End Stage Renal Disease (ESRD) is a complex disease that involves total and permanent kidney failure that affects more 600,000 individuals in the United States alone. Hemodialysis is a life-sustaining therapy for patients suffering from renal failure that requires that blood be withdrawn and cycled through a dialysis machine that performs the function of the failed kidneys. This process must be repeated at regular intervals and thus requires repeated needle punctures and the consequent needle access to a surgically created vascular shunt. These shunts are often created by connecting an artery to a vein with a prosthetic graft (arteriovenous graft [AVG]); these grafts, though widely used, suffer from many disadvantages. First, they do not allow for immediate cannulation and use in dialysis, as they require an initial period for tissue incorporation and healing post implant. Thus, more than 85% of ESRD patients start dialysis via tunneled dialysis catheter (TDC) for long periods while their AVG heal. Because TDCs are associated with a high morbidity and mortality rates, the use of an AVG that can be cannulated immediately after implantation may reduce morbidity in these patients. Second, hemodialysis access injuries due to poor cannulation can result in aneurysms, clotted access, and infections. There is no AVG currently available that offers immediate cannulation after implantation, facilitates successful, error-proof needle entry, and protects from access cannulation injury. To reduce the incidence of needle cannulation injuries and associated complications such as graft thrombosis and aneurysms, InnAVasc Medical, Inc. has developed an immediate access hemodialysis graft that assures routine, successful cannulation and prevents graft injury; the Bullet Proof vascular graft. This graft is constructed of biocompatible materials and has been designed to be easily identifiable, immediately hemostatic, self-sealing and resistant to posterior and sidewall penetration. Preliminary data has shown extreme promise, demonstrating ease of safe, error proof, and immediate cannulation, and a dramatic reduction in time to hemostasis following needle removal. In this Phase II proposal, we will further the commercial development of the Bullet Proof graft by conducting biocompatibility and GLP animal studies with the final device as might be required for submission of an IDE to the FDA as well as conduct a first-in-man feasibility study. The specific goals of this study are 1) Perform biocompatibility testing to evaluate the chemical and material safety of the Bullet Proof graft, 2) Assess the consistency, reproducibility and reliability of the Bullet Proof graft using a GLP animal study, and 3) Conduct a first-in-man feasibility study in a limited and controlled human cohort to demonstrate that the product can perform for its intended purpose as a vascular access graft. Successful completion of these Phase II SBIR studies will allow us to submit for regulatory clearance for the finalized device, aggressively seek a viable and strategic partnership, and proceed with commercialization plans in the US and EU.
End Stage Renal Disease is a complex disease that involves total and permanent kidney failure and affects more than 600,000 people in the US. One of the most common treatments is hemodialysis, a life-sustaining therapy that requires the use of arteriovenous vascular grafts (AVG). There is no AVG currently available that offers immediate cannulation after implantation and protects from cannulation injuries. InnAVasc Medical has thus developed the Bullet Proof, a graft that provides durable, self-sealing cannulation chambers with puncture resistant surfaces and is now furthering the commercial development of the Bullet Proof by conducting biocompatibility and GLP animal studies with the final device as well as a first-in-man feasibility study.
