OneFuse is a Patented combination of demineralized cortical bone, and a carrier. The carrier, in recent studies, “demonstrated advantageous properties in tissue engineering such as formation of pathways for induction of better cell migration, better delivery of nutrients and bioactive molecules to growing cells and better removal of their wastes, thus providing a better environment for tissue regeneration.” As a result OneFuse has a unique characteristic in that it has extremely high cohesiveness while having excellent hydrophilic qualities.
OneFuse is not intended to provide structural support of the bone during the healing process and the following circumstances:• Uncontrolled diabetes
Each lot of OneFuse is tested for BMP’s and growth factors (ELISA)• Samples from the same ten lots were tested per Protocol: BMP-2 ELISA. Each donor lot was tested in triplicate
Prior to donation all donor medical/social history is screened for medical conditions or diseases that would contraindicate the donation of tissue in accordance with the current regulations established by the FDA (21 CFR 1270) and standards set forth by AATB. All donor tissue utilized for processing is provided by recovery agencies registered with the FDA and accredited by AATB. Screening criteria exceeds requirements established by the FDA and AATB.
Serological tests are performed in accordance to FDA regulations and AATB standards.
In accordance with regulations set forth by the FDA and standards by AATB, donor blood samples are collected at the time of recovery and serological testing is performed on each tissue donor (see below) by a CLIA certificed laboratory.• Antibodies to the human immunodeciency virus, type 1 and type 2 anti-HIV-1 and anti-HIV-2
Tissue cultures collected during the recovery process are tested for the following microbial contaminants:• Aerobic
Tissue processing procedures have been validated to inactivate and eliminate the following viruses:• HIV-1 - Human immunodeciency virus type 1
OneFuse has undergone and passed the following series of standard tests relating to its biocompatibility:
Is sodium salt of carboxymethyl cellulose. It is derived from cellulose, which is made water-soluble by a chemical reaction. The water-solubility is achieved by introducing carboxymethyl groups along the cellulose chain, which makes hydration of the molecule possible. CMC is used as a viscosity modifer or thickener, and to stabilize emulsions in various products. CMC is also known for its excellent water retaining capacity.
Studies have shown that porous CMC scaolds demonstrated advantageous properties in tissue engineering such as formation of pathways for induction of better cell migration, better delivery of nutrients and bioactive molecules to growing cells and better removal of their wastes, thus providing a better environment for tissue regeneration.1. HWang CM, Sant S, Masaeli M, Kachouie NN, Zamanian B, Lee SH, et al. Fabrication of three-dimensional porous cell-laden hydrogel for tissue engineering. Biofabrication. 2010;2:035003 (12 pp)
Radiographs of a rabbit spine after posterolateral lumbar arthrodesis using OneFuse
The spinal fusion models of rabbits were prepared following posterolateral intertransverse process arthrodesis bilaterally at L4-L5 section of the lumbar vertebrae. Equivalent amounts of OneFuse Plus putty and gel and the industry leading DBM (control) were implanted into each model. The ability of OneFuse to stimulate new bone formation and interbody spinal fusion as evaluated at 4, 8 and 13 weeks after implantation by conducting a longitudinal radiologic evaluation, biomechanical and histology test. The rabbits models were evaluated for radiologic findings, fusion rate, biomechanical strength and histological findings (graft material residue rate, new bone formation rate). The results indicate biocompatibility and proved a gradual density growth along with successful bone remodeling. Fusion was observed after 13 weeks in the L4-L5 section. In histological evaluation, compact one continuity was noted following a progressive activation of new osteoid tissue and bone marrow cavity formation.
OneFuse has an equivalent effect when compared to the industry leading DBM.
The study was conducted to evaluate OneFuse originating from multiple donors.
OneFuse was transplanted in the hip muscle of an athymic rat, and several histological tests were performed for evaluation of osteoinductive ability. Consequently, the recruitment of osteoblasts and osteoclasts in the sites which contribute to osteogenesis were observed. The osteoblasts which were observed in the site might be interpreted as DBM being degraded to form new bone. The results show that OneFuse has high osteoinductive capacity in a mouse model, contributing to new bone formation in bone-defective regions.