Issue 227

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 are a few shorts from the world of Software as a Medical Device (SaMD):

• In Germany, the national formulary for prescription digital therapeutics (DiGA) removed Kaia Health’s COPD program at the end of May. It seems the program didn’t prove its worth to the operators of the formulary, which lists the reason for the removal as: “No positive care effect could be proven for the DiGA.” Here’s what Kaia posted on its website for patients with an active prescription but no way to download the program from the DiGA formulary: “As of May 31, 2024, Kaia COPD is no longer available on prescription. This means that your health insurance company does not currently reimburse the therapy. Our team is already working to ensure that all patients will soon have access to Kaia COPD again!” Kaia will help individuals with a prescription to individually activate it for free while it figures out its next move. While it was on the formulary, the list price was €332.00.
• The formulary also removed a digital program focused on knee pain for the same reason: Kineto’s re.flex, which was priced at €784,21. It also exited the formulary at the end of May.
• The DiGA formulary also lowered the price of Limedix’s aphasia program from €487.90 to €223.01.
• Germany’s DiGA formulary also lowered the price of ProCarement’s digital heart failure program, ProHeart from a range of €495.00 – €605.00 to between €396.00 and €484.00.
• The DiGA formulary also lowered the price of breast cancer program Pink Coach from €535.50 to €234.50.

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FDA greenlights Akili’s EndeavorOTC and two mystery devices from Alivecor (probably 12L)

The news you know: As expected, the FDA has cleared Akili’s non-prescription EndeavorOTC for adults with ADHD via the 510(k) pathway. Akili began making the digital therapeutic available direct-to-consumer one year ago thanks to the pandemic-era waiver that the agency offered to makers of psychiatric-focused digital health therapies. (Virtual Therapeutics recently acquired Akili as detailed in previous versions of this newsletter.) Here’s part of the device’s indication for use: “EndeavorOTC is an over the counter digital therapeutic indicated to improve attention function as measured by computer-based testing in patients 18 and older with primarily inattentive or combined type ADHD, who have a demonstrated attention issue.”

Not yet announced: FDA cleared two code-named Alivecor medical devices. I think Alivecor is set to announce these FDA clearances next week. Here’s a speculative preview of the company’s latest clearances: Perhaps taking a page from its longtime lawsuit adversary Apple, Alivecor has codenamed its two newest medical devices “Impala” and “Corvair”. Both of these mystery devices received 510(k) clearances from the FDA in recent weeks. One of the two devices is likely Alivecor’s Kardia 12L, a mobile (0.3 lb) 12-lead ECG device, which the company has been testing in recent years (as chronicled by E&O’s clinical trial tracker). It’s possible the two devices are components of the 12L system — one clearance for the device itself and one for the updated KardiaStation mobile app. A few details:

• Kardia 12L is for health professional use only and appears to be a replacement for in-clinic ECG devices.
• The device pairs via Bluetooth with the healthcare professional’s KardiaStation app on their mobile device.
• The 12L detect a comprehensive set of 35 FDA-cleared determinations.

Trials: Oui Therapeutics, Click, Mahana, GAIA, and Woebot

Here’s a round-up of recent changes to clinical trials focused on digital therapeutics.

New trial: Oui Therapeutics eyes obesity market for a future digital therapeutic focused on binge eating Oui Therapeutics, developer of a prescription digital therapeutic focused on suicide ideation, looks to be moving into the obesity market next. This 30-person trial is focused on binge eating. More: “This single-arm, open-label clinical trial will test the feasibility, usability, acceptability, and preliminary efficacy of a digital therapeutic in reducing binge eating and weight in 30 adults with comorbid recurrent binge eating and obesity.” Here’s a little more background from the federal grant posting that is funding this trial: “Among obese adults who seek treatment, more than 25% engage in binge eating; this comorbidity has more severe health outcomes and is more costly to treat than obesity alone. Oui Therapeutics seeks to partner with leading researchers in the field of eating disorders to develop a novel self-guided digital intervention product (called OTX-401) for the treatment of obesity combined with binge eating.”

New trial: Oui also posted details of a new RCT focused on digital therapeutic for suicide ideation in adolescents Oui Therapeutics has so far studied its digital therapeutic for suicide ideation, Aviva, in adult populations. Now it has set up a trial focused on adolescents. More: “This double blind, randomized controlled trial will evaluate the preliminary efficacy of two digital interventions among 114 adolescent participants, and their parents/guardians, in reducing suicidal ideation in the adolescent participants. Adolescent participants, parent/guardian participants, and research assessors will be blinded to treatment assignment.”

Complete: Click Therapeutics study on digital therapeutic for migraine Click’s 558-participant RCT focused on a digital therapeutic for migraine finished up. More: “The purpose of this randomized ReMMi-D trial is to evaluate the efficacy and safety of two prescription mobile applications that provide an interactive, software-based intervention for the preventative treatment of episodic migraine in late adolescents and adults.”

Mahana Therapeutics posts results to its tinnitus-focused digital therapeutic trial “The main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana Tinnitus together with care as usual in approximately 250 adults with symptoms of tinnitus.” More

GAIA withdraws trial focused on convivio, a digital therapeutic for Type 2 diabetes “This trial was designed to evaluate the effectiveness of the dialogue-based online intervention covivio, which was designed to improve diabetes self-management in patients with type 2 diabetes. The study aims to test the hypothesis that covivio has a greater positive impact on glycemic control than treatment as usual.” More

Done recruiting: GAIA’s study on ADHD digital therapeutic attexis GAIA managed to recruit 377 participants instead of the 326 it originally anticipated: “In this randomized controlled clinical trial, 326 patients with ADHD will be investigated regarding the effectiveness of a digital therapeutic for improved ADHD symptomatology, the unguided online intervention attexis.” More

Complete: Kaiser Permanente finishes study on reSET and reSET-O implementation in clinics No results year by KP finished up its study on Pear Therapeutics’ old prescription digital therapeutics with 1,552 trial participants. More: “The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement.”

Complete: Woebot’s study on a chatbot for mental health Woebot previously told E&O that it had exited prescription digital therapeutics as a go-to-market, and it withdrew many of its clinical trials in the wake of that decision. But this one just finished up that focused on the potency and precision of its chatbot for mental health. More: “This exploratory single-arm trial will provide initial learning on the current implementation of precision interventions and generate data and hypotheses to inform the exploration of future interventions by identifying mechanisms and moments in the user journey to target. The DISC-MA app uses a relational agent (Woebot) to engage users in conversations.”

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