Issue 108
Digital health research from Brian Dolan
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:
- The news you know: Aptar, a drug delivery device-maker among other things, is in negotiations to acquire Voluntis. According to the companies’ joint release, if the deal goes through, Aptar would acquire about 65 percent of Voluntis from management and other shareholders for about $61.5 million. The deal would value the company at about $95.3 million.
- NightWare, the prescription digital therapeutic for nightmares, has a brand new site. One thing I didn’t know (but probably should have assumed) until I clicked through to their patient IFU was that the company ships out both an Apple Watch and an iPhone as part of its Rx-only kit.
- More news you know: The Digital Therapeutics Alliance appointed former Cognoa exec Andy Molnar its new CEO as executive director Megan Coder heads to Europe to focus on the Alliance’s international efforts.
- Sharecare began trading on NASDAQ today as a public company following its SPAC merger.
- An E&O subscriber asked me if I knew Flatiron’s annual revenue around the time Roche acquired it (early 2018) for $1.9 billion. I hadn’t seen that figure, but soon after the acquisition, Forbes estimated the number was something like $200 million. In a 2019 filing, Roche ended up sharing how much revenue Flatiron contributed during the last nine months of 2018. Roche extrapolated from that number to get $80 million — that’s how much revenue Flatiron would have contributed to Roche in 2018 had it been acquired on January 1, 2018.
- One more thing… The German government added two new reimbursed digital health offerings to its DiGA program, which brings the total number of reimbursed products via DiGA to seventeen. They’re all in E&O’s DiGA mini-database here. The new ones were online courses from Selfapy focused on generalized anxiety disorder and panic disorder.
Whoa, whoa… Hey there, stranger. Was this paying subscribers-only newsletter forwarded to you? Follow me over to E&O HQ for a minute.
Natural Cycles new FDA 510(k) likely unlocks wearables for birth control
Natural Cycles Nordic, the Swedish digital health company that secured a De Novo clearance for its contraceptive app back in 2018, received an additional 510(k) clearance for its app a week ago.
The FDA has not posted its decision summary letter, and the company has kept the new clearance quiet so far.
Here’s what I think it is.
Natural Cycles has hinted that its next evolution will see the addition of wearable devices to its fertility and birth control software. It is currently running a beta test for Natural Cycles users that pairs the app with an Oura ring. Body temperature data from the ring replaces the Natural Cycle’s own FDA-cleared basal thermometer. This beta test, however, is just for those using Natural Cycles for fertility.
The company has said that some users forget to check their temperature right when they wake up in the morning. Consistent data input is key to Natural Cycle’s software. Temperature-sensing wearables would help solve this issue. They would also provide more data points, including overnight temperature readings taken while the user is sleeping.
Natural Cycles has said that using its software for birth control would require an additional FDA clearance, so its Oura ring beta test does not include birth control features.
The company has also told the press — both back in November 2020 and as recently as early June 2021 — that it was pursuing an FDA clearance to add wearables to its birth control software.
Here’s what Natural Cycles co-founder and CEO Elina Berglund told EU Startups just a few days before the FDA granted the 510(k) in June:
“Our aim is to continue building and improving our user experience and expand further into the US market. Our next step is to enable wearables as part of our product offering, which will seriously take Natural Cycles to the next level. As we’re a regulated medical device we must validate each wearable we add, so we’re in the process of collecting and presenting data to the FDA as well as the European authorities for clearance. Our aim is to ensure users have multiple options, so the wearables function really speaks to that.”
Natural Cycles has also said that it aims to get an FDA clearance that would allow it to pair various off-the-shelf wearables with its software — not just the Oura ring.
That’s a much heavier regulatory lift than getting clearance for the software to work with one particular off-the-shelf sensor platform.
One hint that the FDA struggled a bit with this 510(k) is that it took about nine months to clear it. Natural Cycles submitted its 510(k) in September 2020 and only received clearance last month.
It took 268 days.
(That’s more than 9.5 times as long as it took the FDA to grant Apple’s De Novo for its ECG app!)
