Syntr Health Technologies is committed to the safety of our patients. The onus behind the non-enzymatic design of our platform is to ensure that any tissue processed using our system falls under the scope of “minimal manipulation,” as defined by the FDA.
We are seeking an HCT/P 361 class distinction which includes any tissue and/or procedure that takes place in the same operative session. Currently, our competitors use collagenase or other forms of chemicals and enzymes which exclude their methodology from this classification. Instead, these companies must file under an HCT/P 351 classification which falls under the drug/biologic category and requires an Investigational New Drug certification.
We are fully aware of the FDA’s most recent draft guidance for the Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products which falls under Title 21 of the Code of Federal Regulations (CFR) Part 1271 and the current definition of adipose tissue as an organ that “provides padding and cushioning against shocks and stores fat.”
This definition alone is hotly contested in the research community and currently, the International Federation for Adipose Therapeutics and Science is working with the FDA to broaden the definition of adipose tissue since it is well accepted among the scientific community that adipose tissue serves both structural roles such as insulation, as well as nonstructural roles such as endocrine, paracrine and hematopoietic (stem cell) functions. We are confident the FDA will adopt the broader view shared by the experts in the field of adipose tissue after they hold a hearing on the matter in September.