Manufacturing Process for Albumin-ICG Solder & Denatured Albumin Scaffold

DESCRIPTION (provided by applicant): Long term objectives: Laser Tissue Welding, Inc. focuses its research and product development in areas of innovative sutureless laser tissue welding using biodegradable and biocompatible biomaterials to join, repair and create hemostasis on surfaces of solid visceral organs such as the liver, spleen and kidney involved in trauma, cancer, and transplantation in the presence of dilutional coagulopathies or therapeutic anticoagulation. Specific Aims: Develop new manufacturing processes for 'Albumin-lndocyanine Solder' (AIS) and 'Denatured Albumin Scaffold' (DAS) two biomaterials required for laser tissue welding (LTW). This project will address the manufacturing process and its validation, design control, biocompatibility, gamma radiation sterilization validation, package strength and integrity, accelerated aging for regulatory purposes on a prototype basis. Research design and Methods: Develop and validate the manufacturing process for AIS and DAS biomaterials with processes that can be scaled up and automated. (Approximately 400 samples per product) Potential Technology innovation: The success factor for this technology is the development of a superior support structure made of biocompatible denatured human albumin that can be laser soldered. Anticipated outcomes: After successful prototype manufacturing and validation, we will scale up the manufacturing process to cGMP specifications and begin the regulatory approval process to begin human clinical trials. Potential commercial applications: These are trauma repair of the liver, spleen and kidney (200,000 case/year); liver tumors: primary hepatomas (22,000/yr), and rietastatic liver tumors (65,000/yr); split liver transplant (17,300 patients on the waiting list); partial nephrectomy for benign lesions (500/year); Urethral repair: for hypospadias, urethral stricture, urethral diverticulum, and urethral fistulae (600/yr) and skin approximation (all surgical procedures that currently use sutures) Relevance: 1) LTW will save lives due to its ability to quickly repair (minutes) and control hemorrhage from the surfaces of organs such as the spleen, liver, and kidney with minimal thermal injury. 2) Helps preserves and salvages organs such as liver, spleen, and kidney in trauma cases. 3) Blood conservation by reducing transfusion requirements. 4) Can be used laparoscopically for elective surgeries on liver and kidney.