Traferox Technologies Inc. Receives FDA Clearance for the X°Port Heart Preservation System

MISSISSAUGA, Ontario, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Traferox Technologies, Inc. today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the X°Port^® Heart Preservation System, a device that enables static 10°C heart preservation during transport prior to transplantation.

“The FDA clearance of X°Port Heart marks an important milestone for Traferox and for the continued advancement of 10°C organ preservation,” said Rick Mangat, Chief Executive Officer of Traferox. “The strong clinical evidence supporting 10°C heart preservation, together with the successful adoption of 10°C preservation across leading lung transplant programs, has demonstrated the potential of this approach to improve donor organ preservation and transport. We look forward to working with transplant centers across the US to support the continued adoption of 10°C preservation in routine clinical practice”.

The clearance comes as clinical evidence supporting 10°C heart preservation continues to grow. Published, peer-reviewed evidence has linked 10°C heart preservation to improved early outcomes, including reductions in severe primary graft dysfunction and improved post-transplant survival compared to conventional ice storage¹ and other hypothermic temperatures², including in transplants involving higher-risk donor hearts.

Vanderbilt University Medical Center was the first US institution to investigate 10°C heart preservation clinically, building on the success of 10°C preservation in lung transplantation. As the largest heart transplant center in the US, Vanderbilt has since completed more than 150 procurements using 10°C preservation and reported improved outcomes despite the use of higher-risk donor hearts¹.

“10°C preservation has changed how we approach donor heart preservation,” said Dr. Ashish Shah, Surgical Director of Vanderbilt’s heart transplant program. “It is the standard in our institution for performing heart transplantation.”

X°Port Heart builds on the US commercial launch of X°Port Lung in Q3 2025, which has since been adopted by 7 of the 10 highest-volume US lung transplant centers and more than half of all lung transplant programs in the US. This growing clinical adoption reflects the demand for preservation technologies that combine strong clinical evidence with practical benefits for transplant programs.

“The introduction of X°Port Heart reflects our commitment to advancing organ preservation through technologies grounded in robust science, designed for intuitive clinical integration, and built to deliver sustainable value for healthcare systems,” said Joe Kletzel, President of Traferox. “With X°Port Heart, we are expanding that commitment to heart transplantation while building on the strong foundation established with the market leading X°Port Lung Preservation System and the newly launched TorEx Lung Perfusion System. Together, these technologies reflect our broader vision to provide transplant programs with clinically meaningful, practical solutions across the continuum of organ preservation.”

With the FDA clearance of X°Port Heart, Traferox will begin making 10°C heart preservation available to transplant centers across the United States.

IMPORTANT SAFETY INFORMATION

Indications for Use
The X°Port Heart Preservation System is indicated for static hypothermic preservation of donor hearts at 4-10°C for up to 4 hours using a del Nido (or equivalent) cold storage solution.

Contraindications
There are no known contraindications.

Please refer to the Instructions for Use for complete indications, warnings, precautions, and operating instructions.

About Traferox Technologies Inc.
Traferox Technologies, Inc. is a medical device company headquartered in Mississauga, Ontario, Canada, dedicated to advancing organ transplantation through innovative preservation and organ assessment technologies. Founded in 2021 as a spin-out of University Health Network’s Toronto General Hospital, Traferox develops and commercializes technologies that expand access to transplantation through scientifically validated, clinically practical solutions that are easy to adopt and deliver sustainable value for healthcare systems worldwide.

The company’s growing portfolio includes technologies for donor lung and heart preservation and assessment, with a mission to improve transplant outcomes and increase access to life-saving organs for patients around the world.

Disclosures
Ashish Shah is Professor and the Chair of the Department of Cardiac Surgery, Alfred Blalock Endowed Director in Cardiac Surgery, Medical Director Cardiac Surgery OR Pod & Heart Transplant Surgery, at Vanderbilt University Adult Hospital. He is also a strategic advisor to Traferox Technologies.

Media Contact
Traferox Technologies, Inc.
Media & Investor Inquiries
Email: info@traferox.com
Website: www.traferox.com

¹ Ahmad, A., et al. (2026). Improved outcomes and donor utilization in heart transplantation with 10 °C static cold storage. The Journal of Heart and Lung Transplantation, 45(8), 1229–1237. https://doi.org/10.1016/j.healun.2026.02.004
² Williams, A. M., et al. (2026). Donor heart preservation at 10 °C outperforms 4–8 °C with improved early graft function in adult heart transplantation: A Vanderbilt and Duke multicenter study. Circulation: Heart Failure. Advance online publication. https://doi.org/10.1161/CIRCHEARTFAILURE.126.014240

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4d14d97f-3105-495f-af34-3890b2c177e7