Integra NeuroSciences Direct Salesforce Begins Marketing Helitene Hemostatic Agent
The Helitene® product has been marketed by Integra LifeSciences for surgical applications for over 15 years and the FDA recently approved a premarket approval (PMA) application supplement removing the labeling exclusion for neurosurgical uses.
Helitene® Absorbable Fibrillar Collagen Hemostatic Agent is a soft, white, pliable, absorbent hemostatic agent in fibrillar form that is indicated for use in certain surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
The Helitene® product effectively controls bleeding within two to five minutes when applied directly to the bleeding site and is designed to be totally absorbable if left in situ after hemostasis. The product is available in two sizes, 0.5 gram and 1.0 gram.
Integra NeuroSciences, the neurosurgical division of Integra LifeSciences Holdings Corporation, will now be able to sell the Helitene® product into the neurosurgery market in the United States through its direct sales force of approximately 60 people.
Additional launch activities for the product will coincide with the Trauma and Critical Care meeting in March 2002 and the American Association of Neurological Surgeons meeting in April 2002.
"The ability to sell the Helitene® product into the domestic neurosurgery market provides the Integra NeuroSciences sales force with yet another proven product with a long history of use," commented Stuart Essig, President and Chief Executive Officer of Integra. "Our continued ability to add new products to our salesman's bag on a regular basis has made Integra NeuroSciences a leading provider of implants, devices and monitors used in neurosurgery, neurotrauma, and related critical care. Additionally, Integra NeuroSupplies will offer the Helitene® product in various configurations to its customer base of more than 6,000 neurologists, pulmonologists, and other physicians."
Integra NeuroSciences designs, manufactures and sells implants, devices and monitors used in neurosurgery, neurotrauma, and related critical care. Together with its eight-person clinical development team, Integra NeuroSciences' direct selling effort exceeds 60 field personnel in the United States and Europe.
Integra NeuroSciences also sells its products in approximately 80 countries worldwide through a network of international distributors.
Integra LifeSciences Holdings Corporation, headquartered in Plainsboro, New Jersey, has approximately 600 permanent employees. Please visit the Company's website at http://www.Integra-LS.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements relating to the sale of the Helitene® product for use in new, approved therapeutic applications and the marketing of this product to a new class of customers.
Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results.
Among other things, the willingness of physicians to adopt new products may affect the launch of the Helitene® product for use in new, approved therapeutic applications, and the resources and efforts expended on marketing the Helitene® product may affect sales of the product to a new class of customers.
In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Risk Factors" included in the Business section of Integra's Annual Report on Form 10-K/A for the year ended December 31, 2000 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
CONTACT: Integra LifeSciences Holdings Corporation, Plainsboro
John B. Henneman, III, 609/936-2481
jhenneman@Integra-LS.com
or
John Bostjancic, 609/936-2239
jbostjancic@Integra-LS.com
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