April 13, 2024 – At Limenbio, we are confronting one of the most critical challenges in modern medicine: the race against time to save viable organs for transplantation. For patients awaiting a lung transplant, this race is especially difficult. The current standard, static cold storage, is a passive method that often leads to organ degradation, severely limiting the number of lungs that can be successfully transplanted.
Today, we are proud to share the results of our recent experiment at the First Pavlov Medical University. This research marks a significant milestone in our journey to develop an active organ support system that extends the viability of donor lungs and improves their function after transplantation.
The Problem: Lungs collapse
Our work begins with a fundamental understanding of why lungs are so difficult to preserve. Unlike other organs, lungs are dynamic. They are not designed for passive storage; they require constant mechanical stimulation—the act of "breathing"—to prevent the collapse of their delicate internal structures. The core issue is not just storage; it's the subsequent functional impairment in the recipient. Our mission at Limenbio is to move beyond simply slowing decay. We are creating conditions that actively maintain the organ in a near-physiological state outside the body.
Our Hypothesis: An Active Alternative to Passive Storage
The prevailing protocol—flushing with a solution like Celsior and storing on ice—is a decades-old approach.
We asked a bold question: What if we could actively support the lung during preservation?
Our pilot study tested our proprietary Limenbio Gas Perfusion technology as an adjunct to the standard method. Our primary goal was to demonstrate non-inferiority over an 8-hour preservation period. We hypothesized that by periodically inflating the lungs with our specially formulated gas mixture, we could mimic natural breathing, prevent tissue damage, and ultimately, preserve function better than static storage alone.
Our Methodology: A Closer Look at the Limenbio Protocol
To test our hypothesis, we designed a rigorous ex-vivo study using a rabbit model, a critical step in translational research.
- Control Group: Lungs were preserved using the standard clinical method: flush and storage in Celsior at +4°C for 8 hours.
- Limenbio Group: After the initial flush, we connected the lungs to our prototype device. This system perfused the bronchial tree with a gasmixture using a unique cyclical algorithm: inflation to a safe pressure , followed by a passive deflation phase. This cycle continued for the full 8 hours, providing gentle, continuous support.
After preservation, we assessed the lungs' functionality by connecting them to a ventilator and perfusing them with venous blood. The ultimate test was their ability to perform gas exchange—their raison d'être. We measured the oxygen (pO₂) and carbon dioxide (pCO₂) levels in the blood before and after passing through the lung.
Our Results: Data Indicating Superior Functional Preservation
Although this was a pilot study with a limited sample size (n=3), the data we obtained is highly encouraging and validates our core technological concept.
Blood Gas Analysis Results:
Blood Gas Analysis Results:
What We Found:
Both groups effectively oxygenated the blood. However, our key finding lies in carbon dioxide clearance. The lungs preserved with our Limenbio technology showed a markedly superior ability to remove CO₂, with levels of 11.9 mmHg and 10.7 mmHg, compared to 16.5 mmHg in the control. This suggests that our method better preserves the organ's functional architecture and gas exchange efficiency. For us, this is not just a data point; it's confirmation that our approach of active gaseous support works.
Both groups effectively oxygenated the blood. However, our key finding lies in carbon dioxide clearance. The lungs preserved with our Limenbio technology showed a markedly superior ability to remove CO₂, with levels of 11.9 mmHg and 10.7 mmHg, compared to 16.5 mmHg in the control. This suggests that our method better preserves the organ's functional architecture and gas exchange efficiency. For us, this is not just a data point; it's confirmation that our approach of active gaseous support works.
Our Technology's Place in the Market
While sophisticated normothermic perfusion machines exist, they are extraordinarily complex and expensive. Our vision at Limenbio is to create a more accessible, scalable, and portable solution. The Limenbio technology is designed to be a robust enhancement to standard cold storage, not a replacement for high-end systems. We are building a platform that can be widely adopted to increase the pool of high-quality donor lungs, making transplantation more predictable and successful.
Lessons from the Frontlines and Our Roadmap
This pilot was as much an engineering test as a biological one. We identified crucial areas for refinement, including the development of universal organ adapters and an automated control algorithm for the gas cycle. We also reaffirmed the irreplaceable value of surgical skill, which will guide our training protocols for future partners.
Our path forward is clear. We are already planning independent, large-scale validation studies with leading institutions like the National Medical Research Center, using a porcine model that closely mirrors human physiology. These studies are the next critical step in bringing our technology to the clinics that need it.
Our Vision for Commercialization: An Integrated Solution
When our technology reaches the market, we will offer transplant centers a complete, integrated system. Our business model follows the proven "razor-and-blades" principle: a durable, user-friendly perfusion device paired with high-margin, single-use consumable kits. These kits will include everything needed for a procedure—sterile tubing, custom connectors, and our proprietary gas mixture—ensuring reliability, safety, and a recurring revenue stream.
Conclusion: A Future Built on Innovation
At Limenbio, we believe that the future of transplantation lies in intelligent organ support, not just simple storage. The success of this pilot study is a testament to the dedication and expertise of our team. It proves that our technology has the potential to make a tangible impact on patients' lives. For potential investors, this represents an opportunity to partner with a deep-tech company that has a validated approach, a clear technological advantage, and a scalable plan to address a multi-billion dollar global need. We are not just preserving organs; we are actively building a new standard of care in transplantation.