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TekCyte, has over the years developed collaborations with multiple companies to enhance product performance and deliver added value to their products. Our commitment to continuous improvement through specialised testing and advanced coating techniques enables our partners in the medical industry to bring truly innovative solutions to market.
This case study highlights our successful partnership with Iduron, a leader in life science research tools, in developing highly sensitive plasma-coated plates crucial for discovery research.
Iduron is a specialised glycosaminoglycan (GAG) company, providing a unique and exciting range of GAG products. These products are vital for academic research and development, as well as for the pharmaceutical industry.
Iduron’s main goal is to support the fast-growing area of GAG-based scientific research by offering a complete selection of reagents, related products, and expert guidance.
Iduron sought to develop a new generation of assay plates that would offer unparalleled sensitivity for quantifying specific growth factors. These specialised plates were aimed for critical applications primarily within discovery research, where precision and reliability are important.
While Iduron had the innovative vision for these products, they required a partner with advanced coating capabilities and a rigorous quality assurance process to help transform their concept into a high-performance, market-ready solution. The goal was to create plates that would outperform existing options in sensitivity and provide researchers with more accurate and actionable data.
We partnered closely with Iduron, leveraging our state-of-the-art facility and extensive expertise in surface modification. Our role was to further develop these specialised plasma-coated plates. Through a meticulous and controlled coating process, we applied a proprietary plasma coating designed to optimise the plate surface for the specific assay requirements.
Our collaborative approach extended beyond just application. We worked hand-in-hand with Iduron’s technical team, providing ongoing insights and conducting rigorous testing to validate the coating’s integrity, consistency, and, most importantly, its impact on assay performance.
This iterative process of coating, testing, and refining ensured that the final product not only met but exceeded the stringent sensitivity requirements set by Iduron. This level of engagement exemplifies our commitment to enhancing the value of our partners’ products through our specialised capabilities.
The collaboration between TekCyte and Iduron resulted in the successful development and commercialisation of highly sensitive plasma-coated plates. These plates are now a valuable asset for Iduron’s customers in discovery research, enabling them to quantify growth factors with a level of precision that Iduron proudly states surpasses that of competitors’ offerings.
This success is a testament to our technical capabilities and the strength of our partnership model. The plates are coated exclusively at TekCyte’s facility, and their sales are managed by Iduron through a mutually beneficial profit-sharing arrangement. This long-term, trust-based collaboration shows TekCyte’s capacity to be more than just a service provider. We often become an integral part of our partners’ value chain, contributing directly to their product’s success and market differentiation.
The Iduron case study clearly shows how TekCyte’s special coating and testing services make products even better and more useful. Our true partnership model helps us improve existing products, allowing our clients to offer market leading solutions. By working together and sharing our unique skills, we help our partners reach their business and scientific goals.
TekCyte is the partner you can trust for special coating, testing, and making your products better. We’re ready to help you improve your products and achieve even greater success in the market.
Bringing new medical devices to patients is often challenging, especially when they involve complex drug delivery. Companies often struggle to turn their ideas into working devices and produce them consistently in large numbers while keeping quality high and patients safe. This case study shows how TekCyte helps solve these common industry problems.
Our partnership with Alyra Biotech is an excellent example of our involvement in this work. Here, we successfully helped develop and manufacture their critical medical device, enabling Alyra Biotech to bring its product to the clinic and accelerate its path to market.
Alyra Biotech is a pioneering company dedicated to advancing therapeutic solutions to improving the management of pain and wellbeing in women. They approached TekCyte with a visionary concept for a medical device that required a precise drug release profile.
Alyra Biotech sought a partner with robust research and development capabilities to transform this product concept into a tangible, effective product and quality manufacturing capabilities for human clinical use.
Alyra Biotech had two main challenges to solve to make their new medical device a reality. First, they needed to design the device to release the drug exactly as required while also fitting all the required physical specifications. This meant balancing complicated drug science with practical engineering.
Second, they faced the challenge of manufacturing the device on a large scale. They needed a manual production process that could reliably create many devices of the same high quality, with patient safety in mind. Ensuring every single device was identical was crucial for using them in clinical trials.
TekCyte leveraged its strong R&D skills to help Alyra Biotech achieve its initial goal. Our team carefully tested different ways to formulate drug-release compounds. TekCyte worked closely with Alyra Biotech to refine the delivery method of the drug until it achieved the exact release profile required. This teamwork successfully turned Alyra Biotech’s complex idea into a working and effective solution.
