KIRKLAND, Wash.–(BUSINESS WIRE)–Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for patients with heart failure, today announced the appointment of Matthew Stark, Ph.D., as vice president of clinical and regulatory affairs, and Trevor Moody as the newest member of its board of directors.
“We’re thrilled to have Matthew and Trevor join our team as they both have deep experience working with medical device companies at our current stage,” said Gregory Casciaro, Cardiac Dimensions’ president and CEO. “Matthew’s experience in leading clinical studies and bringing products to market will play a key role as we build our portfolio of clinical data demonstrating the benefits of the Carillon System in providing a viable treatment option for patients with functional mitral regurgitation. It’s an exciting time for Matthew and Trevor to be joining as we anticipate revealing the results of the landmark REDUCE FMR trial by the end of the year, and significantly increasing enrollment in the pivotal CARILLON Trial over the next several months, bringing us closer to submission for FDA approval.”
The company’s Carillon® Mitral Contour System® is a minimally invasive treatment designed to treat the stretched mitral annulus, the underlying mechanical problem of functional mitral regurgitation (FMR). Unlike other mitral regurgitation therapies, the Carillon System is designed to replicate traditional surgical standards through a catheter-based alternative to medications and invasive surgery.
An authority on medical device clinical affairs, Stark brings more than 15 years of experience in clinical study design and oversight to this role. Before joining Cardiac Dimensions, Stark served as vice president of clinical and regulatory affairs for Terumo Aortic, formerly Bolton Medical. Prior to his tenure at Terumo Aortic, Stark established and led the medical affairs department for Spectranetics, Inc. and guided the company through multiple product submissions and approvals. Prior to his time at Spectranetics, Stark managed the clinical study and submission of W.L. Gore & Associates, Inc.’s thoracic stent graft products to the FDA for approval.
“During my career, I’ve been fortunate to witness the potential for improved outcomes in patients’ lives through the development of innovative technologies,” said Stark. “Current treatments meant to improve the quality of life for patients with functional mitral regurgitation fall short, and I’m proud to join a team of experts working to advance the level of care the Carillon System can provide individuals and physicians around the world.”
The company also announced the addition of Trevor Moody to its Board of Directors. Moody currently serves as managing director at M.H. Carnegie & Co. and has more than 25 years of experience in medical technology, including roles in product development, marketing, management consulting, and venture capital investing.
“Trevor’s broad global experience in growth-oriented medical technology markets and his past tenure as interim CEO of Cardiac Dimensions provide him a unique perspective that will be invaluable as we continue our path towards FDA approval and broadening our commercial endeavors outside the U.S,” said Casciaro.
Prior to joining M.H. Carnegie & Co., Moody was a general partner at Frazier Healthcare Ventures, a leading healthcare venture capital and private equity investment firm with more than $2 billion under management. He co-led the medical device team and became known as an active and well-regarded investor with particular depth in medical devices. Prior to Frazier Healthcare Ventures, Trevor was a senior consultant at The Wilkerson Group. Trained as a biomedical engineer with an electrical focus, Trevor also held product development and product marketing roles at Telectronics Pacing Systems and Ventritex, both in the cardiac rhythm management market.
About the Carillon Mitral Contour System
The Carillon® Mitral Contour System® is an innovative minimally invasive treatment for people diagnosed with FMR. The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression, and stabilize or improve quality of life. The Carillon System treats the dilated mitral annulus, the underlying mechanical problem of FMR, with a catheter-based alternative to medications and invasive surgery. Unlike other mitral regurgitation therapies, the Carillon System replicates traditional surgical standards through a simple, minimally invasive approach that offers patients annular reduction, while keeping adjunctive therapy options open.
To date, more than 850 patients worldwide have been treated with the Carillon System. The Carillon System has a CE Mark and is available in certain European markets and other key geographies including Turkey, the Netherlands and Italy. Clinical data from three completed international studies of the Carillon System (AMADEUS, TITAN, and TITAN II) have demonstrated the performance of the device. In addition, the company is near completion of the follow-up period of the landmark REDUCE FMR Trial – the first randomized, blinded evaluation of a therapy for FMR. The results of the REDUCE FMR trial are expected before the end of 2018. The company is also currently enrolling patients in its U.S. pivotal study – The CARILLON Trial. More information on The CARILLON Trial can be found at http://www.cardiacdimensions.com/current-studies/.
About Cardiac Dimensions
Cardiac Dimensions is the leader in innovative, minimally invasive treatment modalities addressing the heart failure patient population. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. Cardiac Dimensions has operations in Kirkland, Sydney, and Frankfurt.
The Carillon Mitral Contour System is limited to investigational use in the U.S. For more information, please visit www.cardiacdimensions.com. Cardiac Dimensions, Carillon and Mitral Contour System are registered trademarks of Cardiac Dimensions.
Rick Wypych, 425-605-5910