Issue 177

Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.

 E&O Fridays.

Well, things are slowing down as the year comes to a close, but here are a few recent happenings in FDA-regulated and pharma-focused digital health…

• So, the massive omnibus spending bill has made its way through Congress but the multi-thousand-page document had nary a mention of prescription digital therapeutics. Yes, it has some helpful extensions for telehealth coverage post-pandemic, but the latest bill from the prescription digital therapeutics lobby, S.5238 – Medicaid and CHIP Access to Prescription Digital Therapeutics Act, which aimed to make it clear to directors of Medicaid plans that they could pay for prescription digital therapeutics for their beneficiaries, was angling for inclusion too and — apparently — failed to get it. Curious to hear your thoughts on this: Are the two prescription digital therapeutics bills (one that creates the new Medicare benefit category and this one mentioned above that clarifies to Medicaid directors that they have the authority to pay for PDTs) crucial to the long-term survival of prescription digital therapeutics as a go-to-market for digital health? Can companies intent on this business model survive if neither of those bills becomes law? Hit reply if you have an opinion on that…
• Apple-AliveCor: Last night I tweeted about breaking news in the Apple-AliveCor patent infringement lawsuits. (Follow me on Twitter here if you’re not already.) The ITC went ahead and decided to green-light a ban on the importation of Apple Watches, because the court found that Apple infringed on AliveCor’s patented ECG technology. However, the ban will not go into effect until the appeals process is completed in the parallel case over at USPTO’s PTAB, where Apple has so far emerged victorious. PTAB decisions are upheld on appeal more often than not, so chances are that the Apple Watch import ban won’t come into effect. Still, it’s notable that the ITC was not swayed by Apple, its big-name healthcare provider partners, or its half-dozen supporters in Congress who all argued that it was in the public’s interest to continue to make the Apple Watch available. Screenshots from the decision documents are over in my Twitter thread here. Typically, when the ITC puts a ban on imports in place it send a letter to the President who has 60 days to overturn it. This morning the ITC did write a letter to President Biden, however, in this case the ban won’t go into effect until the PTAB appeals process is finished, so I wonder if the President will make a decision now or wait?
• Germany has added another prescription digital therapeutic to its national formulary of reimbursed digital health programs. The program is the sixth from HelloBetter to get into the DiGA formulary. The new digital health offering is focused insomnia and costs €599. “HelloBetter Sleep is an interactive psychological therapy program to reduce insomniac symptoms. The online program is based on cognitive behavioral therapy for insomnia (CBT-I) and was developed by experts from science, psychology and psychotherapy together with those affected.”
• Owlet, the baby monitor company that SPAC’d onto the public markets in 2021, announced that it had filed a de novo submission to the FDA, which accepted the request. Here’s what they disclosed about the submitted software as a medical device: “to expand the functionality of Owlet’s Dream Sock’s existing sleep monitoring capabilities to include opportunistic heart rate and oxygen notifications, through software as a medical device that Owlet calls ‘Health Notifications.’ Designed for parents and caregivers to monitor healthy babies at home, the Health Notifications software would provide displays of live heart rate and oxygen saturation for babies, in addition to the opportunistic notifications when these readings move beyond certain ranges.” Remember: Owlet announced that it had submitted a 510(k) for a health-focused remote monitor version of its baby monitor back in October. No 510(k) clearance has emerged yet, however.
• One of the big pharma-digital health partnership new announcements this week: Amalgam Rx expanded its deal with Novo Nordisk: “The new agreement bolsters the existing partnership and product suite between Novo Nordisk and Amalgam by incorporating and integrating with connected insulin delivery devices, continuous glucose monitors, and electronic health records (EHRs). Novo Nordisk is also making an equity investment in Amalgam.”
• One more thing… The other big pharma-digital health partnership news this week was an expanded deal between Click Therapeutics and Boehringer Ingelheim. Here are the specifics: “The additional prescription digital therapeutic under this expanded collaboration builds on development and clinical successes together with key patient insights gained under the companies’ existing collaboration, which has been in effect since September 2020. The CT-155 program has achieved all development milestones to-date and generated supportive data across clinical learning studies in advance of an upcoming pivotal registration study. The companies are pursuing this new therapy after recognizing that a comprehensive treatment strategy for schizophrenia would benefit from a multi-product approach. Click Therapeutics will receive an upfront payment, funding for research and development activities as well as clinical, regulatory and commercial milestone payments up to a total of USD 460 million, plus tiered royalties.”

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Clinical trials: Woebot, Apple, ResMed, Mahana

This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others that E&O mentioned in previous issues.

New: Scripps and Woebot RCT on postpartum depression digital therapeutic

This study aims to enroll 450 participants:

Delayed: Another slight delay for Apple, AHA, and Johns Hopkins’ remote heart monitoring platform (Corrie) cardiac rehab RCT

E&O has been tracking this Apple-supported study for a while and it has hit another delay. It is now set to start in February 2023 after previously aiming to get going this month. More:

Delayed: ResMed-SleepScore’s study of digital therapeutic for sleep health in Germany

This one is a curious study because ResMed acquired a similar app in Germany a few months back: Mementor’s Somnio. This study focuses on a different app that the company is developing with partner SleepScore. The study’s start has been delayed from July 2022 until January 2023. It won’t finish up until August now. More:

Completed: Mahana Therapeutics’ study on its IBS PDT

Mahana is no longer recruiting and expected to finish up its study on its prescription digital therapeutic for people with irritable bowel syndrome this week. The three-month program aims to “reduce the severity of IBS symptoms.” More (though not many details on the study are available):

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