Mar 16 2010
Bovie Medical Corporation (the “Company”) (NYSE Amex: BVX), a
manufacturer and marketer of electrosurgical products, today announced
its financial results for the fourth quarter and year ended December 31,
2009.
“Subsequent to receiving
510(K) clearance for our new products, we anticipate commercialization
of our proprietary technologies either through agreements with other
companies and/or independently.”
Revenues for the quarter ended December 31, 2009 totaled $6,533,177 as
compared to $7,137,838 for the comparable period last year, resulting in net income of $27,388 or $.00 per diluted share as compared to net
income of $38,767 or $.00 per diluted share during the comparable period
in the prior year.
Revenues for the year-ended December 31, 2009 were $26,953,447 as
compared to $28,096,510 for the comparable period in 2008. Net income
for the year-ended December 31, 2009 totaled $595,222 or $.03 per
diluted share compared to net income of $1,831,788 or $.11 per diluted
share in the comparable period in 2008.
The decline in revenues during 2009 was primarily attributable to a
general slowdown in purchasing by hospitals and physicians’ offices
caused by the current economy and political uncertainty surrounding the
medical industry. Net income was impacted by a substantial increase in
professional fees, litigation expenses (including a one-time settlement
payment of $160,000) and expenses related to the occupancy of the
Company’s new facility located in Clearwater, Florida. Gross profit
margins increased almost 2% in 2009 from 2008, primarily due to stricter
cost controls and improved sales mix.
NEW PRODUCT DEVELOPMENT ACTIVITIES DURING YEAR
Resistick II
Resistick II is coating applied to stainless steel which resists eschar
(scab or scar tissue caused by burning) during surgery. Since receiving
510(k) clearance at the end of December, the Company has received
initial contractual sales commitments. Coated electrodes continue the
expansion of the Bovie line of electrosurgical disposables.
Sintered Steel
The proprietary sintered steel technology is a stainless steel sponge
that allows saline to flow through it in conjunction with radiofrequency
energy creating a stick-resistant coagulation effect minimizing bleeding
during surgery. Bovie’s first commercialized sintered device, SEER™ is a
single-use monopolar electrosurgical electrode used for dissection and
coagulation of soft tissue. Late in 2009, we launched a laparoscopic
version of SEER™; procedures using the SEER™ and Lap SEER™ have been
performed in both liver and kidney resections in over 20 institutions
domestically and internationally with continued positive surgeon
feedback.
Bovie submitted a 510k application for marketing of its newest sintered
steel product BOSS™, a bipolar sintered steel electrocautery device. The
device will be primarily targeted to orthopedic surgeons performing hip
and knee arthroplasty procedures; a market comprised of approximately
1.1 million procedures performed in the US annually. The estimated
worldwide market for the sintered steel technology is in excess of $500
million.
Vessel Sealing
The Company recently received 510(k) clearance to market its ICON™ VS
generator designed to perform vessel sealing procedures, while providing
both monopolar and bipolar energy options to the surgeon. The clearance
of the ICON™ VS generator allows the Company to complete testing
required in support of its previously filed 510(k) for Seal-N-Cut™
vessel sealing instruments.
The Seal-N-Cut™ devices accommodate a wide array of possible
applications in either monopolar or bipolar surgeries thereby serving
endoscopic needs in multiple endoscopic fields including Endo GYN,
general surgeries, pediatric surgery, thoracic endoscopy and urology.
Bipolar vessel sealing and coagulation is one of the fastest growing
markets in endoscopy, estimated to exceed $1 billion in revenues
worldwide. As part of the planning for the manufacturing and the
commercialization of the Company’s Seal-N-Cut™ product line, all
Canadian operations are being transferred to our new Florida facility.
J-Plasma™
J-Plasma™ technology utilizes a gas ionization process producing a
stable thin beam of ionized gas that can be controlled in a wide range
of temperatures and intensities, providing the surgeon great precision,
and an absence of conductive currents during surgery. The J-Plasma™
portfolio consists of a proprietary generator, which regulates the
helium gas flow, while controlling the precise energy and rate of
current simultaneously delivered depending on the clinical use. The
computer assisted combination of gas flow and energy profile is
adjustable to suit a specific clinical use. The J-Plasma™ disposable
handpieces are designed for ease of use in all surgical fields allowing
expansion into multiple markets.
Potential markets include gynecology, urology, dermatology, plastic
surgery, neurology, gastroenterology, and veterinary medicine. Bovie
received FDA marketing clearance for J-Plasma™ in the second half of
2009 and continues to perform research on this platform in the areas of
soft tissue coagulation in OB/GYN, GI surgery and dermatology.
The manufacturing and development of multiple systems has commenced with
the goal of distributing to physicians and surgeons in the above
mentioned specialties. Additionally, we are studying the performance of
our plasma technology in promoting wound healing, viral eradication and
oncologic applications. Bovie expects commercialization of its J-Plasma™
system in 2010.
Andrew Makrides, president of Bovie, stated, “Subsequent to receiving
510(K) clearance for our new products, we anticipate commercialization
of our proprietary technologies either through agreements with other
companies and/or independently.”
SOURCE Bovie Medical Corporation