Issue 184
Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.
E&O Fridays.
Here are recent happenings in FDA-regulated and pharma-focused digital health…
- Quite a few FDA clearances in recent weeks. Here’s a quick rundown on three:
- Biofourmis secured a 510(k) for its Everion+ armband wearable. The new clearance is for a sleeker device that improves upon the one the company acquired via its acquisition of Biovotion a few years back. The new Everion+ includes sensors that can track basic vital signs but the key change is built-in cellular connectivity. Biofourmis CEO and Founder Kuldeep Singh Rajput tells me this device will be used across its various business units and customer groups, but given its improved usability (thanks to not needing a Bluetooth hub or smartphone) it will be especially helpful for older patients who live in rural areas.
- TytoCare received a 510(k) for its lung sounds analyzer software as a medical device. Here’s how the company described it a year ago when the same SaMD got its CE Mark: “The Tyto Lung Sounds Analyzer is a clinical decision support standalone Software as a Medical Device (SaMD) that is intended to inform healthcare professionals about the potential presence of an abnormal breath sound in respiratory recordings that may be wheezing in adults and children.” The algorithm works on data collected by Tyto’s already FDA-cleared electronic stethoscope.
- Abbott received 510(k) clearance for APIs for its Freestyle Libre 2 Flash Glucose Monitor and Freestyle Libre 3 Continuous Glucose Monitors. The only change to the indications for use: “Enables users to share their glucose data with authorized client software. Can communicate iCGM data wirelessly and securely to and from digitally connected devices (client software) through a cloud-based communication method.”
- Germany’s national formulary of reimbursed prescription digital therapeutics (AKA its DiGA program) added a new one in mid-February: My7Steps app, a digital intervention that treats mild or moderate depression. The provisionally listed app costs €470.05.
- Speaking of reimbursement: In Pennsylvania, Geisinger’s health plan just added a coverage policy focused on Prescription Digital Therapeutics to its Medicaid Business Unit’s policies library. It cites the Pennsylvania state Medicaid policy that says Pear Therapeutics’ three PDTs “may be considered for coverage under narrow clinical circumstances through the Program Exception process.” Geisinger goes on to make clear that “Unless otherwise specified, the Plan does NOT provide coverage for Prescription Digital Therapeutics, including but not limited to Freespira, reSET, reSET-o, Insulia, BlueStar, NightWare, CanvasDx, Somryst, d-NAV System, EndeavorRX, and [Mahana] to evaluate, diagnose, manage symptoms, or treat an illness, injury, or disease because this technology considered unproven. The Geisinger Technology Assessment Committee evaluated this technology and concluded that there is insufficient evidence in the peer-reviewed published medical literature to establish the effectiveness of these digital applications on health outcomes when compared to established tests or technologies.”
- Meanwhile, Arkansas’ state senate has been kicking around a bill that would direct the state Medicaid program to pay for Pear’s reSET-O as well as other FDA-cleared prescription digital therapeutics that make use of CBT and contingency management to treat opioid use disorder and other substance use disorders (do any other PDTs besides Pear’s fit the bill?). The bill was going through an economic impact review last week but as of yesterday its status is “inactive”.
- Finally, Wyoming’s state legislature is considering a bill that would add $250,000 to the state budget to fund a pilot of (a digital therapeutic for SUD but it may as well just say Pear’s reSET) for people on parole or on probation.
- Big Departure: Pear Therapeutics’ Chief Commercial Officer Julia Strandberg, who has served as the face of the company at industry events in recent years, is set to depart the company effective March 31, 2023. This past week also saw Pear’s stock price briefly dip below $1 a share for the first time. If any company had an interest in acquiring Pear, it sure seems like the time to do it.
- Efficacy sale, 10 percent off: Mahana Therapeutics made a small but important tweak to the marketing language on its homepage this past week. Its site previously stated that Mahana IBS, a prescription digital therapeutic for irritable bowel syndrome, enabled “3 in 4 patients [to] find relief.” This week the company changed the language so it reads “Nearly 2 in 3 patients find relief.”
- One more thing… This section is already too long, but I have to mention a Cigna medical policy I came across this week. The policy basically states that Cigna will pay for Remote Physiologic Monitoring in some cases but it won’t pay for Remote Therapeutic Monitoring in any cases. “Remote Therapeutic Monitoring (RTM) (CPT codes 98975, 98976, 98977, 98978, 98980, 98981) is considered not medically necessary for ALL indications… There are limited published, peer-reviewed data regarding the effect of RTM on health outcomes. At this time there is insufficient evidence to support improved health outcomes with remote therapeutic monitoring compared to standard of care clinical practice.” The policy takes effect on May 11th.
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Orexo folds digital therapeutics business into pharma unit and eliminates DTx management
A reader tipped me off that Orexo had pulled back from its digital therapeutics business and laid off most of its DTx leadership. Orexo is a Swedish pharmaceutical company that is publicly listed, so I dug into the firm’s year-end report for the company’s explanation.
