Field Orthopaedics Receives TGA ARTG Inclusion for EASS Griplasty™ Systems

FIELD ORTHOPAEDICS RECEIVES TGA ARTG INCLUSION FOR EASS GRIPLASTY™ SYSTEMS, WHICH INCLUDES A SINGLE INCISION ALL-SUTURE IMPLANT DESIGNED TO ADDRESS ADVANCED-STAGE THUMB CARPOMETACARPAL OSTEOARTHRITIS (CMC OA).

BRISBANE, AUSTRALIA - Field Orthopaedics, a leader in innovative hand surgery solutions, announces Therapeutic Goods Administration (TGA) authorization of the Extremity All Suture System (EASS) Griplasty^TM Systems to be listed on the Australian Register of Therapeutic Goods (ARTG).

The Griplasty^TM System, part of the Extremity All Suture System, represents a significant advancement in Field Orthopaedics' hand implant portfolio. Designed to address the needs of patients suffering from a common form of peripheral arthritis (1,2), the Griplasty^TM Base of Thumb System offers a versatile and effective solution for hand surgeons.

"The Griplasty^TM implant optimizes the suspension of the thumb to maintain length and support anatomical planes of movement. This represents an exciting opportunity for hand surgeons who are looking to advance the surgical treatment of hand osteoarthritis and improve patient outcomes"  - Dr Marc Richard, Associate Professor of Orthopaedic Surgery, Duke University.

Key features of the Griplasty^TM System – Base of Thumb include:

• Single incision deployment using either dorsal or volar surgical approaches
• 'V-Sling' implant design to provide a broad surface area of multi-axis support
• Precise bi-cortical anchor deployment through a guidance system
• Compatibility with trapeziectomy and tendon transfer procedures

Symptomatic Thumb CMC OA occurs in up to 15% of the population aged 30 years or older, increasing to an estimated 33% of postmenopausal women (1). The Griplasty^TM System's versatility ensures a treatment option for a wide range of patients, catering to the significant market opportunity.

Patryk Kania, CEO and Managing Director of Field Orthopaedics Pty Ltd, states, "We're thrilled to bring the Griplasty^TM System to Australia. In our U.S. limited market release we have achieved excellent outcomes in over 250 patients surgically managed with the Griplasty^TM. It embodies our commitment to innovation in hand surgery and our mission to improve patient outcomes in this under-served area of orthopaedics."

Healthcare professionals can learn more about the Griplasty^TM System at: www.fieldorthopaedics.com/griplasty

About: Field Orthopaedics Pty. Ltd. is an Australian medical device company dedicated to leading innovation in complex hand fracture management, arthritis, and microsurgery, developing purpose-designed products for this unique market.

For media inquiries: investorrelations@fieldorthopaedics.com

Connect with Field Orthopaedics: https://www.linkedin.com/company/field-orthopaedics

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This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forward-looking terms such as "may," "will," "expects," "believes," "aims," "anticipates," "plans," "looking forward to," "estimates," "projects," "assumes," "guides," "targets," "forecasts," "continue," "seeks" or the negatives of such terms or other variations on such terms or comparable terminology. Forward-looking statements include, but are not limited to, statements concerning the Company's expectations, plans, intentions, strategies, prospects, business plans, product and service offerings, new product launches, potential clinical successes, and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. Such forward-looking statements speak only as of the date made, and the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this press release are cautioned not to place undue reliance on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this press release.

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References
1. Higginbotham C, Boyd A, Busch M, Heaton D, Trumble T. Optimal management of thumb basal joint arthritis: challenges and solutions. Orthop Res Rev. 2017 Nov;Volume 9:93–9. 

2. Plotz B, Bomfim F, Sohail MA, Samuels J. Current Epidemiology and Risk Factors for the Development of Hand Osteoarthritis. Curr Rheumatol Rep. 2021 Aug;23(8):61.