Oral Health and Maxillofacial Surgery

Over recent years, we have developed a three-dimensional, high-density bone graft designed to overcome the limitations associated with current bone reconstruction treatments. The graft, named BonoFillTM, is generated from the patients' adipose tissue-derived cells, and consists of a heterogeneous cell population, providing superior osteinductive properties and

promoting graft integration and de novo bone formation. Produced in Bonus Biogroup's GMP-certified clean room facility, BonoFillTM represents a potent therapeutic modality for bone repair. A phase 1/2 open label first-in-human clinical study was performed to evaluate the safety and efficacy of BonoFillTM as a bone graft for reconstructing maxillofacial bone tissue in two clinical indications:

• Bone augmentation

• Bone grafting

Eleven eligible male and female subjects aged 49-65 years were enrolled and underwent the BonoFillTM treatment. Clinical follow-up was performed throughout a period of 20-27 months and included X-rays, CT scans and biopsies collected from the transplantation site. The study was conducted in MY Medical Center, Israel, under regulatory approval and in compliance with the ICH-GCP guidelines . Results of the study demonstrate that BonoFillTM promoted fast and high quality bone tissue regeneration without complications.

There was no chronic bone infection (Osteomyelitis), no significant changes in complete blood count (CBC) and in the subject's general health. The newly-generated bone was of high density and provided stable support for dental implants. To conclude, BonoFillTM is a promising novel solution for bone repair, which will be further studied in additional clinical settings.