Uroplasty Inc. (NSDQ:UPI) beat Wall Street and closed near its all-time high after reporting strong top-line growth for the fourth quarter and full year today.
The Minnetonka, Minn.-based incontinence treatment maker posted net losses of $4.6 million, or 25 cents per share, on sales of $13.8 million for fiscal 2011. That’s a sales increase of 16.2 percent, although net losses also grew by 45.1 percent. Fourth-quarter results were even more dramatic — net losses of $1.3 million, or 6 cents per share, on sales of $4.0 million for the three months ended March 31 added 34.6 percent to the top line, but net losses soared 130.4 percent.
President and CEO David Kaysen told MassDevice that the widening losses were mostly due to a significant increase in the company’s sales and marketing push for its UrgentPC neurostimulation treatment for urinary incontinence. Uroplasty is riding a wave of positive reimbursement decisions for the decision after earlier weathering some that didn’t go its way.
"In late November we hired 14 new sales reps and four field-based reimbursement managers, so we really brought on board 18 new people between November and December this past year. In the January-February-March quarter we had 100 percent of their expense. That will carry forward, but we won’t see a significant increase in sales and marketing expense [beyond that]," Kaysen told us.
The reimbursement landscape has shifted in Uroplasty’s favor since late last year, when it announced a positive decision in late November, only to disclose a negative decision less than two weeks later that sent its shares down to $4.38. Since then, Kaysen said, the company has won nods from 10 of the 13 regional Medicare providers and several regional HMO and PPO insurers. That brings about 31 million Medicare patients and another 70 million privately insured patients under Uroplasty’s coverage umbrella, he said.
And even as it pursues more coverage for the urinary incontinence indication (the treatment is a posterior tibial nerve stimulation device that, unlike competing devices from Medtronic Inc. (NYSE:MDT) and others, is minimally invasive), Uroplasty is also looking for FDA clearance to market the UrgentPC device for fecal incontinence.
"[The fecal incontinence] indication is approved outside of the U.S. Based on that experience, we’ve had a meeting with the FDA where we’ve presented the data we have for overactive bladder and the fact that we would like to pursue the fecal incontinence indication," " Kaysen explained. "We’re pretty certain that this would be a 510(k) de novo application, but it would require some clinical data. Right now we’re in the midst of better understanding what our procedure would be to accomplish that. We may begin that effort late this calendar year, once we get the direction completely defined internally."
Uroplasty will also look to make sure reimbursement is in place for the new indication, should it win favor at the FDA.
UPI stock closed at $7.82 today, close to the all-time high of $7.87 it logged April 5 after winning reimbursement coverage from UnitedHealthcare, the largest U.S. insurer.
Patient Safety Technologies reports losses
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Synovis posts a good quarter
Synovis Life Technologies Inc. (NSDQ:SYNO) posted $2 million in second-quarter profits, or 17 cents per diluted share, for the three months ended April 20. That’s a 57.5 percent increase over Q2 2010, when the company reported $1.2 million in profits, or 11 cents per diluted share. Revenues for the second quarter jumped 12.6 percent to $19.8 million, compared with $17.6 million during Q2 2010.
Medical Action Industries posts higher sales, lower profits
Medical Action Industries Inc. (NSDQ: MDCI) reported profits of $4.4 million, or 27 cents per diluted share, for the three months ended March 31, a 74.2 percent slide from last year’s $16.8 million, or $1.04 per diluted share, in the same quarter. Reported revenue for this quarter was $362.5 million, a 24.9 percent increase over the 2010 quarter’s $290.1 million.
Cardio Vascular Medical Device Corp. carries on without revenue
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