Issue 172
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 going on this week in FDA-regulated and pharma-focused digital health…
- Thanks for all the feedback on The Virta Health Report. Keep it coming (just hit reply to this newsletter to email me). I’m curious what you think about the revenue estimates analysis and the report’s other findings. Up next: I’m working on a long-form report about Big Health, makers of Sleepio and Daylight. Let me know if you have any suggestions — which areas of that company’s business should I dig into? Tips, hints (and Big Health’s old pitch decks) are also always appreciated.
- Scoop: The FDA granted a 510(k) clearance to a wearable device named eWave, which is made by WearLinq. Notably, eWave started out as a crowdfunding project on Indiegogo. The device was crowdfunded as a 24/7 ECG-sensing peel-and-stick sensor that comes with instant interpretation and in-app physician visits, but the actual offering is likely going to fall short of those promises. Just two weeks ago one of the company’s founders wrote: “The bad news is that we won’t get all features we wanted through the FDA and that the device will require a prescription. This was the only way to get the device to market without significant further delays. The good news is that we believe we’re very close to the FDA clearance, I should be able to follow up in the next few days/weeks about what the final offering is and what exactly prescription only means for people in the US. I’ll also include an update on the status for Australia and Canada.”
- Six members of Congress sent a letter to the ITU, which is making its final decision on whether to ban the importation of Apple Watches over alleged patent infringements of AliveCor’s ECG technology. Reps. Eric Salwell, Zoe Lofgren, Donald Beyer Jr., Anna Eshoo, Jimmy Panetta and Linda Sanchez wrote: “While we take no position on the underlying merits of the patent dispute between the parties in this litigation, we are concerned that issuing an exclusion order against Apple’s wearable devices would present a significant detriment to American consumers… an exclusion order would immediately limit access to Apple’s heart-health monitoring wearable devices which are already widely available to the public. A complete restriction would add significant barriers to health and wellness features such as atrial fibrillation, or Afib monitors, which promptly alert users to previously undetected heart conditions.”
- Meanwhile, two members of Congress sent a letter to the ITU on behalf of AliveCor. Reps. Hank Johnson Jr. and Lucy McBath wrote: “As members of Congress, we believe that the public interest is best served when the Commission takes action to protect intellectual property, enforce our nation’s patent laws, and promote fair and robust competition.”
- Orexo announced the final patient has enrolled in its pivotal study for Modia, a prescription digital therapeutic that is used in combination with sublingual buprenorphine/naloxone for the treatment of opioid use disorder.
- One more thing… I’m sure you’ve read this, but in recent weeks, STAT had a great scoop on Highmark’s decision to begin covering prescription digital therapeutics. The part that got me was that the payer made the decision to cover them but it hasn’t yet figured out how much it would pay for them. “Highmark is currently negotiating with product developers about how much it will pay for individual treatments…” Is that the typical order of operations here? In my talks with payer execs (and former payer execs) it seems like the price points of the prescription digital therapeutics on the market are the biggest obstacle. So, I have to wonder: Is Highmark’s willingness to go public with this new policy a negotiation tactic?
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Tracking price changes of prescription digital therapeutics in Germany’s DiGA program
Following a reader’s request, this week I updated E&O’s DiGA Tracker to include all of the price changes that occurred in recent months. Not every change correlates with a decision by the German authorities to include the DiGA in the formulary on a permanent basis, but these are the changes in prices that I’ve noticed since I started tracking DiGA at the advent of the program (all prices are in € and most are based on 90-days of access).
Sympatient’s Invirto for panic disorders. Price: Raised from €428.40 to €620.
mynoise’s Kalmeda for tinnitus. Price: Lowered from €464 to €223.
GAIA’s velibra for panic disorder. Price: Lowered from €476 to €230.
GAIA’s elevida for fatigue in MS. Price: Lowered from €743.75 to €243.
Selfapy‘s course on depression. Price: Lowered from €540 to €290.94.
GAIA’s deprexis for depression. Price: Lowered from €297.50 to €210.
GAIA’s vorvida for alcohol use disorder. Price: Lowered from €476 to €192.01.
Non-smoking Heroes app for tobacco cessation. Price: Raised from €239 to €329.
Oviva’s Direct for Obesity for weight loss. Price: Raised from €345 to €426.96.
HelloBetter for Stress and Burnout. Price: Lowered from €599 to €235. Kranus Health’s
Kranus Edera for ED. Price: Raised from €552 to €656.88.
Head over to the E&O DiGA Tracker to search and sort this data and more from the DiGA apps that were removed from the program as well as those that haven’t had price changes yet.
Clinical trial updates: Akili, Vicore-Alex, Blue Note, Meru-Lilly, Big Health, Story, and Winterlight Labs
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.
Vicore tightens focus of its digital therapeutic from generalized anxiety disorder and depression to just GAD in patients with Pulmonary Fibrosis
Seems like based on the results of the first phase of its clinical trial for a prescription digital therapeutic (named Almee) for people with pulmonary fibrosis, Vicore and its partner Alex Therapeutics are no longer focused on treating both depression and anxiety. Just anxiety now. The study’s page has removed all references to depression and tweaked the outcome measures accordingly. Vicore also broadened the focus from Idiopathic Pulmonary Fibrosis to just Pulmonary Fibrosis and reduced the anticipated enrollment number from 270 to 260. The study is now set to be fully complete by September 2023 — a pushback from the original completion date of March 2023. Finally, Vicore added an explanation for how the wait-list control will work for this second phase in the update:
“In part 2 patients will be randomized 1:1 to either receive treatment with the digital therapy or to act as control group. Note: The control group will be offered access to the digital therapy, under an Exclusive Release of the product, following completion of the Week 12 visit of the investigation.”
