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Amplitude Surgical Receives Australia Regulatory Approvals


Amplitude Surgical received regulatory approvals from the Australian Therapeutic Goods Administration for its Novastep foot product range and its Anatomic knee device.

Marketing of the Novastep products will commence through an exclusive Australian distributor following receipt of reimbursement codes.

Amplitude's Anatomic knee was commercially beta-launched in early 3Q15 at the Australian Orthopedics Association meeting to initiate a 2-year clinical trial, investigating device performance to establish a reimbursement rate for private hospitals approved by Australian mutual health insurance companies. Since beta launch, >40 implantations have occurred.

The Australian market comprised 11% of Amplitude's FY2014-2015 sales. Past approvals for Amplitude in this market include the Score knee, Integrale hip stem and Saturne acetabular cup in 2007 and the Uni Score knee in 2014.

Amplitude's Novastep subsidiary accounts for ~5% of the company's overall sales. For FY2015 (ended 6/30/15), Amplitude recorded sales of €71.1MM (~$76.6MM).

Source: Amplitude Surgical