TekCyte’s next-generation medical device coating technology is helping to create safer and better outcomes for patients. It is anti-thrombogenic, anti-proliferative and evidence also now demonstrates extreme reduction in biofilm.
The BIOINVISIBLE™ globally patented coating technology is an ultra-thin, highly hydrophilic hyperbranched polyglycerol (HPG) polymer that can be chemically bonded to, for example, a stent or catheter surface. This provides a protective barrier against the body’s natural responses to foreign objects, making implantable devices less visible to the body’s immune system.
Stents and other vascular devices coated in this stable and drug-free coating repel accumulation of platelets, proteins, and cells. This aims to reduce complications from stents such as clotting and restenosis and therefore, be more reliable for surgeons and more durable for patients.
“We developed BIOINVISBLE to be easily applied to any existing metal stents. The coating process is scalable to meet future commercial demands, providing medical device manufacturers a reliable, safer and drug-free alternative stent.” says Dr Tony Simula, CEO at TekCyte.
More recently BIOINVISIBLE™ has also been shown to significantly reduce the risk of biofilm on coated surfaces, which could help infection or device failure caused by biofilm. Helping guard against the development of biofilm reduces the likelihood of later medical complications. At the same time, the protective qualities of this world-leading technology also enhance the durability of the medical device that the coating is applied to.
Biofilms are estimated to be responsible for more than 65% of nosocomial infections, almost 80% of chronic infections, and approximately 60% of all human bacterial infections1. Biofilm treatment is very challenging because treatment with antibiotics is often ineffective. Implants are very susceptible to the formation of biofilm, which can develop over days, or even over several months. Once established, surgical intervention to remove/replace the device/implant is the usual course of action.
The safety of any new technology is paramount and according to tests conducted at NAMSA, all studies have successfully shown no evidence of systemic toxicity, irritation, cytotoxicity, hemolysis or sensitivity associated with exposure to BIOINVISIBLE™. This shows the enormous potential of this coating technology as a platform for a range of implanted devices.
“Our research shows that BIOINVISIBLE has the potential to address complications associated with biofilm buildup, without the release of drugs or other active agents,” says Dr Simula.
In fact, TekCyte’s research has shown that catheters and cannulae coated with BIOINVISIBLE could have markedly reduced rates of biofilm from organisms such as Candidaalbicans, Pseudomonas aeruginosa and Staphylococcus aureus.
Urinary tract infections are one of the most common types of infection associated with catheters and is almost always the result of the development of biofilm. According to the Centre for Disease Control in the United States, approximately 75% of UTI’s are associated with a urinary catheter2.
Several studies have shown that opportunistic pathogenic yeast C. albicans can form polymicrobial biofilms, in vitro and in vivo, and that these biofilms can affect disease course and management. Polymicrobial biofilms such as this are often resistant to antimicrobial drugs.
Many researchers have tried to target microbial biofilms to reduce their impact on patient outcomes, however unfortunately current conventional antimicrobial strategies don’t work well to counter biofilm development.
By combating the formation of biofilm on medical devices, it helps to reduce the possibility of later complications for patients. This has long been a complex issue for health practitioners, however, we are now on the cusp of great advances thanks to the active role that BIOINVISIBLE™ can play in reducing complications from medical devices.
“It is clear that BIOINVISIBLE has significant possibilities to address current biofilm challenges and we’re excited by the prospect of working with major device companies to bring to market the first truly biocompatible medical coating” says Dr Simula.
The patented BIOINVISIBLE™ manufacturing process has been scaled up for coating stents and TekCyte is ready to meet commercial demands for the coating in this sector of the industry.
References:
- Candida albicans can form polymicrobial biofilms, in vitro and in vivo https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8894716/#B150
- Assefa M, Amare A. Biofilm-Associated Multi-Drug Resistance in Hospital-Acquired Infections: A Review. Infect Drug Resist. 2022 Aug 31;15:5061-5068. doi: 10.2147/IDR.S379502. PMID: 36068834; PMCID: PMC9441148. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9441148/
