URONEXT LLC — Department of Health and Human Services STTR Phase I: 400

Description

Abstract Erectile dysfunctionEDis a multifactorial disease that affects approximatelymillion American men and is continuing to increase with the increasing prevalence of diabeteshypertension and cardiovascular diseaseWhen first line and second line medications such as the phosphodiesteraseinhibitorPDE iclass of medications or direct injections failsurgical implantation of penile prostheses offers a permanent solutionApproximatelyof men with ED will ultimately fail treatment with PDE i yielding a potential market ofmillion menThe two broad classes of penile prostheses commercially available arethe inflatable prosthesis and the semi rigid prosthesisThe inflatable penile prosthesis relies on a closed system of reservoirspumpsvalves and hydraulic pressure to produce a simulated erection sufficient for intromission and coitusThe malleable is a bendable rodNeither device offers the ideal balance of being a robustreliablesimple and discrete treatment for male EDThe patient and physician perceptions on these device solutions are being too complexnot reliableand not physiologic and the cosmetic appearance is partly responsible as well for the modest uptake of surgical implantation of prostheses as treatment of their erectile dysfunction compared to the number of potential candidatesThus there is a need for a simplerobust surgical solution for men with refractory erectile dysfunction that appears as physiologic as possibleyet remains discrete and balances the various risks and benefits of the above solutionsUronext product is a solution that relies on the molecular rearrangement of a metal alloy to produce a simulated erectionAs suchit has a much smaller profileis very discreteand relies on the intrinsic properties of the metal and is thus very reliableSuch a design has the possibility to open the door to more widespread acceptance of prostheses for the treatment of ED similar to the more widespread acceptance of breast implantsprocedures per yearFurthermorethe much simpler and faster procedure will allow a much greater number of urologists and physicians to propose this solution to their patients PROJECT NARRATIVE The patient and physician perceptions on existing penile prostheses state that the devices are too complexunreliablewith a low cosmetic appeal leading to a modest uptake of surgical implantation as treatment of their erectile dysfunction compared to the number of potential candidatesThusthere is a need for a simplerobust surgical solution for men with refractory erectile dysfunction that appears as physiologic as possibleyet remains discrete and balances the various risks and benefits of the above solutionsThe Uronext shape memory alloy product has a smaller profileis discreteeasy to implant and relies on the intrinsic and reliable properties of Nitinol and shape memory alloys and as suchwill promote a more widespread acceptance of prostheses for the treatment of ED similar to the current acceptance of breast implantsprocedures yr