Issue 228

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

• Looks like my speculation last week was a scoop: Alivecor did get 510(k) clearance for its 12-lead device. More details out this week after the company officially announced it.
• There’s a new bill kicking around Congress that includes language about CMS coverage of prescription digital therapeutics. The bill is currently named the American Medical Innovation and Investment Act of 2024. The bill calls for HHS to send guidance to physicians on requirements for payment under Part B for prescription digital therapeutics before 2026. Within a year of the bill passing, it calls for HHS to send guidance to MA plans to explain when PDTs can be provided as a supplemental benefit. Finally, is asks HHS to provide a report to Congress about whether HHS needs any additional statutory authority to provide payment for PDTs under Medicare. Read the bill here.
• There is a lot of chatter right now about the Supreme Court’s decision to overturn the so-called 1984 Chevron precedent, which will erode some of the powers enjoyed by federal agencies for the past 40 years. I’m curious how this might change things at the FDA and CMS. Let me know if you want to talk about that by hitting reply to this newsletter.
• Meanwhile, in Germany, the national formulary for prescription digital therapeutics (DiGA) provisionally added a new digital health program: Italy’s My Dose Coach, a basal insulin titration app. It costs €478.80 for 90 days.

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Prescription digital therapeutics roll call: Where are they now?

How many digital health companies are still planning to commercialize prescription digital therapeutics in the US? That’s a question I’ve been meaning to dig into in recent months as some of the bigger names file for bankruptcy, get snapped up by former competitors, or quietly take their websites offline. What follows is a quick round-up of recent happenings and current statuses of some of the (currently and formerly) PDT-focused digital health companies that E&O has written about over the years. What did I miss?

Click Therapeutics — Click has managed to stay true to the prescription digital therapeutic go-to-market. It has acquired assets from Pear Therapeutics and Better Therapeutics in recent years. Click also secured an FDA clearance for Rejoyn, a PDT focused on depression that its partner Otsuka will commercialize in the US — a regulatory milestone that likely triggered a handsome payday for the company. Click has become bullish on the FDA’s relatively new guidance on Prescription Drug Use Related Software, which appears to be a big opportunity for the company’s future therapeutics.

Pear Therapeutics — After entering bankruptcy in early 2023, Pear’s assets were sold at auction for a few million. The company’s flagship PDTs, reSET and reSET-O, eventually ended up at virtual clinic company, Pursue Care. The PDTs seem to remain available through a few formularies around the country, but Pursue hasn’t made any formal announcements about its plans for commercializing the PDTs further.

Akili — Earlier this year Akili announced that it would delist and merge with a small VR-focused digital health company named Virtual Therapeutics. It will continue to support the rollout of its ADHD PDT in Japan for its partner Shionogi, which will provide its new parent company with a small revenue stream if all goes well. Akili also recently secured a 510(k) for its OTC version of the PDT. Akili seems to have moved away from the prescription pathway for the foreseeable future. It’s still unclear how Akili’s FDA-cleared, over-the-counter digital therapeutics fit in with the largely employer-focused go-to-market of its new parent company.

Mahana Therapeutics — Mahana acquired one of its competitors, CaraCare, and launched a direct-to-consumer digital therapeutic called Mahana Tinnitus. The company seemed to be developing that product as a prescription digital therapeutic years ago, but apparently switched course. Mahana’s flagship IBS PDT had a little over 800 patients complete the three-month program between August 2021 and August 2023. (An unknown number were prescribed the program but did not complete it during that time period.) Mahana made its IBS PDT free to patients until some time in 2022. It offered a DTC telehealth option to find a prescriber online, but discontinued that in 2023.

MedRhythms — MedRhythms seems to be focused on a prescription digital therapeutic go-to-market as it always has. About a year ago MedRhythms announced that its flagship PDT, InTandem, was now listed with the FDA as a Class II medical device, exempt from the premarket notification procedures. Earlier this year it asked CMS to create a new HCPCS code. CMS seemed likely to reject the application based on its initial response, but the company is still awaiting the decision. Like AppliedVR, MedRhythm’s offering includes some unique hardware, which likely means the company is hoping to classify its product as DME — an easier route to reimbursement.

Swing Therapeutics — Swing continues to develop its prescription digital therapeutics for fibromyalgia pain (see clinical trial updates below), but it appears to spending most of its time on its expanding number of virtual clinics, named Swing Care. Like Oui and Pear, Swing is one of the few PDT companies to leverage virtual clinics as a distribution channel for its PDT. Swing Care currently operates in Michigan, Missouri, Texas, Tennessee, and Ohio as an in-network provider with insurance companies like United and BCBS Texas.

