NxThera has nailed down $18.2 million in new financing and a pivotal CE mark. Execs will put the money and European regulatory approval to use in multiple ways to advance the company's water vapor urology device as a treatment for various prostate and kidney conditions.
Company President and CEO Robert Paulson told FierceMedicalDevices that the new financing includes original investors Aberdare Ventures, Arboretum Ventures and GDN Holdings, plus new investors he declined to name. Overall, the company has pulled in more than $40 million in venture funding since its 2008 launch.
NxThera will use the money, in part, to launch a pivotal U.S. clinical trial for its Rezūm System to treat benign prostatic hyperplasia, or enlarged prostate--with FDA 510(k) clearance the ultimate goal. Paulson told FierceMedicalDevices that the randomized study will begin sometime in Q3, with enrollment numbers to be announced soon. The CE mark covers the same indication the company is seeking in the U.S.
Separately, plans call for using the cash to ready for a 2014 launch for Rezūm in certain European countries. Additionally, the money will fuel expanded research toward using the company's sterile water vapor technology to treat prostate and kidney cancers.
Medical device venture capital investment remains stagnant, save for companies whose technology is close to regulatory approval or commercial use. NxThera's CE mark gives it an edge in the financing space, because the company is poised to gain some commercial sales experience as well as additional data that could help inform its U.S. approval process. And the company is positioned to hit a treatment space with plenty of potential patients. NxThera points to more than 12 million men in the U.S. alone as having been diagnosed with an enlarged prostate. More than 2.5 million U.S. men have faced prostate cancer diagnoses, the company said.
Paulson said the funding round and the CE mark status "are major milestones" for the company.
"The fact that all those events are occurring relatively concurrently is an endorsement of the company's progress and its potential," he told FierceMedicalDevices.
The technology relies on sterile water vapor to deliver targeted treatments designed to improve urine flow, and doctors can perform the procedure in an office over a couple of minutes. NxThera employs 23 people.
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