Clinical trial updates: BI-Noom, Apple-JNJ, Akili, Orexo, Big Health, and AppliedVR
Orexo plans 400-person RCT for Modia OUD digital therapeutic
Orexo is gearing up to kick off its first RCT for Modia, the opioid use disorder DTx that its partner GAIA developed.
“This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC) background therapy compared to SL BUP/NAL alone to change opioid use patterns in subjects with OUD.”
“Approximately 400 subjects will be randomized. The study will include a screening visit and a randomization visit, followed by 24 weeks of study treatment. Subjects will be scheduled for evaluation visits, which will include a UDS and a self-report of drug use, weekly during the first four weeks of treatment, then every other week from weeks 5 through 12, then monthly through week 25. Subjects will also return to the site for only a urine drug screen (UDS) and a self-report of drug use each week between the evaluation visits.”
Boehringer Ingelheim’s Noom vs BodyPort vs Conversa study for HF to finish in November
BI’s digital health for heart failure patients study is likely to finish up in November now that its last target date of May 2021 has passed. BI is conducting the trial with Medullan and it will compare three digital health programs from Noom, BodyPort, and Conversa:
“This study is an unblinded, 4-arm, parallel group randomized controlled trial to measure the efficacy of four digital health technologies in improving the management of care and quality of life of patients with congestive heart failure (CHF). Patients actively managed by one of Yale New Haven Hospital’s heart failure-based clinics will be eligible for this study and approached for consent. Enrolled subjects will be randomized to one of four groups: a control (usual care) arm, or to one of three intervention arms, each of which assesses one of three digital health technologies. These technologies are:
- BodyPort: A data-driven smart scale that provides enhanced cardiac monitoring and risk assessment data.
- Noom: A live, data-driven coaching application providing personalized diet and weight management.
- Conversa: An automated conversational platform providing patient motivation and educational tools for CHF management.
Patients will be enrolled in the study for 6 months. The first three months will typically involve active clinic management and will be the point of our primary outcome assessment, while the final three months will assess stability of effect on patient care and outcomes.”
Cedars-Sinai comparative study pits 2D digital therapeutic up against 3D VR-based DTx
Here’s an interesting study that includes a CBT program and a virtual reality-based digital therapeutic from AppliedVR:
“This study will compare two available, evidence-based, digital pain treatment programs that patients can use at home. The goal is to see if one approach is better than the other, and whether certain patients respond to one more than the other. Study participants will be randomized to receive one of two treatment programs: Skills-Based VR or painTRAINER. Study devices will be delivered to the participant’s home with instructions for use via FedEx; participants will receive remote technical support. They will be followed for 60 days and complete Patient Reported Outcome (PRO) questionnaires to assess functional status, pain levels, and use of pain medications (including opioids). Participants will also be asked to provide consent/authorization to access medical records from their treating facility.”
Big Health’s Sleepio as part of combination therapy for menopause-after-cancer symptoms
Here’s another interesting one. This study, which is taking place in Ireland, indicates that Big Health might put its Sleepio digital therapeutic through the FDA for an indication related to menopause:
“This study will recruit women with vasomotor symptoms of menopause and a prior cancer diagnosis, for whom conventional menopausal hormone therapy (MHT) is contraindicated for any reason. This study will examine if the addition of psycho-social support and digital cognitive behavioral therapy (CBT) for insomnia to standard non-hormonal pharmacotherapy can improve quality of life for these women.”
Akili begins recruiting for its EndeavorRx for teenagers trial
Small update here, but Akili’s next big trial — Software Treatment for Actively Reducing Severity of ADHD in Adolescents (STARS-ADHD-Adolescents) — is now recruiting patients at its Arizona trial site.
Another delay for Apple-Janssen Heartline study on early AF detection and stroke
Here’s one more small update, Apple and Janssen’s Heartline study — A Heart Health Study Using Digital Technology to Investigate if Early AF Diagnosis Reduces the Risk of Thromboembolic Events Like Stroke IN the Real-world Environment — is now expected to finish up at the end of 2024. (That marks another six-month delay for the high-profile study.)
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