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Tuesday, 13 December 2016 08:06

Bonus BioGroup Announces Revolutionary Medical Breakthrough

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Bonus BioGroup Announces Revolutionary Medical Breakthrough

Successful Outcome in First Clinical Trial: Safe, Rapid and Efficient Reconstruction of Maxillofacial Bone by the Company's Injectable Live Human Bone Graft was Achieved in All Subjects

logo4footerBonus BioGroup is proud to announce that Dr. Ephraim Tzur, former head of the Oral and Maxillofacial Surgery Department of Assaf Harofeh Medical Center, who served as principal investigator in the trial and performed all procedures of the trial, presented during the 18th International Conference on Oral and Maxillofacial Surgery in Madrid, Spain, the overwhelming success achieved by the Company's unique graft in reconstructing missing bone tissues in all participating subjects.

The injectable bone graft is produced in the Company's manufacturing facility in Haifa, Israel, and is based on various cell types isolated from a fat sample collected from each subject. This population of cell types is cultivated in controlled sterile conditions on a three-dimensional scaffold. The cells and the scaffold create a construct capable of generating live human bone graft.

The first clinical trial for the reconstruction of maxillofacial bone was conducted in Israel as a Phase I/II study. Its purpose was to evaluate the safety and efficacy of the Company's first generation injectable graft in two clinical indications: (1) reconstruction and elevation of bone tissue in the maxillary sinus of the upper jawbone, and (2) void filling of bone tissue following the removal of cyst in the upper or lower jawbone.

In the first clinical trial 11 subjects underwent transplantation of the first-generation injectable live human bone graft. Subjects were 57 years old on average. The women weighed an average of 58 Kg while the men weighed an average of 82 Kg.

In terms of safety of the first-generation injectable bone graft - Full safety has been demonstrated. None of the subjects experienced adverse events nor reported any unusual symptoms.

In terms of efficacy of the first-generation injectable bone graft - Within three weeks of transplantation, all bone voids were filled with newly formed bone mass. The three-week time point marked the peak of bone height, which was subsequently maintained.

The average baseline bone height was measured 4 mm before transplantation, and approximately 19 mm on average post transplantation, which reflects a five-fold increase of the original bone height. In some cases, bone height reached up to about 25 mm following the transplantation. Two to three months post transplantation, bone tissues solidified and acquired the bone strength characteristic of natural bone.

The average volume of the injectable human bone graft utilized in the study's transplantations was 15ml, and in some cases reached up to 19ml. This compares favourably with the prevalent few ml bone cavities whose current conventional treatments are often unsuccessful.

Starting 6 months following the transplantation, metal dental implants were inserted into the subjects' jaws at the transplantation site as support to dental prosthetics. The insertion of the implants requires a minimal bone height of 10 mm. During the insertion process, bone biopsies were collected from the new bones in order to evaluate their quality. Results of all biopsies indicated that the newly emergent bone tissues were rigid, strong and fully capable of supporting the placement of metal implants.

Efficacy of the first-generation injectable bone graft was confirmed with statistical significance of >0.05, reflecting a confidence level of over 95%. This exceptionally high confidence level in the face of the small sample size of 11 subjects demonstrates that results are non-accidental, robust and repeatable in larger populations. The existing jaw bone bonded with the newly formed bone which reached a height of 15-23 mm, reflecting an average of 15 mm increase in bone height resulting from the transplantation and little statistical variance. Coupled with the high confidence level, results show that treatment with the first generation injectable human bone graft is applicable to all potential subjects requiring dental rehabilitation by dental implants regardless of age, sex and medical history.

As per the clinical protocol of the study, each subject underwent blood tests, X rays and CT scans. Results obtained were consistently normal. Long-term clinical follow-up on months 21-31 following the transplantation was carried out by the principal investigator. All subjects reported good health and complete satisfaction from the treatment.

Pending completion of the clinical trials and obtainment of required regulatory approvals, Bonus BioGroup may introduce to the multi-million worldwide bone market, a first-of-its-kind safe, rapid and efficient bone restoration modality based on a single injection of a lab-grown live human bone graft generated from subjects' own cells.

R&D efforts made alongside the conduct of the first clinical trial culminated in the second-generation injectable bone graft. 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.

On September 8, 2016, Bonus BioGroup announced successful transplantation for the first subject in the Company's second clinical trial for the repair of maxillofacial bone deficiencies employing its second-generation injectable live human bone graft. The transplantation was performed a fortnight following collection of the subject's fat sample.

Both the first and the second clinical trials for maxillofacial bone reconstruction utilize the injectable live human bone graft.

Bonus BioGroup estimates that subsequent clinical trials may be carried out over a time period shorter than that of its first clinical trial. The approval by the Israeli Ministry of Health to carry out the Company's second clinical trial for the repair of jawbone deficiencies may facilitate future approvals of the Company's pipeline clinical trials, including a study aimed at repairing orthopaedic critical gaps in the extremities.

The Company intends to register its shares for trading on a Stock Exchange in the United States in addition to being registered in the Tel Aviv Stock Exchange.

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