Finally got past a major milestone that we waited a year and a month for with CTGI. FDA approval.
CTGI CSMG Technologies Announces U.S. FDA 510(k) Clearance for Live Tissue Connect's VAD System
CORPUS CHRISTI, Texas, Jul 31, 2008 (BUSINESS WIRE) -- CSMG Technologies, Inc.
CTGI 0.95, +0.01, +1.1%) , a technology management company, announced its subsidiary Live Tissue Connect, Inc. (LTC) received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its LTC VAD System. The LTC VAD System consists of a LTC VAD.400 bipolar electrosurgical generator and two disposable sealing instruments. FDA clearance allows LTC to market these products in the USA. The VAD.400 generator and the two disposable instruments are intended for use in open general surgical and gynecological procedures for the ligation of vessels and ducts as an alternative to mechanical clamping (clips or staples) and suturing. LTC's new third generation bipolar system can be used on vessels (veins and arteries) up to 7 mm diameter, on ducts up to 2 mm diameter and tissue bundles as large as will fit in the jaw electrodes of the instruments.
Donald S. Robbins, President and CEO of CSMG Technologies, said, "I am very pleased for our shareholders to be able to announce the most important and long awaited event in the history of LTC. By LTC receiving its first U.S. FDA 510(k) on the generator and the two instruments they are now able to start marketing in the U.S. market. I wish to publicly congratulate all the medical device professions involved with the LTC technology and the LTC team in Santa Barbara, California. I also want to personally thank as well all the CSMG shareholders who have believed in our potential and stayed the course waiting for this key corporate event."
Frank D. D'Amelio, President of LTC said, "The 510(k) clearance of our generator and disposable instruments marks the completion of a major milestone for LTC. The technology embodied within the VAD.400 generator and the interconnecting disposable instruments represents years of scientific research regarding the effects of RF energy on tissue. The LTC bipolar system has undergone extensive animal clinical testing; has been the subject to numerous peer-reviewed papers; and has passed all applicable quality standards. Having now obtained this clearance, we will next implement our USA sales representative recruitment plan and ramp up our production for distribution."
About Live Tissue Connect LTC's surgical tissue bonding / welding device is a patented platform technology that bonds and reconnects human soft tissue through fusion, in contrast with conventional wound closing devices such as sutures, staples, sealant, or glues. LTC currently holds a total of approximately 31 patents and pending patents in the U.S., Australia, Canada, European Union, Ukraine and other countries. For further information on CSMG Technologies and its various subsidiaries, please visit our website at www.csmgtechinternational.com. Sign up to receive CSMG Technologies automated email press releases and other notifications: Please go to: www.csmgtechinternational.com/contact_information.html and fill-in information. This press release may contain forward-looking information within the meaning of Section 21E of the Securities Exchange Act of 1934 as amended (the Exchange Act), including all statements that are not statements of historical fact regarding the intent, belief or current expectations of the company, its directors or its officers with respect to, among other things: (i) the company's financing plans; (ii) trends affecting the company's financial condition or results of operations; (iii) the company's growth strategy and operating strategy; and (iv) the declaration and payment of dividends. The words "may," "would," "will," "expect," "estimate," "anticipate," "believe," "intend" and similar expressions and variations thereof are intended to identify forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the company's ability to control, and that actual results may differ materially from those projected in the forward-looking statements as a result of various factors. SOURCE: CSMG Technologies, Inc. ROI Group LLC Michael Dodge, 212-495-0744 mdodge@roiny.com or CSMG Technologies, Inc. Donald S. Robbins, 361-887-754 President and CEO or K. Bruce Jones, 770-955-0409
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