Issue 120
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 going on this week in FDA-regulated and pharma-related digital health:
- Last Friday’s item about Premera’s medical policy focused on prescription digital therapeutics led to a few interesting emails and calls with readers this past week. One thing I meant to mention was that it was notable (and a bit odd) that Premera went out of its way to create a medical policy about PDTs as a category instead of listing them each as “investigational” therapeutics within the medical policies for their respective therapeutic areas. Any theories as to why they decided to publish the document?
- After a reader asked, I took a look at the E&O Digital Health Public Company Executive Compensation Tracker to come up with a rough calculation of the compensation gap that exists between the women and men listed in the database. Of the 81 executives E&O tracks, 18 are women — about 22 percent. The average total annual compensation for women on the list comes to a little more than $2.5 million. For the 63 men in the tracker, the average total annual compensation comes to a little more than $23.1 million. So, the digital health executive compensation gap between men and women is more than $20 million right now.
- Happify published a little more of the backstory on how it made the decision to pursue prescription digital therapeutics after growing its DTC business to millions of users. Worthwhile post here. Here’s a snippet: “Years ago when Happify first started investors told us that you only know software works after it’s been tested on hundreds of thousands of people. A major strength of Happify Health compared to other PDT companies is that by initially focusing on the DTC market, we were able to test our products with millions of users in real-world settings, as opposed to a few hundred people in tightly controlled RCTs. Limited use makes it tough to know whether or not a product will deliver a user experience resulting in clinical benefit in the real world.”
- The FDA granted 510(k) clearance to BreatheSuite for its “inhaler add-on and mobile application are used to track and train proper inhaler use for chronic obstructive pulmonary disease (COPD) and asthma.” With the clearance under their belt, BreatheSuite seems poised to take advantage of the forthcoming respiratory-specific RTM billing codes.
- Afraid you missed your PDT company’s SPAC exit window? Fear not. A new SPAC with a particular interest in prescription digital therapeutics just filed its S-1. “Once a digital therapeutic earns regulatory approval (by FDA, EMA, etc.), healthcare providers can prescribe the digital therapeutic and insurance billing dynamics are established. Digital therapeutics benefit from an important dynamic: the capital associated with bringing a digital therapeutic to market is lower than traditional therapeutics (given that physical manufacturing facilities are not needed), while the market potential is large.” The passive voice of “insurance billing dynamics are established” really got me.
- One more thing… Denmark’s Brain+ is set to IPO on a public market in its home country. Brain+ is developing a DTx that treats and detects cognitive decline in Alzheimer’s disease and dementia. It put together a lengthy investment memo that digs into its business and the wider digital therapeutics market. The memo also reveals that the company’s only revenue to date comes from “licensing its current, unregulated, product to a number of municipalities and health care providers in Denmark. Turnover from this activity was DKK 293,000 [about $46,000 USD] in the six months to 30 June 2021 and DKK 36,000 [$5,600 USD] in the year 2020.” Read the full memo here.
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WSJ’s Apple-Biogen scoop and ResearchKit as Apple’s regulatory pipeline
The news you know: The Wall Street Journal ran a great piece this week on some of Apple’s healthcare projects. The WSJ pointed to two research studies Apple has undertaken with UCLA and Biogen that may lead to future, FDA-regulated SaMD running on Apple’s devices.
Detect mild cognitive impairment:
“Biogen is collaborating on the study because it hopes it can help Apple develop an iPhone feature to detect mild cognitive impairment early and encourage relevant users to seek care earlier, according to a person familiar with the matter. The company will compare the data against standard tests of brain health including traditional cognitive assessments and scans that track plaque buildup in the brain, according to the documents and the person familiar with the work.”
Passively detect mental health conditions:
“UCLA researchers will track data from the iPhone’s video camera, keyboard and audio sensors, and data from the watch related to movement, vital signs and sleep… Each bit of data could give researchers clues about device users’ emotions, concentration, energy level, state of mind and more… If the research finds that any of that data correlates with relevant mental-health conditions, the hope is to turn those signals into an app or feature that could warn people they might be at risk and prompt them to seek care.”
