bacteria-phobic effect. We now have a group of UK hospitals engaged who are rapidly building a body of evidence that documents that our catheters reduce the incidence of bacterial colonisation and resultant infection.”

Testing and analysis

The polymer coating is currently being evaluated through in-human studies at six UK hospitals. Professor Daniela Andrich of London Bridge Hospital used the product to care for her surgical patients and made the used catheters available to microbiologists at the Centre for Biomolecular Sciences & School of Life Sciences, and the School of Pharmacy at the University of Nottingham, who measured the biofilm and mineral accumulation on catheter surfaces. Early results from the analysis have been encouraging. In work comparing 10 coated catheters and 12 uncoated silicone catheters, has shown a clear reduction of biofilm formation and bio-mineralisation on the polymer coated catheters compared with uncoated catheters.

The 22 coated and uncoated samples, obtained from patients catheterised for bladder management after urethral reconstructive surgery, were allocated non-randomly. The difference in biofilm density on coated and uncoated catheters was immediately apparent and very consistent across uses. Dr Hampton added: “Bacteria mostly gathers at the tip and the base around the urethra, so these are areas most likely to have infections. The study confirmed evidence that our coating acts equally well in preventing biofilm attachment in humans. “These initial results now have been corroborated by over 60 cases as we expand the number of settings taking part in trials. We are looking to grow the body of evidence to support these initial results and welcome anyone interested in conducting trials to contact us. “Future comparisons of greater numbers of catheters, the performance of coated catheters over longer time periods and more detailed microbiological investigations will be required to support this initial evidence. Nonetheless, the results are very encouraging for the battle against HAIs.” The results have gained international recognition after being presented by clinical researchers from UCLH NHS Foundation Trust at the 34th Annual European Association of Urology Congress in Barcelona and the International Meeting on Reconstructive Urology, Hamburg.

Daniela Andrich MD MSc FRCS,

Honorary Associate Professor, Division of Surgery and Interventional Science, said: “Our patients are at high risk of post- operative catheter related wound infection and we are very pleased that there is, finally, a non-antibiotic based catheter that aims to protect the patient and has no risk of antibiotic drug resistance. The surface of the catheter is very smooth and hardly requires lubrication for insertion or

Multicentre trials performed in the NHS confirmed that existing silver and antibiotic eluting products were not successful at reducing

infection rates. Dr David Hampton, CTO, Camstent

withdrawal, which is great for the patient. We will continue to evaluate the catheters in our Reconstructive Urology Practice.”

Increasing capacity and production

On the back of these positive results, Camstent has also recently raised £600,000 to continue clinical evaluations, pursue regulatory milestones, expand its leadership team, double its manufacturing capacity and increase lab space. The increased capacity will enable the company to increase production of the catheter and apply its proprietary coating expertise and patents to other in-body medical devices, with new materials and innovative products.

By doubling the size of its clean room, the company can increase the quantity and variety of products that it can coat. It believes that the manufacturing processes will easily scale to meet demand and can create product prototypes quickly for clinical testing. Building on prior approvals, the company hopes to reduce testing time and cost to


create a pipeline of innovation reaching medical customers. There are also plans to make key appointments to the executive team. Remaining as a founder and director, Dr Hampton intends to expand the outward facing team with the appointment of a market-experienced CEO as well as expanding business development, manufacturing and distributor support. He concluded: “Our latest fundraising marks a step-change for Camstent as we move from small-scale manufacturing to a much larger capacity. We are extremely pleased with the support we received from investors and it demonstrates the growing interest from the healthcare sector. “We’ve made enormous progress in the last year and I am extremely grateful to the efforts of our dedicated team, clinical partners and the scientists at Nottingham University who are helping us to demonstrate the efficacy of our novel approach to tackling patient infections caused by medical devices.”

CSJ MAY 2019

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