Bonus BioGroup Expands Prospective Product Line

Successful Proof-Of-Concept Preclinical Study on the Development of Large Vascularized Human Bone Graft

Bonus BioGroup announces today successful results of a preclinical feasibility study on developing a large single-unit vascularized (blood vessel-containing) live human bone graft that can be attached to patients’ large blood vessels by microsurgical suturing.


The vascularized bone graft is composed of a multicellular culture originating from fat tissue obtained from the patient and other biodegradable components. It is manufactured ex vivo (outside the human body) within one to four weeks, and is intended to encourage the incorporation of the graft with the host tissue by provision of improved blood flow and nutrients.


Over recent months, Bonus BioGroup performed a series of preclinical trials to evaluate the incorporation and performance of its manufactured blood vessels. Following anastomosis (surgical connection) of the artificial vessels to native vessels in an animal limb model, the newly anastomosed vessels displayed the desired biocompatible properties and maintained the animal’s normal motor activity. Follow-up revealed normal blood flow with no leakage at the anastomosis site. Next, the Company plans to evaluate the ability of its manufactured blood vessels to provide blood supply to large bone grafts upon transplantation and until the manufactured blood vessels are naturally absorbed and replaced by endogenous ones.


This study is inapplicable to clinical trials with the Company’s injectable bone graft, as the latter consists of a large number of micron-sized bone grafts and does not require attachment to a major blood vessel for integration with the existing bone tissue.


The study takes place at the Company’s R&D center in MATAM Advanced Technology Park in Haifa and at the Surgical Wing of the Western Galilee Medical Center in Nahariya. It was awarded a grant by the Chief Scientist of the National Authority for Innovation, who reviewed its first year activities and approved support for its second year. This support will not be contingent upon payment of royalties and will be provided in addition to the Chief Scientist’s support of the Company’s R&D program.

 

Bonus BioGroup holds exclusive global rights to develop, manufacture and market large vascularized human bone grafts based on the aforementioned study, against payment of royalties to Technion Research and Development Foundation and the research institute at a rate totaling less than 3% of this product’s sales revenue.


Bonus BioGroup has so far developed two types of human live autologous bone grafts, which share common features: both are manufactured ex vivo, are grown on biodegradable scaffold carriers, 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 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 of the injection site. 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 patients since the simplified intervention requires fewer medical staff and equipment and the rehabilitation process experienced by patients is significantly hastened.