After this, we applied our expertise in designing the manufacturing tools required to meet the exacting dimensions of the final medical device.
Thanks to this successful teamwork, TekCyte manufactured the medical device that Alyra Biotech required for its very important first Phase I clinical trial. The device worked exceptionally well, and the trial was expanded to a second Phase I trial, including even more patients.
We continue to be an essential partner for Alyra Biotech’s medical device for this larger clinical trial phase. Supporting Alyra Biotech’s growth and helping them bring new innovative treatments to patients.
TekCyte enters the second quarter of 2025 with accelerating activity across our technology portfolio, commercial partnerships and contract services. The year ahead will be shaped by global collaborations, clinical translation milestones, and the continued development of BIOINVISIBLE™ – our market-leading low-fouling, anti-infection coating technology.
Our technologies are gaining recognition across medical, industrial and research sectors, with increasing engagement from manufacturers, key opinion leaders and innovators seeking advanced surface solutions. We’re working at pace to deliver coatings that offer both clinical impact and commercial value.
BIOINVISIBLE™ continues to demonstrate its potential to address one of healthcare’s most persistent challenges: implant-associated infections. Originally developed for titanium surfaces, the coating has now proven effective on polyurethane – a critical step forward, given the prevalence of polymer-based implants and devices such as catheters, vascular grafts and pelvic/hernia mesh.
The performance of BIOINVISIBLE™ in reducing bacterial adhesion and biofilm formation positions it as a high-value innovation for orthopaedic, dental, urological and vascular applications. Biofilm-related infections, such as prosthetic joint infections, represent a growing cost burden globally, and manufacturers are actively seeking technologies to improve patient outcomes while reducing clinical risk.
TekCyte is progressing active discussions with several global orthopaedic manufacturers. These include one of the world’s top three companies in the field. TekCyte CEO Tony Simula also attended the AAOS (American Academy of Orthopaedic Surgeons) annual meeting in March to meet directly with suppliers, regulatory experts and decision-makers.
To support these pathways, TekCyte has secured new capital and is initiating laboratory and animal studies to strengthen our evidence base. These studies are expected to begin in the second half of 2025 and will underpin the next phase of product evaluation and co-development.
TekCyte is working with several suppliers of advanced analytical instruments and disposable products used in research and drug discovery applications. In collaboration with our industry partners, we aim to develop products that can improve the accuracy and sensitivity of testing instruments used for the screening of new drugs and therapies, for use in treating a range of medical conditions. Our coatings can help facilitate the search for new treatments that may one day make a difference for patients.
Beyond healthcare, the versatility of BIOINVISIBLE™ is creating new pathways in industrial applications. In collaboration with A/Prof Jingwei Hou (University of Queensland), TekCyte has demonstrated that the coating reduces fouling and improves flow rates in filtration membranes used for both water treatment and dairy protein processing.
This work has led to a collaboration with a New Zealand-based membrane manufacturer. Additional testing is scheduled to commence in Q2 2025 and could pave the way for commercial adoption in the food and water sectors.
TekCyte’s coating capabilities were highlighted in 2024 when Cynata Therapeutics (ASX: CYP) acquired the rights to our CYPATCH wound-healing coating. This followed a successful clinical trial, where the technology showed promising results with Cynata’s stem cell, Cymerus®, in accelerating wound repair in patients with diabetic-related foot ulcers (DFRU). The deal underscores TekCyte’s strength in advancing surface technologies from the lab bench to clinical application. More on this milestone is available here.
TekCyte’s contract services continue to grow as medtech companies look to fast-track development and meet clinical manufacturing requirements. Our facilities support a wide range of coating services, including production for preclinical and Phase I human clinical trials.
With a track record across multiple human clinical manufacturing campaigns, we provide a trusted environment for innovators looking to transfer their processes from the lab to a cleanroom environment suitable for Phase 1 clinical manufacture. From academic spin-outs to emerging biotech ventures, TekCyte is positioned to help turn complex ideas into manufacturable, regulatory-ready products. More information on our service offering is available here.
TekCyte, now in its eighth year of operation, continues to grow with deep technical capability and a clear commercial focus. We are delivering coating technologies that meet critical needs in infection prevention, performance enhancement and translational science. Through partnerships, scientific rigour and a solutions-driven mindset, we remain committed to supporting our partners in bringing better products to market.
