Cairdac

Limitless Energy Pacemaker

Hi,

Welcome all to the first edition of Future Human! If the laws of progress are good to me, you are about to read my worst newsletter ever. Get excited! Only up from here!

I am eternally grateful to the dozens of you (64) that have subscribed only based on a couple LinkedIn posts and messages from my mother. This is a pretty niche group of healthtech founders, doctors, engineers, investors, and childhood best friends.

For those who don’t know me, my name is Andrew Kuzemczak. I am a first-year medical student (M1) at Weill Cornell Medicine interested (unsurprisingly) in the future of medicine and technology. I got my undergrad degree at Yale in molecular biology, discovered the healthtech ecosystem while in New Haven, rerouted to get my graduate degree at Columbia in biomedical engineering, and now find myself at E 69th and York Ave studying to be a doctor. Let’s hope this newsletter cash flows to cover these degrees.

Future Human represents an intersection I have been mentally constructing for a year now (yeah, a year…lowest bidder contracting I guess) colliding healthcare, innovation, and business.

Every Tuesday, you will receive a dive into one insane health tech startup advancing the future human. We will then ask together:

What could this work mean for the sick, the healthy, and the economy?

It’s a cold and snowy day here in Manhattan. I have my tea and am ready to write, so with that, let’s dive in.

The Update and the Question

Here in medical school, we just finished our first organ unit, cardiology. As luck would have it, this (the heart) is my favorite organ, and the one I plan to dedicate my life to. I might become a cardiologist, a cardiothoracic surgeon, or change the plan altogether, but as of right now, the heart reigns supreme.

Amazingly, those exams didn’t convince me otherwise.

I grew up watching my dad, uncles, and older brother, rebuild cars, dirt bikes, and quads. This is relevant for how I will write this newsletter. As a result of my childhood, for the longest time, I have viewed the human body as a machine — call it a car. With that in mind, let me ask you:

When presented a Ferrari, why would you want to work on anything else but the engine?

The human body is the most magnificent and perfectly constructed machine, and few would argue that the center is anywhere but the heart (I will only hear out the neuro folks on this one). With a Ferrari in our minds and the engine in our sights, I thought the best place to start this newsletter was with the heart and a question.

If you ever needed a new battery for the engine of your life, would you accept the classic option that needs replacing or experiment with one that could last forever?

The Story

When we speak of powering your heart, we are speaking of a pacemaker. When we speak of powering it for a nearly infinite period of time, we are speaking of Cairdac. If you were to launch a startup hellbent on creating a limitless pacemaker, you’d want a team combining experts in cardiac rhythm management and electricity capture. That is what An Nguyen-Dinh, founder at Cairdac, did in 2016 with a partnership across piezoelectrics (the ability of certain materials to generate an electric charge when pressure is applied) and cardiac care.

Prior to founding Cairdac, An worked at Vermon, a company specializing in piezoelectric transducers for diagnostic imaging, as Director of Technology and Vice President for Research and Innovation. He would note a few years later that among the needs for electrical innovation in healthcare, cardiovascular disorders remain most deadly and pressing. This realization, mixed with his own expertise in piezoelectric technology, drove the development of Cairdac's pacemaker.

Cairdac's flagship product is the Autonomous Leadless Pacing System (ALPS™), the world's first self-sustaining leadless pacemaker.

Rendering: Cairdac Autonomous Leadless Pacing System (ALPS™)

The Tech

For our physician audience, these next few sentences will be unnecessary. For those who are less versed, here's how a pacemaker works. A pacemaker contains sensors that track heart rhythm. When rate slows down or becomes abnormal (arrhythmia), electrical impulses are sent to the heart to help speed it up and/or stay on rhythm. They normally consist of two parts:

  • Pulse generator: larger portion of the device that contains the battery

  • Leads: wires (1-3 depending on model) that connect the pulse generator to the heart

Most pacemakers are implanted in the left side of a person’s chest. Doctors make an incision in the chest, where they insert the pulse generator. Then, the leads are inserted through a blood vessel in the chest, thigh, or neck and threaded through vessels until they reach the heart. Each lead is attached to the heart in the upper or lower chambers. Pacemakers can be triggered for a variety of reasons, such as slow heart rates and heart blocks. These involve some failure to either generate an impulse for a heart beat, abnormal conduction of the impulse, or an interruption/delay of the conduction between the atria (upper chamber) and ventricles (lower chamber). The standard pacemaker also needs to be replaced every 7-10 years because of battery depletion.

Okay, got it? Back to Cairdac.

