• BioCardia held a positive preliminary clinical consultation with Japan’s PMDA regarding CardiAMP Heart Failure trial results.
• Purpose: preparation for a formal consultation on data acceptability for a potential approval application.
• PMDA requested clarifications on:
• Positioning of composite endpoints
• Statistical power rationale
• Clinical rationale for NT-proBNP subgroup and risk-benefit profile
• Target patient numbers in Japan
• U.S. clinical development status
• BioCardia is finalizing responses and expects a formal consultation by year-end.
• CEO Peter Altman emphasized commitment to patients with few treatment options, highlighting three completed trials in 178 ischemic HF patients and significant benefits seen in the CardiAMP HF study.
日本PMDA要請内容は、BCDAが余裕で対応できる内容のみ。年内の正式相談は確実視🍵
PMDAからの要請内容と難易度
・複合評価項目の位置づけ
→ 解析計画に基づき整理するだけ
・統計学的パワーの根拠
→ 試験デザイン時に既に算出済み
・NT-proBNPサブグループの臨床的意味づけ
→ 米国データで説明可能
・日本での想定患者数
→ 疫学データより推定するだけ
・米国での開発状況
→ FDAとのやり取りを整理して提示
◾️BioCardia Summary (Sept 22, 2025)
• BioCardia held a positive preliminary clinical consultation with Japan’s PMDA regarding CardiAMP Heart Failure trial results.
• Purpose: preparation for a formal consultation on data acceptability for a potential approval application.
• PMDA requested clarifications on:
• Positioning of composite endpoints
• Statistical power rationale
• Clinical rationale for NT-proBNP subgroup and risk-benefit profile
• Target patient numbers in Japan
• U.S. clinical development status
• BioCardia is finalizing responses and expects a formal consultation by year-end.
• CEO Peter Altman emphasized commitment to patients with few treatment options, highlighting three completed trials in 178 ischemic HF patients and significant benefits seen in the CardiAMP HF study.
投資の参考になりましたか？