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    Kumaraguru RajaBrookline Capital Markets

    Kumaraguru Raja, Ph.D., MBA, is a Senior Biotechnology Analyst at Brookline Capital Markets specializing in small and micro-cap healthcare and biotechnology companies, with a focus on drug development across infectious diseases, oncology, and women's health. He covers public companies such as Veru, Adial Pharmaceuticals, Dermata Therapeutics, Agile Therapeutics, and Intensity Therapeutics, and his performance track record includes 31% of recommendations being profitable with an average return per transaction of -9.8%. Raja began his equity research career in 2010 at Citi Research covering large-cap biotech, later serving as Vice President of Biotechnology Research at Noble Life Science Partners before joining Brookline in 2017. He holds a Ph.D. in Biological Sciences, an MBA from UC San Diego, is FINRA-registered, and is noted for his expertise in scientific and financial analysis of drug development pipelines.

    Kumaraguru Raja's questions to BioCardia Inc (BCDA) leadership

    Kumaraguru Raja's questions to BioCardia Inc (BCDA) leadership • Q2 2025

    Question

    Kumaraguru Raja of Brookline Capital Markets inquired about the type of meeting planned with the FDA for CardiAmp, the current screening and enrollment status for the CardiAmp Heart Failure II trial, and the expected timeline for achieving clarity from both the PMDA and FDA.

    Answer

    CEO Peter Altman explained that the company is still deciding on the type of FDA meeting, possibly a Sprint discussion due to CardiAmp's Breakthrough Designation. He noted the CardiAmp HF2 trial is actively enrolling at four sites, with a fifth starting soon, but regulatory submissions are the primary priority. Dr. Altman clarified that they expect clarity from Japan's PMDA by the end of Q4, with FDA clarity to follow slightly later, after the de novo 510(k) submission for the Helix system.

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