Issue 164
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.
Bit of a ghost town here in FDA-regulated and pharma-focused digital health… hopefully this is the quiet before the storm of news coming our way this fall?
- Read on for a few thoughts on Mahana Therapeutics’ slightly unusual go-to-market for its prescription digital therapeutic, Mahana IBS (previously known as Parallel) along with the weekly round-up of digital health clinical trial tweaks and additions.
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Mahana Therapeutics’ freemium go-to-market for its prescription digital therapeutic for IBS
Choosing a go-to-market in digital health typically involves weighing some serious trade-offs. An FDA-cleared, prescription digital therapeutic company, for example, typically does not enjoy the flexibility that a direct-to-consumer health app company has when marketing its offerings.
That brings me to this week’s question: Is a freemium business model an option for prescription digital therapeutics companies?
Well, Mahana Therapeutics seems to have figured out a way. In case you are not familiar with Mahana, here’s its one-sentence pitch for its flagship product:
“Mahana IBS is a new app that uses cognitive behavioral therapy to reduce [irritable bowel syndrome] symptom severity — in 10 minutes a day!”
Here’s how the company’s app description in Apple’s AppStore suggests people get started:
“Get started now: You can start your first session with Mahana IBS now. To continue with the next session you will need a prescription through our simple & easy telehealth consultation or your healthcare provider.”
But remember: Mahana secured its first FDA clearance (a De Novo) for its prescription digital therapeutic for irritable bowel syndrome (IBS) back in the spring of 2020. That clearance (and a follow-up 510(k) for the mobile version of the program) designate the software as a medical device for “prescription use” only.
However, Mahana’s direct-to-consumer marketing campaigns encourage users to download its Mahana IBS app, which includes free access to its first lesson without a prescription. The app prompts new users (a few times, see below) to talk to a health provider via a virtual visit to see if a prescription to access the full program is right for them. 
I emailed Mahana to ask for an explanation as to how part of the program is available without a prescription given its FDA designation. The company pointed out that the first session is more educational and onboarding than therapeutic, while the treatment part of the program doesn’t start until the second session. That matches what the FDA clearance’s device description states too (emphasis mine):
“Typical length of the therapy period is 3 months and is composed of ten (10) sessions. The first session explains IBS symptoms, the key features of the brain-gut axis, and the personalization of the rationale for CBT. The next nine (9) sessions provide personalized treatment for IBS by asking patients questions and getting them to complete interactive tasks.”
But since the first session is included in the device description, does that make it part of the regulated medical device and, therefore, subject to the prescription-only designation too? If you have access to an app data tracking platform, you might notice that Mahana has outpaced Akili most months in 2022 for downloads. While I don’t have any insight into how many of these initial downloads are leading to scripts for Mahana, for its top-of-the-funnel, anyway, freemium seems to be working.
Like Akili’s digital-first, direct-to-consumer marketing strategy, Mahana has sponsored gut health-focused podcasts and gut health-focused consumer publications to drive downloads. Here’s a typical call to action from the end of one of the company’s podcast ads: “Get started now and download the app at Mahanatx.com…”
I’ve asked Mahana for more information on the nuances here (and if the FDA signed off on it). Hope to include an update in next week’s newsletter.
Clinical trial updates from Limbix, Woebot, Sword Health, Picterus JP, and Gaia
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.
Now enrolling by invitation: Limbix SparkRx at Children’s Hospital of LA
Limbix officially announced this study this week, but E&O first wrote about it back in July (Issue 159). The real update is that it is now enrolling participants. This SparkRx study is focused on children in-hospital for specialty care from the cardiology and gastroenterology care teams:
“The primary aim of this pilot study is to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for symptoms of depression among adolescents being treated in specialty medical care settings at Children’s Hospital of Los Angeles (CHLA).”
Results: Woebot’s substance use disorder study results
This week Woebot posted the raw data and results from its substance use disorder study. One of the study authors’ takeaways, which they shared in a medical journal article back in March 2021, was that it was difficult to retain participants. The study managed to enroll 101 participants, but only half of them made it through the duration of the study. Raw data and results here.
New: Gaia’s validation study for a Type 2 diabetes management program, convivio
Gaia, which has a number of prescription digital therapeutics listed on Germany’s national digital health formulary and licenses a trio of digital therapeutics to Orexo for the US market, just posted details on a study to evaluate a new Type 2 diabetes program named convivio:
“This trial was designed to evaluate the effectiveness of the dialogue-based online intervention covivio, which was designed to improve diabetes self-management in patients with type 2 diabetes. The study aims to test the hypothesis that covivio has a greater positive impact on glycemic control than treatment as usual. Patients with type 2 diabetes mellitus will be randomized and allocated to either an intervention group, receiving covivio in addition to treatment as usual, or a control group, which receives only treatment as usual. The primary endpoint is the HbA1c value six month after baseline.”
New: Newborn jaundice diagnostic app study from Picterus JP
Here’s another newborn bilirubin app’s validation study:
“A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) will be conducted to include a total of 250 newborns with a desired distribution of skin color according to Neomar’s scale : skin color 1 and 2: 20%, skin color 3: 30% and skin color 4: 50%. The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant’s sternum. A validated smartphone with Picterus JP will be used to collect digital images.”
New: Sword Health’s patient registry for its pelvic floor treatment Bloom
Sword expects to enroll some 50,000 in its patient registry for its relatively new pelvic health program, Bloom. The company expects this study to finish up in 10 years, so is that a ballpark for how many patients it expects to use Bloom in the next decade?
(Better Question: I know Virta health has one of these posted in the clinical trials database, and I imagine there are a few I’ve missed that have them set up, too. But why doesn’t every digital health company do this?)
More:
“The purpose of this study is to create a research repository, composed of data collected in the course of digital care programs for pelvic health conditions by SWORD Health/Bloom to individuals undergoing those programs. This will allow the investigators to observe the acceptance, engagement and outcomes of programs using this approach in the treatment of multiple pelvic health disorders.”
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