ResearchKit is Apple’s regulatory pipeline: This reminds me of something Apple’s VP of Software Technology Bud Tribble, MD, PhD told me six years ago — way back in 2015:
“One way to think about ResearchKit is as the beginning of a pipeline that will lead to more apps that are screening, diagnostic, management and treatment apps. In fact, it is a necessary, essential first step to figure out what is needed to develop these apps — what works and what doesn’t — before you move into, ultimately, clinical study apps and clearance to use them for diagnosis and treatment.”
Remember, he said that in 2015. So, Tribble told me that before Apple had secured its own FDA De Novos. It was a bit cryptic at the time. As a firm believer that Apple would never deign to go through the 510(k) process itself (I did not anticipate that Apple would find ways to bend the process to its own will), back then I assumed that Tribble was describing ResearchKit as a regulatory pipeline for its partners.
Turns out Apple’s research partners — like UCLA and Biogen — are helping Apple develop FDA-regulated, quasi-diagnostic medical apps — not just the other way around.
Trial updates: AliveCor’s Kardia 12L, Altoida adds PD, Sanofi-Pack Health’s relapsed MM study
Here’s E&O’s weekly roundup of changes and additions to clinical trials focused on FDA-regulated digital health devices and other pharma-related digital health.
AliveCor’s new devices Kardia 6L and Kardia 12L
AliveCor has a lot going on right now as it diversifies its revenue streams, but it’s also still iterating its core device business. Here’s a scoop from a new clinical trial posting:
“Recently, AliveCor developed two new devices: Kardia 12L and Kardia 6L to record 12- lead and 6-lead ECGs, respectively. However, the data generated from the two new devices have not yet been validated for accuracy. The purpose of this study is to evaluate the accuracy of the ECGs recorded by AliveCor Kardia 12L and 6L devices. This will be compared to simultaneous standard of-care 12-lead ECG recordings. The ECGs will be analyzed for accuracy and statistical difference using root-mean-square error and cross-correlation between the median beats.”
This study is to support AliveCor’s FDA submission for Kardia 12L:
“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. The 12-lead ECG used for validation of the recordings and the 12-lead synthesis model is the GE Cardiosoft System which is FDA cleared.”
Altoida adds Parkinson’s to its Alzheimer’s study
This week Altoida made some changes to its big study, “Precision Medicine Initiative Against Alzheimer’s Disease (PMIAAD): Digitally-enhanced, Decentralized, Multi-omics, Observational Cohort.” Most notably, the Altoida study now includes a focus on Parkinson’s.
“…at the decentralized and remote assessment of the symptoms of preclinical stages in Alzheimer’s disease and movement disorders, e.g. Parkinson’s. For this study we are looking for participants aged over 45 without cognitive complaints or with subjective perception of cognitive decline or with mild cognitive complaints.” “Specific aims for the proposed study: a) to develop novel sensitive measures that can provide an early identification of those SCD and MCI individuals harboring AD pathology that are at high risk of cognitive worsening over time; b) to track pre-motor stages in Parkinson’s disease and trials that enable active digital functional biomarkers; c) to track disease progression during pre-dementia and pre-motor stages in clinical practice and trials with measures that enable to capture subtle changes.”
Sanofi, Pack Health, and Fitbit study on Multiple Myeloma
The title of this Sanofi-Pack-Fitbit study gets to most of the details: “Clinical and Patient Reported Outcomes for Individuals With Relapsed/Refractory Multiple Myeloma Treated With Isatuximab: Real-World Insights From Patient Reported, Wearable, and Qualitative Data in the Context of Digital Health Coaching.” 50 participants — all patients treated with Sanofi’s Isatuximab — will receive three months of digital coaching from Pack Health, powered in part by data from a wrist-worn Fitbit device.
Small change: Happify pushed back its Happify Teens study and it is now expected to finish up in February 2022, not November 2021.
Johns Hopkins study to compare cost and effectiveness of an automated DPP from Sweetch to a human-led program
This study hopes to include about 268 participants. Half will be enrolled into an in-person diabetes prevention program near them while the rest will receive a starter kit in the mail from Sweetch for its digital DPP. The kit includes a smartphone app and a Bluetooth-enabled weight scale.
“There will be a total of 3 study visits (baseline, 6 months, and 12 months), each visit includes fingerstick hemoglobin A1C measurement, weight measurement, and completion of several questionnaires. Height will be measured at the first visit. Throughout the 12-month study, participants will be asked to wear a device on the participants’ wrist to measure physical activity for 7 consecutive days following the first visit and once every month thereafter.”
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