Issue 109
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.

It’s a bit of a slow week here thanks to the Fourth of July holiday in the US, so please excuse the somewhat abbreviated issue… Here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:

• E&O first reported on some puzzling new Category III billing codes “for Remote therapeutic monitoring of a standardized online digital cognitive behavioral therapy program ordered by a physician or other qualified health care professional” back in Issue 104. The American Medical Association’s CPT team has now revealed what those codes will be: 0702T and 0703T. Novartis will likely pay attention to the neighboring Cat III codes for “Remote treatment of amblyopia using an eye-tracking device” which are 0704T, 0705T, and 0706T. These utilization tracking codes will go into effect at the start of the year.
• Last week in Issue 108, I noticed that Natural Cycles had secured a new FDA clearance for its birth control software, but the company hadn’t revealed any specifics. I speculated the new 510(k) would allow it to add off-the-shelf wearable devices, including the Oura ring, as a new source of body temperature data. This week the company confirmed that my speculation was correct. The only surprise to me was that Natural Cycles plans to develop its own wearable too.
• This week’s mysterious FDA clearance comes from smoking cessation-focused company Carrot, which offers the Pivot Breath Sensor and its companion app-based coaching program. The new clearance is likely for the second generation of the company’s sensor — a Bluetooth-enabled carbon monoxide detecting device. More details on what’s changing next week.
• Reuters reports that Noom has tapped Goldman Sachs for an IPO that is set for 2022. Noom’s $540 million round of funding earlier this year also made its IPO ambitions clear. (I’m working on a long-form report that digs into Noom — let me know if you have any tips, angles, rumors, etc. that you’d like me to track down by hitting reply to this newsletter…)
• AliveCor secured another FDA clearance that unlocks a new capability for its Kardia 6L device. Now “healthcare professionals [can] use the KardiaMobile 6L device to calculate patients’ QTc interval.” AliveCor is likely to partner with pharma companies thanks to this new feature. “The QTc is a heart rate corrected interval that reflects the integrity of the heart’s electrical recharging system. QT prolongation can stem from congenital long QT syndrome, many disease states, or electrolyte abnormalities. Patients with a prolonged QTc are at greater risk for their hearts to go into a potentially dangerous arrhythmia called Torsades de Pointes which can lead to sudden cardiac arrest. More commonly, QT prolongation is a potential side effect of more than 100 FDA-approved medications including certain antiarrhythmic medicines, cancer therapies, antifungals, antipsychotics, antidepressants, antibiotics, multiple sclerosis (MS) medications, and opioids, among other categories.” Interestingly, this feature was already available thanks to an FDA enforcement policy during the pandemic, but now it is officially cleared too.
• The big digital health pharma partnership of the weeks goes to Holmusk and Otsuka. The three-year deal — worth $4 million annually — focuses on “proprietary analytics and artificial intelligence (AI) on multiple real-world data sources.” It also includes an asset transfer from Otsuka to Holmusk related to predictive analytics for mental health services delivery. More here.
• And the German government has added new digital health programs to its list of reimbursed ones in its DiGA program. The two new ones include a smoking cessation app from a German company and a diabetes management program for people with Type I or Type II. Pricing (in Euros) and more details in the E&O DiGA tracker here.
• One more thing… I thought this Digital Therapeutics 101 overview from Blue Matters, a life sciences-focused consulting firm, was well done. Worth a read if you are just starting to dig into prescription (and non-prescription) digital therapeutics.

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Clinical trial updates: Akili COVID brain fog, AbbVie nocturnal scratch tracker, Blue Note feasibility

More details on Akili’s COVID–19 “brain fog” study with Vanderbilt

I mentioned briefly in Issue 096 that Akili planned to set up two 100-person RCTs focused on cognitive impairment in COVID–19 patients. The company and one of its academic partners, Vanderbilt, recently posted details about their trial:

Small update for Orexo’s big RCT for its opioid use disorder DTx, Modia, which I just wrote about last week — the trial began recruiting in the past few days.

Blue Note aims for 20 instead of 50 participants now for feasibility study

Another small change: This trial scaled back its hoped-for number of participants from 50 to 20 this week. Blue Note Therapeutics’ “single-arm phase II trial focused on cancer patients and cancer survivors in the Veterans Health Administration will gather data on feasibility, acceptability, ease of clinical implementation, and preliminary efficacy of BNT001, a prescription digital software application.”

AbbVie’s atopic dermatitis nocturnal scratching tracking trial

Interesting update on Abbvie’s AD digital algorithm trial: The pharma company changed the designation so that it no longer ticks the box labeling this intervention as an FDA-regulated medical device.

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