Issue 097
Digital health research from Brian Dolan
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:
- The big hire this week: Eli Lilly recruited Apple executive Diogo Rau to join as its new SVP and Chief Information and Digital Officer. (Rau is taking over for Aarti Shah who is retiring.) Rau was the “top executive of information technology for retail and online stores at Apple.”
- Google Health is hiring a Head of Regulatory Policy who will support the company’s “patient-focused medical device/Software as a medical device (SaMD) and consumer product regulatory policy issues/trends/changes occurring in the medical device/SaMD regulated environment.”
- Apparently, co-founder of athenahealth Jonathan Bush isn’t just the executive chairman of primary care startup Firefly, he is also leading a new digital health platform company named Zeus Health too. Zeus describes itself as “an early stage startup focused on accelerating digital health builders with a platform of healthcare-oriented, API-first services.”
- Revibe Technologies (nee FokusLabs) just hired former Amblyotech CEO and founder Joseph Koziak as its new CEO. (Novartis acquired Amblyotech, a digital therapeutic company focused on amblyopia, almost exactly one year ago.) Revibe offers a vibration-reminder watch that it is investigating as part of a therapeutic for ADHD. Revibe also just raised $3 million.
- Empatica has been racking up regulatory wins in recent weeks: The company’s EmbracePlus wearable just received “the European CE mark as a Class lla medical device, for its ability to consistently provide quality physiological parameters to users.” The device “continuously and remotely collects and processes physiological signals from the wrist, including pulse rate, pulse rate variability, blood oxygenation, respiratory rate, skin temperature, electrodermal activity, rest, and actigraphy data.”
- One more thing… Digital and decentralized clinical trials company Medable added yet more funding to its coffers this week with another $78 million led by Sapphire Ventures with a little help from new investor Obvious Ventures and its existing backers.
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As expected: HHS walks back prior admin’s last-minute medical device deregulation maneuver
In Issue 093 (“That weird FDA de-regulatory notice“), I wrote about my surprise that so many digital therapeutics companies were writing in to HHS and the FDA about a de-regulatory notice that the HHS under the Trump administration posted just days before leaving office:
“If you recall, the notice — not a draft rule — called for exempting more than 80 Class II devices from the 510(k) requirement ‘for which premarket review had also been waived during the’ pandemic. The notice cited a lack of adverse events listed in the MAUDE database for the 80+ medical device product codes as evidence that they should no longer require pre-market review. I assumed this notice would be ignored by the industry but so far the notice has 56 comments, which is incredible.”
“Is it really worth all this effort? Is there a chance this notice will slip through?”
The Digital Therapeutics Alliance along with a number of DTx companies sent in comments that urged HHS (under the Biden administration) to re-consider the notice, but they also often took the opportunity to educate anyone who was reading the letter about digital therapeutics. (Read excerpts from their letters in Issue 093 here.)
While the notice likely never had a chance of sticking around, digital therapeutics companies did take advantage of a ripe PR and lobbying opportunity with aplomb.
Still, it should come as no surprise that this week HHS announced it was withdrawing the notice. It went on to list out all the obvious reasons for doing so.
The one reason, however, that had been assumed and whispered but not officially acknowledged as yet was that this HHS notice, which clearly sought to limit the authority of the FDA, was not written with any consultation from the FDA.
Here’s what HHS published in the Federal Register this week on that front:
“Finally, we did not find evidence that HHS consulted with or otherwise involved FDA in its proposed exemption or the issuance of the January 15, 2021 Notice.”
Clinical trial updates: MedRhythms, Koa, Akili, Blue Note, AppliedVR, DynamiCare and more
Mystery hospital working with MedRhythms on Parkinson’s intervention
Maine-based MedRhythms — “a digital therapeutics company building direct stimulation solutions that use clinical-grade sensors, software and music to help restore function lost to neurologic disease or injury” — announced they were starting up a new multi-site clinical trial with help from Boston University and “one of the world’s leading hospitals”.
(Remember: MedRhythm is already working with The Cleveland Clinic on its study with MS patients.)
The new study is a “multi-site clinical trial studying MR-005, a digital therapeutic for PD walking impairments, will evaluate the clinical efficacy of the asset when deployed remotely in the home setting.”
Koa-MGH swap out wait-list comparator in DTx for OCD study
Dutch company Koa Health is moving toward launching its clinical trial with Mass General that will study the digital therapeutics company’s cognitive behavioral therapy app in a patient population with Obsessive Compulsive Disorder (OCD). They hope to get started June 1.
The collaborators changed their plan for a comparator on Tuesday. While the long-standing study design called for a Wait List-based comparator, which has become rather common in DTx studies, now the researchers will randomly assign half of the 120 participants to either:
“12 weeks of app-based CBT on their personal Smartphone or 12 weeks of web-based health and well-being education in addition to completing clinical assessments and questionnaires from home.”
More details on Akili’s COVID “brain fog” study
You probably have read about Akili’s COVID–19 “brain fog” study, but the study is now up on clinicaltrials[DOT]gov too, if you want to dig into more of the details. Not that important, but it is the first time I’ve seen a company announce they were using Zoom for virtual check-ins:
“Participants will also have weekly check-in visits via phone or a secure HIPAA compliant videoconferencing platform (Zoom) with a care manager, who will monitor mood symptoms and gameplay adherence.”
Blue Note Therapeutics Attune study goes live even though PDT is available under FDA waiver
As E&O reported back in Issue 090, Blue Note Therapeutics quietly launched its prescription digital therapeutic for people with cancer in February thanks to the FDA’s COVID–19 waiver for psychiatric devices. Even so, Blue Note’s clinical trial for people with breast cancer or non-small cell lung cancer kicked off earlier this month:
“Patients use the Attune app and undergo 10 sessions of [Cognitive-Behavioral Stress Management] over 30-45 minutes each consisting of cancer-specific educational videos, guided relaxation training, interactive exercises, and discussion modules. Following completion of the 6th session, patients undergo an assessment of intervention reception, update their medications, and schedule a phone call to assess for adverse events. At the end of the 10th session, patients undergo an online or phone de-briefing interview to discuss their experience with the intervention.”
AppliedVR’s study to test VR intervention to reduce pain and anxiety in pediatric surgery patients to finish up in October 2021
This AppliedVR study, which started up way back in December 2015, “aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing various procedures in the Ambulatory Surgery Center (ASC) at CHLA, as measured by self- and proxy-report.” This week the company gave a progress report on timing: It expects the study to finish up in October 2021 instead of October 2020 as previously hoped.
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