X-Therma – a company developing a breakthrough platform for regenerative medicine and organ preservation – announced it has completed an oversubscribed $22.4 million Series B funding round. This funding round was co-led by new investor Starling Locke Capital and fully supported by Series A lead investor LOREA AG, with participation from new/existing investors.
The funding round enables X-Therma to scale its global commercial operations, and it facilitates the company’s progress into the clinical stage with Food and Drug Administration (FDA) Breakthrough Device status – which is aimed at increasing organ availability for transplantation by overcoming time-sensitive limitations.
The funding round will enable multiple key products in X-Therma’s development pipeline: XT-Thrive and XT-NoVo for regenerative medicine and cell therapy and XT-ViVo & TimeSeal for organ preservation for transplants. XT-ViVo & TimeSeal received FDA Breakthrough Device designation, which is linked to products that have the potential to offer more effective diagnosis or treatment of life-threatening diseases with unmet medical needs.
X-Therma’s XT-Thrive enables non-toxic cryopreservation for life-saving regenerative medicines like vaccines, cell and gene therapies, and engineered tissues. And 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 (ranging from -70° C to -196° C). XT-Thrive was tailored to provide high cell recovery and functionality and it is a non-toxic and hyper-effective alternative to traditional cryopreservatives and is plug and play for cell and tissue manufacturing processes.
X-Therma’s XT-NoVo is a non-toxic, serum- and protein-free preservation solution and TimeSeal smart sensor tissue and cell transporter enabling a significant extension in shelf-life of precious cell-based starting materials and finalized products at sub-zero temperatures at -5°C without freezing. And biologics can be stored for up to 7 days, even certain sensitive cell types that usually exhibit a one to two-day shelf life. This could alleviate the burden of coordinating the rapid shipping of products and open the path for a cost-effective cold chain. TimeSeal features integrated and intelligent sensor technology that transmits real-time data that is not limited to temperature and location of the shipped biologics. No extras such as blood, oxygen, or external power supply are required.
X-Therma’s XT-ViVo organ preservation solution and TimeSeal Organ Transport Device can 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 sub-zero temperatures while supporting reduced metabolism and reduced ischemic damage to the organ. TimeSeal is a smart, portable, easy-to-use transporter that transports organs safely and consistently. The organ can be tracked during transport with optimum temperature stability through smart sensor technology. TimeSeal requires no external power, perfusion, oxygen, or blood to keep the organs and tissues alive. The FDA classified XT-ViVo & TimeSeal Breakthrough Device Designation for an intended kidney preservation and storage time of up to 120 hours. These products also have the potential to be used for other organ and tissue applications.
KEY QUOTES:
“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. 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.”
“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. We are ready to get our products to customers and patients and begin getting more organs to patients around the globe. You have time.”
- Dr. Xiaoxi Wei, Ph.D., Co-founder and Chief Executive Officer of X-Therma
“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.”
- Johannes Weggemann, Managing Director at LOREA AG
“I’ve witnessed firsthand the evolution of biotech. 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.”
- Hon. Jim Greenwood, who represented Pennsylvania’s Eighth Congressional District (1993-2005) and served as President and CEO of the Biotechnology Innovation Organization (BIO) for 17 years