Delayed: Akili-NYU Langone’s study of Endeavor in a pediatric multiple sclerosis population pushed back by about a year
Akili’s study was set to start this past August but isn’t likely to get started until January now. As a result, the company expects it to finish up in mid-2024 instead of August 2023. More on the intervention from the study‘s description:
“Endeavor is a digital, non-drug investigational treatment that is delivered through an action video game and is designed to target cognitive deficits in adolescence and young adults with pediatric onset MS.”
Terminated: Blue Note Therapeutics Phase II pilot study of digital therapeutic for treating anxiety and depression in veterans with cancer
Blue Note and the Durham VA Health Care System terminated their study because of enrollment challenges. They managed to enroll 17 out of the anticipated 20 veterans they needed for the study. More:
“This single-arm phase II trial focused on cancer patients and cancer survivors in the Veterans Health Administration will gather data on feasibility, acceptability, ease of clinical implementation, and preliminary efficacy of BNT001, a prescription digital software application.”
Complete: Blue Note’s feasibility study for digital therapeutic treating anxiety and depression for people with breast cancer
No results yet (or too many details at all) but the study, which had 15 participants, focused on this intervention:
“BNT-103 is a prescription digital therapeutic specifically designed to treat the symptoms of anxiety and depression related to cancer. There are 10 sessions provided over approximately 10 weeks.”
Done recruiting: Blue Note’s two-arm RCT comparing its two prescription digital therapeutics attune and cerena
More on the study, which anticipated 352 participants:
“This is a 2-arm randomized controlled study comparing how effective two therapeutic digital software devices are at improving anxiety and other indicators of psychological and physical health in patients with cancer. The study will be completely virtual, meaning participants can take part completely from home without visiting a clinic or study site.”
Stanford, UCSF and Big Health study Sleepio’s efficacy for pregnant people with insomnia
This study aims to recruit 498. While the study’s title indicates a focus on insomnia treatment, the study’s outcome measures focus on depression. (Is that more evidence that Big Health is seeking an FDA clearance for Sleepio focused on a depression claim?) More:
“The digital CBT-I program is called Sleepio (Big Health, Ltd). Digital CBT-I will be delivered by an animated therapist in six weekly sessions that are approximately 10-20 minutes each. Sessions can be accessed via website or app at a time that is convenient for the participant. Session content is based on standard, in-person CBT-I protocols, and includes sleep restriction, stimulus control, cognitive therapy, relaxation techniques, and sleep hygiene education. The program is interactive, automated, and tailored to participant progress. Additionally, participants will receive supplemental CBT-I content tailored for prenatal and postpartum insomnia.”
New: Duke and Story Health study remote monitoring platform for heart failure medication titration
Story is the startup founded and led by Verily’s co-founder and former head of software Tom Stanis. More on the study:
“The Story Health platform will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. Participants will also report any symptoms. All of this data will be transmitted, via the platform, to the treating clinician at the site, who will create care plans for medication titration and make clinical decisions. The care plans will be implemented with assistance from health coaches from Story Health Inc.”
New: Winterlight Labs’ two studies focused on voice biomarkers in schizophrenia and other psychiatric conditions
Winterlight has a pair of new studies with Northwell Health that focus on voice biomarkers and schizophrenia. The first one:
“Longitudinal observational study of the relationship between speech patterns and clinical symptoms in schizophrenia spectrum disorders.”
The second study originally aimed to enroll 604 participants (as noted below), but the company posted the study after it had already finished. No results yet, but they only managed to enroll 255 participants:
“The investigators aim to use linguistic features extracted using natural language processing to aid in diagnostic classification and in predicting dimensional symptoms. This will be done by obtaining clinical diagnoses, language samples, and self-report scales from 604 participants with a variety of psychiatric symptoms. Adolescents will also be included and the investigators will try to predict diagnosis in adolescents using models that were built on adult data.”
New: Meru and Eli Lilly study feasibility of Meru’s mental health program’s efficacy for depression in a cancer population More:
“The goal of this single-arm intervention study is to test the feasibility of the Meru Health Program (MHP) in reducing symptoms of depression and anxiety among 20 people with cancer referred from the Cancer Support Community (CSC). The MHP is a 12-week digital mental health intervention delivered via a smartphone app. The intervention focuses on cognitive behavioral techniques and mindfulness skills with the aim of improving mental health symptoms. The platform provides informational videos, skills practices, group discussion, and messaging with a licensed clinician employed by Meru Health. The licensed clinician supports patients as needed and reviews engagement logs within the app. As part of the intervention, depression and anxiety symptoms are measured on a biweekly basis over 12 weeks. For this study, self-reported surveys will be administered at baseline, week 12, and 2-months post-treatment to measure health-related quality of life and intervention satisfaction. In-depth interviews will be conducted with patients. Two focus groups will be conducted with MHP clinicians and CSC navigators to understand barriers and facilitators to the screening processes and intervention delivery.”
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