History from Initial Development to Commercialization
The basic technology, on which ReBOSSIS has been based, was initially developed by Professor Toshihiro Kasuga of Nagoya Institute of Technology (NIT) and his research team. Back in 2011, Dr. Kasuga and his team started to study on artificial bones for dental care, and contrived an artificial bone to be used for dental implantation. This artificial bone was mainly made of Calcium Chloride, Poly Lactic Acid and Silicone just like the current ReBOSSIS. The initial type of this artificial bone was based on non-woven material. Then, they developed it into fabric-based artificial bone by using electrospinning method. In this method, a solution mixed with Calcium Chloride, Poly Lactic Acid and Silicone turned into a fabric-based material. The research team made repeated trials and errors until they successfully made the fabric-based material into a cottony material of very fine fibers of micrometer in size just like ReBOSSIS. The team needed a great amount of time in determining a proper diameter and thickness of the fiber for effectively activating the growth of osteoblast.
Taking over the successful technology from NIT, we, ORTHOREBIRTH repeatedly improved the artificial bone into the current ReBOSSIS. In August, 2014, we applied to Food and Drug Administration (USA) for its authorization on ReBOSSIS. In October, 2014, we officially obtained FDA510 (k) Clearance and started to sell ReBOSSIS in the States in April, 2015.
Since then, ReBOSSIS has been getting a lot of attention from medical experts.
ReBOSSIS Experiments on Animals
In our process of making ReBOSSIS into a reliable medical product, we have repeated a lot of experiments on animals so far in Japan and other countries. This image shows the 12th month’s result of our experiment on a rabbit performed at University of New South Wales in cooperation with the university. A hole (whose diameter is 6mm and depth is 10mm) was made in a thighbone of the rabbit, and ReBOSSIS was implanted in the hole. The mixing ratio of ReBOSSIS and BMA was 1：1. As you see in the picture, new osteoblasts have grown even in 12 months after the implantation.