NEW YORK, BOCA RATON, Fla. and LONDON, May 9 /PRNewswire-FirstCall/ -- Sky Holdings, listed on the AIM market of the London Stock Exchange, is pleased to announce that its 18% owned investment, Advanced Spinal Technologies ("AST"), has received approval from the Western Institutional Review Board to commence clinical trials for its Technology-Assisted Micro-Mobilization and Reflex Stimulator ("TAMARS") -- previously known as the pamm3 MicroManipulator. AST holds the exclusive license to the intellectual property and commercial rights relating to TAMARS in the United States, Europe, Australia, Japan, and all other countries of the World other than the United Kingdom and the Republic of Ireland.
AST has already filed an application for marketing approval with the Food & Drug Administration ("FDA") of the United States Government seeking approval for the use of the instrument, which is intended for adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine. AST's intention is to position the use of the instrument as a medical device. These clinical trials, while not required for the FDA approval, are a significant step towards becoming a recognised orthodox medicine in the United States and will provide the first independent, publishable documentation of the safety and effectiveness of TAMARS treatments in patients suffering from chronic back pain.
It is widely acknowledged that, around the world, back pain and injury spending is increasing. In the United States alone, where AST has the exclusive license to the intellectual property and commercial rights for the TAMARS instrument, Duke University researchers have demonstrated that $100 billion per annum is devoted to the care and relief of patients with back pain. In any year, 15% - 20% of Americans and 25% - 45% of Europeans suffer from back pain.
TAMARS has become the basis of a carefully designed therapeutic procedure that results in the restoration of spinal flexibility and mobility, and reducing or eliminating back pain. The clinical trials conform to strict United States FDA guidelines and will enroll thirty patients in one of three clinical sites. Patients with back pain for three months or longer are eligible for the study. Results will be evaluated on the Oswestry Low Back Pain Disability Questionnaire, the Roland-Morris Low Back Pain and Disability Questionnaire, the Hannover Activities of Daily Living Questionnaire, and the Visual Analog Scale.
Dr. Jeffrey R. Perelman, M.D., President of AST, stated, "Following thousands of successful treatments with the TAMARS device in the United Kingdom and Republic of Ireland, we are delighted to begin clinical trials of the TAMARS treatment in the United States on patients who, until TAMARS, have suffered with chronic back pain and received little or no relief."
Ross Mandell, CEO of Sky Holdings, commented, "From the first moment we became involved with this incredible technology, it has been our intention commercialise it on a world-wide scale and sell it as an orthodox medicine. The initiation of this clinical trial is a big step towards achieving that status in the United States."
Statements in this press release other than statements of historical fact, including statements regarding the company's plans, beliefs, and estimates as to projected market size are "forward-looking statements". Such statements are subject to certain risks and uncertainties and actual results could differ materially from expected results. These forward-looking statements represent the company's judgement as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
Contact: Ross H. Mandell Sky Capital Holdings, Ltd. (212) 709-1900 Charles McLean The Dilenschneider Group (212) 922-0900
Sky Capital Holdings, Ltd.CONTACT: Ross H. Mandell, Sky Capital Holdings, Ltd., +1-212-709-1900;Charles McLean, The Dilenschneider Group, +1-212-922-0900, for Sky CapitalHoldings, Ltd.