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Vision Sciences(R) Receives FDA Clearance for New EndoSheath(R) Product for In-Office Diagnosis of Acid Reflux Disease
FRIDAY, JULY 18, 2003 7:02 AM
- PR Newswire
NATICK, Mass., Jul 18, 2003 /PRNewswire-FirstCall via Comtex/ -- Vision-Sciences, Inc., (VSCI) today announced that it has received clearance to market its new Slide-On(TM) EndoSheath(R) System for Sensory Testing used in conjunction with flexible ENT (Ear, Nose and Throat) endoscopes from the US Food and Drug Administration (FDA).
The Slide-On EndoSheath System for Sensory Testing is an alternative to a modified barium swallowing study that eliminates the need for fluoroscopy and exposure to X-rays, and can be performed as an office procedure. The exam is used to help diagnose acid reflux disease and swallowing disorders that could lead to aspiration pneumonia. It is estimated that 40 million people in the United States suffer from some form of acid reflux disease affecting a portion of the vocal cords, esophagus and/or stomach.
Ron Hadani, President and CEO of Vision Sciences, stated that "This innovative product offers otolaryngologists, gastroenterologists, pulmonologists and speech pathologists the simplest and most economical way to perform sensory testing as it eliminates the required purchase of an additional specialized endoscope. The Sensory Sheath expands the use of the large installed base of diagnostic ENT scopes as it slides directly onto all the commonly used models and provides the required air channel. The sensory test procedure is performed in the physician's office by introducing small puffs of air that are passed through the sheath. The air puffs elicit a reflex response from the vocal cords, and provide diagnostic information useful in the detection of acid reflux disease and swallowing disorders."
Michael Setzen, M.D., F.A.C.S., an Otolaryngologist in private practice in Manhasset, NY and former Chair of the Board of Governors for the American Academy of Otolaryngology-Head and Neck Surgery, stated that "Problems related to swallowing and reflux have become a significant issue in medicine today and treating these conditions is a major part of the average Otolaryngologist's practice."
Setzen also stated that "Flexible Endoscopic Evaluation of Swallowing with Sensory Testing (FEESST) is a dynamic evaluation of swallowing with testing of sensation, usually performed in an office setting with a flexible endoscope and does not require the use of x-rays. The use of a single-use sheath allows for the safe and efficient passage of a flexible endoscope without requiring lengthy cleaning procedures and the use of chemical disinfectants that may cause irritation."
V. Alin Botoman, M.D., former Chairman of Gastroenterology at the Cleveland Clinic Florida, and currently Clinical Associate Professor at the University of Miami in Florida states, "We found that when we added laryngopharyngeal sensory testing to transnasal flexible laryngoscopy it improved the accuracy of flexible laryngoscopy for diagnosing patients with proximal GERD (Gastro-Esophageal Reflux Disease). Gastroesophageal related pharyngeal complaints are one of the most common reasons patients see Otolaryngologists. This product is a potentially exciting low cost means of expanding the diagnostic armamentaria for functional pharyngeal symptoms for practicing physicians."
The technology for this product was developed by Vision Sciences. The FEESST procedure was developed at the College of Physicians and Surgeons of Columbia University.
Vision-Sciences, Inc. develops, manufactures and markets unique flexible endoscopic products utilizing sterile disposable sheaths, the Slide-On(TM) EndoSheath(R) System, which provide the users quick, efficient product turnover while ensuring the patient a contaminant-free product. Information about Vision Sciences products is available on the Internet at
www.EndoSheath.com, and Company information is available at
www.visionsciences.com. Except for the historical information herein, the matters discussed in this news release include forward-looking statements for the purposes of the safe harbor protections under The Private Securities Litigation Reform Act of 1995. Future results may vary significantly based on a number of factors including, but not limited to, the availability of capital resources, risks in market acceptance of new products and services and continuing demand for same, the impact of competitive products and pricing, seasonality, changing economic conditions and other risk factors detailed in our most recent annual report and other filings with the SEC. In addition, forward-looking statements represent our estimates only as of today, and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our estimates change.
Contact:
Gerald B. Lichtenberger
V.P. of Business Development
Tel: (845) 365-0600
SOURCE Vision-Sciences, Inc.
Und die Zahlen von heute:
Vision Sciences Reports First Quarter Results
WEDNESDAY, JULY 23, 2003 7:02 AM
- PR Newswire
NATICK, Mass., Jul 23, 2003 /PRNewswire-FirstCall via COMTEX/ -- Vision-Sciences, Inc., (VSCI) today announced results for its fiscal quarter ended June 30, 2003. For the first quarter of fiscal 2004, revenues increased by 13% to $1.96 million, compared to $1.73 million in the three months ended June 30, 2002. The net loss for the quarter was $0.3 million, or $0.01 per share, compared to $0.3 million, or $0.01 per share last year. Full results for the first fiscal quarter will be reported in the Company's Quarterly Report on Form 10-Q, expected to be filed with the SEC by August 14, 2003.
In the first fiscal quarter, sales of the medical segment were approximately $1.27 million, an increase of $0.26 million, or 26%, compared to the same quarter last year. Sales of the industrial segment were approximately $0.69 million, a decrease of $0.04 million, or 5%, compared to the same quarter last year. The increase in sales of the medical segment was primarily due to a higher volume of EndoSheath(R) Systems sold to the domestic and international Ear-Nose-Throat ("ENT") market. The decrease in sales of the industrial segment was primarily due to lower volume from the aircraft engine market stemming from continued slowness in air travel.
The unit volume of ENT sheaths increased by 39% in the quarter ended June 30, 2003, compared to the same quarter last year, improving in the domestic and international markets, by 10% and 58%, respectively. In the domestic market, the Company has continued both an incentive program for new customers and an emphasis on the practice efficiencies of the ENT EndoSheath. Both marketing strategies contributed significantly to the increase in unit shipments. In the international market, the Company continues to experience consistently growing demand for its products.
"We are pleased with the increase in unit volume of ENT sheaths, and the improved gross profit of the medical segment, which we believe is a direct result of the improvements in our sales and marketing capabilities, the improvement in our production processes and the on-going drive for product cost reduction," stated Ron Hadani, President and CEO. "The improved gross profit and our continued expense control resulted in the medical segment recording an operating profit of approximately $24,000 for the quarter. Our goal is to build on this success for the remainder of fiscal 2004."
Vision-Sciences, Inc. develops, manufactures and markets unique flexible endoscopic products utilizing sterile disposable sheaths, the Slide-On(TM) EndoSheath(R) System, which provide the users quick, efficient product turnover while ensuring the patient a contaminant-free product. Information about Vision Sciences products is available on the Internet at
www.EndoSheath.com, and company information is available at
www.visionsciences.com. Except for the historical information herein, the matters discussed in this news release include forward-looking statements for the purposes of the safe harbor protections under The Private Securities Litigation Reform Act of 1995. Future results may vary significantly based on a number of factors including, but not limited to, the availability of capital resources, risks in market acceptance of new products and services and continuing demand for same, the impact of competitive products and pricing, seasonality, changing economic conditions and other risk factors detailed in our most recent annual report and other filings with the SEC. In addition, forward-looking statements represent our estimates only as of today, and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our estimates change.
Contact:
Gerald B. Lichtenberger
V.P. of Business Development
Tel: (845) 365-0600
SOURCE Vision-Sciences, Inc.
Gerald B. Lichtenberger, V.P. of Business Development for
Vision-Sciences, Inc., +1-845-365-0600
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