-- アンテリス・テクノロジーズ(ASX:AVR)は、水曜日にオーストラリア証券取引所に提出した書類の中で、同社のグローバルな主要臨床試験であるPARADIGM試験について、米国メディケアの償還資格を取得したと発表した。これは、メディケア・メディケイドサービスセンター(CMS)の全国的な医療給付方針に基づくものである。 PARADIGM試験は、経カテーテル大動脈弁置換術(TAVR)と比較した経カテーテル心臓弁(DurAVR THV)の安全性と有効性を評価するもので、DurAVR THVは、大動脈弁狭窄症の治療薬としてアンテリスが開発した製品である。大動脈弁狭窄症は、大動脈弁の狭窄によって引き起こされる、生命を脅かす可能性のある疾患である。 CMSの枠組みは、エビデンス開発に基づく医療給付(CED)モデルに基づいており、臨床エビデンスの生成を伴う償還を可能にする。 同社は、この償還資格の取得により、米国における治験施設の立ち上げが促進され、参加施設全体での事業展開が加速すると見込んでいる。 同社の株価は、直近の水曜日の取引で2%上昇した。
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