Cairdac and its 30+ engineers developed ALPS™ to offer patients an option that eventually never needs replacing. ALPS™ already offers a 15-17 year lifespan that is only growing longer as the product improves. Put simply, the device captures the heart’s oscillations in order to recharge itself and extend its battery life in the patient.

An puts it: “The objective of the company was to develop disruptive technology for energy harvesting using the kinetic energy of the heart: at every heartbeat we collect the mechanical energy of the heart and we transform it through the piezoelectric material into electricity for powering the electronic circuits of the device.”

Beyond the kinetic energy capture, the device allows Dual-Chamber Stimulation, meaning one device is fixed in the ventricle and another one is fixed in the atrium, with both remaining synchronized allowing the product to treat more than just single chamber arrythmias. The market has moved conclusively to dual chamber approaches, which I will touch on in a moment.

ALPS™ is currently in preclinical testing across three European medical centers. Compatibility and performance is promising and the company plans to initiate clinical trials in 18 months with 20-30 patients in France and Belgium. The goal is to obtain CE marking, which would allow for broader clinical use. They have secured $18.5 million in initial funding to fuel these stages.

The Market

The global pacemaker market was valued at $4.91 billion last year. With a CAGR (compound annual growth rate) of 4.9%, it should reach $6.9 billion by 2031. The market is not massive (for context, the GLP-1 market was $25 billion last year growing 12.1% annually) but it is proven and steady. It also has very permanent drivers. Think:

  1. Growing geriatric population globally (65% of cardiac patients are 65+)

  2. Increased product approval by North American, European, and Asian Pacific authorities

  3. New inorganic activities among market players, namely partnerships and collaborations across international borders

One company continues to dominate though — Medtronic. Medtronic owns 60% of the $5 billion market. It is also the only player with an FDA-approved leadless pacemaker (see above, traditional pacemakers normally come with leads). The Micra™ line comprises a self-contained unit the size of large vitamin pill that attaches directly to the heart (without leads). In 2023, Medtronic also secured FDA approval for the first dual chamber leadless pacemaker — AVEIR™ dual chamber (DR). With more than 60% of people who need a pacemaker requiring pacing in two chambers of the heart (both the right atrium and right ventricle), the approval was significant for further market penetration.

For now though, in the US at least, if you are getting a pacemaker it will likely still have leads and will be one of two variants.

  1. Azure XT SR™ (Medtronic)

  2. Assurity MRI™ (Abbott)

The markets are certainly not consistent globally, so the Cairdac team must look one place for proven revenue and another to join the innovation movement. Let me explain.

North America captures 37.2% of the pacemaker market revenue share. Physicians there, namely US physicians, are notoriously more willing to accept new technologies sooner than foreign providers. Asia Pacific, however, stands as the fastest growing pacemaker region with new innovations approved sooner and more agreements across international lines. LifeTech (China) and Medtronic recently announced strategic collaboration to domestically manufacture MRI-conditional pacemakers in China.

China’s healthcare expenditures are rising faster than nearly any nation as its geriatric population booms. Pacemaker adoption will be key.

Cairdac will need to look both East and West for an accelerating and a proven market.

The Sick

For those we know with a pacemaker, or who remain in need of one, what does this all mean?

Across the US, 3 million citizens have a pacemaker. Annually, 1.4 million are implanted globally. For these patients post-implantation, replacement for battery depletion is the primary intervention. For context:

  1. Traditional pacemakers: Last 5 to 15 years, with an average lifespan of 7 to 10 years

  2. Leadless pacemakers (e.g., Micra™): Last 8 to 13 years

  3. ALPS™ (Cairdac): Lasts 17+ years in current form

Critically, leadless pacemakers are not usually replaced but instead left in place while a new device is implanted alongside. This means ALPS™ not only prolongs the period without surgery (longer battery life), but also eliminates half of the procedural headache for patients and surgeons (no removal of previous device).

While pacemaker replacement surgeries are generally safe (95% success rate), like with any medical procedure, complications can occur. The risk of complications is typically higher for replacement surgeries than for initial implantations due to factors like scar tissue and potential lead-related issues (see above, ALPS™ mitigates replacement and lead issues). Put as a list for those who appreciate them:

  1. No leads = lower infection + complication rates

    • Traditional pacemakers require leads, which can cause infections, fractures, or vein obstructions over time. ALPS™ eliminates these risks.

  2. Smaller size = easier implantation + reduced surgical risks

    • ALPS™, like the Micra™ device, is 90% smaller than traditional pacemakers and is implanted directly into the heart via a catheter, avoiding chest incisions.

