Issue 057.
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Digital health research from Brian Dolan.
Welcome to E&O.
Last week I wrote about Haven’s health coaching partner going public. Next week I am open to ideas — what should E&O dig into? Here’s what’s happening this week:
- What a busy week. I pulled together The Proteus Digital Health Report after the long-running company filed for Chapter 11 bankruptcy on Monday. There’s a bit more on that report below or just head to E&O to read the full 4,400-word report now.
- The other big news this week: On Monday the FDA announced that it had (finally) granted Akili Interactive a De Novo clearance for EndeavorRx (AKL-T01), which is video game-based prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). Perhaps the most remarkable thing about this move by the FDA is that its database shows it only took TWO MONTHS from the time it received Akili’s submission until the agency granted the De Novo. Just in-credible! Felt like at least two years to me. (Even weirder, the FDA says it received the Akili De Novo submission just two days after the agency put in place its corona-related, non-enforcement policy for psychiatric digital health products. Remember, that’s the guidance that led to Akili making its pre-FDA clearance therapeutic available on
a limited basis.) - Speaking of regulatory A-OKs, Pear Therapeutics racked up yet another one as Singapore’s Health Science Authority (HSA) granted market authorization to Pear’s reSET digital therapeutic for substance abuse disorder.
- Big Health, which offers the digital therapeutic Sleepio among others, raised $39 million in a Series B led by Gilde Healthcare and Morningside Ventures. Kaiser Permanente Ventures (KPV), Octopus Ventures, and Samsung NEXT also contributed.
- Following Omada’s acquisition of Physera a few weeks back, Kaia Health has raised $26 million in its Series B led by Optum Ventures, Idinvest, and capital300. Investors Balderton Capital, Heartcore Capital, Symphony Ventures contributed. It plans to launch a third digital therapeutic product focused on knee and hip osteoarthritis. To date, 400,000 people have used its DTx offerings.
- The United States Pharmacopeial Convention (USP) released a white paper this week that it wrote with the health of the Digital Therapeutics Alliance. The paper describes the value of public standards and proposes “how USP’s existing quality framework for chemical medicines and biologics could be adopted by digital therapeutics”. USP wants feedback.
- One more thing: Here’s an unusual deal. Digital health company KRY, also known as Livi, acquired a brick-and-mortar health clinics company to bolster its number of physical locations across Sweden.
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The Proteus Digital Health Report
Proteus Digital Health, one of the original and highest-valued digital health companies, filed for Chapter 11 this week.
This 4,400-word report digs into its mostly unreported origins, explores the company’s relationship with its biggest customer — Otsuka, uncovers the financial details of its recent deal with Tennessee’s Medicaid program, and considers what happens next for digital medicines.
Read the full write-up over at the Exits and Outcomes site.
Quick links to E&O research reports
The links below aim to make it easier for paying subscribers to find the long-form research reports on the E&O site:
The Proteus Digital Health Report (Subscribers-only Link)
The Hinge Health Report (Subscribers-only Link)
The Digital Health Enrollment Report (Subscribers-only Link)
The Omada Health Report (Subscribers-only Link)
The Google Health Report (Subscribers-only Link)
The Pear Therapeutics Report (Subscribers-only Link)
The AliveCor Report (Subscribers-only Link)
Apple’s Healthcare Work Experience (Subscribers-only Link)
Approximating Livongo’s S-1 (Subscribers-only Link)
That’s a wrap on Issue 057 of E&O.
