Issue 248

Welcome back to E&O: SaMD, a paying subscribers-only weekly newsletter focused on the world of digital pharma products, prescription digital therapeutics and other FDA-regulated digital health.

 E&O: Software as a Medical Device

Here’s one quick note before we dig into a company looking to bring a new ADHD digital therapeutic to market as well as the latest updates on digital health-related clinical trials… but first…

• The FDA cleared a new ECG app from Withings, which offers smartwatches, weight scales and connected blood pressure cuffs. Withings has secured a couple of ECG-related 510(k)s in the past so this clearance doesn’t unlock a brand new feature for the company’s devices. Details still forthcoming.

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FDA clears Lumosity-maker’s new DTx for ADHD, Prismira, as Lumos looks to succeed where Akili Interactive’s EndeavorRx could not

While it hasn’t been announced yet: Lumos Labs, a digital health company best known for its direct-to-consumer brain training program, Lumosity, just received a 510(k) clearance from the FDA for Prisimira, a digital therapeutic video game for treating the symptoms of ADHD. Prisimira uses the same product code, QFT, as Akili Interactive’s pioneering EndeavorRx. QFT is for “Digital therapy device for Attention Deficit Hyperactivity Disorder” and only Akili and Lumos have received a 510(k) clearance for that type of device.

Akili 2.0? Lumos is following in the footsteps of a company that had a tortuous path to market. Akili, which went public via a SPAC vehicle a few years ago, ultimately pivoted away from its longtime prescription digital therapeutics go-to-market in favor of a direct-to-patient commercialization strategy. Soon after that pivot it was acquired by little known virtual reality-based therapeutics company Virtual Therapeutics in a deal where VT used Akili’s own cash-on-hand to pay for its acquisition. VT basically bought Akili for nothing. Since the FDA hasn’t posted a summary document yet and Lumos hasn’t announced this new FDA clearance, the company’s plans for the newly FDA-cleared Prisimira aren’t officially out there yet, but E&O has tracked Lumos’s moves into digital medicine over the past few years so it’s easy to take some educated guesses. (E&O first noticed Lumos Labs’ ADHD digital therapeutic back in 2022 when it first shared details about its efficacy trial.)

Self-pay or reimbursed? Rx or OTC? In an interview with the Closing Time podcast last year, Lumos CEO Bob Schafer indicated that the company would likely pursue an out-of-pocket, direct-to-patient go-to-market like Akili did before its acquisition, but he also noted that the FDA is the ultimate decider on whether a medical device should be Rx-only or OTC.

Slowed its roll since Akili and Pear wind-downs: On that same podcast, Schafer said that Lumos planned to raise capital and finance a number of parallel clinical programs in its digital medicine pipeline, but after watching both Akili and Pear fall apart in 2023 and 2024, Lumos decided to focus on its ADHD digital therapeutic candidate.

Profitable consumer business: Despite a very public scolding and $2 million fine back in 2016 from the FTC over what the regulator called “deceptive” claims about its brain training program, the DTC Lumosity business was profitable and generating revenue as of 2024. It has registered more than 100 million users since its launch in 2007 and more than 8 billion sessions. (The company likes to point out that this is a valuable dataset.) All of those years of iteration, the massive dataset, and successful DTC business line set Lumos Labs apart from early prescription digital therapeutics companies.

Future indications for Lumos Labs’ digital medicines: While the company has suggested it would use its ADHD digital therapeutic, Prismira as a trial balloon, the company still lists an ambitious pipeline of digital therapeutic candidates on its website. It is working on digital interventions for these indications: “Mild Cognitive Impairment, Post-Operative Delirium, Stroke, Alzheimer’s Disease (AD), Cancer or Chemofog, Multiple Sclerosis (MS), Traumatic Brain Injury (TBI), Autism Spectrum Disorder (ASD), Posttraumatic Stress Disorder (PTSD), and Schizophrenia.” The company’s pipeline and list of published studies for each indication are at the very bottom of this page here.

Trials: Hinge Health, Big Health, NightWare

New NightWare study focused on cardiovascular health in women with PTSD

NightWare just posted details on a new sham-controlled study focused on premenopausal women. It expects to enroll about 36 participants and should finish up in mid-2028. (NightWare started a similar trial a few years ago but it didn’t focus on women.) More:

Hinge Health and Optum are conducting a study focused on the Enso device and chronic lower back pain

Here’s an interesting one only because it is so rare these days for digital health companies focused on selling to employers to conduct clinical trials: Hinge is working with Optum to conduct this trial, which it expects will enroll 196 participants. The trial should finish up in 2026. More:

Terminated: UCSF-sponsored study of Big Health’s Daylight in low income, marginalized pregnant population

UCSF terminated a study of Big Health’s Daylight because it failed to recruit enough participants. The study focused on treating anxiety in a low income, marginalized people in California. The trial managed to recruit 24 participants but originally hoped for 132. More:

Done recruiting: Oxford study with Big Health focused on treating insomnia in a group of patients with fibromyalgia with insomnia digital therapeutic Sleepio

This study is particularly interesting because Swing Therapeutics, a PDT company focused on fibromyalgia currently prescribes Sleepio to patients via its virtual clinics business, Swing Care. More on this study:

Rutgers completes Sleepio study on suicidal teens with co-occurring insomnia

This study enrolled 12 participants — lower than the originally expected 20. More:

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