Issue 148
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:
- The biggest prescription digital therapeutic news this week goes to Biogen and MedRhythms. The companies revealed details of their licensing agreement, which includes $3 million upfront and upwards of $117.5 million in potential milestone payments in the year ahead. Finally, “MedRhythms is also eligible to receive tiered royalties in the high-single digits to low-teens on potential global sales.” The deal is for just one of MedRhythms’ PDT candidates: “MR-004 is MedRhythms’ pipeline candidate in MS, which aims to improve gait and gait-related aspects of movement, potentially providing [Multiple Sclerosis] patients with improved independence related to mobility. If approved, MR-004 has the potential to become the first prescription digital therapeutic for gait deficit in MS.”
- Japan’s CureApp announced that it received word last month from that country’s medical device regulator that its hypertension treatment app has secured approval. CureApp says its app is the first standalone app to receive market authorization as a medical device in Japan. It aims to launch in Japan and secure reimbursement for its app by year-end.
- AliveCor quietly secured another 510(k), (which may help power its new KardiaComplete service?) AliveCor QT Service’s IFU: “AliveCor QT Service analyses 30 seconds of a previously acquired electrocardiogram (ECG) from AliveCor designed 6-Lead ambulatory ECG devices analyzed as normal sinus rhythm for QT interval measurements. AliveCor QT Service is intended for use in a professional medical facility, such as a hospital, clinic, or doctor’s office by a qualified health care professional, including trained ECG technician. AliveCor QT Service is indicated for use on adult patients (older than 18 years). The device has not been tested for and is not intended for pediatric use. The service is not intended for use in life supporting, or sustaining systems, or continuous ECG monitors, or cardiac alarm devices, or OTC use only devices.”
- Strados Labs also secured a new 510(k) for its remote electronic stethoscope. The yellow highlights below are the new additions to the device’s IFU: “The Strados Remote Electronic Stethoscope Platform (RESP) is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record, and store lung sounds from adult patients in a healthcare or outpatient setting including transition from healthcare setting to outpatient care without interruption. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.”
- The news you probably know: PBM Prime Therapeutics, which has shown more interest in prescription digital therapeutics than other PBMs, is acquiring Magellan Rx for approximately $1.35 billion. It will be interesting to see if this leads to more formulary inclusions for PDTs already on the market.
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How Pear Therapeutics and Better Therapeutics graded their corporate performances in 2021
Typically, a portion of a company’s executive compensation package is tied to the company’s overall performance. Here’s what changes to executive comp at Better and Pear tell us about the companies’ internal grading of their corporate performance last year.
Pear Therapeutics 2020 & 2021 Executive Compensation 
Better Therapeutics 2020 & 2021 Executive Compensation 
First off, I was a little surprised to see how much higher the compensation is at Better vs. Pear. The column that I’m going to focus on here, however, is “non-equity incentive plan compensation”. Here’s more detail on how Pear Therapeutics awards its execs the amounts in that column:
“We pay cash incentive compensation to reward our executives for their performance over the fiscal year, based on performance goals established by the board of directors. Incentive compensation is determined by the board of directors based on two components: corporate performance and individual performance. Dr. McCann’s bonus is based on 100% corporate performance and 0% individual performance, and Mr. Guiffre’s and Ms. Strandberg’s bonuses are based on 80% corporate performance and 20% individual performance. For the year ended December 31, 2021, the target bonus for Dr. McCann was equal to 50% percent of his base salary, the target bonus for Mr. Guiffre for the year ended December 31, 2021 was 45% percent of his base salary, and the target bonus for Ms. Strandberg for the year ended December 31, 2021 was 45% percent of her base salary.”
Pear gave itself an A- for corporate performance in 2021: So, McCann could have potentially earned a maximum of 50 percent of his 2021 base salary as a bonus, which amounts to $225,000. How much of that he received was wholly dependent on “corporate performance” not his individual performance. McCann earned $202,500 or 90 percent of his potential bonus. That suggests the company’s internal metrics (set by its board) show that Pear performed at a 90/100 for 2021.
Better gave itself a C+ for corporate performance in 2021: Better Therapeutics’ Co-Founder and CEO Kevin Appelbaum received a cash bonus of $707,500 in 2021. Appelbaum received $300,000 as a bonus for SPACing the company. He also received $225,000 as a bonus for his and the company’s performance in 2020 — “the Board determined that such corporate performance and individual objectives were achieved at 100%.” The remaining $182,500 in bonus payments to Appelbaum were based on corporate performance in 2021. “Following the end of the 2021 performance year… the Board determined that such corporate performance was achieved at 79%.”
Clinical trial updates from Woebot, Better Therapeutics, HelpWear, and GAIA
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.
Woebot pivots fully-powered RCT into a feasibility and acceptability trial for its alcohol use disorder and substance use disorder digital therapeutic
A clinical trial that Woebot started up in November has considerably changed its details in the government’s clinical trials [dot] gov site. Here’s the original description:
“This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to an education-only control condition, which has no cognitive behavioral therapy and the content is not delivered through a conversational user interface.”
And the new description that replaced the above:
“Prior to launching a randomized controlled trial, this pilot study will investigate the feasibility and acceptability of the administration of a diagnostic interview and collection of a biomarker test, as well as engagement and preliminary efficacy with W-SUDs and the education arm, among a sample of adults who screen positive for problematic substance use.”
The study posting also overhauled its outcomes measures and went from being a Phase II triple-masked study to a phase-less open-label one. More here.
Better Therapeutics first announced its forthcoming trial with Arizona Liver Health last month, now there are details.
The 20-participant feasibility study kicked off in mid-April and is currently enrolling by invitation:
“The treatment, BT-NCBT-00x, consists of … software as a medical device developed by the study Sponsor, Better Therapeutics. It delivers treatment to participants with cardiometabolic disease, using behavioral therapy that targets individual behaviors related to improving dietary quality and physical activity. The study evaluates the use of this behavioral therapy and its effect on clinical measures such as percent liver fat as measured by MRI-PDFF, and Fibroscan Controlled Attenuation Parameter score, liver stiffness as measured by Fibroscan Vibration Controlled Transient Elastography in kPA, body weight and ALT. Participants in this feasibility study will have access to the treatment for 3- months.”
Canada’s HelpWear is studying its continuous heart monitor HeartWare
This study is now recruiting:
“The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter. The HeartWatch is indicated for extended diagnostic evaluation of patients with transient symptoms of possible cardiac origin such as syncope and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. While the use of the device itself can be managed by both healthcare professionals and patients, interpretation of the collected data for diagnosis is restricted to healthcare professionals, as the data must be loaded and analyzed separately after recording.”
Terminated: GAIA’s web-based CBT (Optimune) for cancer
GAIA has terminated its clinical trial citing the pandemic: “Terminated [Participant recruitment was stopped due to corona pandemic.]”
More details:
“The trial aims to evaluate the effectiveness of a novel web-based intervention (Optimune), which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to women with breast cancer who are past the active eradication phase and free from disease recurrence. The present study will test the hypothesis that Optimune has an impact on immune status, markers of inflammation and psychometric outcomes. Therefore, 150 woman with breast cancer will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment (Care-as-Usual, CAU) and receive access to Optimune after a delay of 6 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives 12-month access to Optimune and may also use CAU. The primary outcome measure is the effect on inflammatory parameters six month post-baseline.”
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