Bactiguard, a Swedish medical device company with a mission to increase patient safety and save lives, has entered into an exclusive, global license agreement for orthopedic trauma implants with Zimmer Biomet. The agreement includes an upfront license fee of US$ 3 million payable at signing, additional contingent payments of US$ 2 million, based on US regulatory clearance and royalties on net sales following commercialization.
Orthopedic trauma implants with Bactiguard’s infection preventive technology were CE marked in December 2018 and will be used as a reference in the process of obtaining regulatory clearance.
According to the Orthopaedic Industry Annual Report, the global orthopedics market was valued at US$ 51 billion in 2018, where the orthopedic trauma segment accounted for 14 per cent of those sales. Since 1995, Bactiguard has a successful licensing agreement with Becton, Dickinson and Company (previously C.R Bard) in the US. As a result of this successful partnership, more than 170 million Bactiguard coated Foley-catheters have been sold to date, primarily in the US and Japan.
In 2015, a license agreement for Bactiguard coated orthopaedic trauma implants, covering the ASEAN region in South East Asia, was initiated with Vigilenz Medical Devices. The implants were CE marked in December 2018 and have been approved for sales in Malaysia, where clinical evaluations are currently ongoing.
In 2017, a license agreement with Smartwise was signed in another therapeutic area, whereby drugs and other interventional therapies can be targeted and delivered to specific organs, such as the heart, lungs and the brain. This agreement generated up-front license fees of USD 2.5 million and will generate royalties when the advanced vascular injection catheters have received regulatory approval.
In 2018, a combined distribution and license agreement for China was signed with Well Lead Medical, covering the full Bactiguard product portfolio. This agreement generated initial revenues of some SEK 30 million.
The Bactiguard technology is now approved for use in the urinary tract, respiratory tract, bloodstream and on orthopaedic implants. These metal implants are intended to stay in the body for many months, up to several years and sometimes lifelong and the regulatory approval clearly shows that the technology is safe for patients.