A new class of "injectables" to enter Italy's orthopaedic market thanks to a dynamic partnership with medical manufacturers Contura Orthopaedics

London, June 2022: As part of its ongoing ambition to promote patient access to its unique treatment, Arthrosamid® in Europe, Contura Orthopaedics Ltd has announced the latest in its current series of exciting new partnerships, securing a collaboration with Horizon Lab Company, one of Italy’s leading independent medical device distributors.

Arthrosamid® is a polyacrylamide hydrogel developed by Contura International Ltd. as a long-lasting intra-articular injection, approved in Europe to treat knee osteoarthritis (OA). The treatment has the potential to change the present care pathway for managing OA, which affects around 8,6 million people in Italy¹...current treatments are not long-lasting or involve invasive knee replacement surgery. Despite a large suffering population, there has been very little innovation in the range of OA treatments on offer to help patients – until now.

In a single treatment², a 6ml dose of Arthrosamid® is injected into the joint space to cushion the knee and relieve pain. Arthrosamid® becomes embedded in the synovial membrane, providing increased cushioning and bringing pain relief and improved mobility within days, where the effect is long-lasting³ for patients suffering from knee osteoarthritis. The development of Arthrosamid® followed impressive clinical data with Arthramid® Vet, a related product of the company, used to treat lameness in horses.

Co-owner of Horizon Lab Company, Giacomo Velasco, says;

“We are proud to announce this new professional association with the team at Contura Orthopaedics Ltd. The great innovation in osteoarthritis treatment and the new class of biocompatible, viscoelastic non-degradable Arthrosamid® is the core of our partnership. We are so excited to promote Arthrosamid® in Italy to our clinical partners."

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 months.⁵ 

• 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 year.

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 treatment.⁶

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 Congress⁸. 

• 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 treatment^8. This study will be following patients out to 5 years.

Giacomo Velasco adds: 

“In the last few years, there has been an increasing need for new, evidence-based procedures which may help to delay often inevitable knee surgery take place. We are also very aware that waiting lists for orthopaedic treatments in Italy are at an all-time high."

“We believe the quality and the innovations are the best way to help people improve their quality of life. And, in our opinion, for patients not suitable for surgery, or deemed too young for knee replacement surgery, Arthrosamid® represents a ‘game-changing option’ as a safe non-degrading hydrogel in a single injection which provides long-acting and sustained pain relief." 

Rakesh Tailor, CEO of Contura International Ltd adds:

“We’re absolutely delighted to announce news of our association with Horizon Lab Company as part of our ongoing focus on the European expansion of Arthrosamid^®."

“The discomfort caused by knee OA cannot be underestimated, causing a significant impact on a patient’s quality of life. Everyday activities we may take for granted can become hugely challenging, which in turn challenges medical device innovators, such as our teams at Contura, to commit to the development of new treatment options. For patients not considered suitable for surgery, or who would prefer to explore non-invasive options, Arthrosamid^® does offer a solution for all those seeking sustained pain relief, and we’re proud to be at the forefront of this area of therapeutic care."

About Contura

Contura is headquartered in London and its manufacturing facility is in Copenhagen, Denmark. Contura International Ltd develops and manufactures innovative medical products in women’s health, orthopaedics, and animal health using its unique, patented hydrogel technology. Its hydrogel-based products are non-particulate and biocompatible, making them non-absorbable, non-migratory, and highly durable. For more information, visit contura.com.

About Horizon Lab Company

Founded in 2020 in Repubblica di San Marino, Horizon Lab Company is one of the rising Pharma & Biomedical companies in Italy. Our focus is on Osteoarticular, Neurological area and Aesthetic Medicine; we market medical/surgical devices, drugs, and food supplements. Our mission is to keep high standards to improve patient's quality of life with innovation and quality. Our procedures are certified by ISO quality management standards (horizonlabcompany.com )

^References:

^{1. 2021. The unrecognised burden of osteoarthritis: unmet needs in Europe. (ebook) The Economist Intelligence Unit Limited, page 5. Available at: Unmet needs in Europe_EIU Briefing Paper_Pfizer.pdf}

^{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.}

^{5. 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.}

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