Under the terms of the collaboration agreement, DSI would purchase devices from Ivivi Technologies and pay a royalty on all sales or rentals of such devices. The collaboration agreement, which runs through August 2015, can be terminated by mutual consent or for non-performance by either party, subject to applicable cure periods.
The first phase of the collaboration agreement involves DSI Renal initiating a multi-site, randomized controlled clinical trial to provide additional data on the effect of Ivivi Technologies’s products on the healing of cutaneous ulcers in diabetic patients with end stage renal disease. Following the completion of the clinical trial, DSI Renal would be granted an exclusive license for the distribution of certain of Ivivi’s products in the US for the chronic and end stage renal disease market. Ivivi will supply DSI with product for the clinical trial, with DSI responsible for providing personnel, supplies and equipment necessary for the conduct of the trial. Primary end-points will include time to complete healing, degree of wound healing expressed as a percentage of total volume area healed at a specific time and percentage of non-healing wounds.