Issue 131
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:
- Yet another health app seal-of-approval project shutters: The UK’s NHS has decommissioned The NHS Apps Library, its collection of trusted third-party health and well-being apps that passed NHS assessments of clinical effectiveness, safety, usability, and accessibility. The former website for The NHS Apps Library now reads: “The NHS Apps Library has closed… We have decided to close the NHS Apps Library and instead we will link to recommended apps throughout the NHS website.”
- CMS added a notice of proposed rulemaking to its list of plans for 2022 that looks to make up for the MCIT Breakthrough reimbursement debacle of earlier this year. This new NPRM is named “Transitional Coverage for Emerging Technologies” and described like so: “This proposed rule would establish the criteria for an expedited coverage pathway to provide Medicare beneficiaries with faster access to innovative and beneficial technologies.” It doesn’t mention Breakthrough designation specifically, so maybe this one will have a broader scope?
- Here’s a little scoop: Remember when one of the founders of Constant Therapy (The Learning Corp.) bought the company back from its acquirer, Digital Health Corp. (Issue 065)? Well, one of DHC’s other holdings was an early MSK-focused startup named Reflexion Health. Reflexion managed to secure three 510(k)s for its virtual PT software, Vera, starting in 2015. Recently DHC’s CEO Dr. Joe Smith joined BD as its new Chief Scientific Officer, which got me wondering what happened to Reflexion. Turns out Smith & Nephew acquired Reflexion’s patents and trademarks. I’m curious to see what they do with it.
- Pear Therapeutics announced a couple of new asset acquisitions: a CBT-based digital therapeutic for depression developed by Waypoint Health Innovations and an internet-based CBT program focused on treating the residual symptoms of depression and relapse that was developed by an academic at Sweden’s Örebro University.
- Belgian health tech startup Sunrise just raised $3.6 million to bring its CE-marked sleep apnea wearable diagnostic device to the US and France: “We have developed the measurement of a new biosignal: we analyze mandibular movements during sleep. The sensor communicates with a mobile application. The data collected is processed thanks to artificial intelligence and can be transmitted to the doctor the next morning.” CE Mark but not yet through the FDA.
- Meanwhile, US-based Amalgam Rx’s insulin titration software, DoseCheck, which is already launched in the US, Brazil, and the EU, just secured regulatory clearance from Saudi Arabia’s Food & Drug Authority.
- One more thing… Well, this probably isn’t the last you’ll hear from me in 2021, but it probably is the last E&O Fridays of the year because next Friday is Christmas Eve and the Friday after that is New Year’s Eve.
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AliveCor added about 40,000 KardiaCare subscribers in 2021
AliveCor, which is still battling its big rival Apple in multiple legal arenas, added about 40,000 net new subscribers to its KardiaCare subscription service in 2021. (More on how I calculated that number after a brief intro to KardiaCare.) KardiaCare runs about $10 a month or $100 annually, Here’s how AliveCor pitches it on its site:
“KardiaCare is the world’s only heart health membership that can detect 6 of the most common arrhythmias, including PVCs. Designed to help you get the most out of your Kardia device, KardiaCare provides exclusive features in the Kardia app that will help you better manage your heart health from home. And now our newest feature, Advanced Determinations, has joined the suite of exclusive benefits for KardiaCare members. Detect more arrhythmias than any other personal EKG by joining today.”
If you recall back in January 2021 in Issue 084, I reported on AliveCor CEO Priya Abani’s presentation at the big JP Morgan healthcare conference in San Francisco. Here’s what I wrote back then:
AliveCor shared a few financial details this week at JPM. CEO Priya Abani told the audience:
“In 2020 we delivered 85 percent year-on-year growth in revenue and 130 percent growth in monthly active users. Our subscriber business is growing even faster. Q4 2020 grew 260 percent from Q4 2019. We’re doing all of this at average margins of 65 percent, which will expand by several points in 2021 as we grow over service revenue mix.”
The company also revealed that it currently has 70,000 subscribers to its ECG services.
There are a few interesting metrics in there but the one that stuck with me was the 70,000 subscribers. Abani made those comments at the beginning of January 2021. This week one of AliveCor’s investors and board members, Vinod Khosla, the founder of Khosla Ventures, shared an update on AliveCor during an interview on the Fixing Healthcare podcast:
“So AliveCor has 110,000 subscribers that are self-paying for a monitoring service.”
Clinical trial updates from Kaiser-Pear, AstraZeneca-MGH, Proteus, Akili, Limbix
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.
Kaiser Permanente to study reSET and reSET-O in primary care clinics DIGITS Trial
This is a big study of Pear Therapeutics’ flagship prescription digital therapeutics, reSET and reSET-O. Pear first announced this study in the spring, but the clinicaltrials [dot] gov listing just went live this week and it looks to be a bigger study than originally envisioned. Pear’s release in April said the study would likely include more than 1,000 participants. Kaiser noted in the study posting that they anticipate 13,500:
“In this study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in Kaiser Permanente Washington primary care clinics. The study will evaluate the extent to which two implementation strategy interventions, health coaching and practice coaching, improve the implementation. Primary care clinics are randomized to receive these implementation strategy interventions. Each clinic will have a 12-month active implementation period beginning on its date of randomization. To study the continued use of reSET and reSET-O after the active implementation period is completed, a sustainment period of up 12 months will follow the active implementation period.”
Proteus Digital Health study on pain in cancer patients finally terminated
The sponsor, Southwest Oncology Group, of a feasibility study that Proteus set up shortly before going out of business just pulled out and the trial shut down.
“Study only accrued 2 patients and had difficulty getting sites to participate in a trial with a controlled substance. Study was ultimately discontinued when the DMP software company went bankrupt and was sold. Due to the lack of patient data, only the primary objective was analyzed.”
Small update: AstraZeneca’s AMAZE platform feasibility and perceived value study with MGH’s heart failure patients is now listed as “completed” in clinicaltrials [dot] gov. The only other new information here, however, is that the study included 70 participants instead of the originally anticipated 65. No results posted yet.
AstraZeneca, Novartis and others investigate digital support app for breast cancer patients
This pharma-led study is now recruiting:
“The research team want to investigate whether digital support, an app under preventive hormonal breast cancer treatment can lead to less late side effects, better quality of life and increased adherence to treatment.”
Small update: Akili’s adolescent trial for EndeavorRx expands from 10 to 20 sites as it seeks to recruit 165 teens.
Another small update: Limbix’s study on its prescription digital therapeutic (SparkRx) for teen depression now has results, but the company already launched it (Issue 122) under the FDA’s waiver for digital health psychiatric devices during the pandemic.
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