Issue 102
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.
OK, here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:
- In E&O Wednesdays this week I had an item on Bright Health’s acquisition of Zipnosis. While the price tag was previously undisclosed, I had figured out that the acquisition price was about $49 million. Weirdly, Bright Health filed its S-1 to go public a few hours later and officially disclosed the price of the deal — it was $51 million. (My calculation was an extrapolation from how one Zipnosis shareholder — with a substantial chunk of ownership in the company — made out.)
- Akili finally kicked off its marketing campaign for its ADHD digital therapeutic, EndeavorRx. The DTC ads (which target parents and caregivers, not kids) on Facebook and Instagram read: “EndeavorRx is the first and only FDA-approved video game & ADHD treatment clinically proven to improve attention in children ages 8-12. Made for the mind you love. See the science at EndeavorRx.com” The ads close with indications for use and safety information.
- This social media marketing-driven, telemedicine-supported prescription digital therapeutic go-to-market model is becoming the norm for companies offerings prescription digital therapeutics. Take Mahana Therapeutics, which is developing a prescription digital therapeutic for IBS called Parallel. This week the company 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.”
- This one you likely read about already, but Google showed off a new, quasi-diagnostic, AI-powered dermatology assist tool, which has a CE Mark (Class 1) but no FDA clearance yet. Once you take three photos of the skin lesion or rash and answer a few questions: “The AI model analyzes this information and draws from its knowledge of 288 conditions to give you a list of possible matching conditions that you can then research further.” Google says it will launch the tool via a pilot later this year.
- Amalgam Rx acquired the assets of Geetha, a conversational AI company: “With this transaction, Amalgam acquires Geetha’s turnkey psychosocial engine (personality, moods, motivators, etc.) in 40 languages, algorithms to collect contextual data via chat, AI-based chat model and platform to create low-no code virtual personalized agents, motivational content, common sense ontology for a rich understanding of a user’s life, and learning algorithms to respond to interactions and improve intervention framework.”
- As the May 15 deadline approached, CMS delayed implementation of the MCIT reimbursement pathway for medical devices with Breakthrough Designation from the FDA. A number of digital therapeutics have secured this designation, but many of them were not likely to benefit from MCIT since it requires the device to fit into an existing Medicare benefit category. (See Issue 084 for a recap.) CMS delayed implementation of MCIT not because it viewed it as too restrictive, but rather because of concerns it might be too inclusive of devices that have not demonstrated clinical efficacy for the Medicare population.
- Pear Therapeutics shared results from two health economics and outcomes research analyses for its reSET-O digital therapeutic for opioid use disorder. One of them found “that reSET-O plus treatment-as-usual (TAU) (i.e., transmucosal buprenorphine, face-to-face counseling and contingency management) vs TAU alone resulted in a projected cost savings of $765,321 per million covered lives over five years.”
- One more thing… Memora Health co-founder Nisarg Patel wrote a must-read article for Health Affairs focused on the road ahead for reimbursement of prescription digital therapeutics. Patel discusses many things that E&O has tracked over the past year (he didn’t mention the new potential CPT codes for remote therapeutic monitoring services, however), but he also points to opportunities in Medicare Advantage to lead the way here as well as Germany’s DiGa program as potential inspiration for the US.
Whoa, whoa… Hey there, stranger. Was this paying subscribers-only newsletter forwarded to you? Whatever you do — don’t click here.
Amazon didn’t spin up its own digital behavioral health offerings for its employees.
This week Amazon put out a press release that it would offer its employees a new mental health benefit called Resources for Living (RFL).
The announcement, which did not give any background information on RFL, led to quite a bit of speculation. Longtime readers of E&O should recognize Resources for Living as the EAP from Aetna/CVS.
Resources for Living has partnered with many big employers, including, McKesson, Walmart (Issue 001 of Wednesdays), and The Home Depot (Issue 004). Resources for Living offers a long list of mental health services, which I added below, but the one that jumped out to some was its CBT offering. That’s actually Teladoc‘s myStrength. Resources for Living bundles in myStrength for its employer customers.
So, no, Amazon hasn’t spun up its own homegrown suite of behavioral health offerings. At least not yet.
