Brooklyn-based regenerative medicine company is developing a technology to recover damaged donor lungs, with a broader pipeline spanning organ transplantation.
BROOKLYN, N.Y. — Xylyx Bio, a regenerative medicine company developing bioengineered organ grafts and advanced tissue technologies, has received FDA Orphan Drug Designation for Inspirex™ Lung, its investigational human lung graft for patients requiring lung transplantation. The company also secured a $2.99 million Small Business Innovation Research (SBIR) award from the National Institutes of Health (NIH) to advance the program toward clinical evaluation.
Announced October 20, 2026, the two milestones support Xylyx’s effort to address one of transplantation medicine’s central challenges: the limited availability of viable donor organs.
Restoring Donor Lungs Through Bioengineering
Unlike approaches that aim to manufacture replacement organs entirely from cells or 3D-bioprinted structures, Inspirex Lung is designed to recover damaged human donor lungs that would otherwise be discarded.
The technology uses Xylyx’s proprietary XC™ Platform, which employs a process called xenogeneic cross-circulation. In this approach, an injured human donor lung is connected to a living pig that provides systemic physiological support while the lung remains outside the body.
The pig acts as a biological support system, supplying circulating nutrients, hormones, growth factors, and other biochemical signals while helping regulate metabolism and remove waste products. This environment is intended to support tissue recovery and restore lung function beyond what conventional isolated organ-perfusion technologies may achieve.
Importantly, the resulting graft remains a human donor organ rather than a transplanted pig lung.
The technology builds on years of preclinical research involving Xylyx scientists and academic collaborators. A 2020 study published in Nature Medicine demonstrated functional and structural recovery of injured human donor lungs following 24 hours of cross-circulation. Subsequent research, published in The Journal of Heart and Lung Transplantation in 2025, found no evidence of hyperacute rejection when rehabilitated lungs were re-exposed to human blood in an experimental transplantation model.
These studies provide encouraging evidence for the approach, although clinical safety, durability, and transplant outcomes remain to be established.
Moving Inspirex Lung Toward Clinical Evaluation
The FDA’s Orphan Drug Designation recognizes Inspirex Lung’s intended use in lung failure requiring transplantation and provides potential regulatory and development incentives.
The NIH award, administered through the National Heart, Lung, and Blood Institute, provides approximately $3 million over two years through a Direct-to-Phase-II SBIR mechanism. The funding will support translational safety and feasibility work, including planned first-in-human transplantation studies.
Xylyx is collaborating with transplant researchers at Vanderbilt University Medical Center as part of its broader development effort.
While these milestones represent progress toward clinical translation, Inspirex Lung remains investigational. Orphan Drug Designation does not constitute FDA approval, and the company has not announced a confirmed date for its first human transplant.
A Broader Pipeline of Bioengineered Organs
Inspirex Lung is the lead program within Xylyx’s broader Inspirex organ graft portfolio.
The company is also developing Inspirex Liver, which applies its cross-circulation technology to recover damaged human donor livers. Both the lung and liver programs are listed at the preclinical stage, while Inspirex Kidney and Inspirex Heart are earlier-stage programs currently listed in prototype development.
The shared objective across these programs is to increase the usable supply of human donor organs through bioengineering and physiological rehabilitation, potentially extending the impact of the company’s underlying technology across several areas of solid-organ transplantation.
Beyond Transplantation: Biomaterials and Drug Discovery
Founded in 2016, Xylyx Bio also develops technologies based on extracellular matrix (ECM), the complex biological environment that surrounds cells and helps regulate tissue structure, signaling, and function.
Through its InMatrico® platform, the company offers tissue-specific decellularized extracellular matrix products, including TissueSpec® hydrogel and coating kits derived from organs such as the lung, liver, kidney, heart, and skin. These biomaterials are designed to recreate aspects of native tissue environments for cell culture, disease modeling, organoids, and pharmaceutical testing.
Xylyx also offers disease-focused testing systems, including human pulmonary fibrosis and liver fibrosis assays, intended to help researchers evaluate therapeutic compounds in biologically relevant environments.
A separate program, ExMatrico®, develops proprietary bioactive extracellular matrix peptides known as Matrikynes®, which are being explored for regenerative signaling and tissue repair applications, including topical skin treatments.
Together, these programs position Xylyx as more than an organ-transplant developer. Its work spans engineered organ recovery, tissue-specific biomaterials, disease models, and regenerative therapeutics.
Expanding the Possibilities of Regenerative Medicine
The significance of Xylyx’s approach lies in its attempt to recover organs already available through the donor system, rather than relying entirely on the creation of new tissues or alternative organ sources.
If clinically successful, Inspirex Lung could potentially expand transplantation access by enabling the use of donor lungs currently considered unsuitable for patients.
The FDA designation and new NIH funding mark important steps in that effort, while the company’s broader portfolio illustrates how technologies rooted in tissue biology and bioengineering may contribute to both future transplant therapies and better tools for biomedical research.
Sources: Xylyx Bio announcement, October 20, 2026 · Inspirex technology · Organ graft pipeline · Nature Medicine research · InMatrico · ExMatrico
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