Bactiguard-coated Zimmer Biomet trauma implants receive European regulatory clearance
Bactiguard-coated Zimmer Biomet trauma implants receive European regulatory clearance
Bactiguard-coated Zimmer Biomet orthopaedic trauma implants received European regulatory clearance and CE mark. Preparations for registering the implants in the U.S. market are also ongoing.
"I am very pleased that the CE mark has been secured for Bactiguard-coated Zimmer Biomet trauma implants. This clearance will pave the way for European market launch in 2021. At the same time, we are preparing for the submission of the U.S regulatory file," says Cecilia Edström, Bactiguard CEO.
The partnership with Zimmer Biomet has the potential to expand Bactiguard's current license business and make a substantial contribution to its recurring license revenues.
Background to Bactiguard's license agreement with Zimmer Biomet
In 2015, a partnership was initiated between Bactiguard and Vigilenz Medical Devices for Bactiguard coated orthopaedic trauma implants, covering the ASEAN region in South East Asia. The implants were CE marked in December 2018 and have been used as a reference in the process of obtaining regulatory clearance for Zimmer Biomet's trauma implants. Vigilenz Medical Devices was acquired by Bactiguard in 2020 and is now a wholly-owned subsidiary.
In September 2019, Bactiguard entered an exclusive, global license agreement for orthopaedic trauma implants with Zimmer Biomet. The agreement included an upfront license fee of USD 3 million, additional contingent payments of USD 2 million based on U.S. regulatory clearance and royalties on net sales following commercialization.
(STOCKHOLM, Jan. 21, 2021 /PRNewswire/Source: Bactiguard Holding AB {publ})
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