Arthrosamid nominated for the 2022 Prix Galien UK Awards
In a recent press release1, The Galien Foundation revealed the names of the 34 candidates nominated for the 2022 Prix Galien UK Awards. The nominees fall into the following categories: "Best Biotechnology Product" – 8 candidates "Best Pharmaceutical Product" – 3 candidates; "Best Medical Technology" – 8 candidates; and "Best Digital Health Solution" – 15 candidates. We are delighted to share that Arthrosamid®, a new class of therapy for treating patients suffering from knee osteoarthritis, has been shortlisted in the Best Medical Technology category.
Pioneered by the international manufacturer of therapeutic hydrogels Contura International Ltd, Arthrosamid® offers an alternative to current therapies and fulfils an unmet clinical need in the orthopaedic sphere with effective, long-acting, safe and minimally invasive treatment to alleviate pain associated with knee osteoarthritis (OA).
Consisting of 2.5% cross-linked polyacrylamide and 97.5% non-pyrogenic water, a 6ml dose of Arthrosamid® is injected into the joint space to cushion the knee and relieve pain in one single treatment2. Patients can expect to see improved mobility and pain relief within days where the effect is long lasting3. Arthrosamid® becomes embedded in the synovial membrane, providing increased cushioning and bringing both pain relief and improved mobility to patients suffering from knee osteoarthritis. The development of Arthrosamid® followed impressive clinical data with Arthramid® Vet, a related product of the company, in the treatment of lameness in horses.
The first procedure to be carried out in Ireland took place on Friday, April 22 treating a patient who was likely to be ineligible for knee replacement surgery and, as such, was seeking long lasting and non-invasive pain relief. The patient will now be followed up closely by the clinician to observe the benefits – and it is hoped this first case study will help to pave the way for further clinics and hospitals across Ireland to adopt the procedure and to begin offering Arthrosamid® as a treatment to other appropriate patients over the coming months.
Several clinical studies have been completed for Arthrosamid® with further trials ongoing:
- A prospective open label study4, “IDA”, demonstrated Arthrosamid®’s effect in reducing pain at 6 months, which was maintained at 12 months5. This trial, together with the safety and performance data established for the hydrogel technology, satisfied European regulatory authorities to grant approval (CE Mark) to Arthrosamid® for the symptomatic treatment of patients with knee OA in early 2021. Data published in Osteoarthritis and Cartilage in 2021 found that over 70% of patients had a positive experience of treatment, exceeding a minimal clinically important difference, with a reduction in pain, stiffness and physical mobility at 6 months with pain and physical function maintained beyond one year5.
- New data showing the 2-year results from the “IDA” study was recently presented at the Orthopaedic Research Society International (OARSI) 2022 World Congress. The results showed that a single injection of Arthrosamid® continued to be well tolerated and demonstrated clinically relevant and statistically significant effectiveness in reducing pain, at 2 years after treatment6.
- Positive results from a separate multi-centred, randomised, controlled clinical study, “ROSA”, of Arthrosamid® in 238 patients with knee OA were presented at the OARSI 2022 World Congress7. The study compared the reduction in pain after one year following a single injection of Arthrosamid® with a major brand of hyaluronic acid, a common treatment for the same indication. Results from this study showed that the effectiveness of Arthrosamid® in all patients was numerically superior to hyaluronic acid at 1 year7, but in the under 70-year-olds, Arthrosamid performed statistically significantly better than hyaluronic acid 1 year after treatment8. This study will be following patients out to 5 years.
Commenting on Arthrosamid® being shortlisted, Rakesh Tailor CEO of Contura International Ltd said:
"We are thrilled to be shortlisted for The UK Prix Galien Awards for medical device innovation with Arthrosamid®.
Arthrosamid®, our non-degrading hydrogel for knee osteoarthritis (OA), has been developed for over 20 years and is built on a strong legacy of hydrogel development by Contura International. The discomfort caused by knee OA can significantly impact a patient's quality of life, making everyday activities hugely challenging for patients not suitable for surgery or deemed too young for knee replacement surgery. Arthrosamid® represents a game-changing option; a safe non-degrading hydrogel in a single injection provides a long-acting and sustained pain relief.
For Arthrosamid to be recognised this early in its launch phase is a great sign and hopefully will help Contura Orthopaedics reach more patients with this novel treatment.”
1. The Galien Foundation Debuts 2022 Prix Galien UK Award Candidates in "Best Biotechnology Product," "Best Pharmaceutical Product," "Best Medical Technology" and "Best Digital Health Solution" Categories (prnewswire.co.uk)
2. Christensen, L., Camitz, L., Illigen, K.E., Hansen, M., Sarvaa, R., Conaghan, P.G., 2016. Synovial incorporation of polyacrylamide hydrogel after injection into normal and osteoarthritic animal joints. Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society 24, 1999-2002.
3. OARSI CONNECT 2021 POSTER 336 POLYACRYLAMIDE HYDROGEL INJECTION FOR KNEE OSTEOARTHRITIS: RESULTS OF A 52 WEEK PROSPECTIVE STUDY Henning Bliddal, Anders Overgaard, Andreas Hartkopp, Jannie Beier, Philip G Conaghan, Marius Henriksen.
4. Bliddal H, Overgaard A, Hartkopp A, Beier J, Conaghan PG, et al. (2021) Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: A 6 Months Prospective Study. J Orthop Res Ther 1188:6.
Bliddal H, Overgaard A, Hartkopp A, Beier J, Conaghan PG, et al. (2021) Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: Results of a 52 Week Prospective Study. Osteoarthritis and CartilageVol. 29 S278: 2021.
6. Bliddal H, A, Beier J, Hartkopp Conaghan PG, et al. (2022) A Prospective study of Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: Results from 2 years after treatment. Poster presented at OARSI 2022
7. Bliddal H, Beier J, Hartkopp A, Conaghan PG, Henriksen M, One-year performance of polyacrylamide hydrogel vs. hyaluronic acid: A randomised controlled study. Poster presented at OARSI 2022
8. Bliddal H, Beier J, Hartkopp A, Conaghan PG, Henriksen M, One-year performance of polyacrylamide hydrogel vs. hyaluronic acid in age, BMI, and Kellgren-Lawrence subgroups: A subgroup analysis of a randomised study. Poster presented at OARSI 2022