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Monday, 01 August 2016 08:08

Enrolment of First Three Subjects in Second Clinical Trial

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One Week Following Receipt of Required Approvals for Second Clinical Trial

Bonus BioGroup Enrols First Three Subjects in Clinical Trial with Second Generation Live Injectable Bone Graft for Repair of Maxillofacial Deficiencies

logo4footerBonus BioGroup announces today enrolment of three subjects in its second clinical trial for the repair of maxillofacial bone loss. Upon completion of all preliminary tests confirming the subjects' eligibility to participate in the trial, fat samples will be collected and transferred to the manufacturing facility. Approximately one month later, the first transplantation of the Company's second generation live injectable bone graft will be performed.

This second clinical trial is a Phase I/II study designed to evaluate the safety and efficacy of the Company's second-generation injectable graft in the treatment of lower and upper jawbone loss. 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, although the Company may prolong this period.

Bonus BioGroup developed two types of bone grafts which share common features: both are manufactured ex vivo (outside the human body), are grown on biodegradable scaffold carrier, consist of various cell types isolated from the patient's own fat sample, and are three-dimensional. However, they

differ from one another in size and consistency: 
1. The solid single-unit live bone graft is predesigned in shape and size to precisely match the missing bone tissue;
2. The injectable single-unit live bone graft consists of thousands of micro-grafts which integrate into and augment the patient's natural bone tissue, albeit possible shape complexities. The injectability of this graft and its ability to carry an unlimited number of micro-grafts facilitate the surgical intervention.

The injectable bone graft is transported from the Company's manufacturing facility to the medical center performing the transplantation in a ready-to-use syringe. The injectable modality may prove a great benefit to the medical system as well as to the patient as the simplified intervention requires fewer medical staff and equipment and the rehabilitation process experienced by the patient is significantly hastened.

Compared to its first generation counterpart, the second-generation injectable graft exhibits enhanced properties, including shorter manufacturing period, reduced manual processing, lower manufacturing costs and suitability for mass production.

Of note, both types of bone grafts, the solid and the injectable, are manufactured in the Company's manufacturing facility as live autologous human bone tissue; both comprise of various cell types, and do not consist of non-living bone granules. Bonus BioGroup estimates that its live human bone grafts demonstrate 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.

The Company's first clinical trial, which utilized its first generation injectable bone graft, is in final stages of clinical data processing and statistical analyses.

The Company performed preclinical testing of both types of bone grafts. However its first clinical trial was performed solely with the injectable bone graft, and so will its second. Bonus BioGroup estimates that the current clinical trial may be carried out over a time period shorter than that of its first clinical trial. 
The approval by the Ministry of Health to carry out the Company's second clinical trial for the repair of jawbone deficiencies may facilitate future approvals by the Israeli Ministry of Health of the Company's pipeline clinical trials, including a study aimed at repairing orthopaedic critical gaps in the extremities, with the second generation injectable bone graft.

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