BioCardia has brought on Mark Schwartz to be its vice president of clinical affairs, as it moves forward with a phase 3 trial of its cell therapy treatment for heart failure following a heart attack.
Schwartz has helped lead clinical study design and execution for cardiovascular medical devices, resulting in regulatory approvals for Boston Scientific, The Sorin Group and Guidant, among others.
Most recently, he served as VP of clinical and regulatory affairs for the cardiac resynchronization developer EBR Systems. Before that, he was senior director of clinical affairs for The Sorin Group, leading its U.S. clinical program in heart valve products and cardiac rhythm management.
At Boston Scientific, he served as manager of emerging therapies as well as clinical programs, working on its R&D portfolio and approvals for bradycardia and tachycardia products.
“We look forward to benefiting from his robust experience at market leading companies leading cardiac devices from clinical study through regulatory approval and beyond as we work towards the potential of bringing the first cell therapy for heart failure to the U.S. market,” BioCardia CEO Peter Altman said in a statement.
The San Carlos, California-based BioCardia executed a reverse merger in August 2016 through the shell company Tiger X Medical, after dropping plans to go public itself a few months before.
With the diagnostics company Opko Health coming on as a significant shareholder in Tiger X Medical and serving as an adviser, BioCardia fetched a combined $23 million in cash to fund its phase 3 regenerative medicine development program.
Its CardiAMP cell therapy aims to use a patient’s bone marrow cells to stimulate healing responses in heart tissue, through a catheter-based procedure, including a point-of-care processing platform that prepares cells at the patient’s bedside in under two hours. Currently its pivotal study is enrolling at 18 U.S. sites.
Similar stem cell treatments for the regeneration of heart tissue have separately come under increased scrutiny. In October, the New England Journal of Medicine retracted a 2011 paper on the evidence for human lung stem cells, saying an investigation by Harvard Medical School and Brigham and Women’s Hospital found that some of its images had been manipulated, compared to the original data.
The NEJM also published an “expression of concern” related to the veracity of two papers from 2001 and 2002 that explored heart stem cells and regeneration following a heart attack.
This led the NIH’s National Heart, Lung and Blood Institute to pause its CONCERT-HF clinical trial of patients with chronic heart failure. Though the trial was unrelated to the papers cited by the NEJM, it paused the trial out of an “abundance of caution,” the institute said, following recommendations from a data and safety monitoring board. CONCERT-HF is exploring whether certain cardiac stem cells, either alone or in combination with stem cells derived from bone marrow, are safe and benefit patients with chronic heart failure.