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Aroa Biosurgery Says Randomized Controlled Trial for Symphony Product Meets Primary Endpoint

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Aroa Biosurgery (ASX:ARX) said its randomized controlled trial for its Symphony product, designed for hard-to-heal wounds such as diabetic foot ulcers and venous leg ulcers, met its primary endpoint on completion, and it expects the study to be published by the third quarter of fiscal 2027, according to a Tuesday Australian bourse filing.

The US Centers for Medicare & Medicaid Services (CMS) proposed to maintain the 2026 payment framework for outpatient skin substitute products in 2027, including the current single payment rate of $127.14 per square centimeter.

The change to outpatient skin substitute reimbursement with the implementation of the single payment rate on Jan. 1 led to a major disruption in the market "due to price compression and more patients being treated in the hospital outpatient department rather than other sites of care," the filing added.

The proposal to maintain the current payment framework for 2027 provides market clarity, and the firm believes "Symphony is well placed as the market re-establishes itself, supported by responsible pricing," Aroa Chief Executive Brian Ward said.

Its shares declined 1% in recent trading on Tuesday.

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