Advances Regulatory Strategy for the Mitral Touch in US and Japan
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.
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.
About Mitre Medical Corp.
Mitre Medical Corp 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) in patients with moderate to severe MR. Mitre Medical has the potential to be the new standard of care for FMR. For more information, please visit www.mitremedical.com.
Forward Looking Statements
This press release includes forward-looking statements including, but not limited to, statements related to the development of our technology, our operations and business strategy, our expected financial results, and corporate updates. The forward-looking statements contained in this press release are based on management’s current expectations and are subject to substantial risks, uncertainty and changes in circumstances. Actual results may differ materially from those expressed by these expectations due to risks and uncertainties. Forward-looking statements speak only as of the date of this press release, and we undertake no obligation to review or update any forward-looking statement except as may be required by applicable law.
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Source: Mitre Medical Corp.