Issue 157
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 in FDA-regulated and pharma-focused digital health:
- The FDA cleared Renovia’s digital therapeutic leva for a new indication via a 510(k): “leva Pelvic Health System for the first-line treatment of chronic fecal incontinence (FI) in women. The decision follows the grant of Breakthrough Device Designation by FDA in October 2021. leva had previously been cleared by FDA to treat stress, mixed and mild-to-moderate urinary incontinence (UI) in women. The new indication makes first-line, at-home treatment for FI, also called accidental bowel leakage, available to the over 12 million US women who suffer from the debilitating and progressive condition.”
- Last week (Issue 156) I noted a new letter from the Digital Therapeutics Alliance that thanked the co-sponsors of the bills before Congress that would create a new Medicare benefit category for prescription digital therapeutics. At the time, I speculated that it was the first time that the powerful medical device group AdvaMed had publicly backed the bills. (AdvaMed was one of the letter’s signatories.) Since then AdvaMed confirmed in an email to E&O that my speculation was correct.
- In late June the German government added a new prescription digital therapeutic to its national formulary. This is the first new addition in months. The app is prescribed for 90 days and runs €535.50 per script. “PINK! Coach supports breast cancer patients in changing their lifestyle towards more exercise, healthier nutrition and mindfulness in accordance with the current guideline recommendations. Via coaching modules, patients receive pseudo-individualized information, practical tips, instructions and exercises in the areas of exercise, nutrition and mental health.”
- No official announcement yet but a recent trademark filing from MedRhythms indicates that one of its future products may be branded “Intandem,” where the “d” is designed to look like a musical note. The filing’s legalese isn’t super helpful but the description of the mark includes this: “Computer software program and computer program, namely, downloadable mobile application for recording, editing, transmitting, and receiving data using sensors, algorithms, and artificial intelligence (AI) to deliver individualized sensory therapy for individuals affected by neurologic injury or disease.” Another trademark by MedRhythms is for “Movive” and that one has a very similar set of descriptors attached to it.
- Another potential future brand: Meanwhile, prescription digital therapeutics company Swing Therapeutics may brand its fibromyalgia intervention “Stanza.” The company’s trademark filing describes the mark like so: “Downloadable software applications for use in mobile devices used to treat, manage, and track chronic conditions including fibromyalgia; downloadable software applications for use in mobile devices for providing access to health coaching and behavioral health coaching services.”
- And still another digital therapeutics company is likely to announce a new brand next week — more on that in Issue 158.
- One more thing… In other news, Akili called attention to its EndeavorRx intervention’s side effects in an update to the app’s description on the AppStore. EndeavorRx is an FDA-cleared, prescription digital therapeutic for improving attention in teens with ADHD. The company didn’t previously mention any side effects or adverse events related to using EndeavorRx in its AppStore description, but in April it added this: “The most common side effects observed in children in EndeavorRx clinical trials was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were observed with its use.”
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Clinical trial updates from Best Buy Health, RxWell, Karolinska, Azumio, and Blue Note Therapeutics
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.
Best Buy Health now recruiting for Digital Fall Prevention study in Boston
This one is neither pharma-related nor FDA-regulated, but figured it was worth a mention. Best Buy Health, which has a line of personal emergency response products thanks to its acquisition of Jitterbug-maker GreatCall a few years back, moved into fall prevention in recent years. Last year it even announced plans to bring its Lively brand to the Apple Watch. A new Best Buy Health feasibility clinical trial might be testing that combination of devices and Lively software, but none of the components are specifically named in the study description. Here’s a bit more on the study:
“Participants who enroll in the study will receive a wearable device, a tablet, a tablet stand, and ankle weights for home use, along with instructions and charging accessories. Participants will participate in a 3-month moderate-intensity exercise intervention, which will be supported by a LEPPP study staff member trained and certified in the intervention and delivered remotely through the tablet. The program is designed to gradually progress in intensity and exercise duration over a 12-week period. The exercise intervention parameters will be tailored to individual ability and progressed by the study interventionist based on feedback from participants, motivational coaching calls, and post-exercise surveys.”
