Linkedin bericht Dave Marver van gisteren, 29/2. Vooral de laatste paragraaf is misschien wel interessant voor Anna91.
Thank you MassDevice and Sean Whooley for highlighting ONWARD Medical's 10th FDA Breakthrough Device Designation Award!
This latest award is for our investigational ARC-BCI™ System that pairs our ARC-IM® Therapy with a #braincomputerinterface (#BCI). The ARC-BCI System creates a “digital bridge,” restoring communication between the brain and the body and enabling thought-driven movement after paralysis.
ONWARD Medical is the first company in the world to receive Breakthrough Device Designation (#BDD) for a BCI paired with therapeutic stimulation, underscoring our unique position in the fast-emerging BCI field. Our objective is not to help a paralyzed person control a computer mouse or keyboard, but instead to restore movement of the human body.
This BDD was based on clinical data from two human feasibility studies and gives us priority FDA review, the opportunity to interact with FDA experts throughout the pre-market regulatory review phase, and the potential to seek additional reimbursement.
In 2021, a BCI was paired with ARC-IM Therapy to restore movement of the lower limbs, including walking, after SCI. In May of 2023, the journal Nature Portfolio published the results of this groundbreaking feasibility study conducted by .NeuroRestore highlighting the study participant’s augmented control over his paralyzed legs with the addition of a BCI from CEA-Clinatec. Also in 2023, an additional clinical feasibility study was initiated to evaluate the potential for ARC-IM Therapy and a BCI to restore thought-driven movement of paralyzed upper limbs.
While we are proud the FDA has recognized the innovative nature of our therapies and their potential to address the many unmet needs of the #SCI community, our focus this year is on the expected commercialization of our ARC-EX® System. We are working very hard to bring that important first therapy to market as soon as possible.
De doelstellingen i.v.m. ARC-EX en de focus op dit platform dit jaar werden toch nog eens bevestigd. Ik denk niet dat ze zich kunnen veroorloven om af te stappen van dit platform. Het feit dat de klemtoon de laatste weken op ARC-IN en BCI werden gelegd, lijkt mij veeleer een PR keuze die gestoeld was op het Neuralink nieuws.