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Apreo Health

Apreo Health

Breakthrough Lung Restoration

Andrew Kuzemczak
September 12, 2025

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TL;DR

Apreo Health’s BREATHE Airway Scaffold showed strong early trial results in emphysema patients, with meaningful improvements in lung function and no cases of pneumothorax, a major complication of earlier devices.
The COPD market is projected to reach $35B by 2034; while drug companies dominate chronic bronchitis, emphysema remains underserved, giving Apreo room to pioneer a new implant-based category.
A safe, minimally invasive therapy for emphysema could reduce hospitalizations, oxygen dependence, and caregiver burden while easing the projected $60B+ annual economic toll of COPD in the U.S. by 2029.

Hi friend,

Welcome back to Future Human! The last week has been quite a whirlwind for our team. I mentioned last week, but we held an amazing interview with a remarkable CEO leading a team behind the first and only FDA authorized diagnostic solution to diagnose or rule out autism in children. That was incredible and is currently being turned into newsletter #30.

Twenty four hours after that interview took place, we sort of went viral on LinkedIn (by our standards). Seems you all love AI controversy in healthcare, so welcome to the nearly two dozen new subscribers who came from last week’s LinkedIn posts and comment sections. We had three posts explode, with one reaching 104,000 individuals and driving 450 new followers in two days. Nothing like telling people OpenAI is turning their healthcare initiative over to an Instagram executive to fire everyone up. The comment section was something else! After that post caught steam, I found in my inbox/DMs no joke: a book deal to publish about healthtech, an offer to help sell the trademarked term BioAI^TM, and a nice lady asking if I am interested in her daughter.

The internet remains undefeated.

We welcome engagement and growth in all forms. We remain small, but this was undeniably our best week yet. Welcome to all who have joined Future Human whether through this newsletter, the company LinkedIn page, or my (Andrew’s) LinkedIn. We welcome your feedback always!

Okay, let’s return to medicine.

Imagine if the millions of people with emphysema—a disease that slowly robs them of every easy breath—suddenly had an option beyond inhalers, oxygen tanks, and risky surgeries. Imagine if, instead of waiting for their lungs to fail, physicians could place a small implant that quietly released trapped air, restoring the simple act of exhaling. For decades, the field has chased that vision, only to stumble on complications and false starts. Now, one company is betting it has finally cracked the code.

So with that, let me ask you:

What if the next real advance in emphysema care wasn’t another drug or bulky surgery, but a device small enough to be placed through a scope—quietly reshaping the way patients breathe, move, and reclaim their daily lives?

The Story

For decades, emphysema patients have faced a cruel paradox. Medicine could diagnose the disease, describe its physiology in detail, and track its relentless progression—but therapies that could truly restore lung function remained elusive. Even interventional breakthroughs, like the Zephyr valve developed in the early 2000s, came with tradeoffs: in its pivotal LIBERATE trial, more than a quarter of patients experienced pneumothorax (read: collapsed lung) within 45 days of treatment. For many physicians, this underscored both the promise and the peril of lung implants, leaving the field with unfinished business.¹^,²

It is from this backdrop that Apreo Health emerged. Founded in 2021 out of The Foundry in Menlo Park—the same incubator that had launched Emphasys years earlier—the company was built on the conviction that emphysema treatment could be reimagined. The Foundry’s leaders joined forces with physician-inventor Dr. Martin Mayse, now Chief Scientific Officer, to pursue that vision. Their ambition was not to refine what already existed, but to deliver a safer, more transformative solution for patients living with hyperinflated lungs.

The company stayed quiet at first, running feasibility trials outside the U.S. while assembling the right partners. Then, in early 2025, Apreo stepped into the spotlight. It announced a $130 million financing round co-led by Bain Capital Life Sciences and Norwest, with participation from F-Prime, Intuitive Ventures, Lightstone Ventures, and Santé Ventures. Norwest partners Suraj Shah and Zack Scott described their enthusiasm for the company within the broader momentum of interventional pulmonology, noting how tools like robotic bronchoscopy are opening new possibilities for procedural innovation. Apreo, they believed, was positioned to lead this next chapter.

