X-Therma Inc. Market Research Report
Company Overview
- Name: X-Therma Inc.
- Mission: X-Therma pioneers a breakthrough biopreservation platform, transforming “living” medicines into on demand treatments while empowering patients with access to safe, reliable organs, engineered tissues, and advanced cell & gene therapies.
- Founded By: Xiaoxi Wei, Ph.D.
- Headquarters: 625 Alfred Nobel Drive, Suite B, Hercules, CA 94547, USA
- European Office: Langer Weg 11, 6020 Innsbruck, Austria
- Key People:
- Xiaoxi Wei, Ph.D., CEO & Co-founder
- Mark Kline, Co-founder and Chief Technology Officer
- Mike Osborne, SVP of Commercial, Regenerative Medicine
- Number of Employees: No information is available
- Revenue: No information is available
- Known For: Development of non-toxic, DMSO-free cryopreservation solutions and organ preservation technologies that remove the constraints of time in organ transplantation.
Products
XT-Thrive®
- Description: DMSO-free, serum-free, protein-free, and chemically defined cryopreservation media designed for preservation of mammalian cells at ultra-low temperatures (-70ºC to -196ºC).
- Key Features:
- Non-toxic and non-genotoxic.
- Chemically defined, excludes serum and recombinant proteins.
- Optimized for high cell recovery and functionality.
- Plug and play integration for cell and tissue manufacturing.
- GMP Grade with a Drug Master File registered with the FDA.
XT-ViVo®
- Description: Non-toxic organ preservation solution with FDA Breakthrough Device Designation supporting high subzero temperature preservation up to 5 days.
- Key Features:
- Enables static storage using tried and true techniques by every surgeon.
- Prevents damaging ice crystal formation during organ preservation.
- Supports reduced metabolism and ischemic organ protection.
- Potentials for applications beyond kidneys to other organs and tissues.
TimeSeal®
- Description: A smart, portable organ transport device.
- Key Features:
- Smart sensor technology for real-time temperature and logistics tracking.
- Maintains optimum temperature stability without external power, perfusion, oxygen, or blood.
- Ensures simple and effective organ transplant workflows.
Recent Developments
Commercial Readiness and Approvals
- GMP Commercial Readiness: Achieved GMP commercial readiness with XT-Thrive® to support widespread clinical and commercial applications.
- FDA Acceptance: XT-Thrive® Drug Master File (DMF) accepted by the FDA ensuring compliance for use in biologics, gene therapy, and cell therapy sectors.
Financial Milestones
- Series B Funding: Completed a $22.4 million Series B funding round to scale global operations and progress into the clinical stage, focusing on regenerative medicine and organ transplant innovation.
Product Development
- New Solutions: XT-NoVoTM and TimeSeal® provide a turnkey solution for extending shelf-life of biologics significantly reducing logistical burdens.
- Integration in Cell Manufacturing Processes: The plug-and-play capability of XT-Thrive® facilitates scale-up of bioproduction processes with lower risk of batch variation.
Strategic Presence
- Expanded corporate presence from the San Francisco Bay Area to Innsbruck, Austria, signaling commitment to European markets.
Conclusion
X-Therma Inc. is at the forefront of truly innovative cryopreservation solutions that challenge traditional limitations in regenerative medicine and organ preservation. With robust product offerings such as XT-Thrive®, XT-ViVo®, and TimeSeal®, alongside strategic expansions and consistent advancements in regulatory and commercial readiness, X-Therma is well-positioned to redefine time-sensitive medical procedures globally.