Erectile dysfunction (ED) is a multifactorial disease that affects approximately 39 million American men and is continuing to increase with the increasing prevalence of diabetes, hypertension and cardiovascular disease. When first line and second line medications such as the phosphodiesterase 5 inhibitor (PDE5i) class of medications or direct injections fail, surgical implantation of penile prostheses offers a permanent solution. Approximately 1/3 of men with ED will ultimately fail treatment with PDE5i yielding a potential market of 10 million men. The two broad classes of penile prostheses commercially available are: the inflatable prosthesis and the semi-rigid prosthesis. The inflatable penile prosthesis relies on a closed system of reservoirs, pumps, valves and hydraulic pressure to produce a simulated erection sufficient for intromission and coitus. The malleable is a bendable rod. Neither device offers the ideal balance of being a robust, reliable, simple and discrete treatment for male ED. The patient and physician perceptions on these device solutions are being too complex, not reliable, and 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 candidates. Thus there is a need for a simple, robust surgical solution for men with refractory erectile dysfunction that appears as physiologic as possible, yet remains discrete and balances the various risks and benefits of the above solutions. Uronext product is a solution that relies on the molecular rearrangement of a metal alloy to produce a simulated erection. As such, it has a much smaller profile, is very discrete, and relies on the intrinsic properties of the metal and is thus very reliable. Such 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 implants (200,000 procedures per year). Furthermore, the much simpler and faster procedure will allow a much greater number of urologists and physicians to propose this solution to their patients.
The patient and physician perceptions on existing penile prostheses state that the devices are too complex, unreliable, with a low cosmetic appeal leading to a modest uptake of surgical implantation as treatment of their erectile dysfunction compared to the number of potential candidates. Thus, there is a need for a simple, robust surgical solution for men with refractory erectile dysfunction that appears as physiologic as possible, yet remains discrete and balances the various risks and benefits of the above solutions. The Uronext shape memory alloy product has a smaller profile, is discrete, easy to implant and relies on the intrinsic and reliable properties of Nitinol and shape memory alloys and as such, will promote a more widespread acceptance of prostheses for the treatment of ED similar to the current acceptance of breast implants (300,000 procedures/yr).