At the heart of that chapter is the BREATHE Airway Scaffold, a first-in-class investigational device designed to relieve trapped air and restore function to diseased lungs. Before emerging from stealth, the company completed two feasibility studies: BREATHE-1 in Australia and BREATHE-2 in Europe. These trials enrolled 60 patients and evaluated safety, technical success, and early outcomes. The results, presented as a late-breaking abstract at the 2025 American Thoracic Society International Conference and published in the American Journal of Respiratory and Critical Care Medicine, were compelling: a 92.4% technical success rate, no pneumothorax events, and an average 753 mL reduction in residual lung volume at six months. Patients also saw meaningful improvements in lung function, exercise capacity, and quality of life. Serious adverse events like pneumonia and COPD exacerbations were observed, but notably, the hallmark complication of prior valve therapies—pneumothorax—was absent.⁴

The promise of those findings is now being tested in the pivotal BREATHE-3 trial, launched in August 2025 with the first patient treated at Temple University. Welcome to the US of A. Designed to enroll up to 250 patients across 25 global sites, the study will track outcomes for three years, seeking to confirm both the safety and durability of the scaffold. For CEO Karun Naga, the vision is clear: if successful, the BREATHE device could redefine the standard of care for patients with emphysema-related hyperinflation. For the founders and clinicians who remember the field’s earlier struggles, BREATHE-3 is more than a trial—it is a chance to finally deliver on the promise of interventional pulmonology.⁵

The Tech

At the heart of Apreo Health’s mission is the BREATHE Airway Scaffold, a permanent lung implant designed to do something that most therapies for severe emphysema have failed to achieve: safely release trapped air from hyperinflated lungs while preserving long-term durability. For patients whose lungs are chronically overinflated, every breath can feel like a battle against their own body. Conventional treatments have offered only partial answers. Endobronchial valves, for instance, depend heavily on disease distribution and collateral ventilation—meaning only a fraction of patients can benefit. Other options, like coils, airway bypass, or even surgical volume reduction, either remain experimental or come with risks and limited adoption. This landscape has left physicians with few truly effective tools, and patients with few real options.

The BREATHE scaffold was designed to address that gap head-on. A novel, helix-shaped implant, it is made of self-expanding nitinol—a flexible alloy often used in cardiovascular devices for its memory shape and durability. Delivered through a bronchoscope, the scaffold is precrimped to a 2.1-mm profile, allowing smooth navigation through the 2.8-mm working channel of a standard adult therapeutic bronchoscope. Once in place, it expands to a diameter of up to 10 mm, with a reciprocating, nonoverlapping helical coil design. Available in four lengths—55, 70, 85, and 100 mm—the device is engineered to bridge emphysematous lung tissue with the central bronchi, creating a controlled pathway for trapped air to escape during exhalation. This structural reinforcement reduces the risk of occlusion or migration, while its unique design helps resist foreign body reaction, a critical factor for long-term safety.⁶

The scaffold’s development has been accompanied by rigorous early testing. In May 2024, the U.S. Food and Drug Administration recognized its potential by granting it Breakthrough Device Designation, underscoring the urgent need for alternatives in emphysema care. Apreo’s first-in-human studies—BREATHE-1 in Australia and BREATHE-2 in Europe—represented a critical step forward. A total of 60 patients with severe emphysema, averaging 66 years old with significantly elevated residual lung volumes, were treated across 98 procedures, during which 328 scaffolds were successfully implanted. Technical success rates were high, and early outcomes encouraging: no pneumothorax cases as mentioned earlier.⁵

Clinical results went beyond procedural safety. Patients’ physiological improvements translated into real-world benefits: better spirometry results, increased exercise tolerance, higher quality of life scores, and relief from symptoms that had long defined their disease. In the spirit of unbridled transparency, it is important to highlight 21.7% of patients did experience serious adverse events related to the procedure or device—most commonly pneumonia or COPD exacerbations. That said, the BREATHE scaffold marks a serious step in the right direction as previous products drove these exacerbations in addition to pneumothoraces, the most feared complication in this space. The findings were published in the American Journal of Respiratory and Critical Care Medicine, offering the first clinical evidence that airway scaffolds could provide a safe, durable new pathway for emphysema treatment.

Taken together, the BREATHE Airway Scaffold is a platform built on lessons from past failures in the field, re-engineered to withstand the biological and mechanical demands of diseased lungs.

