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Our bodies are fascinating machines; the way they can repair themselves after injury, or become immune after infection. However even the most advanced machines have flaws. Due to our bodies’ impressive ability to protect against diseases and foreign objects, the rise in biomaterial, and in particular implanted medical devices, surgeons and patients continue to risk complications. At the same time device manufacturers are continually faced with the challenge of reducing complications by creating safer devices.

Biomaterials play a significant and vital role in modern medicine and help with the restoration and healing of patients after a disease, injury, or chronic disorder. However, with the use of certain artificial biomaterials, our bodies react in the only way it knows how, to attack the foreign object. All implanted materials are recognised by a patient’s immune system as foreign, causing cellular and tissue immune responses. If the body responds negatively to the implant, it can lead to inflammation, slowing the healing process, and even failure of the implant. In most cases the body positively responds to an implant, leading to successful biointegration. Hence, the benefits of medical devices far outweigh the risks, allowing for their continued use in today’s medical practice.

The Opportunity

The medical device industry is always seeking to enhance the current devices and improving how the body will react to them. However with so many implants on the market, it is not feasible to redesign all the products to improve their longevity in the body. Fortunately for surgeons and medical practitioners, TekCyte has spent significant time researching exactly this issue to bridge the gap between already effective products, yet improve their likelihood to succeed within the body. For example, over the last several years, TekCyte’s team and its collaborators have developed a patented coating (BIOINVISIBLE™) enabling some devices to appear invisible to the body’s defences, potentially improving the safety and extending the life of implanted devices. The potential for a universal biocompatible coating that will improve all devices is vast, but as we gain a better understanding of how our body responds to foreign material, we are seeking more targeted approaches to making better performing and safer devices.

The Coatings

Device complications may vary for different devices and their location in the body, requiring unique ways to address the issues. There are multiple options one can take when choosing the right coating for a medical device or biomedical application.

TekCyte’s expertise is built around the understanding of and ability to manipulate material surface properties and their interaction with living cells and tissue. The list below provides examples of other advanced coatings with particular biological functions that can be designed and developed by TekCyte for specific purposes. These applications extend beyond implantable devices to include medical research and discovery, diagnostics and bioprocessing.

Cell Growth

Our coatings can be designed to enhance cell growth on the surface of materials through the integration of cell-promoting biological molecules onto the surface of the product.

Cell Adhesion

Similar to cell attachment, coatings can be designed to manipulate the degree of adhesion a cell will exhibit toward the surface of a material. This is useful when transferring cells from a coated device to a location on the body, such as a wound or when the interaction of cells with a surface needs to be transient.

Cell Capture

Coatings can be created to allow for capturing targeted cells on a treated surface. Through utilising specific chemical groups for rapid conjugation of molecules, the coating can allow for chosen cells to stick to the surface.

Cell Repelling

It’s also possible to achieve the opposite effect to cell attachment/adhesion. Coatings, such as BIOINVISIBLE™, totally inhibit the adhesion of cells, and potentially proteins and/or microorganisms to the surface of a product, allowing for an easier removal of the product or to avoid detection by the body’s immune cells. Ultimately, making the product ‘invisible’ to the body.

Cell Attachment

Our coatings can be tailored to make certain cells attach to a surface that they would naturally not attach themselves to. For example, by encouraging the attachment of specific cells, research and discovery of new treatments for disease can be dramatically enhanced.

Cell Selective

Through the use of TekCyte’s BIOINVISIBLE™ coating, and with the addition of a targeted cell capture molecule (e.g., antibody, aptamer), we can create an invisible barrier with virtually no background binding of cells to the surface, apart from the cell of interest.

TekCyte’s team of biomedical researchers and materials engineers can work closely with device manufacturers and biomedical product suppliers to develop advanced coated devices and biomedical products, helping our partners to become leaders in their fields.

