Safety Evidence

Clinical Studies

A Skin Prick Study was performed in the US in accordance with Good Clinical Practice Standards. The single-center, monadic, one-day study enrolled 25 subjects. The study evaluated Omeza® Collagen Matrix for the potential of an immediate allergic reaction following a one-day Skin Prick Method Study. The test article, a positive control (1.0 mg/mL histamine base), and a negative control (aqueous negative control) were tested on subjects using the “Allergy Diagnostic Testing: An Updated Practice Parameter” skin prick test method. During this study, no immediate allergic reaction to the test product was observed for any subjects. Therefore, no potential allergenicity of the test product was observed under the conditions of this study.

A Human Repeat Insult Patch Test was performed in the US to Good Clinical Practice Standards. The study design was based on a modified Human Repeat Insult Patch Test. The study was single site, evaluator-blinded using a within-subject randomization design. The study had (58) subjects enrolled. Omeza® Collagen Matrix was evaluated for the potential to cause irritation and sensitization compared to that of a negative control (0.9% aqueous sodium chloride) based on a modified human repeat insult patch test. Under the conditions of this study, the test product showed to be safe for use with no side effects.

Animal Studies

Two wound healing studies were conducted to assess the implantation and the wound healing endpoints of Omeza® Collagen Matrix on porcine wounds. The first swine study compared the subject product to saline. The two products were applied to 10 full-thickness circular wound sites (approximately 3.0 cm in diameter) on four animals, with 14 and 25 day evaluations followed by pathology and independent expert review. The second swine study compared an exaggerated dose of Omeza Collagen Matrix to Hollister Endoform Dermal Template (K092096), with the products applied to 10 full-thickness circular wound sites (approximately 2.0 cm in diameter) on two animals. The final wound evaluation occurred at 24 days, followed by pathology and independent expert review. Both studies showed no evidence of impairment of wound healing with the use of Omeza® Collagen Matrix, and demonstrated that the subject product was safe and did not trigger adverse biological reactions in the animals.

Additional Testing (Bench)

  • Extrusion: Omeza performed testing on representative lots to quantify the amount of product a typical user can extrude from a vial.
  • Final Product Coverage: The time required for the product to cover 18 sq. cm – target coverage for one vial – was calculated in a simulated model.
  • Product Characterization under Environmental Conditions: Surface morphology of Omeza Collagen Matrix was imaged at varying magnifications using Scanning Electron Microscopy (SEM), to observe and confirm microscopic and macroscopic stability of the OCM structure.
  • Interaction with Wound Exudate: SEM was employed to compare the surface structure/morphology of sterile, dry OCM to OCM immersed in solutions of varying salinity concentrations, simulating moist wound exudate conditions.
  • Sterilization/endotoxins: OCM vials are sterilized using a process validated per ANSI/AAMI/ISO 11137-2. Biologic testing for sterilization validation was also performed. Endotoxin testing confirmed an acceptable level of endotoxins in the final product.
  • Viral Inactivation: Three viral inactivation studies were performed on the OCM utilizing a panel of model viruses per ISO 22442 Part 3 (Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents).
  • Shelf Life: OCM meets requirements for a 9-month shelf life, based on product tested at the end of this period passing all finished product specifications.
  • Collagen Characterization: Standard ELISA techniques were used to determine the types of collagen in OCM.
  • Lot-to-Lot Consistency: Testing of samples from representative lots demonstrated lot-to-lot consistency of all OCM raw materials.
  • Cod Liver Oil Identification and Quantification: Fatty Acid Methyl Ester analysis following AOAC 996.06 was conducted on representative lots to quantify the Cod Liver Oil (CLO) in the final product.
  • Elastic Modulus: The product”s rheological properties were evaluated by analyzing elastic modulus, with results showing that this feature of the final product is consistent across lots.
  • Extractables and Leachables: Extractables testing was completed on the OCM primary and secondary packaging system, following ISO 10993 and USP 1663. No extractable compounds were detected in the product primary packaging above the analytical evaluation threshold.
  • Final Product Specifications: Representative samples of final, sterilized OCM were analyzed for conformance to pre-defined specifications for quantity (%w/w) of collagen, pH, specific gravity, heavy metals, product structure, and bioburden.