Next-Generation Urinary Catheters for Preventing Catheter Associated Urinary Tract Infections: Emphasis on Antibiotic Resistance

Project Information

NANOELAST

Grant agreement ID: 877011

DOI

10.3030/877011

Project closed

EC signature date 11 July 2019

Start date 1 September 2019

End date 29 February 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

AMFERIA AB
Sweden

Periodic Reporting for period 1 - NANOELAST (Next-Generation Urinary Catheters for Preventing Catheter Associated Urinary Tract Infections: Emphasis on Antibiotic Resistance)

Reporting period: 2019-09-01 to 2020-02-29

Summary of the context and overall objectives of the project

Indwelling urinary catheters are life-saving medical devices that are widely used in hospitals and nursing homes to relieve a patient from urinary retention and incontinence. However, prolonged use of these catheters in the urinary tract leads to a life-threatening and disturbingly common complication, called catheter associated urinary tract
infection (CAUTI). CAUTIs are mainly caused by bacteria and affect nearly 10 million patients every year globally. This makes CAUTI responsible for 40% of all hospital associated infections and the costs for treating these infections exceed 100 million USD a year. Furthermore, the global threat of antibiotic resistance has made it extremely difficult
to treat CAUTI via conventional antibiotics and has led to longer hospital stays for the patient and higher mortalities, especially among the ageing population. A strong need exists for new anti-infective catheters that can prevent CAUTIs by enabling a new function that prevents bacterial attachment onto the catheter surface. Such a device will offer several advantages such as, prevention of infections, reduced usage of prophylactic antibiotics, reduced risk of antibiotic resistant infections and faster recovery for the patient.

A societal advantage of such an improved antiinfective catheter is the ability to control the rise of antibiotic resistant infections in the hospital and the community and reduce economic impact.Amferia AB has developed and patented a novel amphiphilic antibacterial material-a mesoporous elastomeric polymer, referred to as NANOELAST, that is able to target and kill bacteria rapidly upon contact. Of special interest is that the material has been proven very effective in killing numerous antibiotic resistant bacteria, prevent biofilm formation and without causing any harm to human cells. Amferia has, in this project, evaluated the NANOELAST as the next generation urinary catheter for infection preventive care.

The overall objectives of this project was to verify the NANOELAST technology as a potential in-dwelling urinary catheter and confirm the antibacterial properties, mechanical properties and processing properties to understand if it may be suitable for scale-up and clinical use. Parallely, the objective was also to identify possible industrial actors who would be suitable to partner with for global manufacturing and distribution.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Overall, the work performed during the project period was technical verification and market evaluation of the NANOELAST material towards urinary cater applications to prevent infection. 4 key results were obtained:

1. The NANOELAST technology has shown considerable promise in developing further towards in-dwelling urinary catheter applications. The decision was based on the microbiology analysis, processing data and market interest. A number of continuation routes have been identified and the most promising options were the development of the entire catheter tube from the NANOELAST material as originally planned.

2. A preliminary technical file was developed which included all microbiology data, rheology data, mechanical testing measurements, plan for sterilisation and biocompatibility data. Part of the above work including mechanical studies, processing studies and biocompatibility studies was published in a scientific Journal ACS Nano . The paper was als featured in official Chalmers University press release and garnered world-wide attention where it has been picked up by blogs, newspapers and social media from over 13 countries including Europe, USA, Middle-east, Asia and Australia. Additionally, the patent concerning the NANOELAST which was filed as a PCT application in March 2019, received a examiners report that indicated the technology to be novel and inventive.
-Tough Ordered Mesoporous Elastomeric Biomaterials Formed at Ambient Conditions; Anand K. Rajasekharan, Christoffer Gyllensten, Edvin Blomstrand, Marianne Liebi, and Martin Andersson ACS Nano 2020 14 (1), 241-254
-https://scienmag.com/nanostructured-rubber-like-material-with-optimal-properties-could-replace-human-tissue/

3. Amferia and a early interested company as mentioned in the Grant agreement has continuously been in contact and evaluated the new data. With this as a background, the potential partner is now interested to jointly developing and begin manufacturing testing of the NANOELAST technology.

4. Lastly, from the current project, we have further identified another interesting opportunity for the application of the technology. This was also for urinary catheters but may enable a faster market translation. This approach has shown very early promising early results form infection-prevention standpoint and received increased interest from the market and clinic. If proven successful, we have the ability to rapidly take this forward to commercialisation and clinical evaluation. This approach also enables cost-efficiency, improved functionality and ease of large-scale processing.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Current in-dwelling catheters are made of latex or silicone elastomers which are in certain cases also coated or impregnated with antimicrobial agents for the purpose of reducing CAUTIs. The antimicrobial agents commonly used are one of the following two substances (a) silver or (b) combination of antibiotic drugs such as nitrofural, sparfloxacin and minocycline. However, as have been concluded in multiple Cochrane-reviews, these catheters fail to significantly reduce CAUTI, both in long-term and short-term use. The nitrofurazone and silver catheters especially were also associated with greater discomfort and pain. The above catheter types also suffer the drawback of releasing antimicrobial compounds that have a negative effect on the normal flora of the urinary tract, and also contribute to development of antimicrobial resistance. Silver based technologies have also shown to induce additional negative effects such as; epithelial cell toxicity causing inflammation and pain.

Amferia's NANOELAST technology intends to solve this problem by developing a catheter that fully prevents bacterial attachment to the surface by enabling a material inspired by the human urinary tract that stops bacteria from attaching to the surface. Today we have developed this technology into a prototype catheter and are in discussion with potential partners for clinical translation. If proven scalable, the NANOELAST technology can enable a new generation of anti-infective catheters. We have achieved our expected results as described above with this phase of the project where the technical feasibility was verified and increased market interest was observed. In the next phase, we will strive to complete the work on manufacturability, clinical evaluation and eventually market launch. Once complete, the NANOELAST will have the potential of saving millions of lives and at the same time reduce the incidence of antibiotic resistant infections.

Furthermore, the funding from the EU enabled Amferia to hire 1 full-time female engineer to work on the project and contribute to the development. Furthermore, the person has acquired an Industrial PhD position as part of the project at Chalmers University of Technology, where she will continue to develop and research the NANOELAST technology for Phase-2 testing.

NANOELAST Catheter Prototype