LidoSite(R) Now Available to Patients in Physician Offices.Physician Offices Can Begin Ordering LidoSite At 888-VYTERIS FAIR LAWN, N.J. -- Marking an advance in the widespread distribution of rapid pain relief from procedures involving venipuncture venipuncture /veni·punc·ture/ (ven?i-pungk´chur) surgical puncture of a vein. ve·ni·punc·ture or ve·ne·punc·ture n. , intravenous cannulation can·nu·la·tion or can·nu·li·za·tion n. Insertion of a cannula. cannulation introduction of a cannula into a tubelike organ or body cavity. and laser ablation of superficial skin lesions, Vyteris, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : VYHN) announced the commercial availability of LidoSite([R]) to the 40 million American patients in physician offices who are needle averse or even phobic pho·bic adj. Of, relating to, arising from, or having a phobia. n. One who has a phobia. . "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 TVG TV Guide (magazine) TVG Televisión de Galicia TVG Tierversuchsgegner (German: Antivivisection) TVG Television Games Network TVG Toronto Venture Group TVG Tri Valley Growers TVG Time-Variable Gain , it is estimated that each year approximately 40 million American patients experienced "high discomfort" with blood draws due to needle pain1. 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[R] Holdings (LabCorp[R]) (NYSE NYSE See: New York Stock Exchange :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 rheumatology /rheu·ma·tol·o·gy/ (-tol´ah-je) the branch of medicine dealing with rheumatic disorders, their causes, pathology, diagnosis, treatment, etc. rheu·ma·tol·o·gy n. , 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 iontophoresis /ion·to·pho·re·sis/ (i-on?to-fah-re´sis) the introduction of ions of soluble salts into the body by means of electric current.iontophoret´ic i·on·to·pho·re·sis n. to carry a combination of the local anesthetic lidocaine lidocaine /li·do·caine/ (li´do-kan) an anesthetic with sedative, analgesic, and cardiac depressant properties, applied topically in the form of the base or hydrochloride salt as a local anesthetic; also used in the latter form as a and vasoconstrictor vasoconstrictor /vaso·con·stric·tor/ (-kon-strik´ter) 1. causing constriction of blood vessels. 2. a nerve or agent that does this. va·so·con·stric·tor n. 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 dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. 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." 2 The American Pain Society (APS) and the American Academy of Pediatrics The American Academy of Pediatrics ("AAP") is an organization of pediatricians, physicians trained to deal with the medical care of infants, children, and adolescents. Its motto is: "Dedicated to the Health of All Children. (AAP AAP - Association of American Publishers ) 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 Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). 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([R]), which provides dermal analgesia analgesia /an·al·ge·sia/ (an?al-je´ze-ah) 1. absence of sensibility to pain. 2. the relief of pain without loss of consciousness. 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 hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. 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
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. 1 TVG, Inc., November 2006, 1,010 respondents, +/- 3.5 percent 2 Blue Cross Blue Shield Association Technology Evaluation Center (TEC) Iontopheresis for Medical Indications. Assessment Program, Volume 18, No. 3. June 2003. Available at http://www.bcbs.com/tec/vol18/18_03.html 3 Position Statement from the American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health and American Pain Society Task Force on Pain in Infants, Children, and Adolescents, 2001, Online: http://www.ampainsoc.org/advocacy/pediatric2.htm. To receive regular email updates, please click (http://www.vyteris.com/home/Contact_Us/index.php) To watch a video on how LidoSite works, please click (http://www.vyteris.com/home/Our_Technology/MOA.php) |
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