FDA approved ProVerum's ProVee System on December 9 under P250011. The Dublin company filed the PMA on April 2, so the review took 251 days. The label covers lower urinary tract symptoms from BPH. Patients need a prostatic urethral length of at least 3.75 cm and a prostate volume of 30 to 80 cc. Product code MER, permanent or semi-permanent prostatic urethral stent.
ProVee is a nitinol expander placed through a steerable delivery system with built-in imaging. It holds the three prostatic lobes open without cutting or heating tissue and can be removed. The ProVIDE trial was randomized, double-blind and sham-controlled. ProVerum says it met every primary and secondary endpoint through 12 months, with no device- or procedure-related serious adverse events and no post-procedure catheters. Steven Kaplan of Mount Sinai was global lead investigator. The approval order requires a post-approval study.
ProVerum spun out of Trinity College Dublin's medical device incubator in 2015. On August 25 it closed an $80 million Series B led by MVM Partners. OrbiMed, Ireland Strategic Investment Fund, Gilde Healthcare, Lightstone Ventures, Atlantic Bridge and Enterprise Ireland joined. Trinity called it the largest round ever raised by an Irish university spinout. CEO Paul Bateman says the device is available for sale in the US now.
Closing the launch round 106 days before the approval order keeps the launch on the company's clock rather than FDA's. Zenflow, whose competing nitinol implant went through the sham-controlled BREEZE trial, raised $24 million last year to fund its own PMA.