Partners

BIOVENTUS

Bioventus – Providing Innovations for Active Healing

Bioventus is proud to partner with the Football Medical and Performance Association (FMPA) to support the health and performance of footballers across the UK. Our mission is to advance active healing through innovative, evidence-based solutions that empower medical professionals and accelerate recovery.

What We Offer

Bioventus is a global leader of innovations for active healing.  Our mission is to partner with the healthcare community to deliver innovative medical devices and meet the evolving needs of patients, allowing them to resume and enjoy active lives. Bioventus develops and/or markets clinically proven and cost-effective product offerings that are backed by clinical data. The products of Bioventus are known for their safety, innovation, and effectiveness.  This includes DUROLANE, a nonsurgical injection for joint pain associated with osteoarthritis and EXOGEN, an ultrasound bone healing system that stimulates the body’s natural healing process, helping fractured bones mend.

DUROLANE® Is a single injection hyaluronic acid (HA) therapy for mild to moderate osteoarthritis designed to provide long-lasting pain relief1

  • 20 years of clinical use2, investigated in 20+ clinical studies3 and 2 million+ patients treated4
  • Designed to stay in the joint, with a longer residency time, than other HA formulationsᶧ5-7
  • May provide up to 6 months of osteoarthritis pain relief 1, 9, 10, 14
  • Reduction in opioid and analgesic use9,12,13
  • Approved for multi-joint indications* 1
  • Safe for repeat use 1,11,14
  • Patient satisfaction11
  • Predictable and sustainable results 11,14
Visit DUROLANE.com to learn more about helping active patients perform at their highest level

*See DUROLANE Summary of Indications for Use below

ᶧClinical outcomes in humans may vary from animal studies

EXOGEN® is a fracture-healing device that uses safe, effective, low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process.†15,16  Clinical studies show that EXOGEN heals fractures not healing on their own and accelerates healing of indicated fresh fractures.17-19

  • 20-minute, noninvasive, daily treatments that fit easily into a patient’s lifestyle
  • 86% nonunion heal rate19-21
  • 38% accelerated healing of fresh fractures17,18
  • Demonstrated 58 days faster healing of fresh tibial diaphysis fractures17
  • 91% clinically proven adherence rate among patients22
  • Exclusively recommended by the National Institute for Health and care Excellence (NICE)23
  • Easy-to-use design, treatment tracking calendar, and short daily treatment time
Visit EXOGEN.com to learn more about helping active patients perform at their highest level

**See EXOGEN Summary of Indications for Use below

†The clinical effect of in-vivo results is not known

Why It Matters

In the fast-paced world of football, timely and effective treatment is essential. Bioventus products are designed to assist you with supporting the needs of your patients. We’re excited to collaborate with the FMPA and contribute to the ongoing development of best-in-class medical care in football.

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DUROLANE Summary of Indications for Use

DUROLANE (3 mL): Is indicated for the symptomatic treatment of mild to moderate knee or hip osteoarthritis. In addition, DUROLANE has been approved for the symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, shoulder, elbow, wrist, fingers, and toes.

DUROLANE is also indicated for pain following joint arthroscopy in the presence of osteoarthritis within 3 months of the procedure.

Contraindications and Summary of Risks: DUROLANE should not be injected if the synovial joint is infected or severely inflamed. DUROLANE should not be injected if there is an active skin disease or infection present at or near the injection site. DUROLANE should not be injected intravascularly or extraarticularly or in the synovial tissues or capsule. DUROLANE should not be injected if the patient is known to be sensitive to hyaluronic acid-based products. DUROLANE should not be injected in patients with pre-existing chondrocalcinosis as injection may lead to an acute attack of the condition.

Risks can include transient pain, swelling and/or stiffness at the injection site.

Full prescribing information can be found on the product labeling and on the website at DUROLANE.com.

DUROALNE Instructions for Use can be found here: DurolaneIFU.pdf

EXOGEN Summary of Indications for Use
EXOGEN is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes the treatment of delayed unions, nonunions,* stress fractures and joint fusion. EXOGEN is also indicated for the acceleration of fresh fracture heal time, repair following osteotomy, repair in bone transport procedures and repair in distraction osteogenesis procedures.

There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel.

Full prescribing information available at EXOGEN.com.

EXOGEN Instructions for Use can be found here: 81087028_Sonic-2020-IFU_OUS_RevC_UK-shorten.pdf

*A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. All revisions of the Instructions for Use can be made available upon request. Contact [email protected] or call 0800 05 16 384 to request an electronic copy.