If you’re a medtech innovator or manufacturer looking for coating solutions with proven performance and a path to scale, we welcome the opportunity to connect.
The increasing use of implantable medical devices has transformed healthcare outcomes across orthopaedics, dentistry, vascular and reconstructive procedures. From hip and knee replacements to vascular stents and hernia meshes, these devices restore function, improve quality of life and, in many cases extend the lives of patients.
Yet a silent threat undermines their effectiveness – biofilm on medical implants. These bacterial communities form on implant surfaces, creating chronic infections that are notoriously difficult to detect and treat. Their impact on both patient health and the healthcare system is profound.
In Australia, as elsewhere, infection and microbial biofilm are recognised as a major cause of implant failure. These infections can result in the need for corrective surgery, extended hospitalisation, and in severe cases, may lead to death. As bacteria readily form biofilms, they are nearly impossible to eradicate without removing the implant itself.
Biofilm on medical implants forms when bacteria adhere to and colonise synthetic surfaces of implants and secrete a self-protective layer. These biofilm structures are highly resistant to antibiotics and immune clearance. Medical implants, whether metallic or polymer-based, provide ideal conditions for biofilm development, making infection prevention especially challenging.
The consequences are serious and biofilms have been implicated in infections across a range of implantable devices, including:
Urinary and venous catheters
Orthopaedic implants
Dental implants
Breast implants
Hernia meshes
Vascular grafts
In orthopaedics, prosthetic joint infections (PJIs) affect approximately 1.7% of patients within two years of surgery.
In Australia alone, the estimated cost of managing PJIs exceeds AU$250 million annually.
The corresponding figure for PJI in the US is almost US$2 billion annually.
These infections often require implant removal, long-term antibiotics and reconstructive surgery. Once an infection has occurred the likelihood of another infection after the revision surgery can increased significantly. The mortality rate for PJI is around 24% five years after two-stage revision surgery.
The surfaces of most synthetic materials are hydrophobic (i.e., able to repel water) and bacteria readily attach to such surfaces. Hence, synthetic materials used in medical devices, Wwhether titanium, silicone or other polymers, attract enough bacteria to activate a biological response that promotes biofilm formation. Even under sterile surgical conditions, there is always the risk of bacteria landing on an implant.
Standard protocols like antibiotic prophylaxis and aseptic handling are critical, but alone they cannot prevent biofilm-related infections. Innovation in implant surface technologies is essential to help tackle this challenge.
In a recent interview, Angela Hewlett MD, MS, Professor of Infectious Diseases and Director of the Orthopedic Infectious Diseases Service at the University of Nebraska Medical Center, was quoted as saying:
“Prosthetic joint infections are the most dreaded complication of total joint arthroplasty [and the mortality rate after revision surgery] is on par with many concerning malignancies and other significant medical conditions.”
TekCyte’s surface coating technology, BIOINVISIBLE, offers a breakthrough approach to tackling this issue at its source. This biocompatible implant coating is drug-free and specifically engineered to form a surface barrier that prevents the attachment that leads to bacteria biofilm on medical implants.
BIOINVISIBLE creates a hyperbranched polyglycerol coating that forms a stable, ultra-thin hydrophilic film. This polymer layer is the opposite of hydrophobic (repels water), attracting water to the surface, to which bacteria find it difficult to attach and colonise (grow).
By disrupting this early-stage event, BIOINVISIBLE effectively reduces the conditions that allow biofilms to form and take hold.
Preclinical laboratory studies, using BIOINVISIBLE-coated titanium and polyurethane, demonstrate significantly lower rates of attachment of bacteria. These outcomes highlight the coating’s, effectiveness, and potential to reduce implant-related infections.
Unlike anti-microbial coatings (that either kill or stop bacteria from growing), and rely on temporary drug or chemical release, BIOINVISIBLE aims to provide long-term performance without exposure to toxic compounds. These chemicals that impact healing and cannot be used for some implants. It addresses several limitations of existing coatings, such as:
As detailed in TekCyte’s article, How BIOINVISIBLE-Coated Devices Can Reduce the Risk of Biofilm, preventing the initial adhesion of bacteria is critical in developing biofilm-resistant implants. BIOINVISIBLE addresses this challenge using a drug and antimicrobial-free coating technology designed to deliver stable, long-term protection against microbial colonisation.
