Shares of Uroplasty Inc. (NSDQ:UPI) surged 15 percent yesterday after the company reported a slew of positive reimbursement news, including a pickup by UnitedHealthcare, the largest health insurer in the U.S.
The UnitedHealthcare decision adds its 33 million-patient roster to the more than 30 million Medicare patients already under the coverage umbrella for Uroplasty’s Urgent PC neurostimulation device to treat urinary incontinence. The Minneapolis, Minn.-based company’s UrgentPC system is a posterior tibial nerve stimulation device that, unlike competing devices from Medtronic Inc. (NYSE:MDT) and others, is minimally invasive.
President and CEO David Kaysen told MassDevice that the decisions expand the total pool of patients with private insurance coverage for the procedure to about 70 million.
"Probably the best and most important part of the UnitedHealthcare decision is that they did a really extensive and thorough review of the clinical data on PTNS," Kaysen told us. "What made us feel good is that, based on that published data, they made the decision."
UPI shares went on a tear yesterday after news of the UnitedHealthcare decision broke, rising from a $6.85 open, peaking at $7.95 before closing at $7.87 for a tidy 14.9 percent gain on the day.
Uroplasty shares rose even higher in pre-market trading, hitting $8.05 before débuting its day on Wall Street at $7.95. Shares were down slightly to $7.74 as of about 10:45 this morning.
Analysts on The Street were as upbeat as Kaysen over the news. Matt Dolan of Roth Capital Partners called his forecast of 45 new accounts for Uroplasty during the first three quarters of this year conservative, noting that “these developments are critical in supporting Uroplasty’s push to add new accounts and drive utilization.”
And Charles Haff, of Dougherty & Co. LLC in Minneapolis, noted that the favorable comparison between UrgentPC and the only other FDA-cleared neurostimulation device, Medtronic’s InterStim (which won pre-market approval from the FDA last November for fecal incontinence).
“The approval of MDT’s InterStim may fuel further adoption of Uroplasty’s Urgent PC device and present upside to our estimates in F12 and beyond,” Haff wrote, noting that his firm’s polls of doctors showed that perhaps as many as half of patients diagnosed with fecal incontinence also suffer from urinary incontinence.
The comparison makes UrgentPC a "viable alternative" for second-line treatment of urinary incontinence after first-line drug treatments have been ruled out "by being much less invasive and costly," Kaysen said.
"Typically the first line of defense is, almost universally, medications. That’s about a $3 billion dollar market for pharmaceuticals. Five or six million patients in the U.S. have tried one or more drugs," he said. "We really view our product as being for patients who’ve tried one or more drugs and stopped."
It’s been up and down for Uroplasty since late last year, when it announced a positive reimbursement decision in late November, only to disclose a negative decision less than two weeks later that sent its shares down to $4.38.
But with nine of the 13 regional Medicare carriers signed on and a 10th (which bestows UrgentPC coverage on a case-by-case basis) poised to succumb, Kaysen is upbeat that the three holdouts will come around.
"We’re meeting with those medical directors and educating them about the clinical data," he told us. "We believe at some point in time these will initiate coverage."