Every invention takes a team to bring it to market. It requires research and development, with a strong team carrying it through to the stage of commercialisation. The story behind BIOINVISIBLE™ is no different. With highly skilled researchers from a number of different scientific disciplines, a project team was created to work together to improve medical devices implanted in the body; BIOINVISIBLE™ was the result – a superior biocompatible coating for medical devices with the potential to render implanted devices ‘invisible’ to the body’s normal immune defences.
The world’s most advanced hyperbranched polyglycerol coating that can be applied at a commercial scale.
Current Stent Practises
The human body is well served by efficient defence mechanisms, which pose several biochemical challenges in the design of blood-contacting devices such as stents and vascular grafts, as well as non-vascular implants. Currently, medical device complications result in implant failure rates of up to 30 per cent, leaving many patients requiring additional medical intervention and surgery causing significant discomfort, morbidity or even death.
The standard practice for most stent manufacturers is to apply a dissolving layer containing a drug to bare-metal stents. These stents are called drug-eluting stents, which have been on the market for over 30 years. While this approach has improved patient outcomes it is known to lead to other complications down the line. These complications need to be managed and come at great personal costs to the patients and financial costs to the healthcare industry.
Professor Claudine Bonder (Centre for Cancer Biology, an Alliance between University of South Australia and SA Pathology) has a PhD in immunology with a particular interest in blood vasculature. She understands the importance of implanted devices to be invisible, however, this has eluded the medical device industry.
“If you were to lay out all the blood vessels in your body, they would reach over 100,000 kilometres,” says Claudine.
“Occupying such a large distance, research and development in vascular health are essential for long-term health and wellbeing of patients.”
With over 25,000 stents implanted into people each year in Australia each year and several million globally, a new concept for the next generation of stents was imperative.
The Research and Development
The initial funding that led to BIOINVISIBLE™ came via the Cooperative Research Centre for Cell Therapy Manufacturing (CTM CRC). The funded project was led by Claudine Bonder and included Professor Nico Voelcker (materials and nanotechnology engineer at the University of South Australia) to explore potential solutions to the issues around the body’s acceptance of a stent as a foreign object. The initial idea was to develop a coating that could act as an invisible cloak, stopping the defensive cells from attacking the stent, and to incorporate into the coating compounds that would help the damaged blood vessel around the stent to rapidly repair.
The first step was to make the device ‘invisible’. The addition of Dr Eli Moore to the team, a young PhD graduate focusing on the biological application of hyperbranched polyglycerol (HPG) polymers, was critical. Eli knew the potential of HPG coatings but realised that for such coatings to be commercially viable the existing approaches needed to be dramatically improved and the team was joined by Dr Glen Benveniste (vascular surgeon at Ashford Hospital).
“The traditional approach to hyperbranched polyglycerol polymers was to grow the polymer in a flask, then attach it to a surface, rather than to grow the polymer directly on the surface”, says Eli.
“I wanted to take this idea and expand it through my own research and connect with others to see what approaches would be feasible on a commercial scale.”
Eventually, a process for growing the HPG polymer directly on the surface of a stent was achieved. The process was novel, simple, environmentally friendly and easily scalable for commercial needs. Importantly, the coating was not only protective but reduced the formation of clots when applied to stents and tested in the laboratory. Two patents were lodged and have now been granted in the US and other major countries.
The second stage of the planned project was to change the HPG coating to pull in endothelial cells, naturally circulating in the blood, to the location of the stent. This would help making the stent safe. But as the new HPG coating was so effective at reducing clots, this second was not required. Focusing on a simple coating sped up development of HPG, and the final product would also reduce manufacturing costs, making it more attractive to medical device companies, and the patients.
Merging with TekCyte
Tony Simula, CEO of TekCyte, was Program Manager of the original CTM CRC project and played a vital role in explaining to the CRC Board that HPG had tremendous commercial potential and getting further funding to develop the technology. This was made easier given the commercial interest the new coating was already receiving from global device manufacturers. Their involvement in the early phase helped the team remain commercially focused and gave them an insight into the path to market for the coating technology.
“The idea of using HPG had significant possibilities to transform the current medical device coating landscape, and I didn’t want to leave the concept without exploring it fully,” says Tony.
“The research showed the ability to address the failure of implantable devices, particularly vascular stents, that can lead to blood clots and other complications.”
“When the opportunity came to provide medical device manufacturers with an alternative stent coating, it was impossible to say no.”
Driven by international medical device company interest, it was decided to continue the development of the coating technology and in-license the patent rights of the new coating into the newly formed company, TekCyte. The ‘BIOINVISIBLE’ name was soon applied to the patented HPG coating process. Tony remains the company’s CEO, which recently completed a round of capital raising to support the commercialisation of BIOINVISIBLE™. With the additional funds, TekCyte is now exploring new markets opportunities for BIOINVISIBLE™, and its unique properties, for industrial applications.
Despite BIOINVISIBLE™ being in the early stages, it is ready for clinical and commercial-scale manufacture at TekCyte’s Mawson Lakes facility. The BIOINVISIBLE™ story is yet to be finished, but it has moved into the next chapter.
