Vitals #9

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Welcome to the 4 new subscribers who have joined Future Human since our last edition! Join 339 other leaders learning about the future of human health by subscribing here:

Hi friend,

Welcome back to Future Human! Happy New Year! We’re gearing up for an exciting year in healthtech innovation. From really seeing if AI can start to improve healthcare efficiency and bring medicines to market to a new administration trying to grapple with this behemoth of an industry, I am sure we will be seeing a lot of insane headlines coming soon and we cannot wait to cover them.

Here in New York, I am beginning my clerkship year tomorrow. I will be starting with internal medicine, so wish me luck. Only 1,000 practice questions and 4,400 flashcards to get through in the next 8 weeks. Can’t wait!

In all seriousness, I am incredibly excited to work with patients and learn in the hospital setting rather than just the lecture hall. It is truly a privilege! I will be busy, but I am hoping with the safeguards in place, the newsletter will not skip a beat. Thank you all for your support! I will keep you updated along the way in arguably the most important year of medical school.

To more lives saved,

Andrew, Nicholas, and Isabelle

1. Scientists are Developing a 'Self-Driving' Device that Helps Heart Attack Patients Recover

Andrew’s Take

I have read about the “digital twin” in many contexts within healthcare. The overarching theme has always been to use the data collected over the course of a patient’s healthcare journey to develop a model of “them” that can then be tested on theoretically instead of the individual themselves to optimize treatment before moving forward. What I have not read about until now is someone aiming to finally insert these algorithms into a device to deliver and adjust medications accordingly.

The Autonomous Closed-Loop Intervention System (ACIS) is a device being developed by scientists at NTT Research, an arm of technology company NTT. This is one of their many projects within the lab’s Bio Digital Twin program, but is arguably their most exciting. As I partially explained above, it aims to construct advanced virtual models of organ systems that can be personalized with an individual patient's data. This offers physicians a detailed representation of their medical status and a testable model for developing treatment plans.

This cardiovascular model brings together pressure and flow readings from all chambers and vessels. Then, physicians could use this bio twin ACIS trained to that patient’s heart data as the “first guess” of what treatment regimen works for the patient based on population data. The device is a feedback control system, so once the patient is hooked up and receiving drugs, pressure/flow feedback will automatically adjust the parameter values to deliver the necessary drugs that that particular patient needs for some prespecified cardiac output. This active monitoring ideally reduces workload for physicians, PAs, and nurses who normally reassess and adjust constantly.

This “self-driving” is undeniably exciting. Looking ahead, I suspect their best approach is to be so evidence-based that physicians will struggle to find reasons why they should not trust the decisions of the algorithm. As I am seeing with physicians and AI, the biggest challenge is adoption among more seasoned providers as trust in these models takes time and certainly tons of data. If they manage to show overwhelming evidence that these models mimic an experienced provider and deliver outstanding outcomes, only then can they plan for mass adoption.

2. HHS & DEA Extend Telemedicine Flexibilities for Prescribing Controlled Medications Through 2026

Andrew’s Take

The DEA and HHS just hit “snooze” on the telemedicine cliff until December 31, 2026, keeping COVID-era rules in place that allow clinicians to prescribe controlled substances without a prior in-person visit. For telehealth companies, this is a big deal. It preserves the core operating model for players in virtual mental health, chronic pain, and substance use disorder care, and avoids a sudden regulatory whiplash that could have forced rapid, expensive workflow changes.

For companies, the upside is stability and time. Another year of flexibility gives teams room to refine clinical protocols, improve monitoring, and generate data that shows remote prescribing can be safe and effective. It also gives payers and employers more confidence to keep backing these models. The risk, however, is complacency. This is still a temporary extension, not a permanent solution. The eventual DEA framework is likely to include new registration requirements, added oversight, and tighter compliance standards that could favor larger, better-capitalized platforms.

This is truly borrowed time. The winners will use 2026 to prepare for a more regulated future, while the losers may be caught flat-footed when the rules finally harden. Only time will tell, but for now, congratulations to them on another year of supporting patients wherever they may be.

