Issue 105
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.
OK, here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:
- There’s another report this week that Facebook is working on its own smartwatch to take on Apple’s Watch. Both the new report in The Verge and a report from The Information back in February cite sources claiming the device will include some kind of heart monitoring technology. This is pure speculation, but it seems likely to me that Facebook would partner with AliveCor to add an ECG feature into its forthcoming smartwatch. (Google/Fitbit and Samsung both have this on their higher-end smartwatches now, so Facebook would have to include it too. And I can’t imagine Facebook getting into FDA-regulated territory, can you?) “The enemy of my enemy is my friend” — right? For a little more intrigue on this: See the image below for a redacted snippet of testimony that AliveCor’s current CTO Siva Somayajula gave during one of the company’s lawsuits against Apple…
- Last week’s update on the increasingly confusing future of CPT codes for digital therapeutics led to a couple of helpful calls this week with readers. There is a faction that does not believe the five forthcoming Category I codes for Remote Therapeutic Monitoring (RTM) Services will be inclusive of standalone, online cognitive behavioral therapy (CBT) programs. (That explains the parallel effort that led to the creation of two Category III codes for remote CBT programs that I wrote about last week.) Still, questions remain — including the big one: Will the CMS Physician Fee Schedule for 2022 include the RTM codes?
- This was curious: Mahana Therapeutics just secured a 510(k) for Parallel, its prescription digital therapeutic for GI issues. But Parallel already received market authorization via the De Novo process last year. Turns out, the De Novo Parallel is “optimized for computer (desktop/laptop) access” and this new follow-on 510(k) is a mobile app version.
- The FDA just cleared Nuvo-Group’s remote monitor as a Class II: INVU “is a non-invasive medical device that acquires and displays vital signs of the pregnant woman and her fetus. It measures and processes signals picked up on the abdominal surface using highly sensitive sensors, special electronic circuitry, and processing software. Two types of sensors pick up the signals: ECG-like sensors that pick up bio-potential signals, and acoustic sensors.” Sense4Baby was the predicate.
- The FDA also cleared an updated version of Voluntis’ Insulia that supports an additional insulin product. Insulia offers “automated insulin dose recommendations and coaching messages for people with type 2 diabetes while enabling the health care team to remotely monitor progress.”
- One more thing… The FDA’s budget proposal for 2022 has quite a few digital health mentions, including the agency’s high-profile De Novo clearance of Akili’s EndeavorRx. One budget request that caught my eye: “Within CDRH, $2 million will be invested in efforts that will allow FDA to advance the development, evaluation, and market authorization of digital health medical devices that help address Opioid Use Disorder (OUD)… Funds will be used to establish a streamlined framework for FDA market authorization of these devices while assuring they meet FDA’s standards… The initiative will help enable infrastructure for systematic evaluation of these devices, increasing analytic capabilities to leverage real world data to support OUD digital technology evaluation, and incentivize the development of new digital risk assessments, diagnostics, and therapeutics, such as through a design-a-thon and other crowdsourcing measures.”
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Pear Therapeutics adds GAD, MDD, cardiovascular, alcohol use disorder to its pipeline
When Pear Therapeutics announced its $80 million funding round in December, the company indicated that it would focus its efforts on commercializing its three already-in-the-market digital therapeutics reSET (substance use disorder), reSET-O (opioid use disorder), and Somryst (chronic insomnia). In the funding announcement Pear’s CEO Corey McCann stated: “This oversubscribed round of funding will allow us to continue to invest in the launches of our three commercial products to accelerate revenue growth, which we intend to reinvest in our robust pipeline and platform.” This week, however, the company changed up its pipeline and added a handful of new therapeutic area targets:
- generalized anxiety disorder (GAD),
- major depressive disorder (MDD),
- cardiovascular, and
- alcohol use disorder (AUD).
I updated the E&O Rx DTx Pipeline Tracker to reflect the changes.
FDA rejects Verily Study Watch-powered, virtual Parkinson’s motor exam as a drug development tool COA
Google’s Verily, a popular destination for former FDA officials, received a rejection letter from the agency this week. The FDA rejected Verily’s request to use its wearable device, called the Verily Study Watch, as a…
“Virtual Motor Exam for Parkinson’s disease, Part III Estimator (VME Part III), as measured by the Verily Study Watch, a Digital Health Technology (DHT) – Passive Monitoring COA, proposed for the assessment of motor symptom severity in adults who have been diagnosed with Parkinson’s disease across the full range of disease progression.”