CYPATCH is a new contender in active wound dressings, pairing the Cymerus® cell technology to tackle major challenges in wound care, including diabetic foot ulcers (DFU). TekCyte’s CYPATCH is a proprietary surface-coating for wound dressings, optimised to deliver adult mesenchymal stem cells directly to the wound bed, accelerating the healing process. This coating technology has been exclusively licensed to Cynata Therapeutics Limited (ASX: CYP or “Cynata”).

For many patients with diabetes, wounds do not heal easily due to reduced blood flow, especially in the legs and feet. These wounds then become easily infected further delaying the healing process. With over 34 per cent of diabetic patients developing these chronic wounds, there are over half a million patients in Australia suffering from ulcers, with most occurring on their feet. If these wounds are not treated, they can lead to life threatening sepsis and/or amputation. CYPATCH is a patented coating technology developed to heal difficult wounds like DFU, by delivering stem cells to the wound, that produce a cocktail of factors to kickstart the healing process. The coating is designed to allow live cells to separate from the dressing and enter the wound, aiding with rejuvenation and the healing process, which is extremely beneficial for non-healing wounds like DFU.

For medical product manufacturing, there is a long process and timeframe from the original research to commercial product, and the story behind CYPATCH is no different. In 2013, the initial project was funded by the Cooperative Research Centre for Cell Therapy Manufacturing (CTM CRC) and led by Dr Louise Smith, former Lecturer in Advanced Materials and Research Fellow at University of South Australia. The project co-existed with a sister project, led by Professor Alison Cowin, Professor of Regenerative Medicine at the University of South Australia, that assisted with the pre-clinical testing of the wound dressing technology. The initial team was rounded off with Prof Rob Short, Post-Doctoral Researchers, Dr Giles Kirby and Dr Stuart Mills, and Plasma Physicist Dr Andrew Michelmore, all of whom are inventors on the patent.

The key to the dressing was finding the ‘sweet spot’ where the cells attached to the dressing but not too strongly that they wouldn’t come off again and enter the wound. After this initial research, the team had the building blocks needed to bring the research to clinical testing for the treatment of DFU’s, however, it required some fine tuning. Once this was successfully completed the pre-clinical testing of the new dressing in both normal and diabetic mouse models were undertaken and showed the technology had potential as a new active wound dressing.

Merging with TekCyte

With a research team who believed in the potential of the product, and armed with positive animal model data, the project was assigned to TekCyte, bringing together the original lead researchers with new medical researchers to generate commercial interest in the technology.

In 2017, a collaborative proof-of-concept study was conducted by TekCyte and Cynata, supported by CTM CRC, using Cynata’s Cymerus® cells, to see if CYPATCH would work to deliver their cells. In preclinical studies, comparing the rate of wound healing, the combination of CYPATCH plus Cymerus® cells outperformed other CYPATCH + cell combinations. With the research underway and a solid product ready for more extensive testing, the team at TekCyte and Cynata set a course to establish the manufacturing process for the combination product that would be suitable for human clinical trials.

The Clinical Trials

In 2021 Cynata licensed the CYPATCH technology from TekCyte with the aim of conducting a first-in-man trial of CYPATCH with Cymerus® cells. In December 2021, Cynata announced the commencement of the clinical trial, which aims to treat 30 adult patients with DFU, comparing CYPATCH populated with Cynata’s Cymerus® cells (CYP-006TK) with the standard care. The trial will focus on two primary outcomes. Firstly the safety of the application, and secondly the rate of healing of the wound, together with monitoring pain and quality of life at 12 and 24 weeks after treatment.

The trial will take place at Royal Adelaide Hospital and The Queen Elizabeth Hospital, Adelaide. The clinical trial will be overseen by Professor Robert Fitridge, Professor of Vascular Surgery at the University of Adelaide, and Consultant Vascular Surgeon with the Central Adelaide Local Health Network. Cynata plans to complete the trial in 2022.

With a strong potential for improving the lives of many diabetic patients suffering from DFU, the CYPATCH coating delivering Cymerus® cells is on track to becoming a game changer in the advanced wound care industry.