

-
安心引流系統AnXin Drainage System迪利歐生醫Delyo廖子庭TZU-TNG, LIAO發明人:TZU-TNG, LIAO、JING-KAI, NG領域:心臟血管外科、重症適應症:臨床預期用途: 本產品為胸腔/縱膈引流系統,用於抽吸與移除手術液體、組織、氣體、體液或可能具感染性之物質,並提供引流狀態之監測與警示。研發階段:目前產品完成雛型第三代,硬體技術目前完成初步人血以及豬血體外驗證。預計今年會完成FDA Q sub,並且導入初步韌體回授。摘要:▌解決的核心問題
胸腔引流管是開心手術後不可或缺的術後照護裝置,負責引流胸腔積血、並提供醫師即時監測病人恢復狀況的依據。然而,臨床文獻顯示,術後胸管阻塞率高達 36%(Boyle EM Jr, 2015)。一旦阻塞,兩大核心功能同時失效:
引流失效:血液無法排出,積壓於胸腔,危及心肺功能
監測失效:醫師無法判斷引流量減少是病人好轉,還是管路堵塞,誤判率達 50%(Akira Shiose, 2010)
再開刀成本超過 6 萬美元/次,台灣每年約 400 例需再手術,累計系統損耗達 2,400 萬美元;美國已有醫院因延誤治療付出高達 600 萬美元賠償金。
現行主要競品(PleuraFlow、Thoraguard)各有結構性缺陷:前者無監測功能、高度人力依賴;後者閥門必須保持乾燥,一旦潮濕進入水氣即失效阻塞,且主機重達數公斤,成本結構不適合短期置管市場,美國市佔率僅 0.5%。
▌產品:AnXin 安心引流系統
AnXin Drainage System 是一套整合主動預防、智慧警示與標準化術後照護的胸腔引流解決方案,重量僅 500 克,輕鬆融入現行臨床流程,無需改變護理作業習慣。
AnXin 擁有三大核心技術模組:
① 螺旋清除導管
採雙軸旋轉清除機制,物理破壞血塊與纖維蛋白附著,同時進行自動清除,減少人工介入。操作壓力嚴格控制在 < -30 cmH₂O,確保安全不傷組織。
② 攜帶式恆壓幫浦
提供穩定負壓(-20 至 -30 cmH₂O),支援病人從 ICU 移動至一般病房甚至走廊,讓術後早期下床活動成為可能,加速復原進程。
③ 智慧韌體
內建壓力感測模組,即時判斷清除效果;依阻塞程度自動調節清除強度;清除失敗時即時發出警報,讓護理師在 5 分鐘內識別阻塞,取代過去 37 分鐘的手動疏通。
▌初步驗證數據
實驗室測試結果顯示,AnXin 相較於傳統引流系統:
引流效率提升 3 倍(AnXin:157 ml/min vs. 傳統:50 ml/min)
管路殘留降低 10 倍(AnXin:0.05 g vs. 傳統:0.5 g)
▌商業模式
採「主機 + 耗材」訂閱式商業模式:
主機 0 元導入,繞過醫院採購審核流程,加速進入臨床試點
耗材患者自費,調查顯示患者付費意願達 64.2%,耗材為主要獲利來源
此模式降低醫院採購門檻,同時確保可持續的耗材收入流。
πCode™ 精準影像晶元磁片敗血症定點照護多元檢測平台πCode™ Precision Image-Coded MicroDisc Multiplex Sepsis POCT Testing Platform博錸生技股份有限公司PlexBio Co., Ltd.曹汀Dean Tsao發明人:林程澤、孫明怡、吳正婷、雷志賢、曹汀領域:Infectious Disease, Precision Medicine, IVD適應症:Sepsis, Pneumonia, Meningitis研發階段:Currently in feasibility and prototype development, with preliminary assay performance and microfluidic PCR/πCode™ hybridization demonstrated. Next steps include assay expansion, system integration, analytical validation, and regulatory preparation.摘要:PlexBio is developing a closed, fully automated molecular diagnostic platform intended to identify sepsis-associated pathogens and antimicrobial-resistance (AMR) markers directly from whole blood. The system integrates culture-free sample preparation, highly multiplexed PCR, πCode™ precision image-coded magnetic microdisc hybridization, automated signal decoding, and result interpretation in a single sample-to-result workflow.
Its key innovation is the combination of direct-from-blood access, broad multiplex detection, and automation designed for the early sepsis treatment window, before conventional blood-culture results become available. Preliminary feasibility studies have demonstrated detection of selected pathogens in spiked whole-blood samples at low organism concentrations and successful integration of PCR and πCode™ hybridization modules.
The platform is designed to complement, rather than replace, existing sepsis workflows by providing earlier pathogen and AMR information to support antimicrobial decision-making. Compared with culture-dependent molecular panels, the proposed system offers earlier intervention potential, clinically relevant breadth, scalable panel expansion, and a deployable cartridge-based business model. The same platform architecture may subsequently be extended to pneumonia, meningitis, and other acute infectious diseases.