Despite the consolidation and “decrease” in “senior management positions” the company isn’t positioning the restructuring move as a pullback from digital therapeutics. It namechecks all three of its DTx products in its year-end report and makes no mention of sunsetting any of them. Here’s Orexo CEO and President Nikolaj Sørensen:
“…We have now taken the step to integrate the two businesses into one organization with one manager, Bob DeLuca. With this change the existing US Pharma business will take full responsibility and accountability for driving sales of digital solutions and the resources in the Digital Therapeutics business area will be integrated into the US Pharma. As I will continue to follow up [with] the businesses separately, we will keep our current segment reporting. Expenses for Digital Therapeutics will decrease primarily due to lower costs related to senior management positions. More importantly, the re-organization will increase our agility and ability to prioritize resources across the business in the US to the areas with the greatest opportunities.”
Sørensen also revealed that across Orexo’s three digital therapeutics Modia (opioid use disorder), vorvida (alcohol use disorder), and deprexis (depression), the company has enrolled 4,600 patients via early access commercial programs and clinical trials.
Finally, Orexo gave an updated timeline for Modia’s regulatory next steps:
“With respect to the MODIA, clinical trial recruitment was completed in Q4 at 437 patients in total. The clinical team is now working with sites to complete the study protocol and begin the process for data capture and analysis with an expected FDA 510K filing based on the study results in H2 2023. Pending FDA approval MODIA is marketed under the Emergency Use Authorization pathway granted by the FDA.”
Orexo brought in $38,000 in revenues from its digital therapeutics unit in 2022. That’s down from the $105,000 in DTx revenues from 2021. If you’d like to dig in more, this year-end report from Orexo has all the details.
Trials: Big Health, Oui, Quit Genius, Woebot, MedRhythms, Limbix, Swing, Akili and more.
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.
New: Big Health study indicates it may be submitting Daylight to FDA with generalized anxiety disorder claim
Big Health has noted that it was considering whether to submit Sleepio to the FDA with claims related to treating depression or major depressive disorder. And one RCT, which I write a little bit about more below, indicates that Big may also submit Sleepio for an insomnia treatment claim. Now, a new randomized trial focused on Daylight (although it does not name the intervention specifically) and its ability to treat generalized anxiety disorder (GAD) suggests that Big is eyeing that for a future FDA clearance too. The trial’s detailed summary notes that it is an FDA-regulated device. More:
“This study aims to examine the effectiveness of app-based digital CBT for anxiety compared to psychoeducation in individuals with a diagnosis of Generalized Anxiety Disorder. The primary outcomes are anxiety symptom reduction and remission after 10 weeks.”
Endpoint switch: Oui Therapeutics swaps out Suicide Attempt Self Injury Interview primary outcome measure for Columbia-Suicide Severity Rating Scale and lowers age requirement
Oui Therapeutics swapped out its primary outcomes measure as noted in the title above. It also raised the age inclusion criteria from between 22 and 70 to anyone 18 years or older. More:
“The primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts. This double blind, randomized controlled trial will evaluate effectiveness of two digital interventions among 391 participants. Study participation will start when participants sign consent. Participants and research assessors will be blinded to treatment assignment.”
New: 4YouandMe, Mind Medicine, Cambridge Cognition and others set-up trial to develop anomaly detection approaches to mental health conditions
Here’s an interesting one from former Apple executive Stephen Friend’s 4YouandMe… the 400-person observational study could kick off this month:
“The Investigators hope to know how objective measures from sensor data translate to core symptoms, episodes and flares across mental health disorders, and develop new (or new applications of) machine learning anomaly detection approaches and determine whether anomalies in expected symptom portraits can be reliably detected and enhanced by the addition of objectively measured data.”
New: Quit Genius RCT for alcohol use disorder program
Quit Genius is hoping to recruit 300 participants for this RCT. The company does not plan to seek FDA clearance for the intervention. More:
“This study is a two-arm randomized clinical trial comparing the Quit Genius intervention for alcohol use disorder (QG-A) to usual care (TAU), comprising medical management of alcohol use disorders with pharmacotherapy.”
Done recruiting: Big Health and UCSF’s RCT on Sleepio for insomnia, which could lead to an FDA submission
Big Health managed to recruit 333 participants for its RCT — one more than the 332 it had hoped to recruit. The company also pushed back primary completion from this month until May. More:
“This study aims to examine the effectiveness of a fully-automated web and app-based digital CBT-I for insomnia compared to sleep hygiene education (SHE) in individuals with a diagnosis of insomnia disorder. Primary outcomes of interest include changes in insomnia severity, sleep onset latency, and wake after sleep onset throughout the course of the study.”
Now recruiting: Woebot and Scripps’ RCT on the feasibility of a postpartum-focused digital health tool. More
Completed: Woebot’s feasibility study on its adolescent mental health digital therapeutic vs teletherapy group-based Zoom sessions that included abbreviated versions of cognitive behavioral therapy.
Delayed: MedRhythms and Boston University’s study on a music-based therapy for Parkinson’s is set to finish up in April 2024 instead of April 2023 now. It is still recruiting its 44 participants.
Now enrolling by invitation: Limbix Health’s study on its digital therapeutic for adolescent depressive symptoms in specialty medical care settings, including hematology, oncology and weight management. Limbix also updated its trial listing to make clear this is an FDA-regulated SaMD.
Done recruiting: Swing Therapeutics finished up recruiting for its Phase III study on a digital Acceptance and Commitment Therapy (ACT) intervention for people with fibromyalgia. The company managed to recruit 275 of the anticipated 300.
Completed: Akili finished up its ADHD in adults study this past January. It managed to recruit 233 out of the 325 it originally anticipated.
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