License collaborations

The Bactiguard technology is suitable for many different applications and areas of use where there is a great need for infection prevention and tissue-friendly properties. We therefore continuously explore new collaborations with partners where our technology can increase the patient benefits and hence the value of the underlying products.

Applications

The coating can be applied to most materials used for medical devices. The coating is applied to the surface by a patented wet chemical process that ensures uniformity and firm bonding to medical devices regardless of the type of product. The coating is very thin and therefore not visible to the naked eye. This also means that other properties of the medical device, such as shape and size are not affected.

Production

The production process is adaptable for new applications and can easily be scaled up. New materials are always tested since every material has a unique surface composition. Bactiguard has successfully applied the coating to several types of titanium, stainless steel, latex, silicone, polymers, ceramics and non-woven materials. Process validation is based on well-defined steps to enable repetition and reproducibility.

Standard product procedures

There are no specific packaging requirements for Bactiguard coated products, which can be sterilised using standardised methods. Nor are there any specific requirements for handling procedures or waste management.

License collaborations

On-going license businesses

BD: Foley catheters

Since 1995, Bactiguard has been a successful licensing partner with the global medical device company CR Bard, now BD (Becton Dickinson). BD acquired CR Bard in 2017 to strengthen their infection prevention. BD markets Bactiguard-coated urinary catheters under the brands Bardex IC and Lubrisil IC in the United States, Japan, UK, Ireland, Canada and Australia.

Vigilenz Medical Devices: Orthopaedic trauma implants

In 2015, Bactiguard signed a license agreement with Vigilenz Medical Devices, a Malaysian medical devices company, for orthopaedic trauma implants for Southeast Asia. Healthcare associated infections are frequent and severe for complicated bone fractures. Our partner Vigilenz Medical Devices has the right to sell orthopaedic trauma implants with Bactiguard's coating on the ASEAN markets. Clinical studies are ongoing.

The orthopaedic trauma implants with Bactiguard's coating for infection prevention became CE marked by the end of 2018 and can now be sold and used in markets that accept EU’s CE mark without further registration. The trauma implants have been classified as Class IIb, i.e. the same risk class as the underlying devices (without Bactiguard coating). 

With the new CE mark as a precedent, Bactiguard intends to establish new partnerships and enter new agreements with one or more major trauma implant manufacturers covering the rest of the world.

Smartwise Sweden AB: Injection catheters

A development project for advanced Bactiguard coated vascular injection catheters was launched in February 2017 with Smartwise Sweden AB. Smartwise has developed advanced injection systems allowing medication and other types of treatment to be delivered directly to damaged tissue in vital organs. This system also allows high doses of cytostatic to be injected into cancer tumours without toxic systemic effects.

Administering medicine and other therapies to vital organs or tumours is a complicated and sensitive form of intervention. The infection prevention and tissue friendly properties of Bactiguard’s coating can reduce the risk of infections, thrombosis and allergic reactions for these seriously ill patients.

During spring 2018, Smartwise entered a collaboration agreement with AstraZeneca, a major breakthrough for Smartwise. The product is currently in preclinical development.

Well Lead Medical: Distributor, Supplier and License partner

Well Lead is today China's largest and one of the world's leading manufacturers of medical devices such as urinary catheters and endotracheal tubes. Since 2018 Well Lead has the exclusive right to sell and distribute Bactiguard's urinary catheters (BIP Foley) in China. At the same time, the process of obtaining product approval for locally-produced urinary catheters, central venous catheters and endotracheal tubes with Bactiguard's coating is initiated. This means that, in a few years' time, Well Lead will manufacture and sell all products in Bactiguard's portfolio on the Chinese market.