Issue 112
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.
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.
Here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:
- Correction: Last Friday in my breakdown of who owns how much of Pear Therapeutics I missed a nuance in one of the company’s tables. Some of the individuals named as individual shareholders of Pear were actually just named as the individuals representing their respective VC firms. So, the 9.6 percent of Pear (pre-SPAC merger) attributed to Zack Lynch includes his firm’s 9.4 percent stake in the company (not his personal stake). The same is true for Andrew Schwab of 5AM Ventures (the firm owned 16.5 percent of Pear) and Timothy Petersen of Arboretum Ventures (the firm owned 9.7 percent). As always, I regret the error (and much else).
- Speaking of Pear: The company just published a “real-world retrospective analysis” that found a “reduction in medical costs of -$2,385 per patient over 6 months in patients who engaged with reSET-O1. In comparison, patients who did not redeem/engage with reSET-O beyond week 1 had a net cost increase of $353.80 per patient during the same time period.”
- One more Pear-related item. I’ve long heard that one of Pear’s biggest backers, Temasek Ventures, would not invest in other digital therapeutics until it saw more traction (or an exit) from Pear. That was my first thought when I saw that Woebot’s recent $90 million funding round was co-led by two Pear backers, Temasek and JAZZ. Curious that news broke around the same time as Pear’s SPAC merger.
- In other funding news: Prescription digital therapeutics company MedRhythms raised a $25 million Series B led by Morningside Ventures and Advantage Capital. Morningside has also invested in two other PDT companies — Cognoa and Cognito Therapeutics — as well as Big Health.
- The FDA has given Biofourmis’ BiovitalsHF, a heart failure-focused digital therapeutic, Breakthrough Device designation: “BiovitalsHF is a software medical application that augments guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy.”
- LifeSignals secured FDA clearance of its single-use, multi-parameter remote monitoring patch “that records Electrocardiography (2-channel ECG), Heart Rate, Respiration Rate, Skin Temperature and Body Posture data for up to five days.”
- One more thing… This week at an Alzheimer’s Association event, Winterlight and Genentech presented findings from their research: “The Winterlight and Genentech teams collaborated by analyzing audio recordings of participants completing the Clinical Dementia Rating Scale (CDR). They examined how both the acoustic and linguistic content of participants’ responses related to overall disease severity. Initial results showed significant associations between the structure and complexity of language and multiple measures of cognitive decline.”
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Still more CPT remote therapeutic billing codes
The list of potential CPT codes up for discussion at the AMA’s CPT Editorial Meeting in September includes a few that seem inspired by the recent CMS decision to reimburse the recently adopted remote therapeutic monitoring (RTM) codes. (Issue 110 has a good recap of RTM if you need to catch up.) Some of the potential CPT codes outlined below are likely to be merged with each other or withdrawn before the official meeting in September. Still, it’s interesting to see how many of these are related to the RTM codes.
Here’s a quick rundown of eight that jumped out at me:
- Digital Behavioral Therapy Management – “Establish code 99XX0 in the Evaluation and Management section to report digital behavioral therapy management using an online cognitive behavioral program”
- Cat III – Digital Behavioral Health Interventions – “Establish code 0X98T to report digital behavioral health interventions via a multiple function digital device”
- Cognitive Behavioral Therapy Monitoring – “Establish code 989X6 to report remote therapeutic monitoring to monitor cognitive behavioral therapy; and delete codes 0X47T, 0X81T”
- Cat III – Digital Pain Management Therapy – “Establish code 0X99T to report augmented reality mobile application for rehabilitative pain control”
- Cat III – Automated Cognitive Health Assessment – “Establish code 0X93T to report automated cognitive health assessment”
- Cat III – Health and Well-Being Coaching Guideline Revision – “Revise the introductory guidelines language for Health and Well-Being Coaching”
- Cat III – Remote Therapeutic Activity Measurement – “Establish codes 0X06T, 0X07T to report remote therapeutic dynamic activities”
- Cat III – Virtual Reality (VR) Procedural Disassociation and Distraction – “Establish codes 0X08T, 0X09T to report virtual reality procedural disassociation and distraction”
Here’s the AMA’s agenda for the September meeting if you’d like to comment on these codes and the dozens of others under consideration.
Clinical trials that finished up recently: AstraZeneca AMAZE, Kaia COPD, and Click’s FACE STRESS
AstraZeneca completes its AMAZE asthma study
AstraZeneca completed its AMAZE Asthma Implementation Quality Improvement Study this week. Here’s a reminder as to what it was about:
“AstraZeneca has developed the AMAZE disease management platform to be used across multiple disease indications to provide a unified experience for the management of patients throughout their patient care journey. AMAZE integrates multiple systems, including a patient mobile application where patients can enter daily symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials. Implementation of AMAZE within clinical practice has not yet been evaluated. The results from this study will be used to inform any changes or modifications that need to be made to the technology platform, its implementation process, and explore impact on clinical outcomes.”
Click Therapeutics completes FACE STRESS study
Click recently finished up a study:
“to evaluate feasibility and acceptability of an Ecological Momentary Assessment (EMA) compared with an EMA plus automated text message intervention for stress management in participants with higher-than-average perceived stress conducted in a remote setting.”
“Intervention includes 3 weeks of EMA (2 daily surveys per day delivered during waking hours to evaluate momentary affects) plus 2 weeks of automated text messages delivered twice a day, which content follows constructs from The Transactional Model of Stress and Coping.”
The company ticked the box that this intervention is an FDA-regulated device.
Kaia Health completes smartphone maintenance program for COPD study
Kaia finished up its study of its COPD app in combo with activity monitoring with 104 COPD patients who just finished pulmonary rehabilitation:
“Increasing Physical activity (PA) is considered to be an important factor in an efficient management of the chronic obstructive pulmonary disease (COPD). The successful methods required to achieve improvements in PA following Pulmonary Rehabilitation (PR), however are sparsely reported. Therefore, the investigators conduct this trial to evaluate the effectiveness of using a COPD management program delivered to the patient through a mobile medical application Kaia COPD-App, after the completion of a PR.”
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