(Re: “nothingburger”. Don’t get me wrong: This is a great move by Amazon on behalf of its employees — it’s just not indicative of any strategic foray into mental health by the tech giant.)
From the announcement:
“Through the new Resources for Living program, Amazon employees, their families, and anyone living in their homes have access to several resources:
- Free one-on-one counseling sessions—three sessions per person, per topic. Amazon will fund up to 24 million counseling sessions per year for its U.S. employees.
- Flexible options including in-person, phone, video, or text conversations for counseling sessions.
- Interactive self-care programs, including self-assessments, and a stress resource center.
- Crisis and suicide prevention support and access to a licensed mental health clinician any time of day.
- Access to a self-paced app that offers computerized Cognitive Behavior Therapy, mindfulness resources, and personalized support for a broad range of mental health and wellness issues.”
Clinical trial updates: Akili, MedRhythms, Bold Health, Big Health, BrainGaze
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 had mentioned in previous issues.
Akili tests out EndeavorRx in teenagers
Just as Akili kicked off its advertisement campaign to parents of kids aged 8-12, it also posted details about a new pivotal study to test out its DTx in older kids:
“This study is a multi-center, unblinded/non-controlled study to evaluate objective attention functioning and ADHD symptoms and impairments in children between adolescents aged 13 to 17 years old, with a diagnosis of ADHD (combined or inattentive subtype), stably on or off ADHD medication, after 4-weeks of AKL-T01 treatment. 150-165 total participants from 4-6 sites will be enrolled. Participants will have two on-site visits: a baseline visit and exit/post-treatment visit for study assessments. Participants will complete a 28-day at-home treatment phase in between the baseline and exit visit.”
Big Health tests Daylight as treatment for GAD in CV patients
Researchers at Boston University just posted details of a new study that will test Big Health‘s Daylight app as a treatment for generalized anxiety disorder (GAD) for patients with a history of cardiovascular disease:
“The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. A recent large-scale efficacy trial of digital cognitive behavior therapy (dCBT) for GAD demonstrated significant benefit relative to waitlist control with a large effect size. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention, followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control).”
Results from Bold Health’s first DTx for IBS RCT
JMIR published the results of Bold Health’s clinical trial for its Zemedy digital therapeutic for people with IBS:
“This was a crossover randomized controlled trial. Participants were recruited online and randomly allocated to either immediate treatment (n=62) or waitlist control (n=59) groups. The Zemedy app consists of 8 modules focusing on psychoeducation, relaxation training, exercise, the cognitive model of stress management, applying CBT to IBS symptoms, reducing avoidance through exposure therapy, behavioral experiments, and information about diet.”
The topline results:
“Both intention-to-treat and completer analyses at posttreatment revealed significant improvement for the immediate treatment group compared to the waitlist control group on both primary and secondary outcome measures. Gains were generally maintained at 3 months posttreatment.”
MedRhythms announces new MS trial with MGH
MedRhythms is running quite a few clinical trials these days. (That might be one reason it just inked a deal with Eversana to outsource much of the commercialization of its first digital therapeutic, MR-001, which treats chronic stroke walking deficits.) This week it announced plans for a new clinical trial for its digital therapeutic for multiple sclerosis, MR-004, in collaboration with Massachusetts General Hospital. (This one builds on its previous one with The Cleveland Clinic.)
“… a randomized crossover trial looking at the impacts of MR-004, a digital therapeutic that digitizes Rhythmic Auditory Stimulation, on functional outcomes such as gait speed as well as neuroimaging compared to standard of care.”
A few days ago MedRhythms also revealed more details about its DTx for Parkinson’s (MR-005) trial with Johns Hopkins.
Braingaze tests video game for Alzheimer’s Disease (AD)
Barcelona-based Braingaze will soon kick off a 60-participant validation study for an interactive video game that it calls a “digital treatment.” (Oddly, the company didn’t tick the box that would declare this to be an FDA-regulated device.)
“Oculomotor behavior and cognitive processing of visual information are intimately connected. AD patients show ocular movement problems. Oculomotor deficits are broadly consisting mainly of different saccade metrics, altered pupil responses, and smaller and irregular eye vergence movements. Here we test an interactive eye-tracking game to improve eye motion control and thereby training cognitive behavior.”
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