BIOINVISIBLE is suitable for a broad range of implantable devices.
The coating process is scalable to meet future commercial volumes, and compatible with the most common sterilisation protocols. It has passed multiple ISO safety and biocompatibility tests, shows no cytotoxicity, and remains stable on titanium for up to three years at room temperature.
TekCyte’s manufacturing systems align to ISO13485 standards and are designed to minimise chemical waste and energy use, making the BIOINVISIBLE coating process both effecient and environmentally sustainable.
As demand for implantable medical devices continues to rise, so too does awareness of the role that biofilm on medical implants plays in infection and device failure. At the same time, growing resistance to antibiotics is reducing the effectiveness of one of the most relied-upon defences against post-surgical infection. This convergence of factors highlights an urgent need to shift focus toward preventative strategies that reduce the risk of infection from the outset.
A coordinated national approach, spanning research, clinical protocols and advanced medical device manufacturing, is essential to improve patient outcomes and reduce the long-term burden on the healthcare system.
TekCyte offers a forward-looking response to this challenge. BIOINVISIBLE’s drug- and antimicrobial-free, biocompatible coating helps prevent biofilm formation at the source, reducing reliance on antibiotics and improving the performance and longevity of implantable devices. By combining safety, durability and scalability, BIOINVISIBLE supports a future where fewer implants fail, fewer patients require revision surgeries, and healthcare systems are less burdened by cost and the growing threat of antimicrobial resistance.
(2023). BIOINVISIBLE Brochure. Retrieved from tekcyte.com/bioinvisible
(2023). How BIOINVISIBLE-Coated Devices Can Reduce the Risk of Biofilm. Retrieved from tekcyte.com
Moore et al. (2022). Hyperbranched polyglycerol coated vascular stents – a non-pharmacological approach to reducing device-triggered thrombosis and restenosis. DOI: 10.21203/rs.3.rs-1544665/v1
Australian Orthopaedic Association National Joint Replacement Registry
National Institutes of Health: Biofilms and Device-Associated Infections
Quote from , Angela Hewlett MD, MS, Professor of Infectious Diseases and Director of the Orthopedic Infectious Diseases Service at the University of Nebraska Medical Center 2024
In the field of biomedical technology, innovation and successful commercialisation are key indicators of a company’s potential. TekCyte Limited has demonstrated both, with its ground-breaking CYPATCH coating technology recently acquired by Cynata Therapeutics (ASX: CYP). This acquisition was driven by promising clinical trial results and highlights TekCyte’s capacity to develop and deliver impactful medical solutions.
As per the ASX announcement from June 2021, Cynata entered into a worldwide exclusive licence agreement with TekCyte to use this technology. Cynata then agreed to secure outright ownership of the underlying TekCyte technology utilised in CYP-006TK.
TekCyte’s CYPATCH technology, a proprietary surface modification technique, forms the core of Cynata’s CYP-006TK, a topical wound dressing for diabetic foot ulcers (DFU). This technology allows for the creation of polymer-coated dressings that effectively deliver Mesenchymal Stem Cells (MSCs) to wound sites.
Cynata completed patient enrolment in its DFU trial in April 2024. Interim analysis of the first 16 patients showed a median percentage reduction in wound surface area of 87.6% in the active CYP-006TK group, compared to 51.1% in the control group. These promising initial results, as stated by Cynata, led to their decision to acquire the patent family in July 2024.
Cynata has now announced the full data analysis and outcomes. The clinical trial results speak volumes:
Notably, the trial indicated that patients with larger wounds experienced even more significant healing with CYP-006TK. This is crucial, as larger wounds often lead to more severe complications, including amputation.
Cynata’s decision to acquire TekCyte’s CYPATCH technology is a significant endorsement of its value. As Dr. Kilian Kelly, Cynata’s CEO and Managing Director, stated:
“Ownership of this technology strengthens our intellectual property position and simplifies our commercial proposition for potential partners.”
Under the original licensing agreement, this acquisition, valued at $230,000 in Cynata shares, demonstrates Cynata’s confidence in CYPATCH’s potential. It also paves the way for future milestone payments to TekCyte as CYP-006TK meets certain development milestones.
Dr. Tony Simula, TekCyte’s CEO and Managing Director, expressed excitement about Cynata taking ownership of CYPATCH, emphasising the productive collaboration between the two companies.
