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Uroplasty Reports Third Quarter Fiscal 2009 Results
Tuesday, February 03, 2009 4:01 PM


- Patient Enrollment in Urgent(R) PC SUmiT Clinical Trial for Expanded Reimbursement Completed Ahead of Schedule -

- Macroplastique(R) Gaining Market Momentum -

- Company Updates Fiscal 2009 Outlook -

- Conference Call to be Held Today at 3:30 pm Central Time -

MINNEAPOLIS, Feb. 3 /PRNewswire-FirstCall/ -- Uroplasty, Inc. (Amex: UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today reported financial results for the third quarter of fiscal 2009 ended December 31, 2008. Net sales for the third quarter of fiscal 2009 were $3.4 million versus $3.7 million during last fiscal year's third quarter.

'As we discussed in conjunction with the release of our fiscal second quarter results, our Urgent PC system to treat overactive bladder syndrome has been facing a challenging market environment created by insurance reimbursement uncertainties,' said David Kaysen, President and CEO. 'While a growing number of physicians are recognizing the benefits of Urgent PC, and the treatment continues to receive reimbursement from many insurance plans, our market momentum has slowed due to the uncertainty with insurance reimbursement.

'A major part of our strategy to expand and support third-party reimbursement coverage of Urgent PC treatment is the SUmiT study, which we announced in October. The study is designed to directly compare the effectiveness of Urgent PC treatment to non-active treatment and the enrollment of 221 patients was completed two months ahead of schedule,' added Mr. Kaysen. The SUmiT study is evaluating reductions in urinary urgency, urge incontinence and frequency of urinary voids, as well as patient quality of life measures. This study, now expected to be completed by late summer of 2009, is taking place at 23 urology and urogynecology centers across the United States.

'Meanwhile, U.S. sales of Macroplastique are building momentum,' added Mr. Kaysen. 'Through our expanded sales focus and training, we are capitalizing on recent market concerns regarding competitive products that treat urinary incontinence. In addition, the January 2009 issue of the Journal of Urology highlighted results from a clinical study of Macroplastique. The study concluded that in the Macroplastique patient group, the dry/cure rate was 36.9% versus 24.8% in the control patient group. The authors of the study concluded that Macroplastique is a safe, effective, minimally invasive material that can be administered on an outpatient basis. The combination of these factors resulted in record sales for Macroplastique in our fiscal third quarter,' concluded Mr. Kaysen.

Fiscal Third Quarter and Nine Month Results for the Periods Ended December 31, 2008

Net sales for the three months ended December 31, 2008 were $3.4 million versus $3.7 million for the same period a year ago. Net sales for the nine months ended December 31, 2008 were $11.8 million, up 22% from $9.7 million for the same period a year ago.

Sales to customers in the U.S. for the three months ended December 31, 2008 were $1.9 million, down one percent, compared with $2.0 million in the same period a year ago. This decrease was due to the reimbursement uncertainty that has developed in the U.S. market for Urgent PC treatments. Sales to customers outside of the U.S. for the three months ended December 31, 2008 were $1.4 million, down 18% from $1.8 million in the year ago period. Excluding the translation impact of fluctuations in foreign currency exchange rates, sales to customers outside of the U.S. declined approximately 5%.

Nine month sales to customers in the U.S. were $6.4 million, an increase of 52% from $4.2 million for the same period last year. Nine month sales to customers outside of the U.S. were flat at $5.5 million as compared with the same period last year. Excluding the translation impact of fluctuations in foreign currency exchange rates, sales to customers outside of the U.S. declined approximately 2%.

Net loss for the third fiscal quarter ended December 31, 2008 was $894,000, or $0.06 per diluted share versus $900,000, or $0.06 per diluted share for the third quarter of last year. For the nine months ended December 31, 2008, net loss was $1.9 million, or $0.12 per diluted share compared with a net loss of $3.1 million, or $0.23 per diluted share for the same period last year.

At December 31, 2008, cash and cash equivalents, and short-term investments were $8.6 million compared with $9.0 million at September 30, 2008 and $10.1 million at March 31, 2008.

'We continue to implement a comprehensive program designed to educate Medicare carrier and private payer medical directors around the country about the benefits and clinical study results of Urgent PC,' continued Mr. Kaysen. 'The medical directors have asked for additional peer-reviewed publications in medical journals on PTNS treatments. We expect the first of such articles to be published within the next 30 days.'

'In the meantime, physicians using Urgent PC are communicating their successes to these medical directors and we are in active communication with professional associations who are involved with reimbursement and believe we have the right people and the right resources to proactively address various reimbursement related issues. It is important to remember that reimbursement uncertainties are common with practically every new medical technology. Gaining a specific CPT code for the procedure is our end goal and we believe our strategies to achieve that endpoint are generating positive responses from the market and will lead to achieving our objective,' Mr. Kaysen concluded.

Guidance

For fiscal 2009, the Company currently expects overall sales to grow by approximately 4% to 7% over fiscal 2008, and U.S. sales to grow between 20% and 25%.



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