Oui Therapeutics — Oui Therapeutics remains focused on a prescription digital therapeutic go-to-market. It is still pre-FDA clearance with its flagship PDT focused on suicidal ideation, but it is also now developing a PDT focused on binge eating disorder in obesity patients. Oui was perhaps the first PDT company to develop its own virtual clinic — it spun out mental health-focused virtual clinic company Vita Health a few years ago.

Better Therapeutics — Better was one of the handful of PDT companies that made the risky move to SPAC itself onto the public markets a few years ago. Click ended up acquiring Better’s assets earlier this year for an undisclosed sum. The deal included one FDA-cleared PDT focused on Type II diabetes, but at the time of the acquisition, Click was more interested in leveraging Better’s assets to create a digital companion to GLP-1 drugs. It said it would not continue commercialization efforts for the PDT as a standalone.

Curio Digital Therapeutics — Curio managed to secure one of the few recent FDA clearances for a prescription digital therapeutic this past April. The post-partum depression PDT is not yet available, per the company’s website.

Nightware — Nightware has been quiet in recent years. Its FDA-cleared Apple Watch-powered PDT for improving sleep disturbances from nightmares and PTSD is still listed in the VA’s catalog at $6,827.62 per unit. That agreement expires in a few weeks and I’m curious to see if it is removed or remains — and whether there is a price change in the latter case.

Luminopia — Luminopia’s big accomplishment in 2023 was successfully petitioning CMS for a new HCPCS code that is relatively specific to its PDT for amblyopia. Since the PDT is software-only, reimbursement remains a challenge.

North Shore Therapeutics — I had assumed for a while that this group shuttered but left its website up. Last year, however, there were signs of life when North Shore began promoting a feasibility study — NST-Spark — for its PDT focused on improving negative symptoms of schizophrenia.

Big Health — Big Health has been slowly moving toward (or at least bolting on) a PDT go-to-market for a few years now. Then it acquired Limbix, makers of SparkRx, a prescription digital therapeutic for teens focused on depression. Limbix made SparkRx available during the pandemic under the FDA waiver and pre-FDA market authorization. Since the acquisition, Big has rebranded SparkRx to Spark Direct and has added disclaimers to make clear it is not FDA-cleared. While the future of Spark Direct is unclear (will it become FDA-cleared and Rx-only?), Big Health is currently waiting on FDA market authorization for prescription versions of its own longtime flagship digital therapeutics for anxiety and insomnia.

AppliedVR — Last year AppliedVR successfully convinced CMS to create a new HCPCS billing code for its PDT focused on chronic lower back pain, RelieVRx. Notably, the device was also deemed DME (in part because it included a unique hardware component).

Arcade Therapeutics — Arcade (formerly Wise Therapeutics) is also staying on the PDT path. Arcade recently made available a version of its flagship digital therapeutic for anxiety pre-FDA clearance. “StarStarter is available non-prescription under FDA enforcement discretion; it is not evaluated, cleared or approved by FDA.” But a look at Arcade’s pipeline indicates its commitment to PDTs remains.

Vicore — Swedish pharma company Vicore has been working with Alex Therapeutics to develop a prescription digital therapeutic for people with pulmonary fibrosis for years. A few months ago the digital therapy, named Almee, received Breakthrough Device Designation from the FDA. Curiously, in the press release announcing that the companies did not refer to Almee as a PDT anymore (it did in 2021 in the original partnership announcement) but rather simply as a digital therapy. The announcement also made clear that Vicore was seeking to partner “with the developers of approved and late-stage molecular therapies for the treatment of pulmonary fibrosis” to commercialize Almee. Maybe Vicore-Alex is thinking along the same lines as Click and the FDA’s PDURS pathway? PDURS did get a mention in this blog post by Alex.

Twill — Twill, formerly Happify Health, merged with Dario earlier this year. As I noted at the time, the announcement made little mention of Twill’s prescription digital therapeutic, Aspiro, for anxiety and depression. Prior to the deal with Dario, Twill was seeking a pharma partner to commercialize Aspiro. The company said it would not bring it to market without one. Dario does not seem interested in the PDT pathway.

