- 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%.