Issue 160
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’s what’s going on in FDA-regulated and pharma-focused digital health:
- Pear pares back: In early June I emailed Pear Therapeutics about a tip I’d received that the company was in the process of a big round of lay-offs. At the time the company said it did not comment on rumors. This week Pear announced that it would “reduce its workforce due to the macroeconomic environment… by approximately 25 employees, which represents approximately 9% of full-time employees.” That’s a much smaller number of employees than the tipster told me back in June. Pear says the lay-offs and other cost reduction measures will help it “reduce operating expenses by approximately $28.0 million over the next 18 months.”
- Out of stealth: E&O readers first heard about Oui Therapeutics back in December (Issue 129) when I started digging into the company’s clinical trials, but the prescription digital therapeutics company came out of stealth this week with an in-depth article over at STAT (sub. req.) During its three years in stealth mode, Oui has raised $26 million from investors including CVS, First Round, Otsuka, Flare, Polaris, and Athyrium. Oui’s pipeline of prescription digital therapeutic (PDTs) candidates includes at least three so far. These first three PDTs focus on preventing suicide attempts in adults, teens, and active military personnel. The company also has plans to develop software tools for providers. More background here.
- NightWare, makers of an FDA-cleared prescription digital therapeutic for nightmare disorder and nightmares caused by PTSD, appears to be raising a new round of funding. A recent SEC filing shows it has raised $700,000 out of a hoped-for $4.5 million so far.
- Big launch news this week goes to AmerisourceBergen, which announced plans for its own digital therapeutics distribution platform, called DTx Connect. Mahana, Cognoa, and Videra Health are signed up to help seed the platform. Importantly, AmerisourceBergen refers to the launch as a “pilot”. Here’s the two-sentence pitch: “A fully integrated ordering, dispensing, and fulfillment platform that aims to facilitate patient access to physician-ordered digital therapeutics and diagnostics. The platform, which seamlessly integrates with electronic medical records (EMR), enables physicians to easily access and order prescription and non-prescription DTx through their e-prescribing workflow and subsequently monitor patient fulfillment.”
- The news you know: Minutes after I finished last week’s Friday edition of E&O, news broke that Verily had secured 510(k) clearance for a version of its Study Watch that incorporated iRhythm’s Zio technology. The new device is officially named: “Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor” but the companies just call it the Zio Watch. It should be commercially available in 2023. “The Zio Watch is a sensor-based device worn on the wrist for non-invasive, clinical grade, long-term continuous monitoring for AFib … a FDA-cleared prescription-based wrist-worn solution that can detect irregular rhythms indicative of AFib and with the ZEUS System can characterize the amount of AFib over time, thus aiding a clinician in diagnosis.”
- Meanwhile, the FDA has issued a 510(k) clearance to MedWand for its physiological remote patient monitor device, but the clearance excludes arrhythmia detection and alarms features. “MedWand combines multiple clinically accurate vitals sensors with a multi-purpose Ultra-HD resolution camera into one, handheld, lightweight device. Data collected can include core temperature, blood oxygen saturation, and pulse rate, heart, lung and abdominal auscultations, electrocardiogram*, and high definition otoscopic, oropharynx, and dermatoscopic exam images. Through approved 3rd party Bluetooth peripherals, the MedWand Mobile and Remote Clinics can also seamlessly capture blood pressure, glucometer, spirometry, and weight data.” The device plus a companion Android tablet and software runs about $2,500.