The Market

The chronic obstructive pulmonary disease (COPD) market is vast, entrenched, and steadily growing. Valued at $23.55 billion in 2025, it is projected to reach nearly $35 billion by 2034, fueled by air pollution exposure, occupational hazards, and stubborn smoking rates across the globe. Because COPD is not curable and requires lifelong treatment, demand for therapies—whether pharmaceutical, device-based, or rehabilitative—remains constant. Patients rely on a mix of oxygen, drugs, pulmonary rehabilitation, and immunization to manage symptoms, but no solution fundamentally alters the progressive course of disease. This has created both an immense commercial market and an unmet clinical need.⁷

Within this space, some of the world’s largest pharmaceutical companies dominate: AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Merck, and Pfizer, among others. Their therapies are primarily drug-based—long-acting bronchodilators, inhaled corticosteroids, or combination therapies—and are tailored to managing chronic bronchitis, the most prevalent COPD subtype. The emphysema segment, though smaller, is expanding quickly as patients with advanced hyperinflation face worsening symptoms and limited options. Despite decades of drug development, inhaled mucolytics, recombinant DNase, and other pharmacologic strategies have shown little promise in reversing emphysema’s core pathophysiology. This leaves an opening for interventional therapies that go beyond symptomatic relief.

Several players are pursuing that frontier. Verona Pharma, for example, spent nearly two decades developing ensifentrine, a first-in-class drug for COPD, which finally earned FDA approval in 2024 after nearly 20 clinical trials. Backed by a $650 million strategic financing deal, Verona is now scaling its launch. While ensifentrine represents a long-awaited pharmacologic advance, its focus remains on bronchodilation and anti-inflammatory effects—incremental gains compared to the structural lung changes seen in emphysema.⁹

On the device side, Intuitive has helped transform the landscape of interventional pulmonology. Its Ion robotic bronchoscopy platform has expanded physicians’ ability to reach small, peripheral lung nodules with precision. Though Ion is a diagnostic tool, its widespread adoption has helped normalize bronchoscopic procedures and “democratize access” to lung interventions, according to Norwest investors Suraj Shah and Zack Scott. This shift has created fertile ground for companies like Apreo to introduce new therapeutic platforms.⁸

This is precisely where Apreo stands apart. Rather than competing head-to-head with inhaler makers or pursuing another bronchodilator, Apreo is pioneering an implant-based therapy designed specifically for emphysema patients with hyperinflation—a group largely underserved by current treatments. Endobronchial valves, one of the few approved interventional options, have been hampered by pneumothorax rates and limited applicability based on disease distribution and collateral ventilation. Apreo’s BREATHE Airway Scaffold, by contrast, demonstrated it could significantly reduce residual volume and improve lung function without the hallmark risks of valves. If confirmed in pivotal trials, this positions Apreo not as another player in the crowded drug space, but as a first mover in a new category: durable, implant-based therapies for severe emphysema.

The competitive landscape underscores the challenge and the opportunity. Pharmaceutical giants will continue to dominate the chronic bronchitis segment, where drug regimens remain the mainstay. But in emphysema, where options remain limited and patient needs unmet, Apreo’s differentiated approach could carve out a transformative niche. If successful, the company won’t just capture market share—it could redefine what treatment looks like for millions of patients living with emphysema worldwide.⁷

The Sick

For patients living with chronic obstructive pulmonary disease (COPD), every breath is work. Damage to the lungs—whether from smoking, air pollution, or genetic causes—narrows the airways, inflames tissues, and traps air inside, leaving patients gasping, coughing, and fatigued with even the most basic activity. In the U.S. alone, more than 14 million adults have been diagnosed with COPD, and many more remain undiagnosed. The burden is uneven: women, American Indian and Alaska Native communities, and rural populations experience higher rates. COPD is the sixth leading cause of death in the country, a driver of disability, and for many, an isolating daily struggle.¹⁰

COPD has two main forms: chronic bronchitis and emphysema. Chronic bronchitis is marked by airway irritation, swelling, and mucus buildup, producing a persistent “smoker’s cough.” Emphysema, the form Apreo is targeting, destroys the delicate walls between air sacs in the lungs. Instead of inflating and deflating like balloons, these sacs lose elasticity, making it nearly impossible to push air out of the lungs. The result is hyperinflation—a feeling of suffocation that worsens with exertion. Patients describe it as living with lungs that are constantly full, like trying to breathe through a straw with no relief.

