Mason’s Start Up Genetesis Receives Significant Recognition from FDA with Breakthrough Technology Designation for Heart Health Another win for Mason’s BioHub—anchored by innovation and activity in cardiology, mental health, and genetics Mason’s disruptive med-tech start-up Genetesis continues to gain national attention with recent “breakthrough device designation” by the FDA for its flagship technology CardioFlux. This comes on the heels of closing a $10.5 million Series B with participation from partners like CincyTech, the Ohio Innovation Fund, and Cuban’s Radical Investments. “The FDA designation recognizes the positive patient impact that is possible with Genetesis,” CincyTech CEO Mike Venerable says. “This accomplishment is a credit to Peeyush and his team.” The FDA program’s objective is to provide speed to market for new product development. Representing a next-gen evolution in heart health technology this designation will serve as a “catalyst” in making CardioFlux available for widespread clinical use. Genetesis received its first FDA 510(k) clearance in 2019. “It’s a testament to the FDA believing in the potential of this technology,” says Peeyush Shirvastava, com-
pany cofounder and CEO. “A lot of value comes with that. We get regular FDA interaction, ultimately for clinical approval of our technology, which would make it widely available throughout the United States.” The City continues to deploy nontraditional strategies to support scaling innovation of its startup and biotech portfolio and is collaborating with Genetesis on a 500-patient, multi-center clinical trial, known as the “Mason Heart Study.” It’s expected that findings used from this early baseline data gathered from the study will be part of the drive to a faster company standup. Genetesis, founded in 2013, is part of a growing bio hub in the City of Mason, which also includes companies like IncludeHealth, Clarigent Health, AtriCure, Masters Drug Company a McKesson Company, Haag-Striet/Reliance Medical, Myriad Neuroscience (which acquired Assurex Health), Mobility Health, and P&G Global Health and Beauty. Genetesis is located in the City’s startup program known as the Mason Tech Elevator, which helps early-stage tech and bioscience companies scale. The City of Mason Congratulates Genetesis! Learn more at genetesis. com.
Kings Mills Elementary Is Getting a Therapy Dog! Welcome to Gily, a golden doodle who will join the staff and students at Kings Mills Elementary sometime in the spring, once she passes her training and certifications. Gily’s name means “joy.” Like Raven, J.F. Burns Elementary School’s Therapy Dog, Gily will have received extensive training on how to interact with elementary students in a school environment, as well as undergone temperament and obedience training. She will be assisting KME School Counselor Keri Perdrixin supporting students. We are sure that Gily will bring a lot of joy to the students and staff at KME! Pictured L-R: Mrs. Perdrix with Gily and Mrs. Emily Sander, JFB Counselor, with Raven.
Spring 2021
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