X-Therma Inc., a biotechnology company developing a breakthrough platform for regenerative medicine and organ preservation, has completed an oversubscribed $22.4 million Series B funding round. The investment enables X-Therma to scale global commercial operations and facilitates the company’s progression into the clinical stage with Food and Drug Administration (FDA) Breakthrough Device status, aimed at significantly increasing organ availability for transplantation by overcoming time-sensitive limitations.
The investment will advance multiple key products in X-Therma’s development pipeline: XT-Thrive® and XT-NoVoTM for regenerative medicine and cell therapy and XT-ViVo® & TimeSeal® for organ preservation for transplantation. XT-ViVo® & TimeSeal® received FDA Breakthrough Device designation, which is given to products that have the potential to offer more effective diagnosis or treatment of life-threatening diseases with an unmet medical need.
“This funding marks a pivotal moment as we prepare to launch our GMP-grade cryopreservation and cold-chain solutions into the commercial market, responding to growing demand in Cell and Gene Therapy and bioprocessing,” says Dr. Xiaoxi Wei, Ph.D., Co-founder and Chief Executive Officer of X-Therma. “It also propels us to the forefront of organ transplantation innovation, with our emerging products that could eliminate time as a critical constraint, with the potential to save millions of lives.”
“Designed as a foundational building block for living medicines, our platform promises to accelerate the development of tailored solutions for critical health care challenges and next-generation treatments,” continues Dr. Wei.
The round was co-led by new investor Starling Locke Capital, fully supported by Series A lead investor, LOREA AG, along with participation from new and existing investors.
“Despite the capital winter challenging the life sciences sector, X-Therma stands out with its exceptional resilience and potential. Finalizing its second oversubscribed round, X-Therma has clearly demonstrated its compelling value to investors and the health care ecosystem,” says Johannes Weggemann, Managing Director at LOREA AG.
“I’ve witnessed firsthand the evolution of biotech,” says the Hon. Jim Greenwood, who represented Pennsylvania’s Eighth Congressional District from 1993-2005, and served as President and CEO of the Biotechnology Innovation Organization (BIO) for 17 years. “As a member of X-Therma’s board and an investor myself, I’m confident X-Therma is poised to revolutionize organ transplantation and regenerative medicine.”
“The market’s response validates our belief in X-Therma’s technologies and their potential to revolutionize not only organ transplantation, but also to extend global organ sharing beyond what was once deemed possible,” concludes Dr. Wei. “We are ready to get our products to customers and patients and begin getting more organs to patients around the globe. You have time.”
XT-Thrive®: Advancing Regenerative Medicine and Cell Therapy
X-Therma’s XT-Thrive® enables non-toxic cryopreservation for life-saving regenerative medicines such as vaccines, cell and gene therapies, and engineered tissues. XT-Thrive® is a DMSO-free, serum-free, protein-free, and chemically defined cryopreservation media for the preservation of mammalian cells at ultra-low temperatures (-70° C to -196° C). Designed and manufactured with the utmost quality in mind, XT-Thrive® is tailored to provide high cell recovery and functionality. It is a non-toxic and hyper-effective alternative to traditional cryopreservatives and is plug and play for cell and tissue manufacturing processes.
XT-NoVoTM & TimeSeal®: A Turnkey Solution for Regenerative Medicine
X-Therma’s XT-NoVoTM non-toxic, serum- and protein-free preservation solution and TimeSeal® smart sensor tissue and cell transporter allow for a significant extension in shelf-life of precious cell-based starting materials and finalized products at sub-zero temperatures at -5°C without freezing. Biologics can be stored for up to 7 days, even certain sensitive cell types that usually exhibit a 1–2-day shelf life. This can alleviate the burden to coordinate rapid shipping of products and open the path for a cost-effective cold chain. TimeSeal® contains integrated and intelligent sensor technology that transmits real-time data not limited to temperature and location of the shipped biologics. No extras such as blood, oxygen, or external power supply are required.
XT-ViVo® & TimeSeal®: Setting New Standards in Organ Transplantation
X-Therma’s XT-ViVo® organ preservation solution and TimeSeal® Organ Transport Device could enable multi-day preservation to remove time from the equation using static storage and tried and true techniques well-practiced by every surgeon. This solution prevents damaging ice crystal formation during organ preservation at subzero temperature while supporting reduced metabolism and reduced ischemic damage to the organ. TimeSeal® is a smart, portable, and easy-to-use transporter to safely and consistently transport organs. With its smart sensor technology, the organ can be tracked during transport with optimum temperature stability. TimeSeal® doesn’t require any external power, perfusion, oxygen, or blood to keep the organs and tissues alive. The FDA designated XT-ViVo® & TimeSeal® Breakthrough Device Designation for an intended kidney preservation and storage time of up to 120 hours. The products also have the potential to be used in other organ and tissue applications.