Verily submitted its request in late January. Here’s the FDA’s reasoning:
“The Verily Study Watch/VME III measures a change in digitally assessed parameters of a subset of Parkinson’s disease motor signs from the MDS-UPDRS Part III (motor examination). However, the MDS-UPDRS Part III and the VME III are limited in their capacity to evaluate meaningful aspects of concepts of interest that are relevant to the patients’ ability to function in day-to-day life. For example, a change in rigidity or finger tapping in the MDS-UPDRS Part III cannot be directly interpreted as being meaningful to patients. However, a change in speech, eating and dressing (as assessed in the MDSUPDRS Part II) represents meaningful change in how patients function in daily life. Additionally, the Verily Study Watch/VME III is a remote assessment that provides an algorithmic representation of change in selected items of the MDS-UPDRS Part III. This raises additional concerns about the ability to interpret changes on the VME III measured by the Verily Study Watch as representing meaningful change in patients’ ability to function. For example, it is unclear how the change in the digital signature for finger tapping (as measured by the Verily Study Watch) could be interpreted as representing meaningful change in patient function.”
“For these reasons, when evaluating drug efficacy in Parkinson’s disease, the FDA prefers content that is more representative of daily life functioning (e.g., consistent with the MDSUPDRS Part II or other similar instruments).”
Clinical trial updates: Happify Teens, Orion VR, S-Alpha, Cognifit
Happify Teens study on stress, rumination, optimism
Happify Health’s clinical trial focuses on teenagers kicked off recruiting this week. Here’s the brief on the 800-participant trial:
“Teen participants (ages 13-17) will be randomly assigned to either the experimental group in which participants receive access to Happify Teens, a digital platform rooted in several therapeutic traditions that aims to improve wellbeing, or a waitlist control group. Both group conditions last 8 weeks. Participants assigned to the Happify Teens platform will have full access to the intervention, with featured tracks that focus on dealing with stress, worries and building skills for greater happiness… Perceived stress, rumination, and optimism will be assessed via self-report at baseline, end of the 8-week intervention, and at 1-month post-intervention.”
Results from Orion’s virtual reality therapeutic for chronic pain study
Finnish pharmaceutical company Orion put out a press release this week about the results from its virtual reality-based digital therapeutic for chronic pain study. Curiously, the post on clinical trials [dot] gov hasn’t been updated in about a year. Here’s how the 42-person study was set up according to the press release:
“The VIRPI trial is a prospective, randomized, double-blind, 3-arm parallel group comparison of DTxP, passive control (a placebo “sham” running on VR specifically developed for this purpose) and an open standard care arm evaluating the safety and efficacy of DTxP in patients with chronic low back pain (CLBP).”
S-Alpha Therapeutics digital therapeutic for public crises and the immune system
There’s not much detail in this listing for a 42-person study focused on a thinly-described digital therapeutic developed by Korean DTx company S-Alpha Therapeutics. (On its website, S-Alpha describes SAT-008 as focused on “public crisis” so I’m guessing it has something to do with the pandemic?)
“SAT-008 is a digital device containing several types of activities related to the immune function of adults.”
One of the primary outcomes measures:
“To measure changes in functions of natural killer cells, T cells, and B cells at 1, 5, and 13 weeks compared to baseline.”
CogniFit gaming study on cognitive functioning and schizophrenia
This study has been going on for a number of years, but a recent update indicates it will likely wrap up by the end of 2021. The study randomized 143 people into two groups. One group received the CogniFit intervention while the other just played a commercially available video game called Sims 4:
“Participants are instructed to play SIMS 4 45-60 minutes, 5 days/week. A minimum of 50 gaming hours will be acquired to ensure observable neuroplasticity in the brain after gaming.”
The CogniFit group is also supposed to play the CogniFit game for the same amount of time. Here’s more on CogniFit’s intervention:
“CogniFit is an internet browser-based digital brain training program, to improve cognitive abilities based on a personalized brain training regimen. Participants are instructed to play all games assigned by CogniFit from three categories (memory, spatial perception, and mental planning) during each training session. After playing the games in these three categories, they are free to choose which exercises they wish to play.”
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