T&R Biofab , a regenerative medicine specialist, announced on the 8th that it has signed a licensing and exclusive sales agreement in China for the artificial scaffold for cranial reconstruction, 'TnR CFI (TnR Craniofacial Implant),' with Chinese medical device manufacturer 'Tianjin Kang'er Medical Device Co., Ltd.'
Under this agreement, TnR Biofab will collaborate with Tianjin Kang'er to jointly pursue regulatory approval for "TnR CFI" in China. Upon approval, TnR Biofab plans to utilize Tianjin Kang'er's distribution network to supply the product to local hospitals. The product has recently been patented in China.
Tianjin Kang'er is a specialized orthopedic, oral, maxillofacial, and neurosurgery medical device company that manufactures titanium and PEEK (Polyether Ether Ketone)-based bone grafting plates and screws, as well as surgical instruments. Currently, the company supplies products to hospitals across China through over 1,000 regional distributors. The Chinese government has designated it a "National High-Tech Enterprise" and a "Tianjin A-Level Medical Device Manufacturing Enterprise."
A T&R Biofab representative stated, “Based on Tianjin Kang’er’s distribution network, we have laid the foundation for ‘TnR CFI’ to enter the Chinese market. The product is currently undergoing the US FDA approval process, and we expect it to contribute to future sales expansion, focusing on China and the US.” They added, “In addition to this contract, we are also in discussions to expand distribution of hemostatic agents and foam dressing products in China.”
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