Ion-Vac technology for a treatment of infected wounds
|AFFILIATION:||Cleveland Clinic, Cleveland, Ohio, United States|
Track: Energy & Resilience
Area: Soldier Technologies
Tech Readiness: TRL 4
Tech Brief: Ion-Vac access antimicrobial properties of a new iontophoretic silver delivery system in infected skin burns. Ion-Vac technology is composed of electrodes containing silver compound and vacuum pump. The electric current flow between electrodes causes the release of silver ions into the wound and reduces bacterial load.
Value Proposition: Ion-Vac has developed a strong intellectual property position, beginning with a U.S. Provisional Patent Application 61/145,984; U.S. Patent Application Serial No. 12/260,786; U.S. Provisional Patent Application Serial No. 61/505,586; and a CIP Patent Application No. 13/543,169, covering a system for wound healing. We will proceed with the regulatory filing, which will consist of a 510(k) submission to the U.S. FDA. Discussions with regulatory consultants revealed that FDA will likely consider the Ion-Vac system as a Class II device, which will be more beneficial than the less rigorous 510(k) regulatory pathway that generally precludes (and in the case of NPWT systems, does preclude) the need for costly and time consuming clinical trials. The Cleveland Clinic group is planning 12 months for 510(k) clearance, which is expected to permit a U.S. product launch in 2017-2018. Assuming 510(k) clearance is obtained and permits market entry in 2018, we believe Ion-Vac’s competitive advantages will enable capture of at least 1% to 2% market share by 2020. This conservative projection translates to a per annum revenue run rate of $18 million and estimated profits over $4 million that year. This will facilitate immediate market access following FDA regulatory clearance of the Ion-Vac system.
Org Type: Early-stage Startup (Seed)
Booth Number: T509