- The FDA hosted a one-day virtual summit this week to sharpen its regulatory approach to computer-aided skin lesion analyzers, which include future smartphone apps that use machine learning to diagnose or detect skin cancer. I tuned into parts of the 8-hour discussion, which reminded me at times of the agency’s approach to Apple’s ECG App. “The imaging modality may be a smart-phone camera or a high-tech imaging device and involve artificial-intelligence and machine learning (AI/ML) based algorithms that analyze images, detect abnormalities, classify lesion types, or assess lesion risks of malignancy. The algorithm may either be built-into the imaging device, or a stand-alone software device also known as software as a medical device (SaMD). The proposed intended user for [skin lesion analyzer] devices being developed may be a lay person, non-dermatologist healthcare provider, or dermatologist.” The American Society for Dermatologic Surgery Association (ASDSA) was one of the few interested parties to issue a comment that, predictably, affirmed that this technology should only ever be in the hands of dermatologists… “they should be required to include detailed disclaimers that include that they are for entertainment and educational purposes and not a diagnostic device, that they are not approved by dermatologists or a recognized medical regulatory authority for self-diagnosis, that an in-person skin examination by a board-certified dermatologist is the gold standard for lesion assessment, and that anyone concerned about a suspicious mole or lesion should contact the office of a local board-certified dermatologist to schedule a skin examination.”
- One more thing… Mymee, which provides digital interventions and support tools for people with autoimmune diseases like multiple sclerosis, lupus, Sjögren’s syndrome and rheumatoid arthritis, acquired Breakthrough Health, developer of a top app (named Emilyn) for people with multiple sclerosis. The companies did not disclose any financial details. Emilyn boasts 50,000 users around the world.
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Clinical trial updates from Sidekick Health, Lumos Labs, Stanford, US Military, Nanowear
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others E&O mentioned in previous issues.
Now recruiting: Sidekick Health’s breast cancer digital therapeutic study
Sidekick’s breast cancer digital intervention study is now recruiting about 66 participants (this is one of the few Sidekick studies that does not disclose a pharma partner):
“Sidekick Health has developed an interactive digital therapeutic program (SK-421) specifically designed for reducing side effects in breast cancer patients. The study will be a single-center pilot study with an intervention group and a comparison group recruiting 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal therapy according to standard breast cancer treatment. The 14-week pilot study will determine whether the interactive digital therapeutic program, supporting lifestyle changes, can positively impact management of side effects, quality of life, physical activity and fitness and medication adherence in this patient population.”
Now recruiting: Military’s mild traumatic brain injury-focused cognitive behavioral therapy study
Here’s the brief summary of the study sponsored by the Henry M. Jackson Foundation for the Advancement of Military Medicine:
“The Center for Neuroscience and Regenerative Medicine (CNRM) Clinical Trials Unit has developed the first cognitive-behavioral therapy (CBT) digital therapeutic (DTx) mobile application to counteract depressive symptoms in military service members and veterans with a history of mild traumatic brain injury (mTBI). This trial will assess the efficacy of the novel CBT-DTx for depression following mTBI compared to an educational comparison DTx.”
Stanford’s 800-person digital health-powered blood pressure study
One to keep an eye on as it is cryptic right now: This study is brand new and incredibly sparse on details but it is aiming for 800 participants, using undisclosed “mobile health” technology and employing a stepped wedge cluster to randomize. The intervention is described like this:
“Mobile health technology using physician-directed, semi-automated management of hypertension.”
Now recruiting: Nanowear to study its FDA-cleared wearable monitor with people with prehypertension, hypertension, no existing conditions, as well as people on dialysis
Here’s a brief summary of the study, which is now recruiting:
“The present study will investigate a set of biomedical sensors with a wireless data communication system and evaluate the sensors’ recording quality. The sensors and wearable wireless system have been approved by Food and Drug Administration (FDA) for recording Electrocardiography (ECG), Trans Thoracic Impedance (TTI), Heart Sounds and Acitigraphy. The sensors and wireless system will be used along with conventional sensor systems (as intended to be used).”
Lumosity-maker Lumos Labs is back and trying to prove safety and efficacy of its game-based treatment for ADHD
I first covered this back in April when the study first surfaced, but now Lumos Labs study is recruiting 472 participants. Curiously, the intervention is not listed as an FDA-regulated device, but the objective of the study sure makes it seem like that’s the aim here, right? Akili clearly has a lead on Lumos, which had to pay the FTC $2 million in fines for health claims it made about its “brain training” games back in 2016. Not many details on this study’s page, but it is using the same measure of attention, TOVA, that Akili used in its studies. Here is a brief description:
“The objective of this study is to assess the safety and effectiveness of an at-home, game-based digital therapy for treating adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD).”
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