The Specific Aim of this Phase II application will be to evaluate the biopsy unit and delivery device in an animal model, make any modifications and redesign resulting from the animal trials and, upon the anticipated successful application, proceed to human clinical trials. Under the Phase I study we have designed and manufactured a functional prototype, and evaluated the device in explanted liver sections and in a live, but terminal canine model (non-NIH funded project). It was observed in an in vivo canine model that the use of the device obtained a suitable biopsy specimen and automatically delivered a coagulant plug that stopped the bleeding from occurring within 5 seconds. It is the OBJECTIVE of the proposed Phase II project will be to evaluate the device in: (i.) a fibrotic swine animal model, (ii.) a cirrhotic swine model, (iii.) a laparoscopic guided human liver biopsy procedure, and (iv.) a controlled, percutaneous human liver biopsy procedure. It is anticipated that limited commercialization of the device will be available towards the end of the study period
The US market for liver biopsy needles is approximately $5 million based on a conservatively estimated 100,000 liver biopsies due to the hepatitis virus and alcoholism. Although offered at a higher price than current needles, we would offer a complete needle, syringe, and delivery system that would also reduce hospital costs of more expensive procedures and complications. The proposed device would realize substantial profits of $600K with minimum (20%) penetration and reduce health care costs by $5M. Additional markets for other highly vascular tissue biopsies will open upon development of the device.