This collaboration will continue as TekCyte provides ongoing support for the technology’s development, ensuring a smooth transition.
TekCyte has a history of developing and commercialising ground-breaking technologies making it a very compelling investment and corporate partner. The successful clinical trial results, the strategic acquisition by Cynata Therapeutics, and TekCyte’s ongoing industry support highlight the company’s road for future growth.
Potential investors and customers are encouraged to explore TekCyte’s portfolio and learn more about its other innovative solutions.
Adelaide-based company TekCyte is now seeking investors to fund the expansion of their revolutionary medtech BIOINVISIBLE – a drug-free medical device coating that could curb global rates of infection from implanted devices and potentially save thousands of lives each year.
Developed for commercialisation out of the Cell Therapy Manufacturing Cooperative Research Centre, based at the University of South Australia, and spearheaded by TekCyte CEO Dr Tony Simula, BIOINVISIBLE is a hydrophilic hyperbranched polyglycerol polymer that acts as a physical barrier on devices such as catheters, orthopaedic implants and stents.
During extensive laboratory testing the remarkable tech demonstrated extreme reduction in biofilm – which means it could drastically reduce infection rates associated with implanted devices. This is in addition to its demonstrated ability to reduce clots, which may reduce blood clots from certain devices like stents and heart valves.
“The World Health Organisation has identified infection as one of their top global concerns due to the growing number of antibiotic resistant bacteria and they anticipate by 2050 there will be 10 million deaths across the planet each year if something isn’t done,” Dr Simula said.
“TekCyte sees a real opportunity with BIOINVISIBLE to tackle the problem of infection from devices like catheters. Virtually every patient admitted to a hospital will have a catheter of some description inserted into their vein. Some catheters like central venous catheters (CVCs) may remain in place for many weeks and, as a result, are much more prone to infection.
“In Australia alone, there are about 4,000 bloodstream infections from CVCs each year and 20 per cent of those patients die. In 2015, this cost Medicare $36 million. In the US, there are around 250,000 infections annually from CVCs with similar death rates.
“And while there are many companies out there that have coatings to prevent biofilm, their tech relies on incorporating drugs, and this all adds to a greater risk of drug resistant bacteria. BIOINVISIBLE, on the other hand, is drug-free and can be chemically bonded to the surface of many devices.”
It’s why Dr Simula is now beelining for the world’s major medtech players, who are based out of the States and Europe, with interest already mounting from companies who produce devices such as catheters.
“Our business model is not to take a BIOINVISIBLE-coated catheter or other device to the market ourselves as that would take up to 10 years for a new company,” Dr Simula said.
“Instead, what we’re aiming to do is to partner with companies that already have a product on the market such as catheters. This reduces time to market as our partner would only need to obtain approval of a new coating on their already approved product. This also gives those companies an opportunity to differentiate from their competitors,” he said.
Dr Simula will travel to Dusseldorf’s Medica Exhibition this November – which is one of the largest medical B2B trade fairs in the world. More than 4500 exhibitors from 66 countries will be on display and an estimated 81,000 visitors from across the globe are expected to attend.
“This is a great opportunity for us to show our tech and gauge more interest in BIOINVISIBLE while showcasing its capabilities,” he said.
Dr Simula has already been working tirelessly with his talented team of eight for years, and commercialisation efforts accelerated once the world opened back up following lengthy COVID-19 lockdowns.
Last year Dr Simula, who founded TekCyte in 2018, after a rich career that spanned publicly listed and private sector biotech/medtech companies, also travelled to New York, Dubai and London for medical conferences where he was able to develop vital networks to pave the way for BIOINVISIBLE’S growth.
He was also asked to present at a Dragon’s Den Innovation Showcase – a program where entrepreneurs pitch their business ideas to a panel of key industry opinion leaders and investors as part of the Charing Cross Vascular Symposium in London.
As to why he thinks the time is now ripe for investors, Dr Simula believes interest is mounting for medtech following a world-wide slump during the pandemic – and with BIOINVISIBLE already showing a range of potential benefits that could extend beyond the medical world, he sees a bright future for this homegrown and life-saving invention.
“There is the potential for BIOINVISIBLE to be used in different ways and we’re already tweaking the chemical process to enable its application to a large number of products such as dental implants and breast implants. We’re also looking at how BIOINVISIBLE can be used to prevent surface fouling – which is the accumulation of unwanted material on solid surfaces. This means it could potentially be used to coat the filtration membranes used in water treatment,” he said.
