Renovo Concepts, Inc. Announces FDA Approval of IDE for Phase I Clinical Trial Of Novel MTR Device for Treatment of Traumatic Brain Injuries

November 20, 2023 [San Antonio, Texas] – Renovo Concepts, Inc., a start-up medical device company, announced today that it has been granted an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) to conduct a Phase I clinical trial of its novel Mechanical Tissue Resuscitation device in the treatment of Traumatic Brain Injuries (TBI). This First-in-Human clinical trial will include nine subjects across two trial sites and the company has contracted Avania to help manage the execution of the study.

“We are happy to have the opportunity to start generating the necessary human clinical evidence to demonstrate the safety and efficacy of this novel technology” said Michael J. Morykwas, CEO and Chief Scientific Officer of Renovo. “The treatment of Traumatic Brain Injuries has remained relatively static over many decades. We believe the timely application of controlled negative pressure can have a significant impact on the treatment and recovery of patients with a TBI, and this safety trial is the first major milestone in moving this device towards full commercialization.”

The U.S. Centers for Disease Control’s (CDC) National Center for Injury Prevention has estimated that approximately 5.3 million people in the U.S. are living with a disability resulting from a traumatic brain injury. Globally, the annual incidence of TBI is broadly estimated in a range between 25 to 70 million per year.

About Renovo: Renovo Concepts, Inc. was formed in 2017 by Louis Argenta, MD and Michael J. Morykwas, PhD, and has an exclusive worldwide license from Wake Forest University to develop and market its Mechanical Tissue Resuscitation (MTR™) device.

To learn more, please see www.renovoconcepts.com