Issue 127
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 happening in the world of FDA-regulated and pharma-focused digital health:
- Biden has tapped former FDA Commissioner Robert Califf to lead the agency once again. Califf is currently a full-time senior advisor to Verily and Google’s other health-related projects. Will these past two years at Google change how he leads the agency this time around?
- You knew this was coming: CMS made it official and rescinded the MCIT rule “because of concerns that the provisions in the final rule may not have been sufficient to protect Medicare patients. By rescinding this rule, CMS can take action that will better address those safety concerns in the future.”
- In other policy news, the Commerce Department is fielding a number of comments from industry both touting the potential of globally scaled digital health programs while pointing to how some countries’ regulations are making internationalization ambitions difficult. (Think: data servers must be located in Germany to do business there, etc.) Here’s how Amazon Web Services framed it up in a recent comment to the feds: “In order to strengthen the international competitiveness of US health services companies, it will be important to address restrictive data localization policies that can inhibit the use of cloud services. We encourage the Commerce Department, and the US Administration more broadly, to advocate for the elimination of these data localization policies in their engagements with key trading partners and through relevant multilateral fora.”
- Speaking of Germany: Finnish startup Kaiku Health, which Elekta acquired back in May 2020, inked a deal with MSD Germany to pilot personalized digital health interventions to people with lung cancer who are receiving MSD Germany’s immunotherapy products. “The Artificial Intelligence-enabled digital solution allows them to follow up on relevant symptoms, provides personalized guidance on symptom self-management, and ensures access for patients to educational materials. The Kaiku Health service will also automatically notify the care team if a patient’s symptoms worsen during the course of treatment.”
- AppliedVR announced a $36 million Series B that brings its total funding to $71 million. Investors included F-Prime Capital, JAZZ Venture Partners, Sway Ventures, and SVB Ventures. AppliedVR is currently awaiting a decision from the FDA on its first de novo submission.
- One more thing… MassHealth (Massachusetts Medicaid) officially added Pear Therapeutics’ reSET and reSET-O to its non-drug product list alongside medical devices and medical supplies. The two reSETs are the only products listed under a new “digital therapeutics” category. Neither requires prior authorization.
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Possible names for the Otsuka-Click major depressive disorder prescription digital therapeutic
At the end of September, Otsuka America filed at least nine trademarks for brands that each claimed the same description — a digital therapeutic for major depressive disorder (MDD). Otsuka, of course, is working with Click Therapeutics to develop and commercialize a prescription digital therapeutic for MDD. So, it follows, that one of the brands below could end up being the eventual PDT’s brand name. Here’s the first paragraph from each of the trademark filings:
“Downloadable computer software for the treatment of major depressive disorder and other mental health disorders, namely, software for collecting biometric data from patients and delivering a cognitive emotional neurobehavioral treatment; Software as a Medical Device (SaMD), downloadable, for the treatment of major depressive disorder and other mental health disorders, namely, software for collecting biometric data from patients and delivering a cognitive emotional neurobehavioral treatment.”
Here’s the list of potential brand names for the Otsuka-Click MDD prescription digital therapeutic:
- NEUVENATE
- REJOYN
- COGNECTION
- TUNERO
- SYNYPSO
- ACTIMYND
- ILLUMORE
- RECOGNICIZE
- ELEVMI
Which one’s the winner?
More on Apple’s recent 510(k) for its irregular rhythm notification feature (IRNF) 2.0 app
I mentioned Apple’s latest 510(k) in last week’s newsletter (Issue 126), but now the FDA has posted the summary document, which reveals a bit more about what Apple changed in its IRNF app between versions 1.0 and 2.0. From the end-user perspective, not a whole lot has changed and the indications for use on both SaMDs are identical, but the summary document explains that the algorithm behind the feature is new:
“IRNF 2.0 includes a new rhythm classification algorithm that leverages machine learning techniques to differentiate between AFib and non-AFib rhythms. The new rhythm classification algorithm uses a convolutional neural network based architecture and was trained extensively using data collected in a number of development studies. In total, the studies included over 2500 subjects and collected over 3 million pulse rate recordings on a variety of rhythms including: atrial fibrillation, normal sinus rhythm, sinus arrhythmia, and other ectopic beats (PVCs, PACs).”
