Origin
Solving the Hardest Sterilization Problem in Medicine
Transplant tissue must be sterile and biologically functional. PuroGen has spent its entire history proving these goals are not mutually exclusive.
The Challenge
Sterility vs. Biological Function
Gamma irradiation achieves sterility — but at the cost of the very properties that make transplant tissue work. Mechanical strength, osteoinductivity, growth factors — all degraded by the radiation dose required for sterility assurance.
The tissue processing industry has long accepted this trade-off as unavoidable. Irradiate to sterilize, accept the biological damage, and compensate with higher doses of tissue or augmented surgical techniques.
Surgeons increasingly reject this compromise. The clinical trend toward non-irradiated tissue reflects a growing understanding that preserved biological activity translates directly to better patient outcomes — faster fusion, stronger integration, reduced complications.
PuroGen recognized this from the beginning. The result is T10⁶® — a process designation built on a proprietary cold sterilization stage and the SteriFlex™ VHP platform, purpose-built to achieve terminal sterilization without biological compromise.
Heritage
Three Decades of Innovation
From foundational biomedical research to the first commercially approved non-irradiated tissue products — a timeline of invention that predates the industry's recognition of the need.
Biomedical R&D in Allograft Tissue Processing
Foundational research into sterilization methods that preserve the biological properties essential for successful transplantation outcomes.
First Cannula-Based Delivery System
Developed the first cannula-based delivery system for minimally invasive spinal fusion — translating tissue processing expertise into surgical innovation.
Allograft Implant Technologies Commercialized
Multiple allograft implant technologies brought to market including bone void fillers and spinal fusion devices. Real-world clinical validation begins.
T10⁶® — Supercritical CO₂ Sterilization
First non-irradiated supercritical CO₂ sterilization process for allograft tissue. PuroGen pioneers a method the industry wouldn't recognize for nearly two decades.
SteriFlex™ Formalized
First non-irradiated tissue products approved in both the United States and Canada. VHP-based sterilization moves from laboratory validation to regulated commercial use.
T10⁶® Technology
Where T10⁶® Began
In 2006, PuroGen invented the original T10⁶® process using supercritical carbon dioxide as the terminal sterilization stage — the first non-irradiated terminal sterilization process for allograft tissue. CO₂ pressurized beyond its critical point exhibits properties of both liquid and gas, enabling penetration into dense tissue matrices while preserving structural proteins, growth factors, and mechanical integrity.
The supercritical CO₂ implementation proved the principle. In 2010, PuroGen evolved T10⁶® to the SteriFlex™ VHP platform for production scalability — delivering equivalent or superior sterility assurance at throughput the original chamber could not support.
Same designation. Same biological preservation. Operationally scalable.
2006
PuroGen invents the first non-irradiated terminal sterilization process for allograft tissue
What T10⁶® Preserves
Clinical Impact
Validated Through Clinical Use
PuroGen-processed tissue has been used in real-world surgical applications across multiple tissue categories — providing clinical evidence that non-irradiated sterilization produces superior biological outcomes.
Bone
Cortical, cancellous, and demineralized bone matrix
Tendon
Structural allografts preserving mechanical properties
Soft Tissue
Dermal, fascia, and amniotic membrane products
SAL 10⁻⁶
Terminal sterilization achieved without irradiation
US & Canada
First non-irradiated tissue products approved in both markets
30 Years
Continuous R&D in tissue processing and sterilization
Market Position
Why It Matters Now
The tissue processing market is shifting. Surgeon preference, clinical evidence, and regulatory evolution are converging on non-irradiated solutions as the standard of care for biological tissue transplantation.
Companies entering this space today face years of development, validation, and regulatory navigation. PuroGen has already completed that journey — with the longest track record of non-irradiated tissue sterilization in the industry.
The market is arriving at where PuroGen has been for three decades.
Partner with the Pioneers of Non-Irradiated Tissue Sterilization
Whether you're developing a new tissue product, transitioning from irradiation, or exploring strategic collaboration — PuroGen brings unmatched depth and a proven platform.