Vyteris Holdings, Inc.
Vyteris Holdings, Inc.: LIDOSITE® NOW AVAILABLE TO PATIENTS IN PHYSICIAN OFFICES
Vyteris Holdings, Inc. / Miscellaneous Release of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer / publisher is solely responsible for the content of this announcement. ---------------------------------------------------------------------- LIDOSITE® NOW AVAILABLE TO PATIENTS IN PHYSICIAN OFFICES Physician Offices Can Begin Ordering LidoSite At 888-VYTERIS FAIR LAWN, NJ – (August 13, 2007) – Marking an advance in the widespread distribution of rapid pain relief from procedures involving venipuncture, intravenous cannulation and laser ablation of superficial skin lesions, Vyteris, Inc. (OTCBB: VYHN) announced the commercial availability of LidoSite® to the 40 million American patients in physician offices who are needle averse or even phobic. 'This marks a significant step in the treatment of pain resulting from needles and laser ablation and provides physicians and patients a new and powerful tool in improving patient comfort,' said Timothy J. McIntyre, president and chief executive officer for Vyteris, Inc. 'As a fast-acting alternative to topical creams or simply trying to ignore needle pain, we believe LidoSite will be well-received by patients and physicians.' With close to one billion blood draws taken a year in the U.S., according to a study by market research firm TVG, it is estimated that each year approximately 40 million American patients experienced 'high discomfort' with blood draws due to needle pain . An overwhelming majority of the surveyed patients who experienced 'high discomfort' – 65 percent indicated they intended to use or ask for LidoSite at their next blood draw – representing an initial potential U.S. market for LidoSite of 26 million patients annually for this segment alone. Working alongside its marketing partner in Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH) in the general practice physician market, Vyteris also announced the retention of experienced specialty sales representatives to make LidoSite broadly available in high demand specialties such as rheumatology, oncology and dermatology. 'Launching LidoSite into the U.S. physician office market represents a strategic and significant accomplishment for Vyteris by offering the first real, scalable product commercialization by the company on its own,' McIntyre said. 'This knocks down yet another important strategic benchmark outlined to our shareholders at the beginning of the year and is another important step in our three-year growth plan.' LidoSite is the first active transdermal patch approved by the U.S. Food and Drug Administration to deal with pain associated with blood draws (venipuncture) IV (intravenous) cannulations and laser ablation of superficial skin lesions. The device uses the process of iontophoresis to carry a combination of the local anesthetic lidocaine and vasoconstrictor epinephrine, which localizes the anesthetic effect, from a patch through the skin layer and into the underlying tissue by way of a mild electrical current. LidoSite is composed of a heart-shaped controller that houses a microprocessor regulating dosing of medication, intervals and duration of dosing and is good for up to 99 patch applications. The use of LidoSite is supported by the Blue Cross/Blue Shield Technical Evaluation Center (TEC), which indicated that 'use of iontophoresis to administer local anesthetic before skin puncture or dermal procedures meets the TEC criteria.' Various Blue Cross/Blue Shield health insurance plans have also previously issued medical practice guidelines supporting TEC findings and indicating that 'iontophoresis is considered medically necessary to administer local anesthesia prior to a venipuncture or dermatological procedure.' The American Pain Society (APS) and the American Academy of Pediatrics (AAP) set forth guidelines³ for adequately addressing acute - or short-lived - pain. These guidelines, which apply to the treatment of children and adults, call for healthcare practitioners to eliminate or reduce pain caused by medical treatments whenever possible. In fact, the APS and AAP agree that acute pain experienced with medical procedures can, in most cases, be substantially reduced and even prevented To find out more about LidoSite or to place an order if you are a physician, call 888-VYTERIS (898-3747) or visit us online at www.vyteris.com/lidosite. About Vyteris, Inc. Vyteris, Inc., a wholly owned subsidiary of Vyteris Holdings (Nevada), Inc. (OTCBB: VYHN), is the maker of the first active drug delivery patch to receive marketing clearance from the U.S. Food and Drug Administration (FDA). Vyteris’ proprietary active transdermal drug delivery (iontophoresis) technology delivers drugs comfortably through the skin using low-level electrical energy. This active patch technology allows precise dosing, giving physicians and patients control in the rate, dosage and pattern of drug delivery that can result in considerable therapeutic, economical, and lifestyle advantages over existing methods of drug administration. Vyteris’ first product, LidoSite®, which provides dermal analgesia prior to venipuncture (IV catheter insertions, blood draws, etc.) and superficial dermatological procedures, was the first FDA approved active patch. For more information, please visit our website at www.vyteris.com. Forward-Looking Information This press release contains forward-looking statements (within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended). When used in this press release, the words 'anticipate,' 'believe,' 'estimate,' 'will,' 'plan,' 'seeks,' 'intend,' and 'expect' and similar expressions identify forward-looking statements. Although we believe that our plans, intentions, and expectations reflected in any forward-looking statements are reasonable, these plans, intentions, or expectations may not be achieved. Our actual results, performance, or achievements could differ materially from those contemplated, expressed, or implied, by the forward-looking statements contained in this press release. Important factors that could cause actual results to differ materially from our forward looking statements are set forth in the Company’s periodic reports on Forms 10-KSB and 10-QSB, including under the heading 'Risk Factors.' All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth in the Company’s periodic reports. Except as required by federal securities laws, we are under no obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. Important Safety Information The LidoSite topical system is indicated for use on normal intact skin to provide local analgesia for superficial dermatological procedures such as venipuncture, IV cannulation, and laser ablation of superficial skin lesions. The LidoSite system is indicated for use on patients 5 years of age and older. The LidoSite system is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, sulfites, or to any other component of the product. It is also contraindicated for use in patients with electrically-sensitive devices (e.g., pacemakers) and should not be used on areas of the body supplied by end arteries or having otherwise compromised blood supply. Iontophoresis with the LidoSite patch may cause local transient skin irritation such as blanching or erythema in the dermis under the patch. Patients over 65 years of age may have greater sensitivity to the LidoSite patch than younger patients. The potential exists for a small child to suffer serious adverse effects from chewing or ingesting a new or used LidoSite patch. Children should be closely observed when treated with the LidoSite system, and LidoSite patches should be stored and disposed of in the proper manner. Please refer to the full Prescribing Information, including the detailed instructions for use, before using the LidoSite topical system. Contact: James Lee The Lee Strategy Group, Inc. Tel: (310) 927-1211 Email: jlee@leestrategy.com 25.09.2007 Financial News transmitted by DGAP ----------------------------------------------------------------------
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