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sojourner

02/22/10 6:30 PM

#31550 RE: SuperSquirrel #31547

SS: A well-reasoned assessment. Emphasis upon lung surgery by LTC is spot on. Apparently, this is where LTC shuts the competition down all hallow. Alas, FDA has not yet approved electrosurgery of any kind on lung tissue given the issue of smoke. Thus, smokeless LTC is the answer, though its approved use in the application will likely require clinical studies. Meanwhile, there are LTC surgeries that can proceed without further ado by FDA or EU. The question of timeline also begs. FWIW, my gut feeling is that announcement of new LTC managment team is close on. Once team is emplaced, one could speculate with some measure of confidence that refitted LTC will attract renewed attention of medical device firms seeking licenses or more. The issue of patent ownership need not bedevil us. The keen parties to the negotiations arguably are comfortable with current licensing arrangement. Perforce of logic, they wouldn't be sitting there otherwise.


CTGI
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lowman

02/22/10 8:36 PM

#31555 RE: SuperSquirrel #31547

While lung resections appear to be a lucrative segment of the LTC platform, let's not forget just exactly what devices HAVE been approved. There's hardly an organ in the human body where
ducts and vessels are not present, or where wound clousure will not be needed after surgery. I'd venture to say that the tools that we're already FDA approved for will be the most frequently used tools of all the various tools patented.

Also, if I'm correct, the LTC technology itself belongs to O.E. Paton, but DR had the patents for most, if not all, the tools.


(A blast from the past)



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."

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.