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Press release published: July 13, 2022
A new first in a human study to assess the safety and performance of FibroFix Cartilage P™ (FibroFix™), an innovative implant that repairs knee cartilage, is starting at Southmead Hospital in Bristol. The FFLEX clinical trial has received nearly £1.2 million from the National Institute for Health and Care Research (NIHR) and will be led by Orthox, the company behind FibroFix™, and researchers from the University of Bristol.
As this is the first time the implant has been tested in humans, the team is initially enrolling six patients with cartilage damage in the knee joint. This first phase of the study will study the safety and performance of the implant in patients. He will also assess the set of instruments used to implant FibroFix™ into the joint. If successful, the next phase of the trial will enroll a larger group of patients to understand the performance of the implant.
FibroFix™ is composed of a protein extracted from silk and has a porous structure. It acts as a scaffold for new cartilage tissue to grow around it. The implant and instrument set have been rigorously assessed to Medicines and Healthcare Products Regulatory Agency (MHRA) standards, allowing the implant to be tested in humans for the first time. time.
Cartilage is a layer of flexible tissue that acts as a shock absorber in the knee. It can be damaged by sudden injury or gradual deterioration as seen in osteoarthritis.
Nick Howells, Principal Investigator and Consultant Knee Surgeon at Southmead Hospital, North Bristol NHS Trust, said: “This implant has great potential to help patients with symptoms of localized cartilage damage in the knee. It is the culmination of a huge amount of work to have reached the stage of a clinical trial and very exciting for us to be able to start testing the use of the implant in patients. This will initially focus on safety and once we have confirmed this will hopefully evolve into clinical performance evaluation.
The lead investigator of the FFLEX study, Michael Whitehouse, Professor of Trauma and Orthopedics at the University of Bristol and NIHR Bristol Biomedical Research Center (Bristol BRC), said: “This technology represents the culmination of an enormous amount of implant development and associated instruments. to enable reliable and repeatable operation. It potentially fills a gap in currently available treatments. It would allow the treatment of immediate pain and limited function for patients with focal cartilage problems. Typically, surgeries for these problems are technique-dependent or require prolonged periods of limited support or restricted activity. The instruments developed for this implant and the implant itself ensure very solid fixation during the intervention and allow a rapid return to normal activity. Successful treatment of focal cartilage damage can help reduce the risk of more extensive joint damage in the future.
Nick Skaer, co-founder and CEO of Orthox, said: “FibroFix is unique in that it emulates the functional properties of cartilage while also facilitating, in laboratory tests, rapid tissue regeneration. It could make a real difference for patients suffering the debilitating effects of severe knee cartilage damage. With our approach, there is significant bone sparing and strong tissue integration of the implant, which we hope can lead to faster recovery. NIHR funding for the FFLEX study is just one of many grants we have received to test FibroFix internationally. We hope this will pave the way for a significant number of patients to be treated with our FibroFix implants every year. »
About the National Institute for Health and Care Research
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
Fund high quality and timely research that benefits the NHS, public health and social services;
- Invest in world-class expertise, facilities and a skilled workforce to translate discoveries into improved treatments and services;
- In partnership with patients, service users, caregivers and communities, improving the relevance, quality and impact of our research;
- Attract, train and support the best researchers to tackle complex health and social protection challenges;
- Collaborate with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
- Fund applied global health research and training to meet the needs of the poorest people in low- and middle-income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low- and middle-income countries is primarily funded by UK Aid from the UK government.
About the NIHR Bristol Biomedical Research Center
Innovative biomedical research at the NIHR Bristol Biomedical Research Center (BRC) takes science from the lab or computer and develops it into new drugs, treatments or health advice. Its world-renowned scientists work on many aspects of health, from the role played by individual genes and proteins to the analysis of vast collections of data on hundreds of thousands of people. Bristol BRC is unique among NIHR’s 20 BRCs across England, thanks to its expertise in groundbreaking population health research.
Orthox is a clinical-stage company that develops medical devices to repair damaged cartilage and other orthopedic injuries. Orthox’s FibroFix Cartilage P™ technology, originating from the University of Oxford, is a revolutionary tissue scaffold based on fibroin, a tissue regeneration protein extracted from silk fibers. FibroFix Cartilage P™ implants remove only damaged tissue, using minimally invasive, bone-sparing surgical techniques that allow rapid rehabilitation of the patient. By combining exceptional strength and low friction with tissue regeneration, FibroFix Cartilage P™ offers the potential for better long-term results, by nurturing the body’s innate ability to heal itself. FibroFix Cartilage P™ products have the potential to address an annual knee joint market alone estimated at over $2 billion.
The company was created out of the University of Oxford and is led by experienced medical technology entrepreneurs. The company has raised over £21m, including awards from major biomedical funding programs including Wellcome (£2.65m in translation prizes), the NIHR i4i program (£1.9m sterling in late-stage product development awards), the UK Innovation Agency (a €1.7m Biomedical Catalyst Fund Award) and Horizon 2020’s EIC Accelerator (a €2.5m grant). Orthox employs 20 people at its Oxfordshire site.
See our website here: http://www.orthox.com/