Process determines performance and regulatory classification.
Gratitude Therapeutics developed STA™ to meet a clear need in modern healthcare: a structural, regulation-aligned, biologically complete tissue solution purpose-built for surgery.
While many biologics are modified, repurposed, or reduced to particulate formats, STA™ is engineered to preserve what matters most– the native extracellular matrix and its signaling environment.
STA™ is manufactured using a controlled, ultra-minimally manipulated process aligned with current FDA guidance for structural tissue.
The natural 3-dimentional scaffold that provides structural integrity and supports tissue repair
Collagen, Elastin, & Other key structural proteins are maintained in their native state
Matrix-bound components inherent to native tissue are preserved within the extracellular matrix structure
STA delivers structural support while preserving the native extracellular matrix composition, consistent with original tissue characteristics
Tensile strength and continuity
Elasticity and recoil
Matrix Organization and Cellular Anchoring
Hydration and matrix support
Healing is a coordinated, multi-phase process. STA™ is designed as a structural allograft, preserving native tissue architecture consistent with its original characteristics.
Days 1 -7
Days 7-21
Weeks to Months
STA™ is classified as a Human Cell, Tissue, and Cellular & Tissue-Based Product (HCT/P) regulated solely under Section 361 of the Public Health Service Act.
Regulated solely under Section 361.
Manufactured in FDA-registered, AATB-accredited facilities under validated, controlled processes.
Designed for seamless integration into standard of care across healthcare systems.
Aligned with current FDA guidance for structural tissue, ensuring clarity and consistency.
STA™ is designed for seamless integration across specialties, settings, and workflows—delivering clincal, operational, and economic value at scale.
Easy to handle and implement across ORs and specialties without disruption.
Reduces product complexity and supports cost-effective care across the continuum.
No refrigeration. No freezing. No reconstitution. Ready off the shelf for immediate use.
Designed for consistency with a 2-3 year shelf life, supporting reliable inventory and reduced waste
361 HCT/P classification provides a clear pathway for confidence and compliance.
STA™ unifies structural support and biologic function in a single platform that is simple to adopt, easy to scale, and built to deliver what systems and patients need most.