Issue 165
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.
Still quiet here in FDA-regulated and pharma-focused digital health…
- The FDA hasn’t updated its 510(k) database since last Friday’s issue, so no new clearances to report this week.
- Verily, a spin-out of Google/Alphabet that was once a 50-50 joint venture with Sanofi, just raised another $1 billion in a round led by Alphabet. More details (including a new CEO) can be found in the announcement here or read on for a quick excerpt on the company’s plans for the money: “The new capital will be used to support a variety of the company’s core initiatives focused on real world evidence generation, healthcare data platforms, research and care, and the underlying technology that drives this work, which all share the goal of making health care better and more tailored to individuals. The company will also consider further investment in strategic partnerships, global business development and potential acquisitions.”
- When Oui Therapeutics officially came out of stealth over the summer, press reports mentioned a previous startup created by Oui’s founder and CEO Dr. Seth Feuerstein — Cobalt Technologies. Cobalt was a pioneer in digital cognitive behavioral therapy (it launched pre-iPhone) that Magellan ended up acquiring in 2014. Since other reports didn’t get the financial details of the acquisition exactly right, here’s an excerpt from the relevant Magellan SEC filing from back in the day: “As consideration for the transaction, the Company paid a base price of $7.9 million in cash, including net receipts of $0.1 million for working capital adjustments. In addition to the base purchase price, the Cobalt Agreement provides for potential contingent payments up to a maximum aggregate amount of $6.0 million. The potential future payments are contingent upon engagement of new members and new contract execution through June 30, 2017.” So, it was about a $14 million transaction in the end — assuming Cobalt hit their earnout numbers.
- OK… Read on for hints about Apple’s future FDA submissions and details on Akili’s first study focused on pediatric cancer-related cognitive dysfunction.
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Apple points to research studies that may preview future FDA-regulated Apple Watch features
Probably stating the obvious, but: One of the reasons I track clinical trials in this newsletter is that they can serve as a preview of which digital health interventions companies are readying for an FDA submission. Studies can be particularly revealing for a company like Apple that is secretive about its future products — FDA-regulated ones included. A couple of court filings from over the summer might shed light on what to expect from Apple’s FDA submissions in the coming years.
Background: Apple and AliveCor are awaiting a final ruling in a case that could result in a ban on imports of the Apple Watch over (alleged) patent infringement. AliveCor has already won an initial ruling from the International Trade Commission judge presiding over the case, but now it goes to a group of judges at the ITC, which is expected to make a final decision in October.
Would banning the Apple Watch harm public health?
Before the judge made his initial ruling in July, he asked for public comments on how a ban on imports of the Apple Watch might negatively affect (among other things) “public health and welfare” as that is one of the reasons that the ITC may decide to forgo a ban even if it rules that Apple did infringe AliveCor’s IP. Anyway, that’s where these letters from Apple’s collaborators come in: They are intended to help persuade the court that removing the Apple Watch from the market — even temporarily — would harm patients and/or set back medical research. Apple’s own response to the call for public comments caught my eye, however, and puts its supporters’ letters in a different context.
Apple hints at future FDA authorizations: In its own letter to the court, Apple highlighted studies conducted by three of its health system collaborators’ comments to the court as examples of research efforts that support future FDA submissions. Here are Apple’s exact words:
“Excluding Apple Watch from the U.S. would severely undercut the extensive research that is already underway, and jeopardize the significant investments in such research, some of which are used to obtain, or support, additional, future FDA authorizations.”
That sentence ends with a flag for a footnote that mentions three letters sent in from Apple’s collaborators at Stanford University Medical Center, Ochsner Health, and Johns Hopkins Hospital. Of those three: Ochsner’s doesn’t mention any studies, Stanford does, and Johns Hopkins’ is vague. (However, read the clinical trial round-up in the next article below for one study that may be the one Johns Hopkins is involved one that may lead to a future FDA submission for Apple.)
Stanford: Here’s an excerpt from the letter that Marco V. Perez, MD Associate Professor, Cardiovascular Medicine, Stanford University sent the court:
“I am currently one of the lead investigators on the REACT-AF trial which will use the Apple Watch to minimize the amount of time that a patient with atrial fibrillation needs to take blood thinning medications. This has the potential to revolutionize atrial fibrillation management and reduce bleeding complications significantly and improve health care costs. This is a multi-million-dollar study funded by the NIH that will begin this year and enroll over the next few years.”
Do you see any signs of a future Apple Watch capability in that study description? Northwestern, which is co-leading the study with Stanford, announced it in August (more details here) but it’s not listed in clinical trials [dot] gov yet.
