DEVELOPMENT OF SUTURELESS AMNIOTIC MEMBRANE GRAFT

描述(申请人提供)：由于首席研究人员在过去十年中的开创性工作，羊膜移植(AMT)用于眼表重建的手术于2001年被FDA批准，并于2004年被Medicare作为标准手术程序报销。许多研究表明，AMT在促进上皮伤口愈合和减少间质炎症、瘢痕形成和不需要的新血管形成方面是有效的。使用首席调查员的专有方法，TIssueTech公司的子公司生物组织公司自1997年以来已经向世界各地的1200多名眼科外科医生分发了1万多种人类羊膜产品(商标名称：“AmnioGraft(Tm)”)。然而，AmnioGraft(Tm)移植程序需要在手术室使用缝合线和手术。在过去的SBIR第一阶段赠款支持下，我们开发了一种“无缝合”羊膜移植(Tm)，目前商标为Prokera(Tm)(以前称为AmnioLens)，作为实现我们的最终目标的第一步，即进行无缝合的AMT，以降低医疗成本并简化患者护理，特别是对那些患有严重眼表破坏的患者，如Stevens Johnson综合征和化学烧伤。既然Prokera(Tm)已经获得了FDA的510(K)类设备批准(2003年12月)，我们希望在这一第二阶段SBIR应用中完成以下三项任务。目标1：使FDA批准的Prokera(Tm)的生产过程自动化，以满足预计的临床使用增加。目的：探讨FDA批准的Prokera(Tm)在上皮破裂前促进因疾病和手术引起的神经营养不良的角膜神经再生的临床应用前景。目的3：开发并完成第二代软裙ProKera(Tm)“ProKera-S”的临床前测试，为接受准分子激光角膜屈光手术的患者提供更多的舒适感。总而言之，我们可能会通过使用Prokera(Tm)进行无缝合AMT来扩大市场潜力，从而进一步促进我们的业务发展。

DESCRIPTION (provided by applicant): Due to the Principal Investigator's pioneering work over the past decade, amniotic membrane transplantation (AMT) for ocular surface reconstruction was approved by the FDA in 2001 and reimbursed by Medicare in 2004 as a standard surgical procedure. A number of studies have shown that AMT is effective in facilitating epithelial wound healing and reducing stromal inflammation, scarring and unwanted new blood vessel formation. Using the Principal Investigator's proprietary method, Bio-Tissue, a subsidiary of TissueTech, Inc., has distributed more than 10,000 human amniotic membrane products (trademark name: "AmnioGraft(tm)") to more than 1,200 ophthalmic surgeons worldwide since 1997. Nevertheless, the AmnioGraft(tm) transplantation procedure requires the use of sutures and surgery in an operating room. Under past SBIR Phase I grant support, we developed a "suture-less" AmnioGraft(tm), currently trademarked as Prokera(tm) (formerly called AmnioLens) as a first step toward achieving our ultimate objective of performing AMT without sutures to reduce the medical cost and facilitate the ease of patient care, especially for those patients suffering from severe ocular surface destruction such as Stevens Johnson syndrome and chemical burns. Now that Prokera(tm) has received FDA's 510(k) approval as a Class II device (Dec 2003), we would like to accomplish the following three tasks in this Phase II SBIR application. Aim 1: To automate the manufacturing process for FDA-approved Prokera(tm) to meet the projected increase of clinical uses. Aim 2: To explore the future clinical applicability of FDA-approved Prokera(tm) to promote corneal nerve regeneration in neurotrophic corneas caused by diseases and surgeries before epithelial breakdown takes place. Aim 3: To develop and complete pre-clinical testing of "ProKera-S", a second generation of softskirt ProKera(tm) that provides more comfort to patients receiving excimer laser-assisted corneal refractive surgeries. Taken together, we may further promote our business development by expanding the market potential using Prokera(tm) for suture-less AMT.