陳瑾惠、朱建平、李經維、楊岱樺、許哲嘉、林寶彥、藍聖閔
Co-developed by National Cheng-Kung University and Joy Medical Devices Corp., Ezechbone® is a synthetic, inorganic, 100% resorbable calcium-based implant device that holds patents in 14 countries. The implant is intimately integrated with surrounding bone and replaced by new bone without inflammatory or other undesirable tissue reactions. Ezechbone® demonstrates high clinical potentials in vertebroplasty, spine fusion, comminuted/burst fracture under acute or nonunion condition, osteoporotic fracture, plastic surgery, etc. Ezechbone® has two primary forms, Ezechbone® Granule and Ezechbone® Cement.
Ezechbone® Granule demonstrates osteoinductive features with a healing process substantially bypassing the “text book”-suggested inflammation route while quickly and directly facilitating new bone formation throughout the entire implantation site. Ezechbone® Granule is much less inflammatory and inducing new bone formation much faster than the so-called “gold standard” autogenous bone graft. In an osteoporotic goat spine implantation study, Ezechbone® Granule demonstrates a high potential of treating osteoporotic fractures. The new trabecular network is found much denser than osteoporotic control goat and comparable to the healthy control goat. The trabecular architecture of implanted goat substantially restores to the normal level. At 6 mo post-op, compared to the osteoporotic control goat, the Ezechbone® Granule-implanted goat demonstrates a more randomly-oriented, smaller-sized and apparently much more active and vibrant lamellar bone morphology without signs of osteoporosis-related delay in the bone maturing process.
One major feature of Ezechbone® Cement is its nondispersive characteristic upon contact with blood or body fluid, largely avoiding the dangerous cement embolism risk. Ezechbone® Cement can be minimally invasively delivered using the novel JMD jBranchTM system that holds patents in 14 countries, especially for spine surgery.
The unique features of Ezechbone® may be demonstrated in the following three clinical applications- the “Three Arrows of Ezechbone®”:
To our knowledge, Ezechbone® Granule-Sternotomy is the only product combining excellent hemostatic efficacy, anti-inflammatory and fast bone healing performance- the three most crucial factors for a successful sternotomy surgery- in one single product. For complicated sternotomy cases, the application of Ezechbone® Granule can drastically reduce the bleeding of patients by as much as >80%. This unique healing performance can lead to significantly-reduced surgical complications, intensive care/ hospitalization time, patient sufferings (quality of life) and healthcare costs.
Despite the various potential advantages of synthetic bone substitute, major synthetic bone substitute products in the current market are poorly absorbed, less biocompatible, or could even induce ectopic bone formation or abnormal synostosis. Ezechbone® Granule-Intraarticular Fractures is ideal for treating acute and non-union joint fractures. The implant contacting bone causes the bone to fast heal, while the implant contacting soft tissues is naturally dissolved without causing inflammation or other side effect. This unique performance distinguishes itself from all major existing competitors for this challenging indication.
Ezechbone® Cement-Spine is ideal for use in acute-stage and nonunion vertebroplasty, fusion, preventive OVCF, repairing failed spine surgery, etc. In a safe, conservative and minimally-invasive way, Ezechbone® Cement is especially ideal to treat senile, osteoporotic patients with chronic, persistent back pains without having experienced a catastrophic fracture or under a health condition inappropriate for a large scale spine surgery.
2.本案已完成商品開發並通過查驗登記,生產上市。 上市前相關之安全及有效性資料,顯示本案產品安全無虞,且作為骨填補材料之誘導骨質生長之性質優異,已具備成熟度。
3.骨癒合速度比標準自體骨要快10倍,並已取得認證並商品化,相較於歐美產品,Ezechbone®也有其優勢,具強大優勢。

陳瑾惠 |
|
學歷 |
Northwestern University Biological materials Ph.D. (Chicago, Illinois, USA) |
現職 |
Vice director, Center for Biomaterials Research (CBR), NCKU Innovation Headquarters |
經歷 |
• Professor, Dept. of Materials Science and Engineering, National Cheng-Kung University, Tainan, Taiwan (1995-) • Director/vice director, Center for Biomaterials Research (2002-) National Cheng-Kung University, Tainan, Taiwan • Visiting Professor/ Visiting Specialist, National Yang-Ming University School of Dentistry, Taipei, Taiwan • Visiting Professor, Dept. of Materials Science, Northwestern University, Evanston, Illinois, USA. • Joy Medical Devices Corp. Technology Founder/ CTO (2010--) |
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