BioInteractions Ltd (BIL) specialises in the development of biocompatible materials for medical devices. BIL has been able to apply its proprietary biocompatible materials technology to existing devices to enhance their compatibility in the harsh biological environment (biocompatibility), thus ensuring that the medical device provokes minimum tissue rejection.

The Company was formed in April 1991 and is based at the Innovation Centre, University of Reading. BIL’s professional team has demonstrated that products coated with its proven technology are among the best currently on the market.

BioInteractions Ltd has established collaborative programmes with major manufacturers who required the improvement in biocompatible properties of their medical devices. The collaborative programme has enabled manufacturers to:

A) maintain market share,
B) enhance market share,
C) increase product range.

Seven generic biocompatible polymers have been developed and are available for use by medical device manufacturers.

1) BIBA-POL (marketed as Haemo-Glyde Coating),
2) BIBA-SLIPCOAT,
3) BIBA-HEPCOAT (marketed as Trillium Biopassive Surface),
4) SURE-HEPCOAT
5) SLICK-HEPCOAT,
6) HEPTHANE,
7) POLYCIL. 

A major breakthrough in the development of biocompatible coatings for extracorporeal circuits has been BIBA-HEPCOAT. This coating is licensed to Avecor Cardiovascular Inc., USA, now a part of Medtronic, Inc. Avecor has marketed the coating as Trillium Biopassive Surface. The biocompatible polymer is a water-soluble polymer consisting of a non-thrombogenic component and an anti-thrombogenic component in the same polymer backbone. The coating process involves two polymers, BIBA-PRIMA and BIBA-HEPCOAT. The first functions as a primer that strongly adsorbs to the surface and has been found to coat all materials used for disposable products in cardiac surgery. BIBA-HEPCOAT is then covalently bound to the primer coat. BIBA-HEPCOAT brings together two biocompatible properties on the same polymer backbone, non-thrombogenic effect and anti-thrombogenic effect. The anti-thrombogenic activity in the polymer is achieved by incorporation of heparin. Animal and in-vitro studies have shown that BIBA-HEPCOAT is amongst best biocompatible coating on the market. The results from these studies demonstrate: -

1) relatively no loss in platelets and neutrophils,
2) relatively no activation of platelets or neutrophils,
3) platelet and neutrophil function is maintained and therefore
4) relatively low impact on blood biochemistry,
5) the absence of micro-emboli for pigs undergoing by-pass surgery with coated circuit as demonstrated by retinal angiography.

BIL believe that they will be the first to show clinical significance of biocompatible heart-lung bypass systems. European clinical trials are in progress and FDA approval has been obtained.

BioInteractions Ltd is the first UK Company to obtain FDA approval for its coating for an oxygenator.

Biomaterials Technology

BIL are able to offer to medical device manufacturers seven generic biocompatible material technologies:

• BIBA-POL is a synthetic polymer designed to be used on cardiothoracic catheters. The polymer formulation consists of three monomer components. The chemical composition of the polymer is tailored not to bind or activate white cells, platelets and proteins. This polymer is described as being non-thrombogenic. The polymer also hydrates to form an aqueous and dynamic boundary layer. This boundary layer has the ability to allow pre-formed blood clots, from the chest cavity, to simply glide out of the catheter, thereby draining the chest cavity more effectively. This polymer has been licensed to SIMS Portex, a manufacturer of cardiothoracic catheters and is marketed as Haemo-Glyde Coating.
• BIBA-SLIPCOAT is a polymer when coated onto PTCA catheters, guide wires and others, has the ability to make the device extremely smooth and slippery.
• BIBA-HEPCOAT, an extremely hydrophilic tetra-polymer. This polymer is specially designed to enhance the haemocompatibility of medical devices. The polymer contains covalently linked heparin to give the polymer non-thrombogenic and anti-thrombogenic properties.  The coating process consists of 2 steps and is carried out from water based solutions. BIBA-HEPCOAT has been licensed to a producer of extra-corporeal devices, AVECOR Cardiovascular Inc., now a part of Medtronic, Inc. The coating is marketed as Trillium Biopassive Surface.
• SURE-HEPCOAT is a heparin coating that attaches tenaciously to the surface of medical devices, including devices made from stainless steel.
• SLICK-HEPCOAT, a coating where there is a need for lubricity as well as excellent biocompatibility.
• HEPTHANE. BIL have developed advanced polyurethane’s where heparin is inherently in the polyurethane.
• POLYCIL is a novel polymer that incorporates an organic anti-microbial agent. It is effective against a wide range of spoilage organisms. The anti-microbial agent is completely bound to the polymer and therefore cannot leach out into the patient.

Expertise