Vitals #4

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Welcome to the 12 new subscribers who have joined Future Human since our last edition! Join 317 other leaders learning about the future of human health by subscribing here:

Hi friend,

Welcome back to Future Human! I hope you all had a restful and safe Thanksgiving! Seems the holiday did not stop the healthcare industry and, surprisingly, our government from making deals and proposing new policies to advance human health. We also have some headlines that were released technically before last week, but the tech was so insane that we had to cover it at some point. So we hope you understand the outdated story (outdated as in >7 days ago). With that said, let’s get into it.

To more lives saved,

Andrew, Nicholas, and Isabelle

1. Abbott to Acquire Exact Sciences for ~$21B

Andrew’s Take

Abbott is diving deeper into the $110 billion cancer diagnostics market. As one of the largest medical device companies in the world (ranked in top 3 depending on how you define devices and if you consider revenue or market cap), it expectedly must gobble up more agile competitors to keep up with the pace of innovation. This trend, large and cumbersome incumbents acquiring smaller up-and-comers to expand their pipeline rather than develop in house is far from novel (see last week’s Vitals: J&J purchasing Halda for $3B). The question now is if they can find true product synergy (sorry to all my corporate warriors for using the word).

Abbot currently offers a handful of oncology products generally used in laboratory settings to provide molecular information that aids in cancer diagnosis and therapeutic decision-making. They have Vysis FISH Assays, a broad menu of DNA FISH probes for detecting specific genetic markers (gene amplifications, deletions, and rearrangements) associated with various cancers (solid tumor for breast, lung, and bladder, and hematological for leukemia and lymphoma). They also can streamline lab workflow with Vysis IntelliFISH Solutions, a product claiming to automate processing and analysing of FISH slides. Finally, they have RealTime Assays, which are molecular tests that detect mutations to classify and guide treatment for hematological malignancies.

Taking a broad view, Abbott’s products deal in the diagnosis realm to confirm suspicions and help select targeted therapies. Where Exact Sciences comes in, and where I like to imagine the board highlighted synergy (sorry), is for the earlier step of screening and follow on monitoring. Exact’s current portfolio offers Cologuard (non-invasive colorectal cancer screening), Cancerguard (multi-cancer early detection blood test), Oncodetect (molecular residual disease testing), and Oncotype DX (tests for personalized treatment decisions in breast and colon cancer). While Abbott offers Exact’s products a path to massive scale, Exact’s tech seems to bookend the current Abbot oncology portfolio. Exact’s screening tech highlights the malignancy early on, Abbot’s Vysis products characterize it genetically and help decide on therapy, and Exact follows the path to assess recurrence. That’s just my read though. Let’s watch and see.

2. MIT Unveils 200-Micrometer Antenna to Power Medical Implants from Inside Body

Isabelle’s Take

PhD student researchers at MIT Media Lab built a sand-grain-sized (only ~200 mm!) injectable antenna that can wirelessly deliver power to deep-tissue implants using a low-frequency magnetic field (instead of a bulky battery). It’s a “magnet → motion → electricity” stack (magnetostrictive + piezoelectric layers) that turns an external magnetic field into usable electrical energy inside the body. The team claims dramatically higher power delivery at this size compared to same-sized traditional coil antennas.

This is so cool because if this scales, it could lead to smaller, less invasive devices like a tiny neuromodulator for Parkinson’s or epilepsy or a mini biosensor that can sit comfortably under the skin (or deeper) without need for follow-up surgeries to change the battery. Doctors and patients have more flexible placement if the “power module” is now a patch or phone-charger-esque.

Repeat procedures are emotionally and physically taxing, and expensive for both patients and the healthcare system. That said, solving wireless power is only step one. The real make-or-break is whether these ultra-tiny devices can be safely packaged for years, stay where they’re placed, and perform reliably in the messy conditions of real life.

But the Media Lab MITers are undoubtedly smart. I am impressed by the team’s interdisciplinary background. I am sure adherence is somewhere on their mind or will be later. For now, I am inspired and am rooting for them to make this work!

Here is their paper detailing this work in the October issue of IEEE.

3. Lawmakers Propose Bill to Establish Medicare Reimbursement for AI Medical Devices

Andrew’s Take

When we added this second newsletter offering, Vitals, I did not think some government legislation would make its way into any of these groupings of cutting edge health headlines. I stand corrected. Although the official text is not publicly available, it appears the legislature is proposing a clearer path forward to reimbursement for AI-enabled medical devices. In their eyes, eligible products offer services using AI, ML, and other software which spit out clinical conclusions that physicians use to narrow their diagnosis and treat sooner. This appears to try and address concerns from manufacturers who are looking down the barrel of millions in R&D costs without guaranteed return at the end once commercialized. I would love to assume these teams think innovation first and payment later, but that would be much too naive.

