Medibio submitted their 510K application on the 30th April 2020, so hopefully approval will be annouced in August 2020. I am antipating the run to continue up to the annoucement and spike on FDA approval. Medibio has two huge names on their Growth & Advocacy Advisory Board: Former U.S. Representative Patrick J. Kennedy & Former Olympian Michael Phelps.
June Quarterly Activities Report and Appendix 4C
Key highlights from the quarter:
Former U.S. Representative Patrick J. Kennedy:
“Medibio’s technology is truly groundbreaking and has the potential to fundamentally change the mental health system for the better. That’s why I am proud to be part of this team,” said Kennedy. “This is a company that is truly on the cutting edge, and their diagnostic and analytic tools will give clinicians the power to treat patients more effectively, using better data, and with a focus on better outcomes.”
Former Olympian Michael Phelps:
“I am honored to accept this appointment because I have personally experienced Medibio’s technology and believe it can help make a profound impact in diagnosing mental health and empowering people to seek the help and support they may need” said Phelps. “In sports, there is so much focus on the physical aspects of performance, and athletes are analyzed from head to toe. But for many athletes, mental health has not been a topic of focus, and the data analysis aspect of it has been missing up until now. I personally suffered from mental health challenges from my teenage years on, and only fairly recently—after reaching a point of desperation—did I acquire the understanding, treatment, and support I needed, which has truly changed my life. For me, self-awareness, from a mental health standpoint, is empowerment. But I’ve seen firsthand—in sports and beyond—how difficult it is for people to understand, discuss, and confront stress, anxiety, and mental health concerns, all of which can seem like an insurmountable barrier to getting the help and support that is needed. I feel that the ease and objectivity with which Medibio’s technology can accurately help to diagnose mental health will make a profound difference in people’s lives. I want to help others who are dealing with these challenges and make the process for them to take action easier and more understandable.”