- 44% increase in transplantable lungs with neurostimulation device (DONATE study).
- Only 33.7% of control group lungs were successfully transplanted vs. 51.1% with therapy.
- O:E ratio of 1.44 for treated donors, meaning 44% more viable lungs than predicted.
Experts agree this neurostimulation technology represents a paradigm shift in lung transplantation, significantly improving organ viability and offering hope to patients on waitlists.
New Device Boosts Donor Lung Viability, Offering Hope on Transplant Lists
BOSTON, MA – June 23, 2026 – For the thousands of patients waiting for a life-saving lung transplant, the news is often grim. Lungs are fragile, easily damaged, and are the least-utilized of all donated organs, with roughly four out of five being deemed unsuitable for transplant. This critical shortage contributes to a heartbreaking reality where patients die waiting for a call that never comes. But a technological breakthrough announced today may offer a powerful new solution to this long-standing challenge.
At the American Transplant Congress, researchers presented compelling data on a novel neurostimulation device that significantly increases the number of donor lungs available for transplant. The technology, developed by Lungpacer Medical Inc., works by restoring natural diaphragm function in brain-dead organ donors, preventing the lung damage that typically renders the organs unusable. The findings from the DONATE study suggest a potential 44% increase in transplantable lungs, a figure that could reshape the landscape of organ procurement and offer profound hope to patients on the waitlist.
The Scarcity of Breath: Why So Few Lungs Make It
The core of the transplant crisis isn't a lack of generosity from donors, but the physiological challenges that arise after brain death. When a patient is on mechanical ventilation without spontaneous breathing, the diaphragm—the primary muscle of respiration—remains inactive. This leads to a common condition called basilar atelectasis, where the lower portions of the lungs collapse like a deflating balloon. This collapse impairs oxygen exchange, leading to hypoxemia (low blood oxygen), and sets off an inflammatory cascade that further damages the delicate lung tissue.
“Roughly three out of four brain-dead donors develop basilar atelectasis, and it is one of the main reasons otherwise transplantable lungs are turned down,” said Dr. Gary F. Marklin, Chief Medical and Research Officer at Mid-America Transplant, who presented the study findings. The result is a tragic bottleneck. While the national lung allocation system has seen recent improvements with the implementation of the Composite Allocation Score (CAS) in 2023, which has reduced waitlist mortality, the fundamental problem of organ supply remains.
“For decades, we’ve had to say ‘no’ to lungs that were just on the edge of viability,” explained a senior thoracic surgeon at a major university hospital, who was not involved in the study. “A technology that can reliably pull those organs back from the brink, right inside the donor, is a paradigm shift. It could fundamentally change the numbers game for our patients.”
A Jolt of Life: Restoring Natural Physiology
Lungpacer Medical’s SupAira® system addresses this problem by going back to basics: making the diaphragm work again. The system uses a temporary, catheter-based approach to deliver small electrical impulses to the phrenic nerves, which control the diaphragm. This process, known as transvenous neurostimulation, causes the diaphragm to contract and relax in sync with the mechanical ventilator, mimicking the rhythm of natural breathing.
By restoring this muscular action, the SupAira system helps keep the lower lungs inflated, improving oxygenation and preventing the onset of atelectasis. Because it is delivered via a catheter, the technology is designed to integrate seamlessly into the complex and time-sensitive workflow of an organ procurement organization's (OPO) donor care unit.
“Every year, thousands of patients die waiting for a lung transplant while most donor lungs are never recovered, often because of atelectasis and hypoxemia that develop after brain death,” said Doug Evans, President and CEO of Lungpacer Medical. “These results show that diaphragm neurostimulation delivered by SupAira can improve respiratory care, so more lungs generously gifted by these donors are available for the patients who need them.”
The DONATE Study: Quantifying the Impact
The DONATE study provided the first concrete evidence of the system's impact in a clinical setting. The trial enrolled 50 brain-dead donors who already showed signs of lung distress. The outcomes were then compared to a carefully selected group of 176 historical control donors with similar conditions.
The results were statistically significant and clinically dramatic. Lungs were successfully transplanted from 51.1% of donors who received the neurostimulation therapy, compared to just 33.7% in the matched control group. Even more telling was the observed-to-expected (O:E) ratio, a key performance metric used by OPOs to measure organ yield. The neurostimulation group achieved an O:E ratio of 1.44—meaning it produced 44% more transplanted lungs than national risk models would have predicted. The control group's ratio was 1.10.
Dr. Marklin summarized the findings: “Transvenous phrenic nerve stimulation improved oxygenation and reduced atelectasis, allowing significantly more lungs to be transplanted... In a situation where every available lung can save a life, the potential impact on the lung donor pool is very significant and important.”
Reshaping the Transplant Ecosystem
The timing of this innovation is critical. OPOs across the United States are under intense pressure from the Centers for Medicare & Medicaid Services (CMS) to improve performance and maximize organ recovery. New federal regulations taking full effect in 2026 will hold these organizations to higher standards, creating a powerful incentive to adopt technologies that demonstrably increase the organ supply.
“The CMS performance metrics are a constant pressure,” commented one OPO administrator not affiliated with the study. “We need innovations that are not only clinically effective but also logistically feasible. A catheter-based system that integrates into our current workflow is attractive. The key will be balancing the upfront cost against the demonstrable increase in organ yield.”
The SupAira system provides an in-vivo (inside the body) reconditioning strategy, which could work in concert with existing ex-vivo (outside the body) technologies like Ex Vivo Lung Perfusion (EVLP). EVLP machines allow lungs to be assessed and improved in a sterile chamber after recovery, but SupAira aims to prevent the damage from happening in the first place. This two-pronged approach—improving lungs before recovery and reconditioning them after—could create a powerful synergy to salvage the maximum number of organs.
With this promising data from the DONATE study, the focus now shifts toward broader adoption and further research to confirm these results across the diverse national donor population. For the thousands holding out hope for a second chance at breathing, this technological advancement represents a crucial step forward.
