SBIR-STTR Award

Advanced Vascular Therapies, (AVT), INC. proposes to further develop a portable pneumatic compression device (PCD) in SBIR Phase I, for sales after ramp-up and FDA clearance in SBIR Phase II. The PCD will be optimized for the critical wound healing needed to prevent amputation for patients suffering from arterial insufficiencies that can be used in the patient's home, providing access not currently available, especially in rural areas. This R&D addresses the portable/remote wound-healing need prominent among the population of patients suffering from arterial insufficiency (often diabetics), exploiting novel blower technology, and cuff design applied to a PCD. Results from an on-going physician-sponsored pilot at a major Midwest Clinic, completely independent of AVT, will be analyzed to inform the design of AVT's next proposed PCD. The treatment approach, measuring dermal perfusion using Laser Doppler Perfusion and oxygen tension to determine efficacy, examines patients before, during, and after use of the AVT PCD.AVT's goals are: 1) Increase patient compliance while reducing healing time, cost, and the need for amputation in comparison with commercially available portable alternatives. 2) Provide close, safe access to treatment to patients that would have to go great distances to a limited number of large clinics to heal otherwise. These include Indian reservations, VA and low income patients. The R&D will be carried out in collaboration, with Dr. Robert D. McBane and Dr. Steven J. Kavros (AVT Medical Director).

ritical limb ischemia (CLI) the most severe form of peripheral arterial disease (PAD)occurs when arterial circulation is insufficient to support the metabolic demands of thetissue. Amputation is often the result. In many diabetic patients the arterial disease isso diffuse and distal that revascularization success rates are low. Mortality rates for CLIpatients are high at 50% within 5 years and 85% within 10 years. Given the obesityepidemic associated with diabetes developing new strategies for treating CLI inpatients without a revascularization treatment option remains a crucial goal and keyopportunity.AVT an Indiana-based small business is developing a new device to treat CLI andother vascular conditions of the extremities. Through a successful Phase I AVTdeveloped a working prototype of its Smart pneumatic compression device (PCD). As acontinuation of those successful efforts AVT and its collaborators are proposing thefollowing Technical Objectives in Phase II:1) Continue to consult with Dr. Robert McBane and use pilot data and his expertise toimprove AVT's PCD prototype;2) Further develop AVT's main PCD prototype and cuff to maintain efficacy whilemaximizing benefits—including ease of use in home or clinic;3) Create additional smart features to enhance use and compliance;4) Transfer the PHI prototype to GMI and provide ramp-up for manufacturing for homeand clinical sales; and finally5) Prepare for FDA passage and regulatory clearance. Once fully developed this newSmart PCD offers an extensive market opportunity as it can be used to treat multipleconditions with compliance feedback that will aid prescribers' treatment plans andpayers' reimbursement validation.The outcome of this Phase II funding will be a portable smart (computer controlled)noninvasive therapy option to help heal wounds in-home or local clinics; especiallyneeded in rural areas where underserved populations have limited access and clinicalgrade treatments are not available. Patients in rural America suffering from diabetic footcomplications (commonly having CLI) are 51% more likely to undergo major amputationand 41% more likely to suffer impatient death. Those that live in poorer regions are 38%more likely to undergo major amputation. AVT's primary objective focuses on increasingpatient compliance while reducing healing time cost and the need for amputation incomparison with commercially available portable alternatives. Given the successfulresults of Phase I and a continued pilot study at a large Midwestern research hospitalAVT believes its Smart PCD can meet this objective.