Aug 17, 2017

Jul 21, 2017 6:47am Amphora plans to start a pivotal trial once it completes two ongoing feasibility studies. Amphora Medical has raised $35.5 million to put its overactive bladder (OAB) treatment through a pivotal clinical trial. The series B round equips Amphora to take its minimally invasive, cystoscopic device into the last step of clinical development next year. Longitude Capital and Boston Scientific led the round with the support of fellow new investor HBM Healthcare Investments. F-Prime Capital Partners and Baird Capital, the VCs that led Amphora’s $12.8 million series A in 2013, also chipped in to the latest financing. Amphora attracted the investment on the strength of the potential for its device to improve the lives of people with OAB, a condition associated with the sudden, hard-to-control need to urinate. Estimates of the prevalence of OAB cluster around 16%. Today, people typically try to manage OAB with behavioral interventions before advancing to drugs that relax the bladder or Botox injections. Another option is to insert a pacemaker-like device to regulate nerve impulses to the bladder. Minneapolis, MN-based Amphora thinks its device can offer a better option to some patients. Like the Nuro system Medtronic gained in its 2014 acquisition of Advanced Uro-Solutions, Amphora’s device seeks to modify nerve activity. But whereas Nuro delivers electrical pulses, the Selective Bladder Denervation System developed by Amphora destroys tissue to dial down signals sent from the bladder. Amphora thinks it can act on the nerves responsible for OAB without affecting those needed for the normal functioning of the bladder. Amphora is currently testing the device in more than 100 patients in two trials taking place in the U.S., Canada and Belgium. Data from these studies will propel Amphora into a pivotal trial in the U.S. “Upon the completion of two ongoing feasibility studies, we expect to initiate the pivotal, randomized, sham-controlled, selective bladder denervation clinical trial in women who are refractory to medical therapy in 2018,” Amphora CEO Tom Ressemann said in a statement. Read more on overactive bladder , medical device venture capital , venture capital (VC) , clinical trial , devices , Boston Scientific , Medtronic , Fidelity Biosciences , Longitude Capital Popular Content