Issue 129
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.
Here’s what’s happening in the world of FDA-regulated and pharma-focused digital health:
- The news you know: DTC baby monitoring device company Owlet pulled its smart sock from the market after the FDA sent it a letter suggesting it should be regulated as a medical device. Owlet posted an FAQ of sorts about the regulatory kerfuffle here: “We plan to work toward the submission of a device application to FDA. We met with the FDA recently to reiterate our commitment to these efforts.” Owlet has been selling its smart baby socks for six years, but it recently went public via a SPAC. Wonder why the FDA decided to make a move in 2021 and not 2015?
- Meanwhile, The Digital Therapeutics Alliance asked the FDA to just go ahead and formally define digital therapeutics already: “In the aforementioned April 2020 EUA, the FDA directly acknowledged the value that digital therapeutics provide to patients, caregivers, and clinicians. However, the FDA has not taken the important step of officially recognizing and defining digital therapeutics in formal guidance. The Agency is already viewed as a leader in the DTx industry. By formally defining and recognizing digital therapeutics in this capacity, the Agency can more clearly communicate and expand its current efforts related to the review and clearance of DTx products.” I like the bit about the agency already being viewed as a leader in the DTx industry. (Does flattery work on the FDA?)
- To wit: The FDA continues to cement its position as a leading regulator of medical products in the US with a new draft guidance on real-world data.
- Elsewhere: ResApp Health announced it has secured TGA clearance (in Australia) and a CE Mark certification (in Europe) for its standalone cough counter app. AstraZeneca currently uses the app in a lung cancer clinical trial as well as in an asthma management program.
- Yet another breakthrough: Pear Therapeutics announced that its alcohol use disorder prescription digital therapeutic received Breakthrough Device designation from the FDA. While the company mentioned this PDT’s brand as “reSET-A” in an old SEC filing it changed the name to a generic candidate number days later. However, since then Pear trademarked the name “reSET-A,” and called the PDT by that name in its recent release.
- The Nuvo Group, makers of an FDA-cleared remote monitoring wearable for fetal and maternal heart rate during pregnancy filed paperwork to go public via a small IPO. Here’s their first cut at an S-1.
- Two weeks ago (Issue 128) I mentioned the first two influencer campaigns that Akili inked for its ADHD prescription digital therapeutic. This week the company added one more influencer to its roster: Dr. Sasha Hamdani, a psychiatrist and ADHD expert, who runs a popular Instagram account with more than 110,000 followers. Here’s one of the ads she created for EndeavorRx.
- One more thing… Click Therapeutics filed a pair of trademarks for “Cleo,” which may end up being the brand of one of the many prescription digital therapeutics in its pipeline. (It’s also the name of a fairly well-known parent and fertility benefits startup.)
Did a friend forward this to you? You, too, can win friends and influence people via newsletter forwards by clicking right here. Become the newsletter-forwarder we both know you were meant to be. Act fast! This offer won’t last forever (I am not immortal).
FDA clears metaMe’s prescription digital therapeutic for IBS pain, Regulora. Plus: How Mahana prescribes its IBS PDT today
The FDA just cleared another prescription digital therapeutic via 510(k): metaMe Health’s irritable bowel syndrome (IBS) intervention, called Regulora. Here’s the indication for use:
“Regulora is a prescription-only digital therapeutic device intended to provide behavioral therapy through gut-directed hypnotherapy for adults 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Regulora is indicated as a 3-month treatment for patients with abdominal pain due to IBS and is intended to be used together with other IBS treatments.”
The number of digital health companies focused on gastrointestinal issues is still small, but metaMe isn’t the only one with an FDA-cleared prescription digital therapeutic on the market. Mahana Therapeutics managed to get its IBS-focused PDT through the FDA via a de novo almost exactly one year ago (Issue 080). Since then Mahana updated the product by adding a mobile version and secured another 510(k) (Issue 105) back in June 2021. I’m curious to see how metaMe goes to market with Regulora.
Mahana Therapeutics has approached their launch with a DTC mindset, as I wrote back in May 2021 (Issue 102), Mahana posted a job opening for a VP of marketing:
“A creative thinker who’s excited about the challenge and opportunity of building a D2C brand in the complex world of healthcare.”
Fast forward to today: When visitors to Mahana’s site click through to take a two-minute questionnaire to see if Mahana’s therapeutic program is right for them, it sends them to a third-party site branded as — bit on the nose here — GutDocNow. GutDocNow is powered by GenieMD’s iVisit video visits platform. 