“We’re super excited by that prospect and it means we have another market that we haven’t even tapped into yet and that’s because we haven’t had the funds and we need investor interest so we can tap into other markets.
“We have already received feedback from US-based surgeons that BIOINVISIBLE could transform the industry and, given the medical coating industry is growing at a ridiculous rate, we feel incredibly optimistic about the impact of our product and its scope.”
Dr Simula said what ultimately makes TekCyte such a special company is the clever team behind him and their unique understanding of the interplay between surfaces and tissue and their ability to change those dynamics for customers.
“Not all coating companies have that capability inhouse. Additionally, our Board are all entrepreneurs in their own right and, from a shareholder perspective, that’s important.”
TekCyte is now welcoming expressions of interest from all investors via their commercialisation partner – the Industry Commercialisation Agency at www.industrycommercialisation.com/tekcyte.
Sarah Webb | Public Relations Small and Mighty Group
Phone: +61 7 3102 4761 | E: sarah@smallmightygroup.com | W: smallmightygroup.com
Tara James | Managing Director Small and Mighty Group
M: (+61) 0409 330 073 | E: tara@smallmightygroup.com| W: smallmightygroup.com
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.
The field of biomedical science and technology has been actively working on improving vascular stents to solve problems relating to the body’s reaction to their presence. Advances in nanotechnology are leading to improved vascular stent coating materials, in some cases making the implantable medical device seem invisible to the body. This is helping vascular surgeons to carry out procedures with higher success rates and better outcomes for patients.
A stent is a small metal, wire mesh tube that is placed inside your blood vessel when it is totally or partially blocked. The stent expands the walls of the artery, keeping the blood vessel open so blood can flow through. Stent grafts, however, which are large stents with a polymer fabric lining, can be used to keep weakened or damaged arteries from bursting.
Stents and other intravascular prostheses are used on damaged or diseased vessels to treat a number of medical conditions. While stents are most often used to treat diseases that affect the arteries, such as coronary heart disease or peripheral artery disease, they can also be used to treat blocked veins caused by conditions like deep vein thrombosis (DVT), post-thrombotic syndrome and May-Thurner syndrome.
There are several types of vascular stents all with different purposes to aid a patient’s recovery from a variety of conditions. The common vascular stents are:
Coronary stents aid the arteries leading to the heart. If there is a buildup of plaque in the coronary arteries, it can reduce the blood flow to the heart, leading to blood clots, and more severe heart attacks.
Carotid artery stents help treat carotid artery disease by opening the arteries. Carotid arteries are in the neck and supply blood to the brain. With damage or plaque-blocked arteries, there is an increased risk of stroke.
The arteries in your arms and leg ensure good blood flow throughout the extremities of your body. Peripheral artery disease can lead to buildup of plaque or blood clots in these vessels causing pain and discomfort. If untreated, serious long-term complications of the disease include critical limb ischemia and amputation in very extreme cases.
Each stent category can be further separated into Drug-Eluting Stents (DES) and Bare Metal Stents (BMS).
Bare metal stents were the original stents used to treat blocked vessels, which is simply a metal stent with no coating, whereas drug-eluting stents are coated with a drug which is slowly released into the surrounding tissue.
Drug-eluting stents are more effective than bare-metal stents at reducing restenosis (the blockage of vessels), however, concerns have been raised about the long term effect of drug-eluting stents. Some early generation drug-eluting stents have a higher risk of causing stent thrombosis after implantation.
Most drug-coated stents approved for peripheral vascular disease are coated with paclitaxel, a very potent cytotoxic agent. While the drug is effective are mitigating restenosis, the implications of the drug delaying normal tissue repair are not well understood.
With drug-eluting stents under review by the U.S. Food and Drug Administration (FDA), there is a growing interest in drug-free stent coatings that can mitigate restenosis.
There is the option to move away from drug-coated stents toward biomaterials that avoid the normal reactions of the body caused by the presence of the stent.
A hydrophilic polymer coating that is bonded to the surface of a device such as a stent, while acting as an invisible barrier to the body’s defenses, could be the solution needed to tackle both thrombosis and restenosis.
TekCyte has developed a nano-scale coating technology based on a hyperbranched polyglycerol (HPG) polymer (BIOINVISIBLE™) designed for stents and other endovascular devices to appear invisible to the human body.
