Issue 214
Welcome back to E&O: PDTs, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.
E&O: Rx Digital Therapeutics
Here are a few quick bullets on things happening in FDA-regulated and pharma-focused digital health:
- Big Health has renamed SparkRx, the digital therapeutic it acquired when it bought Limbix earlier this year. SparkRx was on track to become a prescription digital therapeutic under Limbix, but Big Health just renamed it “Spark Direct” and tweaked the marketing language around it too: “Spark Direct is a digital program that may help individuals live well with major depressive disorder (MDD) and symptoms by providing them with cognitive behavioral techniques that can improve mood. Spark Direct has not been reviewed or approved by the Food & Drug Administration and is not intended to diagnose or treat any medical condition. Please read the instructions for use.”
- Akili received a letter last week that warned the company’s stock price had dropped below $1 and the company’s stock could be de-listed if the share price doesn’t increase. Excerpt: “the Company has 180 calendar days, or until April 22, 2024 (the ‘Compliance Date’), to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days before the Compliance Date unless Nasdaq requires a longer period under certain circumstances.”
- Click Therapeutics announced $20 million in debt financing from HSBC. (Last year Click announced a $15 million loan from SVB.) As part of the recent loan announcement Click gave this update on its progress: “Click Therapeutics has announced four major co-development and commercialization collaborations to date for the treatment of major depressive disorder (MDD), schizophrenia, and substance use disorders. Click is also progressing its lead internal program for the preventive treatment of migraine with pivotal data expected in 2024.”
- One more thing… Last week HumanFirst CEO and founder Andy Coravos rightly pointed out that while Biogen had shuttered its digital health business unit it was continuing to work in digital health in three specific areas: digital biomarkers, digital experiences around rare diseases, and imaging tools.
Was this forwarded to you? Increasingly, E&O is a covered benefit from many forward-looking digital health-focused employers. Why not yours? Consider a Business or Enterprise subscription today. Click this link to become a paying subscriber (there are personal plans available too).
CMS 2024 Physician Fee Schedule reveals a big digital therapeutics nothingburger
Back in the summer CMS included a surprise Request for Information focused on digital therapies, including (but not limited to) cognitive behavioral therapy. The RFI bulleted out about 20 questions focused on digital therapeutics. Last week, in its 2024 Medicare Physician Fee Schedule, CMS included a short summary of the comments it collected from the RFI as well as its own response to the comments. However, only a few of the nearly 20 questions that CMS posed in its RFI received a mention in CMS’ summary or response.
What’s more, CMS appears to be taking no action on the information it gathered via the RFI. The agency did call out the digital CBT code change application from the most recent CPT Editorial Panel meeting in September, but it concluded that it would review those via its typical process. (So, all this effort seemed to be for naught?)
“In response to the commenters’ statement that there are new coding proposals shown in the public agenda for the September 2023 CPT Editorial Panel meeting to allow for reporting of digital CBT (dCBT) and remote therapeutic treatment and other digital therapeutics as incident-to services, we note that we routinely rely on the CPT coding process as a critical part of how services, including those involving emerging technologies, that might be paid under the PFS are understood and provided by medical professionals. While we do not always rely on CPT exclusively, we look forward to reviewing any forthcoming codes and potential recommendations for the valuation of such codes through our standard annual processes.”
What did this RFI accomplish? Did it create more awareness about digital therapeutics at CMS? Or was it a waste of time?
Correction: This article originally stated that CMS published its RFI in the 2023 PFS, but it was actually posted during the summer of 2023. E&O regrets the error — and much else.
metaMe Health seeks a buyer by year-end
E&O has learned that metaMe Health, one of the few prescription digital therapeutics companies with an FDA-cleared product commercially available in the US, is seeking a buyer.
metaMe is soliciting bids between now and Thanksgiving and hopes to close the deal by the end of 2023.
As far as I can tell, the company last raised money in March 2022. It was a $2.2 million bridge round led by Hyde Park Angels with contributions from other individual angels.
(I reached out to the company for comment and will update if I receive any more details on the sale.)
Here are the company’s primary assets that are up for sale:
- Regulora is an FDA-cleared prescription digital therapeutic that offers three months of gut-directed hypnotherapy for adults 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). It is commercially available in the US and Canada.
- Regulora-FD is at the pilot stage. It is a fully functioning prototype of a digital therapeutic that uses gut-directed hypnotherapy to help treat Functional Dyspepsia.
- Regulora-FH is another digital therapeutic asset at the pilot stage. The company has built a fully functioning prototype. It uses gut-directed hypnotherapy to help treat Functional Heartburn.
- Regulora-UC is another digital therapeutic asset at the pilot stage. Also a fully functional prototype currently. It uses gut-directed hypnotherapy to treat Ulcerative Colitis.
- STROBE is a Software-based Treatment for the Reduction Of Bloating Effects. Mayo Clinic researchers developed it. It also uses hypnotherapy and it is a fully functioning prototype at present.
Regulora’s website has an R&D pipeline that mentions a pediatric version of Regulora IBS.
Trials: Akili, Better Therapeutics, Bold Health, Strados Labs
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues. Just two this week:
New: Akili’s EndeavorOTC product registry
Despite going over-the-counter with the adult version of its ADHD video game-based digital therapeutic, Endeavor, Akili has set up a product registry clinical trial. It anticipates 3,000 participants. More here:
“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.”
Delayed and done recruiting: Better Therapeutics’ study as Mass General Brigham
Better finished up recruiting 500 participants for this trial, but it also delayed the study’s end date a year — it will now finish up in December 2025. More:
“The study intervention, BT-001 (the App), will be dispensed at enrollment to the Immediate Intervention App Use arm of the trial. Patients randomized to the Delayed Intervention App Use arm will be provided a ‘control App’ with diabetes control, and then the BT-001 App after 180 days. Each participant is assigned to one 90-day treatment cycle of BT-001. Over the 12-month intervention period, study participants will be able to opt into up to 3 additional treatment cycles of BT-001.”
Delayed and done recruiting: Better Therapeutics’ other 500-participant trial
A different Better Therapeutics study has also been delayed, but this one should finish in November 2025. It also finished up recruiting its 500 participants. More:
“Randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that BT-001 an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compared to a control application added to usual care and across a broad range of patients in a real-world setting.”
Delayed: Bold Health’s clinical trial’s primary completion pushed back until December
It’s been a while since I’ve heard anything about Bold Health. IBS-focused Bold Health originally intended to complete its clinical trial for Zemedy in September, but the primary completion is now set for December 2023. The study’s ultimate completion date remains May 2024. More here:
“The purpose of this research is to assess if a new digital app version of a self-help intervention for Irritable Bowel Syndrome (IBS), is an acceptable and effective treatment for improving the overall quality of life in patients with IBS.”
New: Strados Labs’ wearable auscultation sensor validation study in children
Here’s a new validation study on a wearable sensor called RESP that captures lung sounds like an electronic stethoscope. The study is focused on an in-hospital pediatric population. More:
“This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings.”
Links to E&O’s reports, databases, newsletters
Click below for dedicated pages for each of those categories:
- Read through the long-form E&O research reports here.
- Search and sort the E&O databases here.
- Skim more than 300 past issues of E&O newsletters here.