The document also includes some details on the clinical trial that underpinned the clearance, (but the trial itself is still blinded on clinicaltrials [dot] gov):
“Enrolled subjects wore an Apple Watch and a reference electrocardiogram (ECG) patch concurrently for up to 13 days. For those subjects contributing data to the primary endpoint analysis, 32.4% (n=140/432) presented with AFib as identified on the reference ECG patch and were included in determining the device sensitivity. Of those, 124 received an IRNF irregular rhythm notification with concordant AFib on the ECG patch, and the sensitivity was 88.6%. Of the 292 subjects who did not present with AFib on the ECG patch and contributed data to the analysis of device specificity, 290 did not receive a notification. The AF detection specificity was 99.3%. The remaining subjects (n=141/573) either contributed data to only secondary endpoint analyses and/or did not complete the study. These results support the device’s effectiveness in detecting AFib.”
Clinical trial updates from AliveCor, Apple, Neuroglee, and Pear
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.
AliveCor’s pre-FDA 12-lead Kardia device and Kardia 6L study outcome measures revealed
E&O first mentioned this study back in September (Issue 120) when it first came to light that AliveCor was set to begin studying a 12-lead version of its Kardia device in anticipation of an FDA submission and a new six-lead Kardia device. Since then AliveCor has updated the study to disclose its primary outcome measures, which were left out of the original study post. The study should finish up by Q2 2022, which points to a time frame for the FDA submission (or submissions?) too. The study seems to make a distinction between AliveCor’s current product line of “KardiaMobile” devices and these new in-the-works “Kardia” devices. I wonder if these devices will work without the need for a smartphone?
Tiny update: Just so you know I’m paying close attention here — Anthem and Apple’s asthma study changed its total enrollment figure from an anticipated 900 to an actual 901. Interestingly, this study is of an FDA-regulated device that is not yet cleared.
Neuroglee starts recruiting for its small MCI DTx study
Neuroglee has begun recruiting 55 participants for its Mild cognitive impairment (MCI) digital therapeutic study. MCI is “cognitive decline greater than that expected for an individual’s age and education level but that does not interfere notably with activities of daily life.”
Here’s more on the intervention arm of the study:
“Subjects will be provided with a digital tablet and a wearable device. The digital tablet will be pre-loaded with 10 modules, 1 module per week (1 hour) for 10 weeks to be completed at home. The modules comprise Education, Physical Activity, Reminiscence Therapy and Cognitive Games. The wearable device will be used to track and collect physiological data. Subjects will be instructed to wear the wearable device during the therapy session and during sleep, and as much as possible for the duration of the study. Exceptions for wearing the wearable device include water-related activities such as swimming or bathing.”
Johns Hopkins reSET-O vs TAU study pushes back start to March
Johns Hopkins study of Pear Therapeutics’ reSET-O digital therapeutic for opioid use disorder is now set to kick off in March 2022 instead of at the start of this month.
“This randomized controlled pilot study will enroll 60 participants, who will be randomly assigned to a treatment as usual (TAU) group or a reSET-O+TAU group after being started on buprenorphine in acute care settings (e.g., emergency department) and referred to community treatment. Study enrollment will last for 3 months after discharge from the acute care setting. Participants in the reSET-O+TAU group will be provided with the reSET-O app and will be encouraged to engage with the app for the 3 months following discharge from the acute care unit. The app works as an extension of cognitive behavioral therapy, providing psychoeducation related to opioid use disorder. All participants will be assessed at study intake and every month during the 3-month intervention.”
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