3. Sanofi to Acquire Dynavax, Adding an Adult Hepatitis B Vaccine and Shingles Candidate to the Pipeline

Andrew’s Take

We are starting the new year with a pharma incumbent acquiring a smaller competitor to shore up their pipeline — not shocking, but still exciting! Sanofi is buying Dynavax to gain access to their adult hepatitis B vaccine (HEPLISAV-B®) and differentiated shingles vaccine candidate (Z-1018). At a high level, this is a pretty focused and uncomplicated move. Sanofi gets a marketed hepatitis B vaccine with real U.S. traction and a shingles candidate that could eventually play in one of the largest adult vaccine markets around. Sanofi has been aiming to lead in the adult vaccine space for some time. They already sell several flu shots: Fluzone for people 6 months and older, Flublok for ages 9 and up, and Fluzone High-Dose for adults 65+. They also have MenQuadfi (meningococcal vaccine for adolescents and adults).

For Sanofi, the upside is obvious. HEPLISAV-B simplifies hepatitis B vaccination with fewer doses, which fits perfectly with real-world clinical workflows and employer-driven vaccination programs. With Sanofi’s global commercial scale, there’s room to expand access internationally and squeeze more value out of an already differentiated product. The shingles asset is naturally a bit more undifferentiated, but it adds longer-term optionality and gives Sanofi a potential future lever in a market that is massive (but competitive).

Where this can go wrong, as with any M&A deal, is execution. Integrating a smaller, focused biotech into a large pharma machine is almost never seamless. If the shingles program stumbles in clinical development, part of the strategic narrative falls apart. There’s also competitive pressure: incumbents in adult vaccines won’t sit still, and incremental improvements may not be enough to win. Excited for both teams and good luck to the new united group.

4. FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care

Andrew’s Take

StimLabs just secured FDA’s 510(k) clearance of Theracor, the first human umbilical cord–derived medical device in sheet form for wound care. The team already offers Corplex P, a particulate form of the derivative, but the sheets can not be better used in diabetic ulcers, pressure injuries, and surgical wounds. It gives clinicians a structurally intact option that can be easier to place, conform, and secure, especially for larger or more complex wound beds.

The multi-form approach is always smart. I actually just learned today that we have the IV form of acetaminophen-Tylenol at the hospital but it is quite expensive per dose, so its convenience is only reserved for patients who cannot take anything by mouth. For StimLabs, this lets the company meet clinicians where they are instead of forcing a single approach. In wound care, flexibility often wins. Different wounds behave differently, and providers value products that adapt to real-world clinical variability. This also strengthens StimLabs’ positioning as a regenerative medicine company that is steadily expanding indications and formats rather than relying on one flagship product.

Now comes time to formulate reimbursement policies. Advanced biologic wound products often face scrutiny from payers, and clinical enthusiasm doesn’t always translate into broad coverage. The company will need strong post-market data and clear economic value to gain traction. If they can demonstrate consistent outcomes and ease of use, Theracor could help push the wound care space toward more biologically derived, format-flexible solutions rather than tweaks on legacy dressings.

5. Insilico Medicine Lists on Hong Kong Stock Exchange, Showing AI Drug Discovery Momentum

Andrew’s Take

I mentioned AI’s adoption as a key trend to look out for this year, and we are kicking it off strong. Although the listing technically happened in 2025, we thought covering Insilico Medicine’s IPO was critical in our first letter of the year. Insilico just pulled off one of the biggest biotech moments in Asia by listing on the Hong Kong Stock Exchange. For context, Insilico is one of a few companies identifying new drug targets and molecules using generative AI to speed up the timeline to care and reduce drug development costs. What makes its listing unique is that it went public on the Main Board under Hong Kong’s Chapter 8.05 rules, which require revenue or profits rather than the purely research-stage focus seen in some biotech listings. This is some serious confidence from global investors, as the offering was massively oversubscribed, especially on the public side.

For Insilico itself, the new capital gives the company more fuel to accelerate its AI-powered drug discovery engine, including funding further clinical work, improving its generative AI models, and expanding automated lab capabilities. These capabilities are key because Insilico is not just licensing out the algorithm. They aim to build a pipeline of candidates internally for disease states across oncology and immunology.

This listing also validates the AI drug discovery model in the public markets, encouraging other AI-focused biotech firms that have long talked about speeding up R&D timelines but struggled to prove it outside early-stage deals. It might even push the pharma incumbents to more seriously integrate AI at scale or risk losing ground.

Drug discovery, even with AI acceleration, remains an arduous process. As long as public market pressures for returns do not get in the way, I believe Insilico is well positioned to be one of the first to bring a truly AI developed drug to the market.

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