- Patent portfolio secures innovation for the future of heart replacement - TUCSON, Ariz., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first U.S. and Canadian commercially-approved total artificial heart, today announced the strengthening of its intellectual property portfolio with the recent grant of U.S. Patent No. 12,383,722 B2 covering systems and methods related to its next-genera ...

Financial Data and Key Metrics Changes - Total operating expenses increased to $5.5 million in Q2 2025 from $4 million in Q2 2024 [24] - R&D costs decreased to $1 million in Q2 2025 from $2.1 million in Q2 2024, primarily due to reduced costs associated with the ReAssure trial [24] - G&A costs rose to $4.2 million in Q2 2025 from $1.9 million in Q2 2024, driven by pre-commercialization activities [24] - Net loss on a GAAP basis was $6.5 million in Q2 2025 compared to a net loss of $5 million in Q2 2024 [25] - Non-GAAP net loss was $5.1 million in Q2 2025 compared to $3.8 million in Q2 2024, with the increase attributed to higher G&A expenses [25] - Cash and cash equivalents stood at $13 million as of June 2025, expected to fund operations into 2026 [26] Business Line Data and Key Metrics Changes - The company is preparing to launch Orlynda, targeting the uncomplicated urinary tract infection market in the U.S. [6][8] - The market generates approximately 40 million prescriptions annually, with about 26 million for at-risk patients [9] - The initial launch phase will focus on 20 targeted geographic territories, covering around 2,300 high-value physician targets [10][11] Market Data and Key Metrics Changes - The uncomplicated urinary tract infection market in the U.S. has not seen a new branded oral treatment in over 25 years, indicating a significant opportunity for Orlynda [9] - Rising rates of antimicrobial resistance are eroding the efficacy of existing treatments, highlighting the need for new therapies [10] Company Strategy and Development Direction - The company aims to successfully launch Orlynda to address unmet needs in the uncomplicated urinary tract infection market [7] - A commercial supply agreement has been executed with ACS Dabfahr for the production of Orlynda, ensuring a reliable supply chain [15][16] - The company plans to optimize physician targeting and resource allocation based on market dynamics and prescription patterns [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of Orlynda, emphasizing the significant need for new treatment options in the U.S. market [31] - The company is focused on building a strong commercial presence and ensuring access to Orlynda for patients [12][21] Other Important Information - The FDA has granted Orlynda ten years of market exclusivity, expiring in October 2034 [19] - The company has requested authorization for an additional 80 million shares to ensure financial flexibility for strategic objectives [27][28] Q&A Session Summary - No questions were registered during the Q&A session, indicating a lack of immediate inquiries from investors [30]