FDA Clearance for AST
15 Junio 2005 - 12:00PM
UK Regulatory
For immediate release: 15 June 2005
Sky Capital Holdings Ltd.
("Sky" or the "Company")
Sky Capital Holdings, Ltd announces that its affiliate, Advanced Spinal
Technologies, has received Food and Drug Administration premarket clearance.
Sky Capital Holdings, Ltd (Sky or the Company) , whose shares are admitted to
the AIM market of the London Stock Exchange, is delighted to announce that its
18 % owned affiliate, Advanced Spinal Technologies, Ltd (AST) , has received
premarket clearance from the US Food and Drug Administration (FDA) for
distribution of the TAMARS device , marketed in the United States as the
Advanced Spinal Mobilization Instrument (ASMI), for the adjustment,
mobilization, or manipulation of the musculoskeletal joints of the spine by
licensed health care professionals.
The device is currently marketed in the U.K. and Ireland as the
Technology-Assisted Micro-Mobilization and Reflex Stimulator (TAMARS) and was
previously marketed in the U.K. and Ireland as the pamm 3 Micro-Manipulator .
TAMARS has become the basis of a carefully designed and novel therapeutic
procedure that results in the restoration of spinal mobility.
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.
Jeffrey R. Perelman, M.D., President of AST, Ltd, stated, "Following the
successful use of the TAMARS device in the United Kingdom and Republic of
Ireland, we are thrilled to receive FDA premarket clearance to begin the
treatment of patients in the United States ."
Mr. Ross Mandell, Chairman of Sky Capital Holdings, Ltd, commented, "Securing
FDA premarket clearance together with the clinical trials that we are
undertaking are critical steps towards the development of Advanced Spinal
Technologies' business plan. I would like to compliment Dr. Perelman and his
team for receiving FDA premarket clearance so expeditiously."
For further information:
Advanced Spinal Technologies
info@advancedspinaltech.com
Tel. 001 561 338 9700
Mr. Ross Mandell
Sky Capital Holdings Ltd.
Tel. 001 212 709 1900
Mr. Ben Simons
Hansard Communications
Tel. 0044 207 245 1100
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 judgment as of the date of this release. The company disclaims,
however, any intent or obligation to update these forward-looking statements.
END
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