Bonus BioGroup Receives Israeli Ministry of Health Approval for Clinical Trial Testing Second Generation Injectable Human Bone Graft for Maxillofacial Repair

Bonus BioGroup announces Israeli Ministry of Health approval to carry out a clinical trial with its second-generation injectable human bone graft for the repair of maxillofacial bone loss.
The approved clinical trial, the second to be held by Bonus BioGroup, is a Phase I/II study designed to evaluate the safety and efficacy of the Company's second-generation graft in the treatment of lower and upper jawbone deficiencies. The study will take place in Israel and will include up to 20 participants, men and women aged 18-70. As per the Ministry's instructions, the clinical follow up for each participant will last 6 months from treatment.
The Company's first clinical trial, which utilized its first generation product, is in final stages of clinical data processing and statistical analyses.
The current approval is believed to facilitate future approvals by the Israeli Ministry of Health of the Company's forthcoming clinical studies, which may be carried out over a time period shorter than that of the first clinical trial. One such study for the repair of critical gaps in the extremities – hands, feet, arms and legs – is now being prepared and is planned to employ the second-generation graft.
Compared to its first generation counterpart, the second-generation graft was developed to exhibit enhanced properties, including shorter manufacturing period, reduced manual processing, lower manufacturing costs and suitability for mass production. Representing yet another innovative product developed by Bonus, the second-generation graft, now syringeable and injectable, includes a large amount of autologous living cells in the quantities required for the augmentation of each patient's bone deficiency. The graft is transported from the Company's manufacturing facility to the medical center performing the transplantation in a ready-to-use syringe. The new injectable modality may prove a great benefit to the medical system as well as to the patient as the reduced complexity of the intervention requires fewer medical staff and equipment and the rehabilitation process experienced by the patient is significantly hastened.
The Company estimates that its live human bone graft demonstrates qualities superior to any other non-living bone graft. Since the manufactured grafts originate from and return to the same patients, the Company believes that they will be fully integrated and immunologically tolerated by patients. Upon introduction of Bonus BioGroup’s grafts into patients’ bodies, the biological identity of the transplants is expected to be recognized by the patients’ immune system. Thus the common immunological response and rejection typical of foreign donor tissue transplantation are anticipated to be prevented.