Read on for a few other excerpts that don’t seem to tell us much about Apple’s future plans, but are still interesting because they include financial details related to Ochsner’s Apple Watch-powered care programs:
Ochsner: From a letter sent in by Dr. Richard Milani, Chief Clinical Transformation Officer and Vice Chairman of the Department of Cardiology, Ochsner Health System:
“Indeed, recently, Apple announced a new feature that tracks AFib burden. Ochsner Health is building a management program around this Apple technology, called AFib History, which will give physicians weekly reports about the percentage of time a patient has spent in AFib (termed the ‘AFib burden’) based on data collected from Apple Watch. We expect this to be a program that saves many lives, including by preventing strokes…”
“To date, Ochsner has invested approximately $600,000 into building its AFib Management program. This involves a team of cardiologists, advanced practice providers, Epic software developers and engineers as well as app developers.”
Milani also mentioned some dollar amounts around Ochsner’s investment into its fall prevention and management program, which also uses the Apple Watch:
“In 2021, Ochsner Health launched a pilot program related to fall prevention and management called ‘Connected Stability’. This program relies on Apple Watch and iPhone, and has been a huge success among the approximately 350 patients who participated. The program uses fall detection on Apple Watch to detect when a patient falls. Specifically, Apple Watch can detect if a patient falls, and then offers users a chance to indicate through Apple Watch whether they are okay or if there is an emergency. If Apple Watch cannot detect any movement from the user within about one minute of the fall, it will automatically contact emergency services. In addition to this existing functionality, Ochsner has developed its own program through which a healthcare professional from Ochsner will contact a patient for whom Apple Watch has detected a fall to find out if they need any medical assistance (particularly for patients who have fallen but do not believe they need to go to the hospital).”
“For patients that have participated in the pilot program, we have been able to reduce falls by approximately 50%…”
“Ochsner has invested approximately $3 million into its fall prevention pilot program. As mentioned above, more than 350 patients have participated so far. Ochsner plans to roll out this program nationally within the next year. Ochsner currently has more than 20 healthcare professionals working on this program, and we expect those numbers to grow significantly as the program expands.”
Clinical trial updates: Akili for pediatric cancer cognitive dysfunction and Johns Hopkins-Apple’s AFib management study
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.
New study reveals more details on Akili’s Cancer-Related Cognitive Impairment digital therapeutic plans
One of the potential conditions that Akili mentions briefly in its pipeline of digital therapeutics is cancer-related cognitive impairment or CRCI. A new study led by Children’s National Research Institute in DC will focus on the feasibility and acceptability of EndeavorRx in a pediatric population of cancer survivors. Here’s more on the anticipated 50-participant trial:
“Survival rates are increasing for common pediatric cancers, including acute lymphoblastic leukemia (ALL) and brain tumors; yet, the life-saving treatments for these cancers place survivors at heightened risk for sustained cognitive effects. … Few non-pharmacological interventions exist to ameliorate these cognitive late effects. EndeavorRx, an FDA-approved electronic attentional-control training program, may be one intervention to help remediate executive functioning difficulties experienced by survivors. Although the program has been efficacious for youth with Attention-Deficit/Hyperactivity Disorder (ADHD), it has not yet been tested among survivors of childhood ALL or brain tumor.”
“We propose to assess the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a pilot randomized, controlled trial. Survivors of ALL or brain tumor who are between the ages of 8 and 16 and have been off-therapy for at least one year will be included. The goal is to enroll and screen approximately 50 survivors across three pediatric oncology centers, in order to identify 40 participants with attention difficulties who will be randomized to one of two treatment arms. Participants will be assigned to either the EndeavorRx intervention, which includes 25-30 minute sessions per day, 5 days per week, for one month, or an active control condition of the same duration and intensity.”
“Patients will undergo neurocognitive testing pre- and post-intervention, and parents will complete questionnaires regarding their child’s functioning. It is hypothesized that this attentional-control training program will be both acceptable and feasible, with sufficient enrollment, positive satisfaction ratings, and acceptable treatment adherence. It is also anticipated that participants will show increases in performance-based and parent-rated attention, as compared to those in the active control condition.”
Pushed back: Johns Hopkins’ (and Apple’s) next Corrie study to start in November instead of this month
E&O has reported on this study before, but the news this week is that Johns Hopkins has pushed back its start date from September 2022 to November 2022, (which also means the study’s completion date is two months later). Speculation: If Johns Hopkins is helping Apple develop a future FDA-regulated SaMD, it is most likely based on the work it is doing via Corrie. Apple originally helped Johns Hopkins develop Corrie as a CareKit app focused on heart attack recovery, but in this study, the Corrie platform is focused on AFib management:
“The overall objective of this proposal is to evaluate the feasibility of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life. Researchers plan to evaluate the feasibility and preliminary efficacy of this novel digital toolkit in improving quality of life and decreasing AFib burden in a pilot randomized clinical trial (RCT).”
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