Issue 245

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 quick things focused on FDA-regulated digital health… before we get into new FDA clearances and Mahana’s insolvency-triggered firesale:

• An E&O reader responded to my issue focused on the preliminary pricing for the new DMHT G codes, which some local MACs are reimbursing at a mere $129, by asserting that the amount is not sustainable. The reader argued that the ballpark cost of acquiring a patient (CAC) for a prescription digital therapeutic is around $200. The MACs are currently paying an amount on par with a direct to consumer product (maybe even a little lower), but that channel has a much lower CAC. The reader also pointed out that $129 is even lower than what many of the digital interventions receive for payment in Germany via its national formulary, DiGA.
• Is it weird that CMS hasn’t announced anything about a HCPCS Committee meeting in May for non-drug and non-biological items and services? (That’s the venue where companies like Pear, MedRhythms, Luminopia, and others created billing codes for their digital interventions.) Has CMS ever skipped a spring HCPCS meeting before? Is this collateral damage because of federal worker cuts? For what it’s worth, I asked the HCPCS Committee for a comment and they only confirmed that they have yet to post anything on their website yet.
• Click Therapeutics completed its 120-person clinical trial focused on a component of its digital intervention platform, called DiNaMo internally. “The purpose of the proposed study is to evaluate initial effects of the DiNaMo component on measures of undesired behavior intensity and related outcomes in a variety of conditions, such as atopic dermatitis and psoriasis.” The study title gave away a bit more detail on its focus: “An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis.”
• Finally, it has been widely reported now that Woebot had made the decision to shutter its consumer app in June. A simple message on the company’s FAQ confirms without further detail: “The team at Woebot Health will be retiring the Woebot app and the last day to use it will be on Monday, June 30th, 2025.” E&O reported back in 2023 (the same week that Pear sold its assets for a mere $6 million) that Woebot was pausing any further development of its prescription digital therapeutics assets. Now it is pausing its main DTC offering.

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Who is buying Mahana Therapeutics’ assets in its insolvency firesale? Nerva, for one.

As I reported last year, prescription digital therapeutics pioneer Mahana Therapeutics became insolvent some time around August 2024 and began the assignment for the benefit of creditors (ABC) process, a common alternative to formal bankruptcy proceedings, that some call “a private funeral.” Mahana Therapeutics tapped Silicon Valley’s ABC specialists, Sherwood Partners, which set up an LLC named Mahana LLC on August 30, 2024 that will act as a temporary trustee of the company’s assets.

Soon after, in December 2024, Bayer announced that it planned to acquire Cara Care’s assets in early 2025. Curiously, Bayer didn’t mention that it was acquiring the assets from Mahana or that the reason it was acquiring those assets was because Mahana was insolvent.

Bit random: Meta Platforms Inc. (formerly known as Facebook) actually acquired the trademark to Mahana Therapeutics’ early infinity symbol-inspired “M” logo back in 2022. Mahana subsequently rebranded and began using its sun-like logo, which it kept up until its insolvency last year.

Fast forward to this week and we finally have news about another company acquiring (at least some of) Mahana Therapeutics’ assets: Nerva.

Alex Naoumidis, the Co-CEO and co-Founder of Nerva, told E&O that his company had acquired some of Mahana’s assets. Like Mahana, Nerva’s core focus is on irritable bowel syndrome (IBS). Nerva uses gut-directed hypnotherapy as its primary mechanism of action while Mahana’s flagship digital intervention Regul8/Parallel/Mahana IBS used CBT.

Nerva did not acquire Mahana’s flagship IBS intervention, which had FDA clearance and was a prescription-only digital therapeutic. Nerva also did not acquire Mahana’s Tinnitus digital intervention, which the company had tried to sell DTC before its insolvency. As we get into more below, Nerva acquired Mahana assets focused on a future version of the company’s digital intervention, which hadn’t yet seen the light of day.

I reached out to a number of companies in the past two days to try to figure out who acquired Mahana Therapeutics’ core assets, but so far I can’t figure out who did — if anyone. (Hit reply to this newsletter if you know.)

Read on for more details on Nerva’s acquisition of Mahana’s 2.0 digital intervention.

FDA clearance tracker: Freespira, Luminopia, Cognoa, Whoop

Despite the turmoil at HHS, the FDA has continued to clear digital health software devices at a steady clip. I’m still waiting on more details and summary documents for some of these (including other recent ones I wrote about like Whoop’s first 510(k) for its upcoming ECG feature). In fact, it’s been about a month of waiting for some of these documents, which sure seems to be a result of the cuts at the agency.

Freespira: Freespira recently secured a new 510(k) clearance for its digital intervention, Freespira Breathing System, which treats symptoms associated with panic disorder, panic and anxiety attacks, and PTSD. No details yet on what changed with the device to warrant a new 510(k), but the company first submitted the device to the agency back in 2023 — so this one was a long time coming.

Luminopia: E&O already reported on this 510(k) two weeks ago but now we know the specifics. Following E&O’s report, the company announced that its prescription digital therapeutic for amblyopia is now cleared to treat patients aged 8 to 12 years — expanding its existing label from patients 4 to 7 years old to patients 4 to <13 years old with amblyopia associated with anisometropia and/or mild strabismus. Luminopia says that this expands its possible patient population by about 400,000 8- to 12-year-olds in the US with amblyopia. I asked Luminopia CEO Scott Xiao in an interview about the company’s next steps. While it is still working to continue to commercialize its program, Luminopia’s next regulatory submission will focus on expanding to patients 13 and up — including adults. Here’s a reminder of Luminopia’s pipeline plans (this hasn’t been updated to reflect this most recent FDA clearance):

In case that’s too small, the other indications in Luminopia’s development pipeline include cortical blindess from stroke, Strabismus, and TBI vision rehab. As a reminder, Luminopia has already successfully applied for and received a HCPCS billing code for its flagship intervention: HCPCS Level II code A9292, “Prescription digital visual therapy, software-only, FDA-cleared, per course of treatment” That code will likely work for future Luminopia interventions too since it isn’t specifically tailored to amblyopia.

Cognoa: Still waiting on details about this new FDA clearance for CanvasDx, a digital diagnostic aid for autism spectrum disorder. I think it is unlikely that this is a label expansion to include older children since Cognoa doesn’t appear to have done any clinical trials with participants older than 6 or younger than 18 months, which aligns with the company’s original FDA clearance.

Whoop: Also still waiting on more details about Whoop’s FDA clearance. We know it adds an ECG function to Whoop’s wearable device, but the agency hasn’t posted any other information about the clearance and Whoop hasn’t announced it yet. I still think they are waiting for a second FDA clearance that will allow it to detect irregular heartbeats — then I expect Whoop will announce both new features.

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