For those working in an early-stage life science entity, priorities are most commonly linked to demonstrating proof-of-concept, architecting a blueprint that can get a potential product into the clinic, and figuring out how to finance the lengthy risk-laden process. Many initially promising products never make it through the clinical and regulatory processes. Once a product has been reviewed and finally cleared by the regulatory agency it is certainly cause for celebration - that celebration however is short-lived as it is critical to rapidly change focus from a development organization to a commercial-stage going concern.
Today we wish to pause for that scarce and brief celebration opportunity for CID4 portfolio company, Boulder, CO-based Sophono, Inc., which recently received FDA clearance for their new abutment-free bone conduction hearing device. The Otomag Alpha 1(M) product is a treatment for hearing disorders such as conductive and mixed hearing loss as well as single sided deafness. The Alpha 1(M) differs from currently available implanted bone conduction hearing devices by incorporating a unique magnetic coupling. The Otomag system does not require an abutment (a titanium screw protruding out of the side of the head) or permanent hair removal, nor is the associated daily hygiene routine required by an abutment necessary. Thus the Alpha 1(M) may significantly reduce complications commonly associated with current bone anchored hearing devices.
According to the National Institute on Deafness and Other Communication Disorders, the U.S. has approximately 36 million adults who report some degree of hearing loss, and of these individuals only 1 out of every 5 people who may benefit from a hearing device actually wear one.
So, a hearty congratulations to the Sophono team for achieving a milestone that many set out to attain, though in reality and for a broad spectrum of reasons, very few can or do. The Sophono team has worked tirelessly to achieve its first FDA cleared product. Now it is time to roll-up your sleeves and apply the same laser focus to getting the Alpha 1(M) out into the world where it can make a real difference in the lives of those who suffer from hearing loss.Comments