Back to metaMe and Regulora. One of the key differences between Regulora and Mahana is that Regulora uses hypnotherapy while Mahana is CBT-based. Curiously, there is already a hypnotherapy-based digital therapeutic for IBS on the market named Nerva from Mindset Health. Nerva, however, does not have FDA market authorization. It’s available DTC from Apple’s App Store (an Android version is still in the works) and it’s priced at just under $70 for three months of access. (I emailed Mindset, which is based in Australia, about their regulatory strategy and will include an update when they get back to me.)
Update. Mindset’s Co-CEO and Co-Founder Chris Naoumidis emailed me back:
“At the moment we’re focused on creating accessible consumer digital therapeutics where people learn to self-manage the symptoms and live well with low-risk chronic conditions (e.g. IBS) or otherwise support a healthy lifestyle. We believe low-risk & functional conditions like IBS provide an opportunity to take a meditation app-like approach and make evidence-based self-management tools in the health & wellness space that are accessible without a prescription. Our products are not intended for treatment purposes, unlike the Mahana & MetaMe products, which are intended for IBS treatment (e.g. ‘digital treatments’) and make specific therapeutic claims regarding outcomes that IBS patients receive through their digital therapeutic offerings.”
Finally, there is a third group of gut health-focused startups that I’m tracking, virtual care providers like Oshi Health, Bold Health, and Vivante Health. Who am I missing that’s working on digital interventions for digestive health?
Clinical trial updates from Oui Therapeutics, Dopavision, Talkspace, and Big Health
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others E&O mentioned in previous issues.
Oui Therapeutics posts a few details about its first big study for Aviva, its suicide ideation digital therapeutic
Here’s an interesting one from Oui Therapeutics, which is the startup led by Seth Feuerstein, a former Magellan Health exec who also started pioneering digital CBT startup Cobalt Therapeutics before selling it to Magellan around about 2014. This is actually Oui’s third clinical trial, but the other two were small feasibility ones. The new trial will be much larger:
“This double blind, randomized controlled trial will evaluate effectiveness of a digital intervention versus a sham among 391 participants.”
Details on the intervention remain scarce, but the company sometimes refers to it as “Aviva,” which has a somewhat helpful product page here. An early grant proposal from 2020 included a few hints:
“The digital therapeutic being studied is built on face-to-face CBT treatment protocols proven to be effective in clinical trials. Successful execution of the goals of this Phase I project will generate a version of Aviva that is ready to be tested for efficacy with stabilized patients in a clinical trial. In the long term, this project will have a beneficial impact on the field of suicide prevention through the development of mobile technology designed to advance the delivery and dissemination of effective interventions.”
Now recruiting: Dopavision’s myopia PDT study
Dopavision is now recruiting participants for its “trial is to investigate the safety and efficacy of MyopiaX — a digital treatment intended to slow the progression of myopia in children and adolescents.”
Talkspace to study 10,000 in a new prospective study to enhance engagement
Beleaguered mental health startup Talkspace is working in partnership with Mental Health America (MHA) and the University of Washington’s Schools of Medicine and Computer Science Engineering (UW) on a prospective study:
“The investigators propose a naturalistic and experimental, theory-driven program of research, with the aim of understanding 1) how consumer engagement in self-help and clinician assisted DMH varies and what engagement patterns exist, 2) the association between patterns of engagement and important consumer outcomes, and 3) the effectiveness of personalized strategies for optimal engagement with [digital mental health] treatment.”
Big Health’s pilot Sleepio study with the VA hits primary completion
Check out all of the details here, and below is a quick descriptor of the 10-person pilot:
“The proposed study is a multiple baseline design pilot study which seeks to evaluate the impact of digitally administered CBT-I, using the Sleepio platform, for the treatment of insomnia disorder among Veterans with co-morbid psychopathology.”
Michael J. Fox Foundation and Evidation aim to enroll 100,000 into the big Parkinson’s Progression Markers Initiative (PPMI) study
This expansion was actually announced in a press release yesterday, but in case you missed it:
“The study is reopening to enroll vastly more participants, notably including online enrollment of up to 100,000 individuals with and without a Parkinson’s diagnosis. First launched in 2010, PPMI is a critical component of the Foundation’s relentless mission to accelerate better treatments, cures and even prevention of the disease…”
“These participants will share data online and through a smartphone app; some also will contribute biological samples and undergo assessments at nearly 50 clinical sites around the world. In order to accelerate frameworks for prevention of Parkinson’s disease, PPMI will work to characterize Parkinson’s risk by studying cohorts representative of the full continuum of disease — those not diagnosed; the newly diagnosed; and those with progressing disease.”
Links to E&O’s reports, databases, newsletters
The Exits & Outcomes site is designed to make it easy to find long-form research reports, databases, and past newsletter editions. Click below for dedicated pages for each of those categories:
- Read through the long-form E&O research reports here.
- Search and sort the E&O databases here.
- Skim more than 180 past issues of E&O newsletters here.
