Xylyx Bio announces FDA Orphan Drug Designation and $2.99M NIH SBIR grant award for its lead organ graft product, Inspirex™ Lung

Inspirex™ Lung is an investigational human whole lung graft being developed to increase the supply of lungs available for transplantation

BROOKLYN, N.Y., Oct. 20, 2026 /PRNewswire/ -- Xylyx Bio, Inc., a regenerative medicine company developing bioengineered technologies for organ transplantation, tissue repair, and pharmaceutical drug development, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Inspirex™ Lung, its lead investigational candidate for the treatment of lung failure requiring lung transplantation. The company also announced it was awarded a $2.99 million Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) to support translational development and clinical evaluation of Inspirex™ Lung.

Addressing Unmet Need in Lung Transplantation

Lung transplantation can be lifesaving for patients with end-stage lung disease, yet more than 75% of donor lungs go unused, often due to acute, reversible injury. Approaches that can repair and restore donor organs could make more lungs available to the patients who need them. Xylyx Bio's proprietary XC™ Platform uses xenogeneic cross-circulation to provide systemic physiologic support to injured donor lungs to restore them to meet standard transplant criteria, resulting in Inspirex™ Lung, a human whole-lung graft for clinical transplantation.

"Patients with lung failure often die waiting for a transplant, while most donated lungs are not used," said Andrea Nye, MPH, MBA, President and Chief Executive Officer of Xylyx Bio. "Inspirex Lung is designed to address both sides of that equation by restoring injured donor lungs that would otherwise go unused to increase the number of lungs available for transplantation. Orphan Drug Designation and this NIH SBIR award represent important milestones as Xylyx advances Inspirex Lung toward first-in-human clinical studies."

FDA Orphan Drug Designation and NIH Grant Support Further Inspirex Lung Development

Xylyx Bio's translational work using xenogeneic cross-circulation for donor lung repair has been demonstrated in preclinical research published in peer-reviewed journals, including Nature Medicine and The Journal of Heart and Lung Transplantation.

FDA Orphan Drug Designation is intended to encourage the development of treatments for rare diseases or conditions affecting fewer than 200,000 people in the United States. Subject to applicable requirements, sponsors of designated products may be eligible for incentives including tax credits for qualified clinical trial expenses, exemption from marketing application user fees, and the potential for seven years of orphan drug market exclusivity following marketing approval.

The NIH Direct-to-Phase II SBIR grant award provides $2,999,266 of non-dilutive funding over two years to support safety and feasibility studies of Inspirex Lung, including first-in-human transplantation studies. Research reported in this press release is supported by the National Heart, Lung, and Blood Institute of the NIH under Award Number R44HL182545. The content of this press release is solely the responsibility of Xylyx Bio and does not necessarily represent the official views of the National Institutes of Health.

"The organ shortage crisis remains severe," said John O'Neill, PhD, Chief Scientific Officer of Xylyx Bio. "With Xylyx's xenogeneic cross-circulation platform, we're working to move beyond organ preservation and short-term assessment toward active, sustained organ repair. These milestones demonstrate our progress bringing Inspirex™ Lung into the clinic and, ultimately, closer to a new option for patients who need a lung transplant."

About Inspirex™ Lung

Inspirex™ Lung is an investigational bioengineered human lung graft designed to increase the number of lungs available for transplantation. Produced using Xylyx Bio's proprietary XC™ Platform, Inspirex Lung is created by providing systemic physiologic support via xenogeneic cross-circulation to repair injured donor lungs that would otherwise go unused, with the goal of restoring them to meet standard transplant criteria. Inspirex Lung has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of lung failure requiring lung transplantation. Inspirex Lung is investigational and has not been approved by FDA or any other regulatory authority.

About Xylyx Bio

Xylyx Bio is a regenerative medicine company developing bioengineered technologies for organ transplantation, tissue repair, and pharmaceutical drug development. The company's Inspirex™ program, built on its proprietary XC™ Platform, aims to increase the supply of organs for transplantation. Xylyx also provides disease modeling and drug testing products and services through its InMatrico™ and InOrgano™ programs to enable more physiologically relevant, predictive drug testing. For more information, visit xylyxbio.com.

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SOURCE Xylyx Bio, Inc.