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. ? ?
