Brooklyn, New York, U.S., October 20, 2026
Xylyx Bio, Inc. has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for Inspirex™ Lung, its investigational bioengineered human lung graft designed for patients with lung failure requiring transplantation. The company also secured a $2.99 million National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant to advance the product’s translational development and clinical evaluation. These milestones support Xylyx Bio’s efforts to address the critical shortage of transplantable donor lungs by developing a technology intended to repair injured organs that might otherwise be discarded. The funding will support safety and feasibility studies, including planned first-in-human transplantation studies, as the company works toward clinical evaluation. Inspirex Lung remains investigational and has not been approved by the FDA or any other regulatory authority.
FDA Orphan Drug Designation Supports Lung Graft Development
Inspirex Lung is being developed to increase the supply of lungs available for transplantation by restoring injured donor lungs to a condition that may meet standard transplant criteria. Lung transplantation can be lifesaving for people with end-stage lung disease, but the availability of suitable donor organs remains a significant challenge. Xylyx Bio estimates that more than 75% of donated lungs go unused, often because of acute and potentially reversible injury. The FDA’s Orphan Drug Designation is intended to encourage the development of products for rare diseases or conditions affecting fewer than 200,000 people in the United States. Eligible sponsors may qualify for development incentives, including certain tax credits for qualified clinical trial expenses, potential exemption from application user fees and, if the product is ultimately approved and applicable requirements are met, seven years of orphan drug market exclusivity. Orphan Drug Designation is not equivalent to FDA approval or clearance. Inspirex Lung must undergo the relevant regulatory and clinical evaluation to establish its safety and effectiveness before it can be marketed for transplantation. For Xylyx Bio, the designation represents an important regulatory milestone as the company prepares to advance its investigational organ graft toward human clinical studies.
$2.99 Million NIH Grant to Support Clinical Evaluation
The company has received a $2,999,266 NIH SBIR grant, awarded through the National Heart, Lung, and Blood Institute (NHLBI). The non-dilutive funding is intended to support two years of translational development, including safety and feasibility assessments and planned first-in-human transplantation studies. The research program is designed to generate evidence needed to evaluate the bioengineered lung graft and prepare for its potential clinical use. Key development priorities include assessing graft quality, safety and function, as well as determining whether repaired donor lungs can meet requirements for transplantation. The funding follows earlier preclinical research investigating Xylyx Bio’s organ-repair technology. The company has reported findings in peer-reviewed publications, including Nature Medicine and The Journal of Heart and Lung Transplantation. These studies provide scientific context for the development program, although preclinical evidence cannot establish safety or effectiveness in human transplant recipients. The NIH grant is particularly important because first-in-human transplantation requires extensive safety assessment and regulatory oversight. Future clinical studies will need to evaluate potential complications, graft performance and patient outcomes before the technology’s clinical benefits can be determined.
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XC Platform Aims to Restore Injured Donor Lungs
Inspirex Lung is produced using Xylyx Bio’s proprietary XC™ Platform, which uses xenogeneic cross-circulation to provide systemic physiological support to injured human donor lungs. The approach uses a porcine biological system to support the repair process, with the goal of restoring lung function and improving the suitability of otherwise unusable organs for transplantation. Unlike approaches focused primarily on organ preservation or short-term assessment, the technology is designed to support active organ repair. If successfully developed, it could potentially expand the pool of lungs available for patients waiting for transplantation. The approach remains experimental, and important questions about graft quality, immune responses, residual animal-derived components, infection risks and long-term function will require careful evaluation. Clinical research will be necessary to determine whether the repaired lungs can be transplanted safely and provide durable function. For Xylyx Bio, the FDA designation and NIH funding mark progress toward translating its organ-repair platform into clinical development. The next milestones will depend on the results of further safety and feasibility studies and the applicable regulatory requirements. Ultimately, Inspirex Lung aims to address a major unmet need in transplantation by making more donor lungs potentially usable. Its clinical value will depend on whether future studies demonstrate that the technology can reliably produce safe, functional grafts and improve access to life-saving lung transplantation.
Source: Xylyx Bio press release