Limbix – Big Health acquired Limbix last year in a deal that included at least $9 million in stock. More on the fate of Limbix in the Big Health write-up above, but the short version is that Limbix’s PDT, SparkRx, is now available as Spark Direct. It doesn’t have FDA clearance and does not require a prescription. So, it’s not a PDT — at least for now.

BehaVR – BehaVR merged with Fern Health and pivoted away from PDTs. The new company, called RealizedCare “works with health plans, employers and value-based providers to identify, assess and engage members with chronic pain through a fully managed solution.”

Renovia – Investment firm AXA IM Alts created a new company called Axena in early 2023 with a $25 million round. Axena acquired all of Renovia’s assets related to its FDA-cleared PDT Leva Pelvic Health System. Renovia’s old CEO became the CEO of the new company, Axena, for a little over a year before leaving in May. Soon after Axena announced that it raised $9 million in additional funds. Axena also successfully lobbied CMS to create a new HCPCS code for its PDT.

metaMe Health — As E&O reported last year, metaMe, which managed to secure FDA clearance for its PDT for IBS was up for sale at the end of 2023. It seems like no deal was ever brokered, however. The company’s website still states that Regulora is no longer available in the US, but it is available in Canada through a partner.

Blue Note Therapeutics — Blue Note had been developing prescription digital therapeutics focused on mental health issues for cancer patients. While it launched a couple during the pandemic, the company’s websites are now offline and it seems like what remained of the team found new jobs as of this past March.

Woebot — Woebot told E&O in May 2023 that it was no longer pursuing prescription digital therapeutics as a go-to-market. That was right around the time Pear’s assets sold (for very little) in a bankruptcy auction.

Neuroglee Therapeutics — Neuroglee pivoted into a virtual clinic and is no longer pursuing prescription digital therapeutics as a go-to-market.

Cognoa — Cognoa secured a 510(k) clearance for a digital diagnostic for autism back in 2021. While it has long planned to follow that up with a digital therapeutic, the company hasn’t shown much progress on that front in the meantime.

Trials: Swing Therapeutics and Akili

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

New (and complete) trial: Swing Therapeutics’ extended trial of its prescription digital therapeutic for fibromyalgia pain This trial was redacted until recently and now that it is unredacted, we can see that it is finished. Usually, companies only ask for their trials to be unredacted once they manage to secure FDA clearance. So, this is a bit of a puzzle. FDA clearance incoming? Or is this an indication of an abandonment of FDA clearance and the PDT pathway? More: “This study is designed as a 9-month extension of the original study (PROSPER-FM). The purpose of the extension study is to assess the long-term (up to 1 year) response to a digital therapy in the treatment of fibromyalgia.”

Complete: Swing Therapeutics trial finishes up with far fewer participants than originally expected  Swing also updated another of its clinical trials to reflect that it was now complete. The trial originally anticipated about 500 participants but in the end it had just 130 participants. More: “The objective of this study is to assess the clinical impact of a digital therapy for the management of fibromyalgia. Study participants receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia. The primary endpoint is the Patient Global Impression of Change (PGIC) at week 12. This is a virtual, single-arm, pragmatic, non-significant risk study.”

No longer recruiting: Akili product registry for EndeavorRx  This trial ended up recruiting just 150 of the anticipated 500 participants. More: “The EndeavorRx Prospective Product Registry aims to collect real world data from participants receiving the digital therapeutic, EndeavorRx, under conditions of routine clinical practice.”

No longer recruiting: Akili EndeavorOTC prospective product registry Here’s another Akili trial that is no longer recruiting and fell way short of the original enrollment expectation. It enrolled 198 out of a hoped for 3,000 participants. More: “The EndeavorOTC product registry aims to collect real world data from EndeavorOTC users. The objectives of this registry are to describe clinical and demographic characteristics, treatment patterns, clinical and quality of life outcomes, and healthcare utilization in EndeavorOTC users in a real-world setting.”

No longer recruiting: Akili EndeavorOTC study with college students ends recruitment early Seeing a pattern here… so I’m guessing this is related to the company’s merger with Virtual Therapeutics. This study originally hoped for about 500 participants but only managed to enroll 69. More: “Eligible students will be randomized* to two cohorts: the first will receive immediate access to AKL-T01, and the second will complete weekly online surveys and receive access to AKL-T01 after the first group has completed the recommended 6 weeks of use. Regardless of group assignment, all participants will receive full 12-weeks of access to AKL-T01 during the course of the study.”

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