative known as Harmonization by Doing (HBD).  HBD is focused on moving Japanese and U.S. clinical study sponsors and regulatory agencies toward the use of a single global clinical trial protocol for evaluating cardiovascular devices rather than parallel country-specific protocols.

Mitre addresses a leading unmet clinical need.  Open-heart surgery, the current standard of care for mitral valve surgery, has well-documented procedural risks primarily driven by the requirement to place the implant within a patient’s heart.  Approximately 50% of patients with severe MR and an indication for cardiac surgery are turned down due to increased perioperative risks.*  The Mitral Touch is designed to eliminate these risks by being positioned on the outside of a beating heart.

“Advancing access to Mitral Touch on a global scale is our core mission – providing simpler, safer and more effective options to improve lives and reduce the economic burden on health care systems worldwide.  Investing in innovation is the path forward, and we are excited to be on the leading edge of this initiative. We strive to provide the outstanding clinical outcomes seen in our European study to US and Japanese patients,” stated John MacMahon, Chief Executive Officer of Mitre Medical.

* PMID: 17350971

About Harmonize by Doing (HBD)

Harmonize by Doing (HBD): Through the U.S.- Japan Medical Device Harmonization by Doing (HBD) the U.S. (FDA) and Japanese (PMDA) regulators, academia, and industry develop internationally agreed-upon standards for global clinical trials related to cardiovascular devices, and addressed regulatory barriers that may delay timely medical device approvals in both countries.

HBD has a workgroup focused on moving Japanese and U.S. clinical study sponsors and regulatory agencies toward the use of a single global clinical trial protocol for evaluating cardiovascular devices rather than parallel country-specific protocols. This would mean the FDA may accept data from Japanese clinical studies using the joint protocols. Encouraging single global clinical trial protocols will facilitate device evaluation in both the U.S. and Japan by improving the timeliness and cost-effective generation of more informative clinical datasets for pre-market, and potentially post-market evaluation. This will particularly benefit patients currently underserved by existing approved therapies.  To learn more about Harmonize by Doing, please visit https://www.fda.gov/medical-devices/international-programs/usjapan-regulatory-collaboration.