Filing of a 510(k) Pre-Marketing Notification Application with the FDA for Exogenesis Hernia Mesh

OrthoNext Digital Platform for the JuniOrtho Plating System Receives FDA Clearance

“Together, OrthoNext and the JuniOrtho Plating System provide a complete solution for surgeons looking for a plating system to address the specific demands of advanced deformity and trauma reconstruction of the lower extremities in the pediatric population,” said Orthofix President of Global Orthopedics Paul Gonsalves.

SonarMed, New Pediatric Monitor Alerts Clinicians To Potential Airway Obstructions During Ventilation Launched

"The SonarMed airway monitoring device has revolutionized the way we care for our littlest patients. There is no other device in the world that can tell you where the endotracheal tube is located within the airway continuously in real-time, and whether the tube is obstructed or even partially occluded," said Jamie W. Powers, M.D., MBA, neonatologist at Huntington Hospital in Pasadena, California.

Exogenesis Corporation announced today that it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its first proprietary soft tissue repair device, Exogenesis Hernia Mesh. Exogenesis expects feedback from the FDA during the next quarter and anticipates entering the US market with Exogenesis Hernia Mesh following FDA premarket clearance.

Dmitry Shashkov, President and CEO of Exogenesis commented, “We are excited to reach this important milestone in our product development. Our Accelerated Neutral Atom Beam1 (“ANAB”) surface treatment technology is already being deployed on other FDA-cleared devices, however Exogenesis Hernia Mesh is our first proprietary product developed entirely in-house. ANAB has the bioactive potential to improve medical device implant responses in man and we are excited to bring this exciting technology one step closer to the clinical community.”

Exogenesis will highlight the Exogenesis Hernia Mesh and other developments of its ANAB enhanced medical device technology during two upcoming international conferences: The International Symposium on Surfaces and Interfaces for Biomaterials (ISSIB, Quebec City, Canada, July 22-25 2019) and American Vacuum Society International Symposium and Exhibition (AVS-66, Columbus, Ohio, October 20-25 2019).

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