GelAtlas 水膠式三維組織培養平台GelAtlas Hydrogel-Based 3D Tissue Culture Platform國立成功大學生物醫學工程學系/整合機械生物系統實驗室Integrated Mechanobiosystems Lab, Department of Biomedical Engineering, National Cheng Kung University涂庭源Ting-Yuan Tu發明人:吳氏金銀、陳澔霖領域:創新醫材/3D 組織培養適應症:癌症藥物測試與病人來源腫瘤模型研究研發階段:原型/實驗室驗證摘要:GelAtlas 是一套水膠式三維組織培養平台,設計用於提升類器官、腫瘤球體與病人來源腫瘤組織模型的培養穩定性、影像分析品質與實驗再現性。透過可調控的水膠微孔陣列,GelAtlas 可將三維組織固定於明確位置,支援長時間培養、高解析影像追蹤、藥物反應測試與完整組織回收。此平台可由單晶片驗證擴展至多腔室格式,適用於學研單位、CRO 與藥廠研發流程,作為研究用三維組織模型與藥物篩選平台。
新興片狀細胞工程於關節軟骨重建之應用Advanced Bioengineering of Cell Sheets for Articular Cartilage Reconstruction曾厚老師團隊Prof. How Tseng's Team曾厚How Tseng發明人:曾厚領域:再生醫療之細胞治療適應症:退化性關節炎研發階段:ovaltseng@gmail.com摘要:Our patented, redox-responsive Cell Sheet Engineering (CSE) platform delivers a paradigm-shifting treatment for osteoarthritis, addressing a massive global unmet clinical need. By replacing conventional thermo-responsive systems with a smart substrate grafted with poly(gamma-glutamic acid) and disulfide linkers, our technology achieves a biomimetic hydrated stiffness of 16.2 MPa. This perfectly mirrors native human cartilage, providing the essential mechanical cues to suppress chondrocyte dedifferentiation. Utilizing a mild reducing agent, the platform enables the non-enzymatic harvesting of intact cell sheets with a fully preserved extracellular matrix (ECM). This scaffold-free approach eliminates foreign-body reactions and physical tissue integration barriers. The preserved endogenous ECM acts as a natural biological adhesive, driving seamless graft integration and the robust regeneration of high-quality, Collagen II-rich hyaline cartilage in vivo. Commercially, this chemically specific detachment ensures highly uniform, GMP-compatible manufacturing scalability. Backed by US patent US9,546,349 B2, our highly reproducible platform is uniquely positioned to capture the regenerative medicine market, offering a scalable, clinically superior, and commercially viable therapeutic strategy for functional articular cartilage repair.
利用養殖耐熱型銳枝鹿角珊瑚製備之永續骨材與其專利燒結技術Sustainable Cultivated Heat-resistant Pocillopora acuta Coral-Derived Sintered Biomaterial for Enhanced Bone Regeneration國立中山大學National Sun Yat-sen University溫志宏Zhi-Hong Wen發明人:Zhi-Hong Wen 、Tien-Chieh Chang、Long Chang領域:醫療器材、生醫材料適應症:牙科植牙生醫骨粉、骨科臨界創傷骨缺損重建、顱顏外科與外科骨骨折修復。研發階段:已完成專利佈局摘要:本技術針對全球臨床骨缺損修復的龐大需求,推出一款源自人工養殖、具備耐熱特性的鹿角珊瑚高性能仿生骨移植物。我們有效善用豐富且可再生的海洋資源,透過專利的熱燒結製程去除有機物質以確保臨床安全性,並完美模擬人類骨結構並維持優異的物理強度。 本材料具備極佳的生物相容性,離體細胞實驗證實其完全無細胞毒性,且能顯著加速骨母細胞的貼附與增殖,同時大幅上調核心造骨標記基因(ALP、OCN、Runx2、osterix)的誘導表現。長達 5 個月的大鼠顱骨臨界大小缺損活體模型更證實,本製備材料具備與新生骨生長同步的同步降解率,其新生骨體積、骨質密度與再生總骨質量均顯著提升。 本技術擺脫了傳統野生珊瑚採集所面臨的生態破壞、變異性高與 CITES 國際法規禁令,透過高度品質可控、規模化的人工養殖平台,能為全球每年超過 50 億美金的骨科與牙科骨材市場,提供穩定、安全且具高度臨床價值的工業化供應鏈解方。目前核心技術已成功發表於國際期刊 Materials & Design 並取得台灣發明專利,具備極高的商業轉譯可行性與 B2B 技術授權潛力。
MedSelect®: 功能性腫瘤藥性決策平台MedSelect®: Building the Functional Oncology Decision Infrastructure蔚流生物科技Fluidiconic Biotechnology Inc.穆宣佑Steven Mu發明人:領域:Functional Oncology / Tumor-on-a-Chip / Precision Oncology / Drug Discovery適應症:Solid tuomr研發階段:Early Commercialization and Traction摘要:Fluidiconic Biotechnology is building the functional oncology decision infrastructure for next-generation cancer drug development. Our MedSelect® platform integrates human-relevant tumor-on-a-chip models, intelligent automation, and functional oncology databases to accelerate drug discovery, optimize therapeutic strategies, and improve translational success.