DEVELOPMENT OF SUTURELESS AMNIOTIC MEMBRANE GRAFT

描述（由申请人提供）：由于主要研究者在过去十年中的开创性工作，用于眼表重建的羊膜移植（AMT）于2001年获得FDA批准，并于2004年作为标准手术程序由Medicare报销。许多研究表明，AMT在促进上皮伤口愈合和减少基质炎症、瘢痕形成和不需要的新血管形成方面是有效的。使用主要研究者的专有方法，Bio-TissueTech，Inc.的子公司，自1997年以来，已向全球1，200多名眼科医生分发了10，000多件人羊膜产品（商标名：“AmnioGraft（tm）”）。然而，AmnioGraft（TM）移植程序需要在手术室中使用缝合线和手术。在过去SBIR第一阶段的资助下，我们开发了一种“免缝合”羊膜移植物，目前注册商标为Prokera（tm）（以前称为AmnioLens），作为实现我们最终目标的第一步，即在不缝合的情况下进行AMT，以降低医疗成本并方便患者护理，特别是对于患有严重眼表破坏（如史蒂文斯约翰逊综合征和化学烧伤）的患者。既然Prokera（tm）已获得FDA的510（k）批准作为II类器械（2003年12月），我们希望在此II期SBIR申请中完成以下三项任务。目的1：实现FDA批准的Prokera（TM）的生产过程自动化，以满足临床应用的预期增长。目标二：探索FDA批准的Prokera（TM）在上皮破裂发生之前促进由疾病和手术引起的神经营养性角膜的角膜神经再生的未来临床适用性。目标3：开发并完成“ProKera-S”的临床前测试，这是第二代软裙ProKera（tm），为接受准分子激光辅助角膜屈光手术的患者提供更舒适的环境。综上所述，我们可以通过使用Prokera（tm）的免缝合AMT来扩大市场潜力，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.