BioCardia Reports Expected CardiAMP Heart Failure Japan Approval Timeline Based On Pharmaceutical And Medical Device Agency Consultation Minutes
Portfolio Pulse from Benzinga Newsdesk
BioCardia, Inc. anticipates submitting for approval of its CardiAMP Heart Failure treatment in Japan by late Q4 2024, following a consultation with the Japan Pharmaceutical and Medical Device Agency (PMDA). The submission will be based on the existing data.
December 18, 2023 | 12:18 pm
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POSITIVE IMPACT
BioCardia is set to submit for Japanese approval of its CardiAMP Heart Failure treatment by late 2024, which could lead to future revenue growth in the Japanese market.
The news of a planned submission for approval in Japan is a positive development for BioCardia, indicating progress in the international regulatory process. This could lead to an expansion of the company's market and potential revenue growth. The impact is scored as positive (1) due to the potential for future sales and market expansion. The relevance is set at 100 as the news is directly about BioCardia. The importance is at 75, considering that regulatory approval is a significant milestone for medical treatments, but the actual approval and subsequent sales are still uncertain. The confidence level is at 80, reflecting the clear timeline provided but acknowledging that regulatory processes can be unpredictable.
CONFIDENCE 80
IMPORTANCE 75
RELEVANCE 100