Issue 200
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 are a few quick happenings in FDA-regulated and pharma-focused digital health…
- Smoke Free 23’s smoking cessation app, which is provisionally listed in Germany’s nationwide reimbursed prescription digital therapeutic formulary (often called DiGA for short), raised the price of its 90-day program from €249.00 to €389.00.
- More on Germany’s DiGA program: As E&O has noted in previous issues, a couple of European digital therapeutic companies participating in the DiGA program have ended up in bankruptcy court thanks in part to the DiGA program’s clawback requirements that follow price negotiations as part of a permanent listing on the formulary. This lengthy article in European tech news site Sifted has quite a bit of color on that dynamic. Worth a read.
- Back in the States: Mahana Therapeutics, which has been quietly developing a digital therapeutic that treats tinnitus — in addition to its IBS-focused flagship offering — also quietly removed a section of its company website devoted to its tinnitus program. E&O first reported on this tinnitus effort back in January. Mahana is also working on a version of its IBS DTx for young adults. Finally, E&O has learned that Mahana has begun to study a digital therapeutic code-named “V-Pain” but I can only speculate on what that might focus on. I’m curious if Mahana’s website edits reflect a temporary contraction at the company — leading to a tighter focus on its core IBS product — similar to the belt-tightening the rest of digital health is experiencing.
- The results of Swing Therapeutics’ Phase II randomized control trial (named SMART-FM) of its digital therapeutic for fibromyalgia, Stanza, are in Springer’s open-access Journal of Behavioral Medicine. The headline from the results section: “Results of this multicenter, active-controlled pilot study indicate the FM-ACT program is safe and may be efficacious in aiding FM management.”
Whoa, whoa… Hey there, stranger. Was this paying subscribers-only newsletter forwarded to you? Follow me over to the E&O pricing page for more info on how to sign yourself up.
MedRhythms’ first prescription digital therapeutic, InTandem, gets FDA-listed.
The big news this week is that MedRhythms has secured an FDA listing for its first commercial product, InTandem, which was previously code-named MR-001. InTandem is a Class II medical device but its category is 510(k)-exempt, so it didn’t have to go through that pathway. MedRhythms’ CEO and Co-founder Brian Harris told me via email that:
“MedRhythms determined the appropriate regulatory path based on the intended use, indication for use, and technology, as well as the risk profile of our device. With all that, InTandem is a Class II, 510(k) exempt, prescription use-only device. For InTandem, a clinical trial was essential to validating our novel product’s safety and effectiveness. MedRhythms believes in pursuing the highest evidentiary standards for our products. InTandem (developed as MR-001) met the primary endpoint in a successfully completed pivotal study, announced in January of this year. The full result is currently pending publication.”
(E&O actually dug up the trademark for InTandem exactly a year ago this week. I wondered at the time if that would be the name of MedRhythms’ first product.) If you aren’t familiar with MedRhythms’ first digital therapeutic, the company describes it as an “evidence-based neurorehabilitation system to improve walking and ambulation in adults with chronic stroke walking deficits.” MedRhythms’ R&D pipeline also includes interventions focused on Multiple Sclerosis and Parkinson’s.
(Read through its various pipeline assets along with those of other PDT companies in E&O’s Pipeline Tracker here.)
(Correction: As I explained in the next newsletter edition, my speculation that MedRhythms is launching a nationwide virtual clinic was incorrect, according to the company. More at the top of Issue 201 here.) Pivot to national virtual clinics continues? Like Swing Therapeutics’s Swing Care clinic (and sort of like Oui Therapeutics and its spin-out Vita Health), MedRhythms is also building a nationwide virtual clinic that will help it distribute its FDA-listed program to patients. Here’s how a recent job posting explained MedRhythms’ experience providing care as well as its future ambitions:
“MedRhythms started in 2013 and since then has conducted over 30,000 hours of direct patient care through in-home care and contracting with facilities in the Northeast. The company built the program at Spaulding Rehabilitation Hospital, a top-ranking rehabilitation hospital in the U.S. and Harvard Medical School affiliate, in Boston. This program is now the most comprehensive program of its kind in the country. MedRhythms recently launched a national tele-therapy platform, where they can treat clients in any geography.”
