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Company expecting FDA approval later this year for CardioFlux.
March 21, 2023
By: Michael Barbella
Managing Editor
Genetesis Inc. has appointed three new members to its executive leadership team who will oversee and execute key aspects of commercialization and clinical research for its flagship solution, CardioFlux. The company expects the product to be approved by the U.S. Food and Drug Administration (FDA) later this year. “As we inch ever closer to the FDA granting our De Novo request, expanding our team to cover new disciplines and encompass additional experience has become critical,” Co-Founder/CEO Peeyush Shrivastava said. “It will take a team of diverse talents to achieve our next set of clinical and commercial milestones, but I know the experts that have chosen to partner with us will be instrumental in helping us get there.” Dr. Robert Takla has joined Genetesis as chief medical officer, where he will develop and lead clinical strategy while building out innovative partnerships with other key players within heart medicine. Most recently, Takla served as the chair and medical director of Emergency Medicine at Ascension St. John Hospital in Detroit. Prior to joining the leadership team at Genetesis, Takla was an early proponent of the use of magnetocardiography (MCG) in the emergency department and led several early trials researching the efficacy of MCG in the efficient diagnosis of acute heart disease. “To my knowledge, I was one of the first physicians to explore the promise of MCG and look for ways to adopt the technology into my clinical practice,” Takla said. “Coming from emergency medicine, my career has been dedicated to delivering efficient and effective care, but I’ve seen firsthand how physicians struggle to properly address their chest pain patients. Joining this team as we bring the promise of MCG to patients and physicians alike feels like a natural extension of the path I’ve taken thus far.” Dr. Mazen Albaghdadi has assumed the role of vice president of Medical Affairs, where he will oversee the intersection of research and clinical science with the company’s commercial activity. Albaghdadi currently practices interventional cardiology as the director of Cardiac Catheterization Laboratory and Associate Program Director of CardiologyFellowship at Naples Heart Institute in Naples, Fla. With more than 50 publications to his name, Albaghdadi is a champion of early-stage medical devices with novel applications in cardiac science. Kevin Hillsman is now vice president of Market Access, where he will oversee the expansion of patient access to CardioFlux by establishing new reimbursement pathways and executing other key market access initiatives. Hillsman’s recent experiences include a successful stint within HeartFlow’s Market Access team followed by time spent leading market access at Abbott Labs for its Cardiometabolic division. In these roles, Hillsman demonstrated an ability to navigate the complex payor ecosystem surrounding both Medicare and commercial health plans, bridging the gap between health plans and medical device providers to increase patient access to innovative and impactful solutions supporting cardiac health. Genetesis Inc. is a medical imaging company redefining the way ischemic heart disease is detected and understood. The firm is developing CardioFlux, the industry’s first clinically-ready imaging solution to be based on the principles of magnetocardiography. Genetesis was founded in 2013 and is based in Mason, Ohio.
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