Biological evaluation of Evolvecomp composite materials (GF40PLD96, GF40PLD85, GF40PLG85)

Evolvecomp composite materials were tested for cytotoxicity, irritation or intracutaneous reactivity, sensitization, acute systemic toxicity, and genotoxicity (medical device
composed of Evolvecomp composite materials). An implantation study included the endpoints of material-mediated pyrogenicity, and systemic toxicity
(subacute/chronic).

Biocompatibility study for bioresorbable natural mineral fiber composites long-term effects:

Rabbit study with 26 weeks results; injection molded and continuous natural mineral fiber pin with standard negative control article (HD-PE).

4 weeks micro-CT:  cortex already closing.

13 weeks micro-CT:  bone growing around the implants

No difference in histology between the test articles and negative control.

Biocompatibility study for bioresorbable natural mineral fiber composites long term effects:

Dog study with 52 weeks results; continuous natural mineral fiber pin with reference pin without natural mineral fibers.

Natural mineral fiber composite at 6 weeks (A) and 12 weeks (B): Osseointegration and no fibrous capsule from 12 weeks ->

NB: new bone ; FM: fibrous tissue ; Os: Osseointegration

Significantly improved bone growth around natural mineral fiber composite.

Biocompatibility test for Evolvecomp™ composite materials. Testing conducted by NAMSA and Eurofins.

Evolvecomp™  material tested in the customer’s product biocompatibility tests.