Issue 219
Welcome back to E&O: Prescription Digital Therapeutics, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.
E&O: Rx Digital Therapeutics
Here’s a quick rundown of things happening in FDA-regulated and pharma-focused digital health:
- News you know: The FDA granted a De Novo clearance to DermaSensor, which aims to “help Primary Care Physicians detect skin cancer at the point of care with the first AI-powered medical device for all three common skin cancers.” The device was already available in Australia and New Zealand.
- German regulators added two more digital health apps to its national formulary for reimbursed digital health programs (DiGA). They also changed the price of four others and permanently added one that had been provisionally listed for the past two years. The next few bullets have the details:
- One of the new DiGA comes from German company Vantis. It’s called “Vantis | CHD and Heart Attack” and describes itself as a daily companion app for people with coronary heart disease or a previous heart attack. It runs €595.
- The other new one is from Perfood and it’s called glucura diabetes therapy. It runs €499.80.
- Meanwhile, IVPNetworks’ Novego for managing depression lowered its price from €249 to €199.
- PrehApp also lowered the price of its knee-focused MSK program, companion patella, from €345.10 to €223.49.
- Selfapy lowered the price on two of its DiGAs: its bulimia program and its binge eating disorder program both used to run €540 each, but are now both priced at €232.
- Finally, Bayoocare’s “My Tinnitus App – Digital Tinnitus Counseling” program is now permanently listed on the national formulary.
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Facebook, sorry, Meta’s AI-powered well-being chatbot “Zenny” now in a 1,244-person RCT
Here’s a scoop. Meta Platforms Inc, the company formerly known as Facebook, is developing a chatbot named Zenny that it describes as a “bot-based universal prevention program aimed at improving well-being.” The chatbot is pre-programmed with 40 modules of content and it is delivered via Meta-owned WhatsApp.
A randomized control trial focused on Zenny’s effectiveness quietly kicked off in Austria during the summer of 2022. However, Meta and its Austrian research partners only posted details about the trial, named WELL, this week — a year and a half later.
“The WELL research project aims to test new ways to improve well-being through self-care tools. The project is being conducted through a collaboration between the University of Klagenfurt and FAIR, Meta’s Fundamental Artificial Intelligence Research team.”
Here are a few specifics about how Zenny works:
“This prevention program includes a variety of modules that target common areas related to well-being including interpersonal relationships, emotional regulation, beliefs and behaviors, problem-solving, sleep hygiene, goal setting, personal growth, and healthy habits. The intervention modules are based on existing empirically supported intervention techniques from traditional cognitive-behavioral therapies and other third generation therapies such as mindfulness training and dialectical behavioral therapy. The focus of the program is to introduce psychological concepts that have been shown to be effective for managing emotions and problems to a broader public audience.”
This other part of the study’s description indicates that Meta may see Zenny as a way to help digital health companies increase enrollment in their programs (similar to the recent Omada-Amazon partnership):
“Another focus is on helping individuals connect with resources that are available related to subjective well-being. Often individuals who may be interested in self-help interventions do not know where to seek help and interventions that they may find (e.g., apps), may not be scientifically valid. By providing recommendations on resources that are specific to an individual’s needs, this may reduce one barrier to care.”
The study posting ticks a box that suggests Meta does not plan to seek an FDA clearance for Zenny, which lines up with the self-help language Meta sticks to above. The study also has a dedicated web page that indicates the study is no longer recruiting participants. That site summed up the study this way:
“This project was designed to test a new self-care application as a way to improve well-being.”
Trials: Big Health, BDC, 2Morrow, Leva Pelvic Health, GAIA, and Pepsi
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues.
Complete: Big Health’s RISE study on depression Big managed to recruit 61 participants for this study, which was originally was supposed to be fully complete in February but ended up finishing in December. More:
“This study aims to examine the effectiveness of app-based digital CBT in individuals with a diagnosis of Major Depressive Disorder. The primary outcomes are depression symptom reduction and engagement with fulfilling activities after 5 weeks.”
