News Release Details
DUROLANE® Among High-Molecular Weight Hyaluronic Acid Treatments Linked to Significant Improvements in Knee Osteoarthritis Pain by American Academy of Orthopaedic Surgeons
DURHAM, N.C., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Bioventus Inc., (Nasdaq: BVS) (“Bioventus” or the “Company”), a leader in innovations for active healing, announced that the American Academy of Orthopaedic Surgeons (AAOS) recently released updated clinical practice guidelines (CPG) indicating that high molecular weight cross-linked hyaluronic treatments, including Bioventus treatment DUROLANE, showed statistically significant improvement in certain knee osteoarthritis (OA) patients. The recommendation follows a review of 28 studies assessing intra-articular hyaluronic acid (HA) injections when compared to controls.
The CPG states that viscosupplementation, in the form of intra-articular HA injections, can represent a viable option for some patients who failed other treatments when appropriately indicated. Patients with low to moderate arthritic knees (Kellgren Lawrence (KL) I-III) have better results than those with severely affected knees (KL IV). In addition, the CPG highlights statistically significant results that were associated with high molecular weight cross-linked HA, but not with mid or low molecular weight HA.
DUROLANE is a single-injection osteoarthritis (OA) treatment that is lightly cross-linked and has the highest reported molecular weight of all US-approved HA products.1, 2
“These updated guidelines from AAOS now match how we have always recommended the utilization of our HA products for knee OA pain,” said John Nosenzo, Chief Commercial Officer, Bioventus. “Now patients and physicians will have even more confidence in using HA therapies with high molecular weight such as DUROLANE.”
“The updated clinical practice guidelines from AAOS better aligns with the clinical practice and experience of most physicians. HA injections, including DUROLANE, are a viable option for patients who fail treatments such as NSAID’s, weight loss, and exercise,” said Vinod Dasa MD. “We applaud the Academy for recognizing the patient population that benefits from these treatments to manage their low to moderate OA knee pain.”
DUROLANE, which has more Level 1 clinical studies than any other single-injection HA, has demonstrated providing greater reduction in OA knee pain versus Synvisc-One®.3 It has longer lasting pain relief versus a steroid injection, is safe for repeated courses of therapy, and repeated use of DUROLANE does not increase the incidence of adverse events.4, 5 Visit www.durolane.com for more information.
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment & joint preservation, restorative therapies and bone graft substitutes. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter.
Bioventus, the Bioventus logo, and DUROLANE are registered trademarks of Bioventus LLC. NASHA is a registered trademark. Synvisc-One is a registered trademark of Genzyme Corporation.
Indications for Use: DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen. Do not inject DUROLANE with knee joint infections, infections, or skin disease in the area of the injection site. Do not administer to patients with known hypersensitivity (allergy) to HA preparations. Risks can include transient pain or swelling at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children.
NOTE: The above indications presented are for the US market; indications may vary by country. Consult with your local Bioventus representative for approved use within your region of interest. Full prescribing information can be found in product labeling, at www.durolane.com or by contacting Bioventus Customer Service at 800-836-4080.
References: 1.Bioventus LLC. Q-Med Molecular Weight of DUROLANE, MA-10789. Data on ﬁle, RPT-001313. June 2021. 2.Nicholls M, Manjoo A, Shaw P, Niazi F, Rosen J. Rheological Properties of Commercially Available Hyaluronic Acid Products in the United States forth Treatment of Osteoarthritis Knee Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2018 Jan 3;11:1179544117751622. doi: 10.1177/1179544117751622. PMID: 29326532; PMCID: PMC5757428. 3. McGrath AF, McGrath AM, Jessop ZM, et al. A comparison of intra-articular hyaluronic acid competitors in the treatment of mild to moderate knee osteoarthritis. J Arthritis. 2013; 2(1):108. doi:10.4172/2167-7921.1000108. 4 Leighton R, Åkermark C, Therrien R, et. al. NASHA® hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014; 22(1):17-25. 5. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2018.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning the expected benefits, clinical development and market opportunities of DUROLANE. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, statements about the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to differentiate the hyaluronic acid (“HA”) viscosupplementation therapies we own or distribute from alternative therapies for the treatment of osteoarthritic; the proposed down-classification of non-invasive bone growth stimulators, including our Exogen system, by the U.S. Food and Drug Administration (“FDA”); our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; competition against other companies; the negative impact on our ability to market our HA products due to the reclassification of HA products from medical devices to drugs in the United States by the FDA; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including Bioventus’ Annual Report on Form 10-K for the period ended December 31, 2020, as updated in our Quarterly Report on Form 10-Q for the quarter ended July 3, 2021 and as such factors may be further updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement.
Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business.