References

  1. Bioventus LLC.Instructions for Use – 1082010, DUROLANE 3ML. April 2023, 00057764 Revision G.
  2. Q-Med Scandinavia, Inc. Q-Med’s product for the treatment of osteoarthritis in the knee approved in Europe. Posted May 8, 2001. https://news.cision.com/q-med/r/q-med-s-product-for-the-treatment-of-osteoarthritis-in-the-knee-approved-in-europ,c42321
  3. Bioventus LLC. Claim for amount of studies investigating DUROLANE. Data on file, RPT-001367.
  4. Bioventus LLC. Supporting quantity of global patients treated with a single DUROLANE injection. Data on file, RPT-001056
  5. Sakamoto T., Mizuno S., Tominaga A., Tokuyasu K. (1987). Biological fate of sodium hyaluronate (SPH). (4). Studies on absorption, distribution, metabolism and excretion of ¹⁴C-SPH in rats after intravenous, subcutaneous and intramuscular administration. Journal of Applied Pharmacology, Vol. 33, Issue 6, pp. 849–857. Published in Japan. ISSN: 0300-8533.
  6. Larsen, N.E., Dursema, H.D., Pollak, C.T., & Skrabut, E.M. (2011). Clearance kinetics of a hylan-based viscosupplement after intra-articular and intravenous administration in animal models. Journal of Biomedical Materials Research Part B: Applied Biomaterials, 100B (2), 457–462. PubMed ID: 22102374.
  7. Lindqvist U, Tolmachev V, Kairemo K, Aström G, Jonsson E, Lundqvist H. Elimination of stabilised hyaluronan from the knee joint in healthy men. Clin Pharmacokinet. 2002;41(8):603-13. doi:10.2165/00003088-200241080-00004.
  8. Edsman K, Melin H, Näsström J. A study of the ability of Durolane to withstand degradation by free radicals while maintaining its viscoelastic properties. Poster presented at: 55th Annual Meeting of the Orthopaedic Research Society; February 22-25, 2009; Las Vegas, NV. Poster 1149.
  9. McGrath AF, McGrath AM, Jessop ZM, Gandham S, Datta G, Dawson-Bowling S, Cannon SR. A Comparison of Intra-Articular Hyaluronic Acid Competitors in the Treatment of Mild to Moderate Knee Osteoarthritis. Journal of Arthritis, Volume 2, Issue 1, 2013.
  10. Krocker, D., Matziolis, G., Tuischer, J., et al. (2006). Reduction of arthrosis associated knee pain through a single intra-articular injection of synthetic hyaluronic acid. Zeitschrift für Rheumatologie, 65(4), 327–331. https://doi.org/10.1007/s00393-006-0063-2.
  11. Carney, G., Harrison, A., & Fitzpatrick, J. (2021). Long-term outcome measures of repeated non-animal stabilized hyaluronic acid (Durolane) injections in osteoarthritis: A 6-year cohort study with 623 consecutive patients. Open Access Rheumatology, 13, 285–292. https://doi.org/10.2147/OARRR.S331562.
  12. McIntyre, L.F., Beach, W., Bhattacharyya, S., et al. (2017). Impact of Hyaluronic Acid Injections on Pain Management Medications Utilization. American Journal of Pharmacy Benefits, 9(6), 195–199.
  13. Mackowiak, J., Jones, J. T., & Dasa, V. (2020). A comparison of 4-year total medical care costs, adverse outcomes, and opioid/prescription analgesic use for 3 knee osteoarthritis pain treatments: Intra-articular hyaluronic acid, intra-articular corticosteroids, and knee arthroplasty. Seminars in Arthritis and Rheumatism, 50(6), 1525–1534. https://doi.org/10.1016/j.semarthrit.2020.01.003.
  14. Leighton R, Åkermark C, Therrien R, et al. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-center, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014;22(1):17-25. doi:10.1016/j.joca.2013.10.009.
  15. Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus. J Bone Miner Res. 2001;16(4):671-80.
  16. Bioventus LLC. EXOGEN® User Guide. Last updated 2020. 81087028_Sonic-2020-IFU_OUS_RevH.pdf
  17. Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994;76(1):26-34.
  18. Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 1997;79(7):961-73.
  19. Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH. Low-intensity pulsed ultrasound in the treatment of nonunions. J Trauma. 2001;51(4):693-703.
  20. Zura R, Della Rocca GJ, Mehta S, et al. Treatment of chronic (>1 year) fracture nonunion: heal rate in a cohort of 767 patients treated with low-intensity pulsed ultrasound (LIPUS). Injury. 2015;46(10):2036-41.
  21. Mayr E, Möckl C, Lenich A, Ecker M, Rüter A. Is low intensity ultrasound effective in treatment of disorders of fracture healing? Unfallchirurg. 2002;105(2):108-15.
  22. Schofer MD, Block JE, Aigner J, Schmelz A. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord. 2010;11:229.
  23. National Institute for Health and Care Excellence. EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing. Medical technologies guidance [MTG 12]. Last updated October 8, 2019.

SMK – SMK-006121(A) 11/25