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Welcome to E&O.
Last week’s newsletter had a glass-is-more-than-half-full 55 percent open rate. Here’s what’s happening this week:
- I spent most of Thursday just outside of Washington DC at a workshop convened by IEEE and US Pharmacopeia focused on thinking through standards for smart pills — sometimes called digital pills, signaling pills, or as FDA-savvy lawyers call them, ingestible event markers. A few initial thoughts and findings from that below.
- This slide deck and these presentation notes from Princeton University computer science professor Arvind Narayanan make for a great primer on how to cut through AI hype. It’s not healthcare-specific but references some medical use cases. He breaks down AI claims into the genuine, the far from perfect but improving, and the dubious.
- You probably read this already, but just in case: Don’t miss this profile of Ginger from MIT’s Sloan business school site. The write-up digs into the mental health company’s pivot from — what we’d call a digital therapeutic today — to a virtual provider of mental health services. How many current DTx companies will go that route in the next five years?
- San Francisco-based Omada Health plans to open an office in Atlanta after considering 25 cities around the country.
- At the American Heart Association event this week a cardiologist from Cleveland Clinic gave a presentation about how he helped an AFib patient restart on a direct oral anticoagulant (DOAC) after reviewing EKG readings from an AliveCor device. One cardiac electrophysiologist on Twitter wondered if this bolsters the case for a single-dose, pill-in-the-pocket DOAC treatment protocol for some lower-risk AFib patients informed by AliveCor devices.
- Pennsylvania-based health insurer Highmark Health is evaluating Moving Analytics‘ home-based cardiac rehab program. Patients discharged from the Allegheny Health Network with heart conditions requiring rehab will be offered the program. The evaluation will conclude in April 2021.
- The Icahn School of Medicine at Mount Sinai published results of a small study (58 patients) that used its Rx.Universe app prescription platform to distribute digital health tools, including its digital therapeutic for heart failure, HealthPROMISE. More here.
- Finally, Google Health offered up not one, but two, videos on YouTube this week, to help explain what exactly Google is doing with your health records.
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Smart pills and standards.
I spent most of Thursday at a workshop put on by IEEE (the international standards group that brought you the 802.11 WiFi standard, among others) and USP (the non-profit, 200-year-old private organization that helps the FDA regulate drug products, among other things).
The discussion centered on whether smart pills, like the ones from Proteus Digital Health and EtectRX, might benefit from some standardization, and, if so, which parts of smart pill systems should be standardized.
The general consensus among some of the speakers after the first day was that the communication protocol used to send data from the ingested device to some kind of reader is the most obvious place to start.
(A quick aside… According to one of the smart pill engineers at the event, the number one challenge facing smart pills in the near future: convincing the public that an ingestible sensor that uses your body as a conductor, won’t actually shock you.)
EtectRx and its executive team featured prominently in the day’s discussions. While Proteus was referenced in almost every presentation, no one from the company took the podium or sat on-stage.
This standards process looks to be one way that EtectRx, which started in 2009 but was re-capitalized and reborn just a few years ago, hopes to differentiate itself from Proteus — a longtime digital health unicorn that got started at the turn of the century in 2001.
Both Proteus and EtectRx have developed smart pills that send signals from inside the patient’s body when they come into contact with gastric fluids in the stomach. In their current configurations, however, where that signal goes differs.
Proteus sends its ingestible sensor signal through the patient’s body (which is the conductor) to a patch worn on the patient’s abdomen. This patch collects other biometrics as needed and relays the ingestion signal along with other biometric data to the patient’s smartphone.
Instead of a peel-and-stick patch, EtectRx currently has the patient wear a receiver around their neck, but the company hopes to send that signal to a variety of devices in the future. That’s why it wants to standardize smart pills’ communication protocol.
If the IEEE and USP can work with the industry to create a standard here then companies like EtectRx could send that signal to an Apple Watch, Google Home Assistant, or directly to a smartphone. (Assuming, and this is a big assumption, those device makers are willing to update their hardware to support this new standard too.)
Proteus, of course, could take advantage of such a standard too, but it has invested resources into the peel-and-stick sensor, which positions Proteus as much more than an ingestible event marker in the longterm. Etect likely would be happy to rid its system of the neck-worn device altogether and just use the consumer electronics people already have.