  3. Longer battery life (17+ years) = fewer replacements

    • Model not only optimizes energy consumption, but captures kinetic energy, reducing the need for frequent replacements.

I expect to read about the great ALPS™ vs. Micra™ fight in the coming years. For now, with the patient in mind, ALPS™ appears to exit victorious.

The Economy

Here’s an unsurprising stat for you — 1 in 3 US adults received care for a cardiovascular risk factor or condition in 2020.

Here’s another — annual inflation-adjusted (2022 USD) health care costs of cardiovascular risk factors are projected to triple between 2020 and 2050, from $400 billion to $1.34 trillion. Productivity losses are projected to increase by 54%, from $234 billion to $361 billion in that same time.

Now it’s certainly not great to reduce anyone to their “productivity” and “cost”, but we are in the economics section, so I’ll dabble.

As mentioned back up top, pacemakers help regulate heart rhythms by deploying electrical impulses. Patients whose hearts are not in normal rhythm are said to have “arrhythmias”, the most common of which is atrial fibrillation (afib). Afib is also associated with more deadly conditions including atrial flutter, heart failure, and stroke. Now that our finance friends have that, let’s move on quick!

Afib patients are approximately 5x as costly as non-afib individuals in the US healthcare system ($15,553 vs. $3,204). He who can treat them the best can capture quite the premium.

When the Micra™ device was released, it cost around $10,000, compared to approximately $2,500 for traditional pacemakers. Now that 10 years have passed and a dual chamber variant is available, I would venture to say the price is much higher.

Recall 60% of new pacemaker patients need dual chamber pacing and 1.4 million pacemakers are implanted annually. Let’s assume Cairdac ALPS™ could capture just 5% of the market and charges a premium $13,000/device given its kinetic energy capture technology (which offers 30% improvement in battery lifespan, from 13 to 17 years, at present).

Using some consultant level math we find a $546 million opportunity for Cairdac ALPS™ globally.

My Thoughts

An infinite battery for our Ferrari engine is an amazing first modification. Certainly an exciting place to start for Future Human.

I’ll be tracking Cairdac closely and will keep pestering the founder and the CEO to hop on the phone (my messages will not stop, guys!). What they are doing is, in its current form, a radical improvement for those who need cardiac rhythm management. In its ideal form, offering infinite battery life, it is life altering.

With such a promising opportunity, the competition is expected. I had a lot of fun reading about how other startup and university teams are attempting to capture energy in their own way. Think chemical energy capture (Celtro), solar energy capture through the skin (Monash University), and hydroelectric power with blood flow (University of Bern).

Cardiac innovation is arguably the single most valuable pursuit healthtech engineers, founders, and investors can have to improve and save the most lives. I will vary this newsletter across a range of medical sectors, but I look forward already to returning to our most prized organ — the motor, the center, the heart.

If you want to learn more about Cairdac and ALPS™, check out their website and DM An or the CEO Edouard Fonck on LinkedIn. Perhaps if you’re an investor they will respond sooner!

I always appreciate feedback, questions, and conversation. Feel free to reach out on LinkedIn @andrewkuzemczak.

References

  1. https://ojoyoshidareport.com/straight-from-the-heart-startup-celtro-eyes-self-powered-pacemakers/

  2. https://www.cairdac.com/team

  3. https://www.imeciclink.com/en/articles/complete-paradigm-shift-cardiac-rhythm-management-crm?utm_source=chatgpt.com

  4. https://www.biospace.com/press-releases/cardiac-pacemaker-market-to-surpass-usd-6-838-6-million-by-2031-coherent-market-insights#:~:text=According

  5. https://www.coherentmarketinsights.com/market-insight/cardiac-pacemaker-market-1765

  6. https://www.yalemedicine.org/conditions/cardiac-pacemaker#:~:text=A

  7. https://www.fda.gov/news-events/press-announcements/fda-approves-first-leadless-pacemaker-treat-heart-rhythm-disorders

  8. https://abbott.mediaroom.com/2023-07-05-Abbott-Receives-FDA-Approval-for-Worlds-First-Dual-Chamber-Leadless-Pacemaker

  9. https://www.ahajournals.org/doi/10.1161/CIR.0000000000001258

  10. https://pubmed.ncbi.nlm.nih.gov/16238910/

  11. https://nauka.gov.ua/en/news/the-battery-that-never-gets-flat/

  12. https://www.bioworld.com/articles/517988-cairdac-raises-185m-in-funding-to-develop-self-powering-leadless-pacemaker?v=preview

  13. https://healtheconomicsreview.biomedcentral.com/articles/10.1186/s13561-024-00551-1#:~:text=The