Fidia Introduces in the US the 3-injection regimen TRILURON™ (sodium hyaluronate)

On March 26, 2019, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health awarded Pre-Market Approval for TRILURON™.

TRILURON™ is a Hyaluronic Acid (HA) based intra-articular viscosupplement indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen).

TRILURON™ treatment cycle consists of 3 injections given at weekly intervals.

The launch of the 3-injection product, TRILURON™, represents an important new, convenient treatment option for physicians and their patients. It also completes the HA viscosupplement portfolio offering for Fidia Pharma USA Inc. building on the successes of Hymovis®, the only 2-injection HA-based hydrogel viscosupplement and the flagship Hyalgan®, a 5-injection regimen and the first HA product approved for treatment of knee OA pain in the United States. With a full range of HA-viscosupplement products available, Fidia Pharma USA is uniquely positioned to provide proven solutions for a broad range of patients with pain associated with osteoarthritis (OA) of the knee. Additional products available from Fidia Pharma USA, NuDYN™, an acellular injectable, flowable, shelf-stable, amniotic membrane allograft and CartiJoint™ FORTE dietary supplement, enhance the robust and growing portfolio of quality non-surgical solutions being made available to physicians providing orthopaedic and musculoskeletal care to their patients.

About Fidia Pharma USA Inc.

Fidia Pharma USA Inc., headquartered in Florham Park, NJ, is a wholly-owned subsidiary of Fidia Farmaceutici S.p.A.

Fidia Pharma USA Inc. is focused on expanding Fidia’s position in the U.S., while upholding the company’s mission to provide consumers with innovative products that offer quality, safety, and performance.

About Fidia Farmaceutici S.p.A.

Multinational company, with R&D, manufacturing, marketing and sales capabilities, and an extensive product portfolio mainly based on hyaluronic acid in joint care, wound healing, ophthalmology, aesthetic and autologous biological products. Over 55 years of R&D have placed Fidia at the forefront in the production of natural and functionalized Hyaluronic Acid technology, with different ranges of molecular weights and over 700 related patents. Manufacturing operations –located in Italy – comply with the strictest international regulations and safety standards. Fidia extends its global reach through local partners in 100+ countries worldwide, as well as wholly owned subsidiaries.

For more information, please visit www.fidiapharma.us or contact Giorgio Masetti at info@fidiapharma.us

Important Safety Information

TRILURON™, Hymovis^® and Hyalgan^® are 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 and to simple analgesics (e.g. acetaminophen). TRILURON™, Hymovis^® and Hyalgan^® are contraindicated in patients with known hypersensitivity to hyaluronate preparations or gram-positive bacterial proteins (Hymovis^® only) or patients with infections/skin diseases in the area of the injection site/joint. Their safety and effectiveness have not been tested in pregnant women, nursing mothers or children, use in other joints or with other concomitantly with other IA injections. See package insert for full prescribing information including the full warnings, precautions, and side effects. Rx Only. TRILURON™, Hymovis^® and Hyalgan^® are trademarks of Fidia Farmaceutici S.p.A., Abano, Terme, Italy. ©2019 Fidia Pharma USA Inc., Florham Park, NJ. FID782-11.2019

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