This type of coated vascular medical device could be a vast improvement on existing vascular stents, with potential to improve the performance, safety and durability of short- and long-term implanted devices.
The use of biomedical coatings to create better implantable devices is not restricted to vascular stents. These coating is being considered and applied to a variety of devices that are implantated into the body. TekCyte offers custom services that can integrate its BIOINVISIBLE™ coating with your implantable device. It can also investigate and design bespoke coatings that have tailored surface properties and functions, for your specific requirements.
Advances in biomedical equipment, systems and materials are opening new opportunities to create custom made biomedical coatings for the medical industry that have previously been unavailable or too expensive to consider developing for commercial applications.
"Our combined biological and biomaterials expertise means we can design ultra-thin, scalable coatings tailored to specific biomedical and medical needs and requirements," says Tony Simula, CEO at TekCyte.
Creating innovative medical devices that align with current regulations and best practices can be difficult. Custom made products can be time consuming and expensive to execute. With an individual and personalised design to achieve the desired outcome, tailor-made products can require extensive time and research to manufacture. However, with the use of biomedical coatings, medical device companies can alter the properties of their devices to suit their specific manufacturing and performance needs.
TekCyte is one medical manufacturing company that is leading the field in tailor-made coatings for a variety of applications to assist with an array of biomedical needs. Using the latest technologies, TekCyte can tailor-make coatings for medical devices and biomedical companies to create novel products for an increasingly competitive commercial landscape.
Our custom design advanced coatings that can significantly influence the behaviour and interaction of cells and living tissue with surfaces, enables us to develop any bioselective application. Once we know the nature of the desired cellular interaction with a natural or synthetic material, we can work with you to create a bioselective surface coating that performs as you would like it to. Our knowledge of the biomedical regulatory environment means that our processes are scalable and can meet international standards of quality and consistency.
Polymer coatings can be designed to enhance cell growth on the surface of many materials. This can be achieved by applying various polymer coatings alone or designing polymer coatings that allow the integration of cell-promoting biological molecules into the polymer coated surface.
Coatings can be created with specific chemical groups for rapid conjugation of biological molecules to a surface. Conjugated molecules can then be used for a range of biological applications, such as capturing target cells specifically on a treated surface.
Polymer coatings can be developed that encourage specific cells to adhere to surfaces that would not normally adhere. These surfaces can be used for extended periods (e.g. months) under culture conditions or submerged in aqueous environments.
When a very low background of non-specific binding is important; combine TekCyte’s BIOINVISIBLE™ coating with a cell capture molecule. Antibodies or aptamers can be conjugated directly onto our BIOINVISIBLE™ coating, to create a low binding surface that will only capture the cell of interest.
Coatings can be designed to manipulate the level of attachment of cells to a surface for specific conditions or environments.
Surface coatings can also be designed to reduce the adhesion of cells, proteins and/or microorganisms to the surface of a material, i.e. low-binding surfaces or low-fouling surfaces.
With its knowledge of medical manufacturing requirements, TekCyte takes a collaborative approach to partnering with medical device development companies to enhance their products. Working with national and international companies our technologies will allow the healthcare sector to offer better treatments and improved outcomes for its patients.
TekCyte has coating technologies with patents granted in Australia, United States, Europe, Japan and China, such as BIOINVISIBLE. It can create and test new biologically functional coatings for its customers or offer its own technologies, under license to create commercially-scalable custom made products. TekCyte offers this service on a project basis to suit the specific needs and requirements of the client company. This is a win-win situation for medical device and biomedical manufacturers.
This is a win-win situation for medical device manufacturers. TekCyte offers medical coating services to the market, with the expertise to create commercially-scalable custom made products
Synthetic materials are commonly rejected from the body’s natural defence mechanism. However, there is untapped potential to develop synthetic materials with the innate ability to avoid the body’s natural defence mechanisms from activating. While current materials used in devices has an acceptable level of biocompatibility, there are still resounding concerns leading to device failure. This is frequently occurring in the treatment of vessels for patients with peripheral arterial disease (PAD), where restenosis remains a significant challenge for vascular surgeons.
Eli Moore, Biomaterial Specialist at TekCyte, has recently co-authored Hyperbrancked polyglycerol coated vascular stents – a non-pharmacological approach to reducing device-triggered thrombosis and restenosis.
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Adelaide SA, 5095, Australia
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