Now recruiting: UPMC’s RxWell RCT compares app-based program to treatment as usual for 16- to 22-year-olds with depression
This study is an interesting one because RxWell is an intervention developed by a health plan: UPMC. It was posted back in December but just started recruiting this past week:
“Randomized Controlled Trial comparing a coach-enhanced digital cognitive behavioral intervention (d-CBI) (RxWell) + treatment as usual (TAU) versus TAU alone for moderate depression as determined by Patient Health Questionnaire (PHQ-9) threshold as part of routine pediatric care. The study will be completed in pediatric practices with embedded behavioral therapists across 3 institutions (Children’s Hospital of Pittsburgh, Boston Children’s Hospital, Rady Children’s Hospital, San Diego).”
Swedish researchers set up a feasibility study for anxiety digital therapeutic
Researchers at the Karolinska Institute have posted details about a new study on a digital therapeutic for anxiety that uses an exposure-based intervention. Companies including Pear Therapeutics have acquired digital therapeutics from researchers at Karolinska in the past. Here’s a bit more on the study:
“This study investigates the feasibility and preliminary efficacy of a self-guided, exposure-based intervention for individuals who suffer from severe health anxiety. The study is a prospective single-group study based at Karolinska Institutet, Stockholm, Sweden, where 20-25 adults with DSM-5 Illness anxiety disorder or Somatic symptom disorder are enrolled in 8 weeks of unguided exposure-based treatment via the Internet. Outcomes include self-reported health anxiety symptoms, credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events.”
Azumio’s neural network for Type II diabetes screening study to start this month
While E&O covered this one in the past, the company pushed back the start date of this study from May until this month. It’s not yet recruiting yet. (If the company’s name is familiar, it’s probably because you remember its very popular Instant Heart Rate iPhone app, which has been around since the early years of digital health.) Here’s a bit more on the study:
“The Validation of the Diabetes Deep Neural Network Score (DNN score) for Screening for Type 2 Diabetes Mellitus (diabetes) is a single center, unblinded, observational study to clinically validating a previously developed remote digital biomarker, identified as the DNN score, to screen for diabetes. The previously developed DNN score provides a promising avenue to detect diabetes in these high-risk communities by leveraging photoplethysmography (PPG) technology on the commercial smartphone camera that is highly accessible. Our primary aim is to prospectively clinically validate the PPG DNN algorithm against the reference standards of glycated hemoglobin (HbA1c) for the presence of prevalent diabetes. Our vision is that this clinical trial may ultimately support an application to the Food and Drug Administration so that it can be incorporated into guideline-based screening. Detailed Description.”
German study rewrites primary and secondary outcome measures after app detecting arrhythmias study finished up
Daiichi Sankyo Europe and German company Preventicus GmbH made quite a few edits to their study‘s outcome measures after it wrapped up in February. No results yet, but now I’m even more curious. Here’s a bit more on the study:
“This feasibility study will develop and evaluate pathways to identify participants with wearable-detected absolute Arrhythmia (AA) and to enable local study teams to contact them regarding participation in a controlled trial of oral anticoagulation in this population, which will be conducted after the feasibility study.”
Blue Note Therapeutics is finished recruiting for its phase II trial
Not much more of an update on this study, but here’s a bit more to refresh your memory as to what this one is focused on:
“This phase II trial studies the effect of a digital application (app), BNT001, on cognitive-behavioral stress management in patients with stage I-III breast or lung cancer. The app is designed for cancer patients to treat anxiety and depressive symptoms related to their cancer diagnosis. The purpose of this study is to develop and refine procedures for eligibility screening, suicide risk assessment, and delivery of the app prior to the launch of a phase III randomized trial. The impact of the app in managing stress and improving quality of life and mood is a secondary aim.”
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