New: BDC hopes to succeed where Pear failed with a personalized prescription digital therapeutic for opioid use disorder
Here’s an interesting one from a startup I hadn’t heard of before — Biomedical Development Corp. More on how BDC positions itself vs Pear under this description of the study:
“The study is a parallel intervention examining the KIOS app, a digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition. KIOS will offer individualized, evidence-based behavioral intervention strategies responsive to the patients’ current clinical status outside the setting of the doctor’s office or treatment facility. KIOS makes it possible to process patient-entered data and provide responsive behavioral advice to patients specific to their condition in real time. KIOS gives patients 24/7 access to behavioral intervention strategies that can augment and improve response to routine clinic-based counseling interventions.”
BDC is a part of a startup accelerator down in Texas. Here’s how that site described BDC at a 2022 demo day (and notice the not-so-veiled reference to Pear):
“Biomedical Development Corporation is developing KIOS, a digital health therapeutic for the treatment of opioid use disorder (OUD). KIOS will be an FDA-approved digital therapeutic medical device used adjunctively to medication assisted therapy. In contrast to other digital products for OUD, only KIOS offers continuously available, individualized, evidence-based behavioral intervention strategies responsive to a patient’s evolving clinical status outside the context of the doctor’s office or treatment facility.”
Done recruiting: 2Morrow study on chronic pain digital therapeutic
2Morrow’s feasibility study on a digital therapeutic for chronic pain is done recruiting for its 100-participant (anticipated) two-arm trial. More:
“This study will evaluate the existing 2Morrow Chronic Pain Self-Management Program, in the form of a mobile app, as a digital therapeutic for improving patients’ pain self management and function who suffer from chronic pain. Specifically, the investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes.”
New study: Axena tests duration of use (8 weeks vs 16 weeks) for Leva Public Health digital therapeutic
Axena Health, makers of the Leva Pelvic Health digital therapeutic, received a favorable decision for its HCPCS code application last year. Now, with help from researchers at the University of Wisconsin-Madison, the company is testing how 8 weeks of using its digital therapeutic compares to a 16-week course of treatment. More:
“The goal of this clinical trial is to learn about how the duration of use of The Leva Pelvic Health System affects treatment of fecal incontinence in women. The main question it aims to answer is to test whether use of the The Leva Pelvic Health System for 8 weeks is as good as using it for 16 weeks.”
New: GAIA study on digital therapeutic, relevis, for subacute and chronic back pain
Gaia must be the most prolific developer of digital therapeutics. The company recently posted two studies focused on new digital therapeutics. The first one is relevis, a DTx for subacute and chronic back pain. More:
“relevis is a digital health application designed for individuals with subacute or chronic back pain, accessible through a web browser. The application consists of six physical exercise modules that cover four exercises with three different levels of difficulty, each, and ten interactive ‘conversations on different topics (changes in the body, pain development and processing, chronic pain, pain and mood, relaxation and mindfulness, becoming active against pain, stress and pain, nutrition and pain, sleep and pain, work and pain). ‘Conversations’ are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.”
New: GAIA study on digital therapeutic, attexis, for ADHD
Another one from GAIA:
“In this randomized controlled clinical trial, 326 patients with ADHD will be investigated regarding the effectiveness of a digital therapeutic for improved ADHD symptomatology, the unguided online intervention attexis.”
New and recruiting: PepsiCo is still tinkering with personalized nutrition, launches 3,000-person Aspire2B app study
Pepsi is setting up a 3,000-participant non-randomized pilot study to see if its nutrition app works as intended. It’s a new study posting but the study appears to have kicked off in March 2022. Pepsi’s R&D team is still recruiting participants. More here:
“Aspire2B is a mobile wellness app that uses non-invasive measurements to predict various physiological states and estimate biological age. Users are then enrolled in nutrition, fitness, or sleep challenges within the app that are aimed at improving overall wellness and thus helping to reduce biological age. Mobile health (mHealth) interventions require numerous decisions that integrate behavioral theory, user feedback, and technical and practical feasibility considerations. The main purpose of this research program is to test if the application works as intended. This pilot study program is managed internally by Pepsico clinical researchers.”
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