XI

X Therma Inc.

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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.