ENGLEWOOD, Fla., Sept. 21, 2005 (PRIMEZONE) -- SinoFresh HealthCare, Inc. (OTCBB:SFSH) today announced that it has concluded its first meeting with the United States Food and Drug Administration (FDA) as part of the submission process for an Investigational New Drug (IND) application for its virucidal, fungicidal, and bactericidal nasal spray. Completing the meeting moves the Company one step closer in its pursuit of a New Drug Application (NDA) for a prescription drug for the treatment of sinusitis, the leading chronic disease in America affecting over 30 million individuals.
William Wilferth, Head of Research and Development for SinoFresh commented, "FDA provided constructive guidance suggesting that we address some Phase I and Phase II requirements before proceeding to Phase III clinical trials. We achieved our objective of emerging from the meeting with a clear clinical path and potential timetable to reach NDA approval. We hope to enter into Phase III clinical trials by October of 2006."
Stated Charles Fust, SinoFresh Chairman and CEO, "We believe this would be the physician's first course of action to eliminate the cause and symptoms of patients suffering upper respiratory attacks related to chronic rhinosinusitis. The worldwide cost to treat chronic sinusitis and related conditions is in the tens of billions of dollars each year." He continued, "While we move our research agenda forward in this area, we will also continue research previously begun for other indications such as prevention of methicillin-resistant Staphylococcus aureaus (MRSA) infection, and prevention of the common cold."
About SinoFresh HealthCare, Inc.
SinoFresh HealthCare, Inc. is a developer and marketer of innovative upper respiratory system therapies. The Company is researching broad-spectrum antiseptic approaches to reducing viral, bacterial, and fungal organisms that are suspected to cause pathogenesis of the mouth, nose, and throat. The Company's lead product, SinoFresh(tm) Nasal Mist, is a hygienic cleansing spray that kills germs and removes other nasal-sinus irritants. The Company is also researching how antiseptic cleansing may alleviate chronic sinus distress, a condition that may affect 37 million Americans annually. SinoFresh(tm) Nasal Mist is available in Wal-Mart, Walgreens, Rite Aid, CVS, and other drug, grocery, and mass merchandise retailers. More information is available at www.sinofresh.com.
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements speak only as of the date on which such statements are made and involve risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission, including risks summarized in the Company's Annual Report on Form 10-KSB for its fiscal year ended December 31, 2004 (file No. 0-49764). The Company's actual results could differ materially from such forward-looking statements. The Company undertakes no obligation to update any forward-looking statement or statements to reflect new events or circumstances or future developments.
SinoFresh(tm) is a trademark of SinoFresh HealthCare, Inc.