One of the six introducers of the House version of the bill, Rep. John Joy, R-Pa, said the bill aims to secure an accurate payment code under the Centers for Medicare and Medicaid Services for easy billing moving forward. The devices that eventually qualify under the bill will receive a new tech ambulatory payment classification, APC (system used by CMS to pay hospitals for novel outpatient services like costly procedures and drugs).

Government intervention may seem out of place in the wild west of artificial intelligence, but when patient care and safety is involved, someone has to corral the different players and steer them properly. That involvement is not always beneficial, but financial incentives for high capex and risky return pathways have worked well before. Look no further than the Orphan Drug Act of 1983, which encouraged the development of drugs for rare diseases (those affecting fewer than 200,000 people). The government promised 25% tax credits for clinical trials, fee waivers, grants, and seven-year market exclusivity to spur innovation. Before 1983, only 38 drugs were approved to treat rare diseases. Since its passage, more than 7,000 rare diseases have been identified and 1,100 orphan indications for treatments have obtained FDA approval. Hopefully the impact is just as positive here.

4. Bayer’s Blood-Thinner Asundexian Achieves Phase 3 Endpoints – Reducing Stroke Rate Without Increasing Major Bleeding

Andrew’s Take

We may finally have a new mechanism in blood thinning, or at least a new leader. For those even tangentially involved with medicine, you have surely become acquainted with the anticoagulants and antiplatelets we offer patients like apixaban (Eliquis), rivaroxaban (Xarelto), warfarin (Coumadin), and aspirin. The first two, more specifically, are direct oral anticoagulants (DOACs). They are the most commonly prescribed class as they require no routine blood monitoring. The DOAC class targets the multistep coagulation cascade, and apixaban and rivaroxaban specifically inhibit Factor Xa in the cascade to pause fibrin creation.

The issue, as all of us know, is that thin blood also bleeds easily. For this reason, scientists have been looking for a new factor to target in the cascade for years with little luck. Earlier this month even, BMS and Johnson & Johnson stopped a phase 3 trial for their own FXIa inhibitor in acute coronary syndrome early because of futility. Bayer, however, seems to have broken the trend. Last week, their phase 3 trial of asundexian for secondary stroke prevention (SSP) met BOTH its primary efficacy and safety endpoints. Put simply, stroke risk was much lower on asundexian than on placebo and it did not increase risk of major bleeding. Both Bayer and BMS have bet big that FXIa inhibition is the key to stopping clots without raising bleeding risk, and it seems Bayer has had the first big win.

My quick analysis is that this is a big win in the small arena of secondary stroke prevention. The superbowl of anticoagulation is atrial fibrillation (afib), and nobody has nailed that yet. Bayer even paused its Phase 3 with this product in afib. These results in SSP are positive, but more has to be done to tackle the most common arrhythmia in the world. This news boosted both Bayer and the J&J and BMS partnership, where their product which failed in acute coronary syndrome is still being studied in SSP and afib.

5. WellTheory Partners with Instacart to Improve Autoimmune Dietary Experience

Andrew’s Take

For a long time I have wondered when Instacart and other meal delivery services would dip their toes into medicine via the nutrition and food access route. It appears I now have my answer. WellTheory (an autoimmune care platform) is working with Instacart to incorporate the Instacart Health Fresh Funds (stipends) into their care model. The 300,000 members in the WellTheory network will soon be able to access grocery stipends that can help them purchase clinically recommended foods directly from grocers on Instacart.

This may not be the highest tech story in our list this week, but it is just as impactful. It attacks a common healthcare friction point: converting clinical nutrition advice into accessible, affordable daily action. The grocery stipends directly address the affordability and accessibility barriers faced by autoimmune patients needing anti-inflammatory diets. Many current autoimmune care models rely solely on symptom-masking interventions. This, without nutritional direction, is far from complete. Other models that do offer dietary advice fail to complete the loop by not connecting patients with nutritional resources. WellTheory seems to be among the first to fill the implementation gap, and they did not have to even create the tech themselves.

Instacart covers over 98% of U.S. households, including 95% of those in food deserts and almost all SNAP-enrolled households. This equitable scale is a major step in the right direction. We could not be more excited to follow this collaboration and see the impact it makes. Cheers to the power of partnership!

We hope you enjoyed this edition of Vitals!

We always appreciate feedback, questions, and conversation, so feel free to reach out on LinkedIn or by replying to this email.

To more lives saved,

Andrew, Nicholas, and Isabelle