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 happening this week in the world of pharma digital products and FDA-regulated digital health:
- The big digital health pharma deal was AliveCor’s tie-up with AstraZeneca: The two will “research new disease management solutions in cardiovascular, renal, and metabolism (CVRM) therapeutic areas… [and] translate AliveCor’s potassium detection technology and science, which enables potassium measurement outside of blood draws, into real-world disease management applications and solutions.”
- The FDA published a recap of its CDRH accomplishments in 2020, and the first specific highlight it mentioned was Akili’s De Novo clearance. The agency also relayed that it has now deemed more than 400 devices worthy of being a part of its Breakthrough Devices Program. Of those, 25 have secured market authorization to date.
- Dr. Mario Weiss, the CEO and founder of GAIA, announced today that the digital therapeutics company’s depression-focused DTx now has permanent reimbursement in Germany: “Today our antidepressant software therapy deprexis received full reimbursement status in Germany.” He also claimed that GAIA has now has three “permanently reimbursement DTx products in Germany.”
- Meanwhile, the French government announced the 30 initial apps and digital health services that will be included in the health app store and personal health records site it plans to launch for all French citizens. The batch of 30 includes health apps and other offerings from companies including Biogen, Abbott, Doctolib, Withings and more.
- IBM is considering a sale of IBM Watson Health (PE, strategic, or SPAC). According to the Wall Street Journal, the business unit has “roughly $1 billion in annual revenue and isn’t currently profitable.”
- Limbix won an SBIR grant for up to $3.6 million from the National Institute of Mental Health (NIMH): “The grant will support a large-scale pivotal clinical trial conducted in partnership with the Duke Clinical Research Institute to evaluate the efficacy and safety of the company’s flagship product, Limbix Spark, which was developed to treat adolescent depression.”
- (This study is generating a lot of headlines this week, but it was actually announced in September at an Apple event.) Canada’s University Health Network is launching a study “in collaboration with Apple to test if remote monitoring with Apple Watch can help with early identification of worsening heart failure… data collected using an Apple Watch will be compared to data routinely collected from the rigorous physical tests that patients normally undergo, to see if Apple Watch health sensors and features, including the Blood Oxygen app and mobility metrics, can provide early warning for worsening heart failure.”
- Psychedelic therapeutics company MindMed acquired digital health company HealthMode for about $37 million. HealthMode’s founders include Daniel Karlin MD, who is a former exec in Pfizer’s digital medicine group and the former chief medical officer at NightWare.
- If you missed E&O Mondays this week, I reported on a recent and still unannounced $8.7 million funding round for autoimmune-focused digital therapeutics company Mymee as well as a still-unannounced $13 million for cancer-focused DTx company Blue Note Therapeutics.
- UK-based Aktiia announced that its 24/7 wearable blood pressure wearable received CE Mark approval as a Class IIa medical device and is now available for sale in Europe.
- Here’s some speculation based on a job ad: I think Japanese diagnostics and IT company Sysmex has a digital therapeutics project in the works. This blinded job ad from “a global manufacturer for diagnostic equipment and information-management systems” company “is looking for a Project Director for DTx (Digital Therapeutic)” who will be “responsible for leading the development of the company’s new project, [a] Digital Therapeutic business.” (Who knows what they mean by DTx since the term is used so freely these days, but another one I’ll keep an eye on.)
- Joe Powers, who previously kickstarted Headspace’s initial foray into digital therapeutics (more on that below) and most recently founded a new digital therapeutics startup named North Shore Therapeutics, just left to join Otsuka Pharmaceuticals (US) as its new Chief Digital Business Officer. Otsuka is both the recent acquirer of Proteus Digital Health’s assets as well as a partner to Click Therapeutics.
- One more thing… Speaking of Otsuka-Proteus, I took a look and found a recent Facebook and Instagram campaign that the company ran for its ABILIFY MYCITE sensor-embedded drug. The campaign includes four creatives, but the one that caught my eye is a short video with the text (italics from the original): “Tired of seeing other people’s selfies? Try a platform that can help you better know yourself. Digital technology meets medicine with the ABILIFY MYCITE System, helping you keep track of specific health data.”
Did someone forward this newsletter to you? Here’s your next click.
The 2021 HealthXL-E&O Prescription Digital Therapeutics Report
As I mentioned at the end of last year, one of the projects I’ve been chipping away at for the past few months is a comprehensive overview and snapshot of the state of prescription digital therapeutics. I was lucky to have the opportunity to collaborate with HealthXL on this report, which is an update to one they produced back in 2018. You’ll see quite a bit of my reporting from E&O sprinkled in throughout the report, but it also includes a lot of HealthXL‘s data on DTx investments and clinical studies conducted by digital therapeutics companies. It’s also beautifully designed by the HealthXL team with a nod to some of E&O’s style. Figuring out the scope for the report was a challenge, of course. What is a prescription digital therapeutic? We decided to frame it in a way that captured how people talk about the category currently, so we relied on the Digital Therapeutic Alliance’s definition of a digital therapeutic. But to scope out what a prescription digital therapeutic was, we came up with another framework. These were the four buckets of PDTs that we came up with:
- PDT companies with Rx products that are regulated by the FDA as Rx-only.
