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海南又一款第三类医疗器械获批上市
Hai Nan Ri Bao· 2025-09-19 01:35
据悉,这是我省今年获批的第7个第三类医疗器械产品。近年来,我省多措并举持续精准指导帮扶 第三类医疗器械产品研发注册,目前累计已有28个第三类医疗器械产品获批上市,获批数量近三年平均 每年翻一番。 此外,省药监局对纳入国家药监局医疗器械审评前置试点范围的品种,给予重点关注和指导,提供 全程跟踪服务。目前,我省共2批5个产品入选审评前置重点品种,数量约占全国入选总数的十分之一。 海南又一款第三类医疗器械获批上市 累计已有28个产品获批 海南日报讯(海南日报全媒体记者 李梦瑶)近日,海南百迈科医疗科技股份有限公司自主研制的一 款第三类医疗器械"可吸收性外科缝线"获国家药监局批准上市。该产品是由75%乙交酯和25%己内酯的 共聚物材料制成的无菌可吸收性单股带倒刺缝线,主要用于适合使用可吸收缝线的软组织缝合。 ...
临床医生在南京创业,凭一根手术缝合线获华泰紫金投资、新工投资追投
Sou Hu Cai Jing· 2025-07-31 13:46
Group 1 - The core idea of the article highlights the successful completion of the B+ round financing by Nanjing Pulimeng Medical Technology Co., Ltd., led by Huatai Zijin Investment and XG Industrial Investment [1][8] - The founder Liu Ping, with a medical background, identified a gap in the medical device market during his postdoctoral research in the United States, which fueled his entrepreneurial ambition [3][5] - Pulimeng's first product, an absorbable surgical suture, was approved for market in July 2020, featuring a unique cutting process and design that significantly improves suturing effectiveness compared to traditional products [5][3] Group 2 - Over its nine years of establishment, Pulimeng has developed two key technology platforms for biodegradable polymer material preparation and personalized processing of biodegradable medical devices, resulting in over 20 self-developed products [5][7] - The company's flagship product, the absorbable knotless barbed suture, utilizes a special processing technique and has a degradation period of approximately 180 days, simplifying the suturing process and reducing surgery time [5][3] - In the aesthetic medicine sector, Pulimeng has launched a recombinant collagen dressing and completed clinical trials for its "童颜针" (youthful needle), with promising data on its PLLA microsphere particles [5][3] Group 3 - The industrialization base project of Pulimeng was selected as a major project in Jiangsu Province for 2024, which has been completed and is set to enhance the company's production capacity and technological innovation [7][8] - The company has undergone multiple financing rounds, including nearly 100 million yuan in A round financing in 2022 and close to 200 million yuan in B round financing in 2023, with the latest B+ round financing amount undisclosed [8][7]