One of the region’s best-funded startups has beefed up its executive team by three as it expects to land a key U.S. Food & Drug Administration approval later this year.
Genetesis, a Mason-based medtech startup whose flagship technology, CardioFlux, can rapidly scan for various heart conditions without the use of radiation, contrast or exercise, said the three new hires, including a chief medical officer position, represent new roles for the company.
Collectively, they will oversee and execute key aspects of commercialization and clinical research for CardioFlux.
The additions come as the company expects FDA market authorization later this year. Genetesis is seeking “de novo” approval, a pathway for novel medical devices. The designation would kickstart the company’s commercial efforts.
“As we inch ever closer to the FDA granting our ‘de novo’ request, expanding our team has become critical,” Peeyush Shrivastava, co-founder and CEO of Genetesis, said in a release.
“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 joined as chief medical officer, effective Sept. 1, 2022. In the role, he will develop and lead clinical strategy while building out partnerships with other key players within the heart medicine field.
Most recently, Takla served as the chair and medical director of emergency medicine at Ascension St. John Hospital in Detroit. Genetesis said Takla was an early proponent of the use of magnetocardiography, or MCG, in the emergency department and led several early trials researching its efficacy in the diagnosis of acute heart disease.
Magnetocardiography is the science that enables CardioFlux to measure the natural magnetic fields produced by the heart. CardioFlux offers an alternative to traditional cardiac stress testing, which often involves exercise, the use of pharmaceuticals and/or radiation exposure.
“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,” Takla said in the release. “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 joined Genetesis as vice president of medical affairs, effective Oct. 3, 2022. He will oversee the intersection of research and clinical science with the company’s commercial activity.
Albaghdadi currently practices interventional cardiology. He’s the director of cardiac catheterization laboratory and associate program director of cardiology fellowship at Naples Heart Institute in Naples, Fla.
Lastly, Kevin Hillsman joined as vice president of market access, effective Jan. 3, 2023. He will oversee the expansion of patient access to CardioFlux by establishing new insurance reimbursement pathways and executing other market access initiatives.
Hillsman’s recent experiences include a stint within HeartFlow’s market access team followed by time leading market access at Abbott Labs for its cardiometabolic division.
The hires bump the Genetesis team to 31, including three co-op/intern positions hired from local universities.
The new roles are remote-based but Takla, Albaghdadi and Hillsman will work from the Mason office frequently, a company spokesperson said.
Genetesis, founded in 2013, has raised $40 million and is backed by an investor pool that includes Mark Cuban and Austin-based Mithril Capital, a venture firm co-founded by billionaire Peter Thiel, among others.
