Issue 222
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 a quick rundown of things happening in FDA-regulated and pharma-focused digital health:
- US-based prescription digital therapeutics company Mahana Therapeutics has acquired Germany-based Cara Care, another digital health company with a focus on digestive issues. No financial terms were disclosed. (However, at least one of Cara Care’s investors is now an investor in the combined entity, which suggests that this wasn’t entirely a cash deal?) I’ve written about Mahana’s tinnitus programs previously, but the announcement describes Mahana’s ambitions as including digital health programs for “Irritable Bowel Syndrome (IBS), Irritable Bowel Disorder (IBD), Celiac Disease and Heartburn” plus a pipeline focused on “Tinnitus, Pruritus, and Vulvodynia.”
- While the number of digital health companies that focus on a prescription digital therapeutic go-to-market continues to shrink, at least one new one emerged earlier this year: Hello Therapeutics. One of its investors described it like so: “Hello Therapeutics is a digital Women’s Health company focused on developing evidence-based treatments for the symptoms of menopause. Their first development candidate is a prescription digital therapeutic (PDT) designed to treat VMS (hot flashes and night sweats) with the same indication statement and pivotal clinical study endpoints as hormone therapies and NK3 inhibitor treatments.”
- The FDA granted Boston-based Beacon Biosignals, which acquired France-based Dreem last year, another 510(k) clearance. The latest is for SleepStageML, an algorithm that appears to use polysomnograph and EEG data to determine sleep stage. No summary document yet so details are thin.
- News you know: Ten days ago the FDA announced that it had cleared Dexcom’s Stelo as the first over-the-counter continuous glucose monitor. Dexcom says it plans to launch the device in the US this summer and its focus initially seems to be on people who have Type 2 diabetes but who are not on insulin. An investor presentation made clear that Dexcom also plans to market Stelo to people with pre-diabetes and gestational diabetes. It also listed potential in patient monitoring and more general health and wellness applications — like its DTC partner Levels.
- Finally… this week the FDA’s CBER, CDER, CDRH, and OCP published a very short paper outlining how they are working together to regulate AI in medical products. It includes a list of relevant guidance documents the agency plans to publish this year and more. Quick read and worth a skim here.
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Better Therapeutics is the latest prescription digital therapeutics company to fail
The last remaining publicly-listed prescription digital therapeutics company is shutting down. Better Therapeutics decided Wednesday night to voluntarily de-list its stock from Nasdaq, terminate its employees, and “explore strategic alternatives, including assignment for the benefit of creditors and/or a wind-down of the Company.”
Better’s board and CEO resigned this week and its remaining executives were terminated. An accountant in Massachusetts was appointed as the new CEO to help manage the company’s end stage.
Last month, Better announced that the FDA had granted its prescription digital therapeutic for advanced liver disease Breakthrough Device Designation. Better’s flagship offering, however, was AspyreRx, a cognitive behavioral therapy prescription digital therapeutic for Type 2 diabetes. The company received a De Novo clearance for AspyreDx in July 2023, but failed to gain commercial traction in the seven months since then.
The company’s three-year growth plan is laid out in the slide above — taken from its recent investor presentation.
Trials: Alivecor’s 12 lead, Click-BI updates, GAIA
This is a recurring feature of E&O SaMD that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues.
Complete: Alivecor’s FDA study for its next device Kardia 12L
I’d expect Alivecor to submit a 12-lead version of its Kardia ECG device to the FDA some time soon. Its 221-person study just finished up. More:
“The purpose of this study is to collect clinical validation data to support an FDA submission for a 510(k) for the Kardia 12L hardware which enables the simultaneous diagnostic quality recording of all 6 limb leads and any chest lead. We will be recording both Leads V2 and V4 in a sequential fashion along with the Limb leads and a simultaneous 12-lead ECG to validate the hardware and a Deep Neural Network model which expands the 7 leads into a complete 12-lead ECG.”
Delayed: Click Therapeutics and Boehringer Ingelheim add a year to study on two digital therapeutics for schizophrenia
Click and BI were set to complete this study in June 2024 but have pushed back the end date to July 2025. The trial is still recruiting the 432 anticipated participants too. More:
“This study evaluates the efficacy of two prescription digital therapeutics (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.”
Completed (early): Click and BI’s study of an abbreviated version of its PDT for schizophrenia finished up a little early
This study was set to finish in March but ended up being done in February. More on the 53-person study here:
“The purpose of the proposed study is to evaluate the overall effects of use of an abbreviated version of CT-156 (the Study App) in participants aged 18 years or older with schizophrenia.”
Delayed: Click also added another six months to its study on two digital therapeutics for the prevention of migraine
This one was originally set to finish October 2023 but is now set to end May 2024. 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.”
Almost complete: Click’s exploratory study on a digital intervention to disrupt scratching in atopic dermatitis and psoriasis is set to finish this week
Click managed to recruit the 120 anticipated participants in this study, which is set to finish on March 18th. More on the study here.
Now recruiting: Woebot study on potency and precision of its LLM-based therapy bot
Woebot hopes to recruit about 200 participants for this study. 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. Eligible participants will be assigned to use DISC-MA, in which Woebot selects from a list of responses based on natural language processing.”
Now recruiting: Gaia’s study on Attexis, a digital therapeutic for adult ADHD
More:
“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.”
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