Curious how the pivot to national virtual clinics works out for prescription digital therapeutics companies. With (at least) three companies setting them up now, it’s probably fair to call it a trend, right?
App downloads: How Akili’s direct-to-consumer experiment with EndeavorOTC is going so far
Nearly a month ago I wrote about Akili’s surprising move to launch an over-the-counter version of EndeavorRx for adults thanks to the FDA’s (barely still in effect) non-enforcement policy for psychiatric digital health devices during the public health emergency:
“In its first major deviation from the traditional prescription digital therapeutic go-to-market, Akili announced this week that it had commercially launched a version of its ADHD digital therapeutic, EndeavorOTC, available direct-to-consumer (no prescription required) for adults. Up until now, Akili’s EndeavorRx has only been available (via prescription) to children aged 8 through 12. The company also recently submitted a version of EndeavorRx to the FDA for adolescents aged 13 through 17, but it is waiting for a 510(k) before releasing that into the market.”
EndeavorOTC went live in Apple’s AppStore on June 6th, 2023 so it’s been available for one month. According to data from Sensor Tower, EndeavorOTC has managed to generate just shy of 9,000 downloads since then — 8,991 downloads as of this writing.
During the same one-month period EndeavorRx generated just 681 downloads among iPhone users. EndeavorRx has generated fewer than 3,000 downloads in 2023 so far.
In one month, EndeavorOTC managed to generate about the same number of downloads that EndeavorRx brought in over the past year. Of course, these are just downloads. We’ll have to wait until Akili’s next quarterly investor call to find out how much revenue those thousands of downloads generated for the company. Anyone can download the app to check out a demo so it’s not a perfect proxy for paying OTC patients. It is, however, an indication of an upper limit.
Trial updates: BehaVR, Oui Therapeutics, Lumos
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.
Almost complete: BehaVR and University of Utah’s Phase 1 trial to establish safety of MORE-VR for opioid use disorder (OUD)
BehaVR’s Phase 1 study on MORE-VR, which started on October 4, 2021 is set to finish up next month. MORE-VR stands for “Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.” Here’s a quick summary of the study‘s objective:
“This is a Phase 1 trial that aims to establish the safety of MORE-VR, as well as to collect feasibility, usability, and engagement data, for patients receiving medications for opioid use disorder (mOUD).”
New: Oui Therapeutics study on a social network intervention for suicidal adolescents
This one is only new because I missed it in the last few round-ups. (Really, I missed that Oui Therapeutics was leading the study.) There’s not a whole lot of detail in the study‘s description, but here’s a bit:
“The Electronic Youth-Nominated Support Team (eYST), is experimental. The purpose of this study is to get feedback from users about eYST. Another purpose of this study is to learn how well eYST helps youth… Assessment data from multiple stakeholders (i.e., youth, parents, and support adults) will be collected at baseline, 4 weeks, 8 weeks, and 12 weeks via self-report and semi-structured interviews.”
Now recruiting: Lumos Labs study on two programs’ ability to improve cognition
This is one of the more general studies currently underway for Lumosity-maker Lumos Labs, a company that seems to be a new fast-follower of Akili’s. This one is now recruiting. More on the study:
“The objective of this study is to assess the effectiveness of two digital programs for providing mental stimulation, improving cognition, and inducing changes in brain structure and function.”
Slight delay: Lumos Labs study on its EndeavorRx competitor
As noted above and in previous newsletters, Lumos Labs is working on a competitive offering to Akili’s EndeavorRx. Interestingly, this study also uses the same (somewhat controversial) primary endpoint as Akili did for EndeavorRx, which really makes clear that Lumos intends to use Akili’s game as its predicate device when it submits this to the FDA. One key difference is that Lumos is starting with adults with ADHD instead of kids aged 8-12 like Akili did. Anyway, this study, which is still recruiting, just got pushed back from an expected primary completion date of June 2023 to October 2023. It will be fully buttoned up and over by December. More on the study:
“The objective of this study is to assess the safety and effectiveness of an at-home, game-based digital therapy for treating adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD).”
For more: E&O tracks the clinical trials of prescription digital therapeutics-focused companies in this tracker over at the E&O site. I’ll add the studies above to the tracker before the next newsletter.
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 300 past issues of E&O newsletters here.