EtectRx submitted its smart pill system, called ID-Cap, to the FDA in October 2018 and is still hoping to lock down a clearance before 2019 comes to a close. Compared to Proteus, Etect is tiny — it has around 10 employees. Still, with studies underway at Brigham and Women’s in Boston and a hoped-for 510(k) clearance any day now, the company is looking to break out in 2020.
Proteus, meanwhile, has had a challenging year. According to LinkedIn data, the company peaked at 426 employees in May 2019 and today — six months later — it’s down to 367. (LinkedIn numbers can be squishy for headcounts since they often include board members, investors, etc. but, directionally, you can see the trend.)
Thoughts on digital pills, standards, or Proteus and EtectRx’s prospects? Send them my way.
Novartis eyes new digital therapeutics, diagnostics for heart failure with Biofourmis, Precordior deals
Novartis inked two related partnership deals in recent days, both focused on heart failure.
Novartis partnered with Biofourmis for a commercial rollout of a digital therapeutics program for heart failure patients in Southeast Asia. If it goes well, it could lead to global deployment, according to Biofourmis:
“Biofourmis … announced today it has been selected by Novartis, a global healthcare company, to collaborate on a commercial project for managing patients with heart failure (HF) beginning in Southeast Asia, with potential plans to expand globally. The goal of the program is to improve clinical outcomes by using Biofourmis’ lead product BiovitalsHF, which captures data from wearable biosensors and leverages the FDA-cleared Biovitals Analytics Engine to identify early signs of HF exacerbations to enable early interventions in patients with HF with reduced ejection fraction.”
On the same day, Biofourmis announced its first acquisition: Biovotion.
“Biofourmis … announced today it has reached an agreement to acquire Zürich, Switzerland-based Biovotion AG, a leading developer of a cutting-edge clinical-grade wearable biosensor platform. The acquisition includes all of Biovotion’s assets, including the market-leading Everion biosensor and more than 60 global patents covering most of the wearable and sensor technology that exists for the arm or hand.”
At the end of the week, Novartis added another digital health partner focused on heart failure patients: Finland-based Precordior.
“Novartis has entered global collaboration agreement with the Finnish startup Precordior. The goal of the collaboration with Precordior is to further develop and deploy technology that detects symptoms of heart disease using a smartphone.”
Precordior instructs users to lay a smartphone with their software on it on their chest. The company claims its software can detect symptoms of heart failure based on subtle movements of the person’s chest. It already has an ECG app called CardioSignal.
“Precordior’s application uses sensors found on most modern smartphones. When the smartphone is set to the chest, it measures heart movement. The collected data is analyzed in the cloud using methods that utilize machine learning. The global collaboration can promote the use and export of Precordior’s technology and help those suffering from heart disease to recognize their symptoms and receive timely treatment.”
Astellas Pharma pays Welldoc $15M upfront to bring Bluestar to Japan
Welldoc inked its first pharma partnership in years: Astellas Pharma has tapped the pioneering digital health company to bring Bluestar (for diabetes) to Japan. The two companies will also co-develop digital therapeutics for other medical conditions and more. The agreement includes $15 million upfront to Welldoc as well as development and commercial milestones plus royalties on future product sales:
“Astellas Pharma … and Welldoc … today announced that the companies have entered into a collaboration and license agreement directed toward the development and commercialization of digital health solutions. Under the agreement, Astellas and Welldoc will jointly develop and commercialize BlueStar in Japan and certain other Asian markets for patients with diabetes, collaborate to broaden the adoption of BlueStar in the U.S. market, and jointly develop and commercialize digital therapeutics in other therapeutic areas globally.”
Quick links to E&O research reports
Previous newsletter editions are available on the E&O website so that newer subscribers can browse through past issues.
The links below aim to make it easier for paying subscribers to find the long-form research reports on the E&O site:
The Google Health Report (Subscribers-only Link)
The Pear Therapeutics Report (Subscribers-only Link)
The AliveCor Report (Subscribers-only Link)
Apple’s Healthcare Work Experience (Subscribers-only Link)
Approximating Livongo’s S-1 (Subscribers-only Link)
So long Issue 029 of Exits & Outcomes.