CSMG Technologies Subsidiary Live Tissue Connect Awarded European Union CE Mark Certificate

CORPUS CHRISTI, Texas, Sep 02, 2008 (BUSINESS WIRE) -- CSMG Technologies, a technology management company, announced its subsidiary, Live Tissue Connect Technologies (LTC), has been awarded CE Mark (ConformitA(C) EuropeA(C)ne) certification for its Bipolar Forceps by BSI Product Services in its capacity as Notified Body for the Council Directive 93/42/EEC.
The CE Mark allows LTC to market its forceps with the previously CE Mark certified VAD.400 generator within the 30 countries of the European Economic Area (EEA) and Switzerland. This announcement follows LTC Technologies previously announced 510(k) clearance from the FDA to market both the aforementioned generator and forceps in the United States.
Obtaining CE Mark certification is an extensive process that requires evaluation of the device by the Notified Body to ensure compliance with EU directives and standards. To become certified, a company must have an established quality system and must submit a technical file providing evidence of compliance that the product meets applicable directives and standards.
The LTC Bipolar Forceps consist of two configurations of disposable instruments and are used exclusively with the LTC VAD.400 generator. Its intended use is for the application of electrosurgery in general surgery and gynecological procedures for the sealing of arteries, veins, and ducts. The Bipolar Forceps system is an alternative to mechanical clamping (clips or staples) and suturing, and can be used on veins and arteries up to 7mm diameter, on ducts up to 2mm diameter and on tissue bundles as large as will fit between the jaws of the instrument.
Donald S. Robbins, President and CEO of CSMG Technologies, said, "I am very pleased to announce LTC has received this CE Mark certificate. Combined with their FDA 510(k) clearance, LTC may now begin the process of marketing their sealing system in both Europe and the United States. I want to congratulate the LTC Technologies division, headquartered in Santa Barbara, whose efforts succeeded in securing this very important certification."
Frank D. D'Amelio, President of LTC Technologies added, "We have set forth an aggressive schedule for commercialization of LTC's technology and we continue to execute against that plan as evidenced by the receipt of this CE Mark certificate and our recent FDA 510(k) clearance. In addition, achieving this CE certification demonstrates our commitment to be a global organization with world-wide distribution. Our sales recruitment efforts are proceeding according to plan and potential dealers have expressed much enthusiasm for our technology and the opportunity to join the LTC sales team."

CSMG Technologies Announces U.S. FDA 510(k) Clearance for Live Tissue Connect’s VAD System

CSMG Technologies, Inc., (OTCBB: CTGI), 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.”

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CSMG Technologies Subsidiary Live Tissue Connect Presents Its Bipolar Continuous Welding of Tissue at the 2008 Future Medical Forum

CORPUS CHRISTI, Texas--(BUSINESS WIRE)--CSMG Technologies, Inc. (OTCBB: CTGI) a technology management company, announced Mr. Frank D’Amelio, President of Live Tissue Connect (LTC), a subsidiary of CSMG Technologies, presented at the 2008 Virtus International Future Medical Forum in Tampa, Florida. This medical forum focuses on the impact new technologies and materials have on the discovery, development, and design of medical devices. The Future Medical Forum is a significant medical device event, as it brings together some of the leading minds and decision makers in the medical device industry for a two day conference.
Mr. Donald S. Robbins, President and CEO of CSMG Technologies, said, “We are pleased that LTC’s President, Frank D’Amelio, has been invited back to the Future Medical Forum for a second consecutive year. Since last year, Live Tissue Connect has made significant technological advancements and is excited to introduce them to the world’s leading medical organizations and ancillary support companies.”

Tissue Welding

Thu, 22 May 2008
CSMG Technologies, Inc. (OTCBB: CTGI), a technology management company, announced that its Live Tissue Connect ("LTC") subsidiary has completed the onsite audit portion of the CE Mark registration in accordance with the European Medical Device Directive – 93/42/EEC. LTC announced it has already received their ISO 13485:2003 certification for the design and manufacture of Bipolar Forceps Systems. This Quality Management System certificate was issued by BSI Management Systems, one of the world's leading certification bodies.

Live Tissue Bonding Technology
Tissue Welding
The tissue bonding / welding device is a platform technology that bonds and reconnects living soft biological tissue through fusion without the use of foreign matters or conventional wound closing devices such as sutures, staples, sealant, or glues. The technology leaves little or no scar tissue visible to the naked eye after a few months. Unlike other tissue coagulation methods that tend to destroy tissue by charring, searing and necrosis, the tissue welding patented platform technology bonds and reconnects incised tissue and avoids charring, searing and necrosis, using a low heat delivery method aimed at restoration of the normal functions of the live organs and tissue. The smokeless capability of the tissue welding technology has a significant benefit to the medical professional health services provider because current technologies for R F frequency welding or bonding have significant smoke that the carcinogens have been found carry infectious microorganisms from high risk HIV and Hepatitis patients during surgery.

Robert D. Tucker PhD, MD. Dr. Tucker is with the University of Iowa, Department of Pathology and the Department of Biomedical Engineering. He will be presenting his teams' comparative results with the LTC bipolar sealing system at the 17th annual Congress of the International Society for Gynecologic Endoscopy, the World Congress of Gynecologic Endoscopy and SEGI Annual meeting which will be held in Bari, Italy from June 4th to 7th 2008