Bonus BioGroup to Hold Pre-IND Meeting with FDA Focused on Proposed Clinical Trial in the US

Bonus BioGroup reports a Pre-IND (Preliminary Investigational New Drug) meeting to be held in December 2015 with the Food and Drug Administration (FDA) in order to discuss the development of the Company’s live human bone graft as treatment for craniomaxillofacial bone deficiencies. This meeting precedes submission of a full IND (Investigational New Drug) application.
As preparation for the meeting, Bonus BioGroup provided the FDA with a briefing package containing information on the biological properties and quality of the Company's product. Following the meeting, a comprehensive application will be submitted to the FDA to allow Bonus BioGroup to conduct a clinical trial for the repair of craniomaxillofacial bone deficiencies in the US.
In April 2014, Bonus BioGroup commenced a clinical trial designed to test the safety and efficacy of its product in the repair of upper and lower jawbone defects by the Company's live human bone graft.
The clinical trial for the repair of craniomaxillofacial bone deficiencies is aimed at evaluating the safety and efficacy of Bonus BioGroup's live human bone graft across all craniomaxillofacial bone lacks, and will not be limited to the upper or lower jawbone. Broadening the array of clinical indications may expand the treatment options available to potential patients and cover more complex medical conditions.
Within the clinical trial for the repair of upper and lower jawbone defects, the Company utilized for the first time its injectable graft. This modality facilitates the surgical procedure by reducing the number and complexity of the required intervention and also hastens the rehabilitation process experienced by the patient.
Within the clinical trial for the repair of craniomaxillofacial bone deficiencies, the Company plans to employ its second generation injectable graft, which was developed to exhibit enhanced properties, including shorter manufacturing period, reduced manual processing, lower manufacturing costs and suitability for mass production.