Issue 178
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.
Alright, let’s get back to it: Here are a few recent happenings in FDA-regulated and pharma-focused digital health…
- In the last issue of E&O before the holidays, I mentioned the news that Amalgam Rx had deepened its partnership with Novo Nordisk and that Novo had made an equity investment in the company too. Well, a filing over the holidays showed that Amalgam has raised more than $17 million so far out of a hoped-for $45 million. The date of first sale is listed as three days before the Novo announcement went out last month.
- Austrian company SOFY managed to get its web-based depression therapy program into Germany’s DiGA national formulary: “The application guides patients through the program along the ‘Activity Feeds’ and plays out multimedia information and exercises from psychodeduction for self-help on a daily basis. It also contains elements of computer-based cognitive behavioral therapy.” It runs €357.00 for the first 90 days and then for an additional 90 days it costs another €178.50.
- German company Elona Health also managed to get its digital health program listed in DiGA: “Digital health application for interlinked outpatient psychotherapy that intelligently combines digital interventions and regular talk therapy, thus supporting the treatment of unipolar depression.” It costs €535.49 for 90 days.
- German (and American) company Kaia Health also secured a spot in Germany’s DiGA formulary over the holidays. Kaia COPD. “Kaia COPD is a digital application for adult patients with COPD, developed together with lung specialists. It conveys evidence-based and guideline-compliant content of pulmonary rehabilitation in order to improve physical performance and health-related quality of life. Kaia COPD consists of the therapy elements movement, patient education as well as relaxation and breathing techniques.” It costs €415.00 for the first 90 days.
- German company Selfapy added another digital program to the DiGA formulary: its Online Course in Binge Eating Disorder. “The Selfapy online course is a digital application for those affected by binge eating disorder. The course imparts methods and techniques based on cognitive behavioral therapy and supports the implementation and documentation of the exercises with the aim of improving the user’s symptoms.” It costs €540.00 for the first 90 days.
- Selfapy also got its online course on Bulimia Nervosa into the DiGA formulary. It’s a similar program to the one above and also costs €540.00 for the first 90 days.
- The FDA cleared the second generation version of BioBeat’s “wireless noninvasive remote monitoring system intended for use by healthcare professionals for spot check collection of physiological data in home and healthcare settings.” The new 510(k) adds “hemodynamic parameters (stroke volume, cardiac output),” which were not a part of the first gen offering. The company’s wearable patch, which is part of both clearances, is unchanged in this submission.
- News you know: Akili reported topline results from its adolescent study, which E&O tracked closely over the past year. The company will use the positive results to ask the FDA to expand EndeavorRx’s label to kids aged 13-17 with ADHD. EndeavorRx is currently only indicated for kids aged 8-12. More on the results here.
- Akili also tweaked its EndeavorRx site in recent days to remove a line that promised “A Prescription for EndeavorRx costs no more than $99.” It now reads: “The cash price for EndeavorRx is $99.” And a footer explains that “If insurance covers EndeavorRx, the out-of-pocket cost will vary based on insurance plan benefits.” The site also has a new banner announcement that Highmark BCBS now covers EndeavorRx. So, connect those dots as you may.
- One more thing… metaMe Health, which already has an FDA-cleared prescription digital therapeutic on the market for IBS (named Regulora), announced a new licensing agreement with two researchers for “exclusive worldwide rights to use and distribute a newly developed gut-directed hypnotherapy (GDH) protocol for the treatment of functional dyspepsia (FD), a chronic disorder of the upper gastrointestinal tract that currently lacks substantially effective therapy options.” More
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).
Clinical trials: Apple-Janssen, Big Health, Woebot, 4YouandMe-Evidation
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.
Done recruiting: Apple-Janssen’s Heartline study stops recruiting with 34,244 Medicare beneficiaries enrolled
Remember: When Apple and Janssen first announced plans for the Heartline study it was planning to enroll a headline-grabbing 150,000. More recently the companies scaled back their ambitions to 24,000 enrolled, but the study just stopped recruiting and topped out at 34,244 participants onboard. Evidation Health is also partnered with the companies on the trial. Here’s more on the study, which makes use of both Apple Watches and iPhones:
“The primary objectives of this study are to identify and diagnose Atrial Fibrillation (AF), evaluate improvement in cardiovascular (CV) outcomes, improve direct oral anti-coagulant (DOAC) adherence and persistence, and better characterize participants and identify predictors of disease.”
Completed: Big Health’s Sleepio study for treating insomnia in women experiencing symptoms of menopause who had a prior cancer diagnosis
Just an update that this trial is now complete:
“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.”
Completed: 4YouandMe’s digital signals of stress in Crohn’s study
4YouandMe, which is led by a former Apple healthcare exec, just finished up a study they are sponsoring focused on digital signals of stress in Crohn’s. As the name suggests, this is a study hunting for biomarkers. Evidation is helping them put on the study. More:
“There is little information on how Crohn’s disease progresses in between a patient’s clinic visits and how stress impacts symptom change including flare-ups. The purpose of this research study is to see if digital tools like smartphones, and wearable devices are helpful in finding out new information that may explain fluctuation in symptoms. This study is a feasibility study that will try to identify biomarkers, collected through a smartphone app and wearable devices paired with clinical information collected during clinic visits to track participants’ overall health for 6 to 12 months. The data collected will be used to identify and predict symptoms associated with Crohn’s disease flare ups. The aim of this work is to inform knowledge of what triggers Crohn’s disease worsening that might lead to advances in management.”
New and completed: Woebot observational study of WB-LIFE
“WB-LIFE is a mobile application program grounded in validated psychotherapies (including cognitive behavioral therapy, interpersonal, and dialectical behavioral therapy), that enlists the relational agent Woebot to guide users in managing their mood. The user experience is driven by artificial intelligence and centers around mood tracking, evidence-based tools, and goal-oriented, tailored conversations.”
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 200 past issues of E&O newsletters here.
