香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 Peijia Medical Limited 沛嘉醫療有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股 份 代 號：9996） 自願公告 國家藥監局批准TaurusTrio™經導管主動脈瓣系統的註冊申請 本公告乃由沛嘉醫療有限公司（「本公司」，連同其附屬公司統稱「本集團」）自 願作出，為本公司股東及潛在投資者提供有關本集團最新業務發展及新產品 研發進度的最新資料。 本公司董事（「董事」）會（「董事會」）欣然宣佈，於2025年12月11日，本公司收到 中華人民共和國國家藥品監督管理局（「國家藥監局」）就TaurusTrio™經導管主 動脈瓣（「TAV」）系統（「該系統」）的註冊申請發出的批准。 茲提述本公司日期為2022年1月14日的公告。TaurusTrio™ TAV系統由本公司 基於自JenaValve Technology, Inc.（「JenaValve」）獲得的Tr ...

戴维医疗（300314）(300314.SZ)公告，公司新产品电动手术台获得了浙江省药品监督管理局颁发的 《医疗器械注册证》。 ...

Financial Data and Key Metrics Changes - The company experienced a decline in revenue growth quarter over quarter in the U.S. over the last six quarters, attributed to hospital capacity and workflow management issues [4] - Gross margin took a step back in the quarter but the company maintained full-year guidance of 74% gross margin, expecting an acceleration to above 75% in the second half [47][48] Business Line Data and Key Metrics Changes - International performance has exceeded expectations with double-digit growth across major European markets, not solely driven by China [3][34] - The U.S. commercial footprint has expanded significantly, but growth has been slower than anticipated due to operational constraints [7][10] Market Data and Key Metrics Changes - The total addressable market (TAM) in the U.S. for severe emphysema patients is estimated at 500,000, with only about 10,000 procedures expected in 2025, indicating significant room for growth [10][8] - The company is seeing strong interest from the physician community and patient advocacy, which is expected to drive future growth [3][8] Company Strategy and Development Direction - The company is focusing on initiatives like AeriSeal® and the AeriSeal® Convert2 clinical trial, which is expected to expand the patient base by 20% once approved [5][55] - There is a strong emphasis on educating community pulmonologists to improve referral networks and streamline the patient treatment process [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming short-term operational challenges and expects to see sustained growth from initiatives implemented [12][24] - The company anticipates that international markets will continue to grow, with a significant opportunity in China and Japan, particularly with the upcoming commercial launch [34][43] Other Important Information - The company has tightened its operating expense guidance to $128 to $130 million for the year, focusing on maintaining cash burn while funding growth initiatives [48][49] - Management highlighted strong cash management practices, which have been crucial in navigating the current operational landscape [63] Q&A Session Summary Question: When do we see U.S. growth translate into more sustained and meaningful growth? - Management expects growth to begin translating now, with ongoing initiatives starting to show results [7] Question: How much of the slowdown in the U.S. is structural versus temporary? - Management believes the slowdown is primarily due to operational constraints rather than market saturation [10] Question: How sustainable are the trends in StratX® volume? - Management indicated that they expect sustained growth over time, with early indicators showing positive results [22][24] Question: What are the timelines for commercial launch in Japan? - The company is currently enrolling patients for a study and expects a significant ramp in 2026, with broader commercial launch anticipated in 2027 [43][46] Question: How does AeriSeal® help address challenges in the U.S.? - AeriSeal® is expected to expand the TAM and provide treatment options for patients who currently do not qualify for existing procedures [55][56] Question: How is the company managing competition from new device entrants? - Management acknowledged the interest in the market but expressed confidence in their established data and experience with existing products [51][52]