- PDT companies that are regulated by the FDA as Rx-only, but not because of the digital therapeutic component of their product. (Maybe because of a higher-risk component, like a medical calculator.)
- PDT companies with over-the-counter products (not FDA-regulated as Rx-only products) but are using a prescription (or prescription-like) distribution channel.
- PDT companies that only have over-the-counter products in the market today but are planning an FDA-regulated Rx-only product.
As a paying subscriber to E&O, you have access to the report (PDF) right here. I’m also going to look into the best way to host this on the E&O site, but for now, the link above is your best bet. As always, let me know what you think by hitting reply to this email.
Times up for Headspace Health’s 2020 prediction
Joe Powers, who just joined Otsuka (as noted above), originally helped Headspace move into digital therapeutics back in late 2017 as the founding director of the company’s digital therapeutics-focused subsidiary, Headspace Health.
Headspace, of course, is one of the biggies in DTC meditation apps. It has also moved into selling to employers and other btob channels, but it has yet to deliver on a prescription digital therapeutic.
Do you remember this? Rather famously, Headspace Health told the press in June 2018 that they would have the world’s first prescription meditation app through the FDA in 2020. Here’s Headspace Health’s original positioning from a few years back:
“Headspace Health is pioneering new ways to incorporate the Headspace meditation experience into digital medicine. We are on-track to deliver the world’s first prescription meditation app in 2020 when we anticipate our first product in a portfolio of newly developed, clinically-validated and FDA-cleared meditation programs specifically designed to treat a broad range of stress-related chronic diseases.”
Powers left the company one month after the company made this incredible prediction, and after he left the buzz was that Headspace had shrugged off its plans for prescription digital therapeutics. But six months later in January 2019, the company hired Pablo Pantaleoni as its Headspace Health VP and General Manager to try again. Then in October 2020, seemingly with no FDA-clearances on the horizon, Pantaleoni departed.
And now, of course, it is 2021. Headspace’s self-declared deadline has passed and its digital therapeutics subsidiary no longer mentions “digital therapeutics”. Did it make any progress?
In recent years, Headspace has collaborated on and sponsored clinical trials that tested its mindfulness therapy in patient populations dealing with chronic pain, workplace stress, stress-induced eating, and chronic pelvic pain. While studies focused on workplace stress and related issues are likely helpful as Headspace sells its program to self-insured employers, it seems more likely that the company was targeting a therapeutic area like chronic pain, depression, or anxiety for its prescription digital therapeutic ambitions.
Oddly, I could not find any trials that demonstrated that Headspace had moved beyond its mindfulness offering for a DTx play. Typically, those would include interventions like cognitive behavioral therapy (CBT).
Judging by its job openings over the years, it’s also unlikely that Headspace has brought on any talent that has experience developing FDA-regulated Software as a Medical Device. And while all signs point to Headspace pivoting away from prescription digital therapeutics and refocusing on its DTC and employer channels, the company told me today that it has no plans to shutter its Headspace Health subsidiary:
“Headspace Health is still an active subsidiary and has taken meaningful steps towards building new offerings that will enable Headspace to deliver more therapeutic benefits to our members. Particularly for offerings that require clinical research prior to launch, the path to market can take time, and we’ll share more updates about our roadmap as we’re able to.”
“When we originally launched this subsidiary, we did expect that the product would require FDA clearance. It is possible that this will be relevant in the future, as FDA clearance is based on the risk and safety level of our solution. As we add additional features and expand the breadth of our offering, we are keeping regulatory considerations in mind. Our priority has been to take a human-centered approach to designing evidence-based interventions that our members want to use and provide meaningful clinical benefit. Headspace’s commitment to this direction is unwavering.”
What do you think:
- Will Headspace Health morph into an employer-focused business unit?
- Will a prescription-only Headspace offering ever come to market?
- Will anyone else — ever again — publicly announce a launch date for a pre-FDA prescription digital therapeutic?
Click Therapeutics talks in-licensing interventions vs homegrown
This week on Eugene Borukhovich’s Digital Therapeutics podcast, I asked Click Therapeutics’ CEO David Klein about his company’s R&D strategy.
E&O: One tack that I’ve seen a few prescription digital therapeutics companies use is to license or acquire digital interventions that have already demonstrated some level of evidence via an RCT. Click seems to do its own research, however, and it does not acquire or license these interventions — if I understand your model correctly? Can you walk us through why a company might go either route and maybe mention a few of the benefits or the challenges for choosing either path?
Here’s a snippet of Klein’s response:
“I think, ultimately, our thesis was and is (and perhaps always will be) that the phone is really the modality that we’re currently treating people with. The phone is always on someone. The phone is a center of data collection and the interventions can be personalized based on those data, both from the entire patient population and from the individual patient.” “So, when you look at what’s been happening in this space, I think, to your point, yes, there have been other companies that have essentially, in-licensed what I would regard as pretty old academic technology — web technology — and filed FDA clearance based on those data. What you end up with is a program that was developed a very long time ago and designed specifically for patients to access via a desktop computer. And that’s something that does not harness the power of data and personalization in a mobile phone.”
While I’ve covered much of the other nuances involved here, I hadn’t considered that this strategy likely results in a failure to take advantage of modern — mobile — technology.
Listen to the whole interview with David Klein right here.
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