Financial Data and Key Metrics Changes - Research and development expenses increased to $936,000 in Q3 2025 from $931,000 in Q3 2024, and increased to $3.8 million for the nine months ended September 2025 from $3.0 million for the same period in 2024, driven by the closeout of the CardiAmp heart failure study and new enrollment in the CardiAmp heart failure II trial [14] - Selling general and administrative expenses decreased to $0.6 million in Q3 2025 from $0.8 million in Q3 2024, and decreased to $2.4 million for the nine months ended September 2025 from $2.8 million for the same period in 2024, primarily due to lower compensation and professional services [15] - Net loss was $1.5 million for Q3 2025 compared to $1.7 million for Q3 2024, and $6.2 million for the nine months ended September 2025 compared to $5.5 million for the same period in 2024 [15] - Net cash used in operations decreased to $1.5 million in Q3 2025 from $1.7 million in Q3 2024, and for the nine months ended September 2025 decreased to $4.9 million from $5.5 million for the same period in 2024 [16] Business Line Data and Key Metrics Changes - The CardiAmp heart failure II clinical study is actively enrolling, with four centers currently involved and three having randomized their first patients [8][28] - The CardiAmp cell therapy in chronic myocardial ischemia trial showed an average increase in exercise tolerance of 80 seconds and an 82% reduction in angina episodes at the six-month primary endpoint [10] Market Data and Key Metrics Changes - Japan's PMDA has shown interest in heart failure therapies due to its aging population and limited options for treatment, which may enhance the market potential for the CardiAmp system [6][38] Company Strategy and Development Direction - The company is focused on advancing regulatory submissions for the CardiAmp cell therapy and Helix delivery system, with plans for a meeting with the FDA regarding the approvability of the CardiAmp system [7][13] - The company is pursuing non-dilutive funding for the CardiALLO allogeneic mesenchymal stem cell therapy, with expectations of clarity on funding in Q1 2026 [11][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for the CardiAmp heart failure II program, citing strong clinical data and support from physicians involved in previous trials [28][38] - The company is in a waiting mode for formal clinical consultations with Japanese regulatory authorities, with most preparatory work completed [35] Other Important Information - The company ended the quarter with $5.3 million in cash, which is expected to provide a runway into Q2 2026 without additional financing [16] Q&A Session Summary Question: Clarification on CardiAmp CMI data - The CardiAmp CMI data includes five patients enrolled at their primary endpoint out to six months, with compelling results compared to previous data [18][19] Question: Recruitment challenges for CardiAmp heart failure II trial - Enrollment is proceeding smoothly, aided by cell population analysis to set dosages, with no significant challenges reported [23][24] Question: Next steps for Japanese regulatory approval - The key hurdle is a formal clinical consultation to determine if existing clinical data is sufficient for safety and efficacy in Japan [33][34]