Bonus BioGroup Announces Receipt of European GMP and International ISO-9001 Certification

 

Bonus is pleased to announce today that SWINET – Swiss Institute for Inspection, Education and Training – an EMA (European Medicines Agency)-recognized Institute for inspection and accreditation, certified Bonus BioGroup and its facilities to meet the European Good Manufacturing Practice (GMP) standard and the international ISO-9001 standard in development, production, quality assurance and supply of the Company's products for clinical trials in humans.

The Company's 1,000sqm facilities at MATAM Advanced Technology Park in Haifa comprise clean room production facilities designed for the manufacture of live human bone transplants, quality assurance laboratories and research and development laboratories.

Dr. Shai Meretzki, CEO of Bonus BioGroup, commented, "Bonus BioGroup is proud to announce international recognition of regulatory compliance in all its areas of operation, starting with the development of live human bone based on cells originating from patient's own fat tissue, through production in the Company's clean rooms and quality control measures, to supply of the final products for use in clinical trials. The Company's compliance with quality standards is another milestone towards commercialization of the Company's products".

Bonus BioGroup is currently holding a clinical trial for the repair of human facial bone deficiencies, including upper or lower jawbone deficiencies, by human bone transplants.

Bonus BioGroup’s transplants are individually manufactured for each patient from their own fat tissue. For this reason, no one graft is biologically similar to another, yet all are estimated by the Company to be histocompatible and induce full immunological tolerance by their recipient patient's body. This biological tailoring precludes the frequent phenomenon of foreign tissue rejection, typical of foreign donor tissue transplantation.