ACRO Biomedical has successfully developed a platform supercritical CO2 extraction technology to remove the cells, fats and non-collagenous proteins from pig skin, bone, cartilage, cornea, artery, nerve, ureter, and organs like heart, kidney, liver and pancreas, and used these decellularized tissues and organs for human tissue engineering. The skin and bone derived medical device biomaterials have received FDA approvals from Taiwan, US, Singapore, Vietnam, and Philippine. The pig cornea derived medical device is under human clinical trial in four medical centers in Taiwan.
( English provided by company. )
The DNA and amino acid sequences of the collagen from pig is 99% identical to those of collagen from human. The cells, fats and non-collagenous proteins of the tissue and organs were removes, while the intact collagen scaffolds were left as biomaterials for human therapeutic purposes. The data showed that the decellularized porcine skin and bone are excellent in human skin and bone regeneration, and no sign of immune rejection has occurred. Therefore, ACRO Biomedical decided to go for the whole pig application and make the most out of each tissue and organ from the pig, with the hope to reach the goal of whole pig circular economy.
- Tissues and organs were collected right after the pigs were slaughtered. After removing excess blood by rinsing the tissues and organs, they were then cut or ground into the desired sizes before proceeding to the supercritical extraction process. Finally, the decellularized tissues and organs were packed and gamma irradiated for sterilization and became ready-to-use medical devices.
- During the R&D stage with each product, the evaluation of the feasibility for the clinical application was performed by ACRO Biomedical and professional partners.
- Each device has to go through a series of biocompatibility tests according to ISO10993 regulation to prove its safety. And then go through the GLP certified facility to test its performance on animal model. If the device is classified as class III medical device, it has to go through human clinical trial before it can be approved by regulatory authority.
- Business model for marketing the products is to cooperate with agents and distributors, and at the same time, keep the R&D and production as key value in the company.
- ACRO Biomedical is dedicated to turning the waste tissues and organs into precious medical device products for the uses in human tissue engineering and regenerative medicine. This is an extremely high value-added business for the pig farming industry.
- The tissues and organs from one pig can be worth of ten million US dollars using our supercritical CO2 extraction process.