The novel technology that forms the basis of Oxtex’s self-inflating tissue expander devices was created when two plastic surgeons in Oxford sought help from scientists to solve a problem.

The difficulty was that, in many reconstructive surgical procedures, there is simply not enough surrounding soft tissue available to carry out the reconstruction.

Tim Goodacre and Marc Swan, consultant plastic and reconstructive surgeons at the John Radcliffe Hospital, were working with the Spires Cleft Centres when they had the idea to develop a medical device to use in the treatment of congenital disorders, particularly cleft palate where traditional methods of skin expansion were not suitable.

They felt that a simple, effective, low-cost device could be developed to give better long-term outcomes and improve a patient’s quality of life. It could also have a significant social impact in the developing world where the treatment for children born with congenital disorders is inadequate.

Medical devices that successfully expand tissue have been around for some time.

A commonly used option is a small balloon which is implanted into a patient and inflated with regular injections of saline.

The problem is that the patient has to travel to hospital for repeat saline injections which are not pleasant and the design of the device makes it unsuitable for some of the more complex anatomical areas where tissue expansion would be most beneficial.

It was the desire to overcome such limitations that saw the surgeons collaborate with a team of biomaterials scientists led by Jan Czernuszka, lecturer in materials at Oxford University.

Guided by the surgeons’ ‘wishlist’ for ideal devices, the scientists developed a self-inflating hydrogel material where, crucially, the rate and direction of expansion can be controlled.

The technological breakthrough resulted in the unique hydrogel material that is used for Oxtex’s tissue expander devices. Early studies verified the hydrogel’s expansion performance and the surgeons’ vision took shape.

The next challenge was to take it from the lab into patients and last summer Oxtex was spun out from the university with seed funding to bring the technology to market.

The new company gained an early boost to its profile by winning Oxfordshire Bioscience Network’s Best Emerging Medtech award in September.

Chief executive David Jackson said: “With a self-expanding device, patients would no longer need inflation injections as the hydrogel’s properties allow expansion through osmotic fluid absorption once implanted.

“Obviously this is much better for patients as they wouldn’t have to make regular hospital visits and there are cost savings for both patients and hospitals as a result.”

While Oxtex originally targeted the human plastic surgery market, veterinary soft tissue surgeons have been quick to recognise the potential of the device.

With one-in-four dogs and one-in-six cats getting cancer and suffering from scarcity of skin in areas such as the lower limbs, vets regard tissue expansion as a viable option to improve the reconstructive process when tumours are removed.

Over the past year Oxtex has been working with specialist veterinary centres including the Animal Health Trust charity and the Liverpool Vet School to understand how tissue expansion can be used to benefit animal patients. Good progress has been made and the first trial in cats and dogs is due to begin in September.

Mr Jackson said: “The veterinary market has less stringent licensing requirements than for human use products, and we anticipate launching our first commercial product in early 2013 following completion of the animal trials.”

Oxtex will also start a clinical trial in Malaysia to assess the use of tissue expanders to help correct crossbite.

Mr Jackson said: “This is a common defect, particularly in Far Eastern populations where the teeth and jaw are not aligned, causing progressive dental problems and jaw pain for sufferers. The simplicity of our approach provides a high chance of success in the mouth where balloon expanders are just not practical.”

The company continues to work closely with the Biomaterials Group and has installed a clean room manufacturing laboratory at Oxford University where funding from a Technology Strategy Board grant is supporting the scale up of the manufacturing process.

Further down the line Oxtex anticipates widening its product offering. The company has a patent for a novel Interpenetrating Polymer Network which can be used to make refined hydrogel devices and allow bespoke shaping at the point of use, potentially enabling the development of a whole new range of surgical procedures.

Mr Jackson added: “The challenges for a medical device spin-out are not to be underestimated, but we have made good headway in our first year. Our clinical trials mark an important step towards our goal of creating a simple, effective solution that is available to all who would benefit from its use.” * This page is co-ordinated by Oxford Innovation www.oxin.co.uk