Existing treatments help manage symptoms but rarely change the trajectory of emphysema. Lifestyle changes, smoking cessation, and medications like bronchodilators or steroids can ease breathing. Pulmonary rehabilitation and oxygen therapy offer support, but not a cure. For those with advanced disease, surgery may be considered—bullectomy, lung volume reduction, or even transplantation—but these are invasive and come with major risks. Less invasive interventions, such as endobronchial valves, have become part of treatment guidelines, but their effectiveness depends on disease distribution and collateral ventilation, limiting the number of patients who can benefit. Other experimental options, like coils or airway bypass, have not demonstrated consistent, durable benefits. In short, patients and physicians have been left without a safe, reliable therapy to directly tackle hyperinflation.

This is the patient context into which Apreo’s BREATHE Airway Scaffold enters. By providing a bronchoscopically delivered, permanent pathway for trapped air to escape, the scaffold addresses the suffocating physiology of emphysema directly. Early trial results showed significant reductions in residual lung volume alongside improvements in lung function, exercise tolerance, and quality of life. For patients, this could mean fewer hospitalizations, less time tethered to oxygen, and the ability to walk, climb stairs, or simply move through daily life without constant fear of breathlessness.

COPD may still lack a cure, but if the scaffold continues to deliver on its early promise, it could reshape what it means to live with emphysema. Instead of cycling through medications, hospital visits, and invasive surgeries, patients may have access to a minimally invasive therapy that restores both lung mechanics and dignity.

The Economy

COPD is an economic handicap. In 2019, COPD-attributable medical costs in the United States were estimated at $31.3 billion, with state-level spending ranging from $44.8 million in Alaska to over $3 billion in Florida. The burden is spread across payers: private insurance covers $11.4 billion, Medicare $10.8 billion, and Medicaid $3 billion. And this is only growing—national costs are projected to nearly double to $60.5 billion by 2029.¹¹

For individual patients, the financial strain is stark. Adults with COPD incur annual medical expenditures of about $16,000 per year, compared to just over $6,000 for those without the disease. Even after adjusting for demographic and other conditions, the “excess cost” attributable to COPD averages nearly $5,000 per patient annually. These out-of-pocket costs pile up through frequent hospitalizations, long-term medications, oxygen therapy, and in many cases, expensive surgeries. For patients already facing disability and reduced ability to work, COPD can quickly drive financial ruin.

The toll extends well beyond direct healthcare spending. Caregivers—often spouses or family members—shoulder hidden costs. A recent study identified more than 220,000 informal caregivers for people with COPD, with over a third reporting health problems related to caregiving. Nearly 40% faced professional challenges, and 83% said their social and leisure activities were negatively impacted. These ripple effects translate to lost productivity, strained households, and an undercounted drag on the economy.¹³

Globally, the scale is even more sobering. Between 2020 and 2050, the macroeconomic loss from COPD is projected at $4.3 trillion, with the United States, China, and India bearing the largest absolute burdens unsurprisingly. Relative to GDP, the U.S. ranks among the hardest hit, with COPD projected to sap nearly 0.2% of national output. These losses reflect not only healthcare expenditures but also diminished labor participation and premature mortality—factors that compound across decades.¹²

Against this backdrop, the arrival of a safe, durable, and minimally invasive intervention for emphysema could have transformative economic implications. Current invasive options like lung reduction surgery or transplantation are prohibitively expensive and reserved for only the sickest patients. Endobronchial valves, though included in guidelines, are suitable for only a fraction of patients and can lead to costly complications such as pneumothorax. Apreo’s BREATHE Airway Scaffold, by contrast, is designed for broad applicability and durable effect without the high complication rates that drive downstream costs.

My Thoughts

The story of emphysema has long been stuck between knowledge and action: medicine could define the disease in detail, but therapies lagged behind, either too risky, too narrow, or too incremental. The emergence of Apreo’s scaffold signals more than just another device—it represents a shift toward tackling the suffocating mechanics of emphysema head-on, with early data suggesting both safety and real functional gains. If its pivotal trial delivers, the technology could carve out a new category in a COPD market otherwise dominated by symptom-managing drugs, reshaping not only the clinical standard of care but also the economic burden. Beyond the numbers, I see the incredible potential to transform breathlessness from a daily prison into a manageable condition, restoring independence for patients and relief for families.

To more lives saved,

Andrew

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