The past few days have seen new pivotal trial announcements from two startups eyeing FDA submissions for their digital health offerings.
On Thursday Cognoa unveiled an investigation for its pediatric development monitoring and diagnostic tool. This will be a multi-site, prospective, blinded, active comparator study of the tool, which is intended to support primary care autism diagnoses among children aged 18 months or older. Cognoa is targeting a 2020 premarket submission for the product, which has already received a Breakthrough Device designation from the agency.
“Building upon Cognoa’s previous successful clinical studies, this pivotal study is an important milestone for our company,” Brent Vaughan, CEO of Cognoa, said in a statement. “In tandem, we have established our commercial model with our partner, EVERSANA, that will enable access to our digital therapeutics by physicians through existing prescription, distribution and reimbursement infrastructures for utmost efficiency.”
The second, announced this afternoon, is for MedRhythms’ stroke rehabilitation platform, which combines sensors, software and music to improve neurologic function following injury or disease. This randomized controlled trial will be spread across five sites (Shirley Ryan AbilityLab, Kessler Foundation, Mt. Sinai Hospital, Spaulding Rehabilitation Hospital, Boston University Neuromotor Recovery Lab), and will recruit stroke patients who sustained walking impairments following the event. The company noted in its announcement that this trial is being organizing following successful results from a feasibility study of the system, which will be presented at an academic meeting early next year.
“This clinical trial marks an important milestone toward MedRhythms’ mission to make this high-quality intervention available to those who need and deserve to have it,” Brian Harris, CEO and cofounder of MedRhythms, said in a statement. “As this new industry grows, it is important for digital therapeutics to demonstrate efficacy with the support of rigorous clinical trials, and this RCT is an integral step in MedRhythms’ evidence generation strategy to do so.”
WHY IT MATTERS
There’s been no shortage of discussion on the need for clinical data and regulation among a young digital health industry, especially as these products are seeking validation and reimbursement from established players in the system. Both of these trials are being conducted with an end goal of FDA clearance, which if successful would help each make their business case to payers, pharmas providers alike.
THE LARGER TREND
Cognoa currently has two products enjoying Breakthrough Device designation, as well as a child development app that according to the company has been used by more than 250,000 parents tracking their child’s growth. In April, the company exclusively licensed a Stanford University School of Medicine AI system that uses Google Glass to encourage socialization among children with autism spectrum disorder.
MedRhythms, meanwhile, is building up a range of rehabilitation offerings that use its platform, with a pipeline that includes products for post-stroke, aging and fall prevention, multiple sclerosis, traumatic brain injury and Parkinson’s disease. The Portland, Maine company was launched out of Spaulding Rehabilitation Hospital, and over the summer established a Stroke Scientific Advisory Board to guide its products.
