Fidia Introduces HYMOVIS® ONE, a Leading-Edge Hyaluronan, at the AAOS 2026 Annual Meeting in New Orleans, LA
HYMOVIS® ONE, being launched in the U.S, is a viscoelastic hyaluronan hydrogel engineered using a proprietary process that increases lubrication, shock absorption properties, as well as providing clinically meaningful improvements in pain and function for patients with painful symptomatic knee osteoarthritis (OA)
Fidia Farmaceutici S.p.A, together with its wholly owned subsidiary, Fidia Pharma USA Inc., will introduce HYMOVIS® ONE at the American Academy of Orthopaedic Surgeons (AAOS) meeting in New Orleans, March 2–6, 2026.
HYMOVIS® ONE is a pioneering HA-based intra-articular (IA) therapy indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics. It is the first and only non-crosslinked, non-avian (bacterially fermented) single-injection HA viscoelastic hydrogel for OA knee pain relief available on the market in the US.
HYMOVIS® ONE is bioengineered using a proprietary process that results in a natural hyaluronan similar to the hyaluronan found in the synovial fluid present in human joints1. Due to reversible hydrophobic interactions between alkyl side-chains, rather than cross-linking, the non-crosslinked HYMOVIS® ONE molecule (HYADD®4) has increased elasticity, viscosity and residence time in the joint.1,4,* Its unique molecular structure significantly improved lubrication, reducing friction on cartilage in a preclinical analysis.2* The molecule recovers to its original structure even after repetitive mechanical stress3*. In a clinical pivotal study, HYMOVIS® ONE delivered clinically meaningful and effective improvements in pain and function for patients with OA knee pain, with no pseudoseptic reactions and no serious adverse events, at 12-weeks (3 months) and 26-weeks (6 months).1
The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health gave premarket approval (PMA) for HYMOVIS® ONE on April 9, 2025 and HYMOVIS® ONE has been commercially available in the US starting January 2026.
“The launch of HYMOVIS® ONE signals the continued growth and success of Fidia Pharma USA Inc. and builds on our success with the first FDA-approved HA treatment (Hyalgan®) for OA knee pain in the U.S. With a comprehensive portfolio of HA viscosupplement products including HYMOVIS® ONE, Hyalgan®, Triluron® and Hymovis®, we are uniquely positioned to provide solutions for the broad range of patients with OA knee pain.” states Antonio Marielli, President of Fidia Pharma USA Inc.
For more information, please visit Fidia Pharma USA Inc. at the AAOS Annual Meeting at Booth 2601.
*Preclinical data may not be indicative of human clinical outcomes.
Indication
HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).
Important Safety Information
HYMOVIS® ONE is contraindicated in patients with known hypersensitivity (allergy) to hyaluronate preparations or gram-positive bacterial proteins. Do not administer HYMOVIS® ONE to patients with infections or skin diseases in the area of the injection site or joint.
The safety and effectiveness of HYMOVIS® ONE has not been established in pregnant women, nursing mothers, or children or for the use of in joints other than the knee, or concomitant use with other intraarticular (IA) injections. The effectiveness of repeat treatment cycles of HYMOVIS® ONE has not been established. No serious adverse events or pseudoseptic reactions were reported in the HYMOVIS® ONE clinical study. The adverse events experienced and reported in the HYMOVIS® ONE clinical study were joint swelling, metatarsalgia, neck pain and headache.
References:
1. HYMOVIS® ONE Summary of Safety and Effectiveness Data (SSED) P150010/S005
2. Bonnevie ED, Galesso D, Secchieri C, Bonassar LJ (2019) Frictional characterization of injectable hyaluronic acids is more predictive of clinical outcomes than traditional rheological or viscoelastic characterization. PLoS ONE 14(5):e0216702. https://doi.org/10.1371/journal.pone.0216702.
3. Finelli I, Chiessi E, Galesso D, Renier D, Paradossi G. A new viscosupplement based on partially hydrophobic hyaluronic acid: a comparative study. Biorheology. 2011;48(5):263- 275.
4. HYMOVIS® ONE data on file, Fidia Farmaceutici S.p.A., Italy.
Hymovis and HYADD 4 are registered trademarks of Fidia Farmaceutici S.p.A., Abano Terme, Italy.
©2025 Fidia Pharma USA Inc., Florham Park, NJ, 07932, a wholly-owned subsidiary of Fidia Farmaceutici S.p.A. FID1141-12.2025.
