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Medical Forum / General / General / December 2004

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Live Biological Tissue Bonding/Welding--Scam??

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Ben Sharvy - 01 Dec 2004 23:09 GMT
I'm tempted to buy stock in a speculative company whose principal
product is described below. I don't know enough to know if it is a big
waste of money, or a plausible gamble. Has anybody heard of this
alleged breakthrough technology? (The company's symbol is CTUM).

Overview

The status of our tissue bonding project is that we have completed
more than 2,500 human surgeries in Ukraine clinical trials and
continue to develop new methods of surgical procedures and
instruments. We have started the development of equipment from
prototype model to a commercial model. The equipment bonds the soft
biological tissue with a special miniature surgical instrument. No
glues, sutures, staples or other foreign matter are used. The process
is best described as a welding process. The scar tissue is either
minimal or non-existent. Tests conducted in Louisville, Kentucky by
U.S. surgeons on rabbits' stomachs resulted in scar tissue only forty
microns wide six months after surgery. It appears that the Ukraine
scientists have developed a superior, all-purpose, seamless method of
bonding soft biological tissues, which method is characterized by
simple manipulation applicable to different surgical operations and
the fast restoration of tissues without the formation of coarse scars.
Apparently there is no need for prolonged special training of surgeons
and surgical personnel.

The Ukraine prototype for the equipment was successfully demonstrated
to physicians and surgeons in the U.S. in June 1996 on the blood
vessels, nerves and stomachs of rats and rabbits. Additional,
subsequent demonstrations on animals were performed in Ukraine by
Ukraine surgeons with U.S. surgeons in attendance. In 1998 the U.S.
surgeons performed successful tests on animals in Louisville,
Kentucky. Testing on humans in Ukraine began in mid-year 1998. One
patient had a blood vessel welded, and the other patient had a torn
uterus repaired using minimally invasive surgery instruments.
According to the Ukraine doctors, both patients recovered in the
normal amount of healing time without side effects.

E.O. Paton Institute of Electric Welding of the Ukraine National
Academy of Sciences and International Association of Welding filed
U.S. and international patent applications on the process in February
1999. Two U.S. and one Australian patents have been issued, but no
other patents have been issued. We own the technology and have been
assigned the exclusive world rights of the patents - should they be
issued. See Exhibit 10.3 filed as part of our Form 10-SB.

We have begun the process for FDA discovery and developing the
regulatory and commercial equipment models for submission to FDA. We
have engaged U.S. regulatory and equipment consultants to assist in
this process.

To date we have submitted no applications, requests or testing results
to the Federal Drug Administration but plan to during the next 12
months. We have not marketed the bonding equipment in the Ukraine or
any other non-U.S. country but we plan to market the commercial
equipment once regulatory approval is received. We have continued our
plans to manufacture prototypes in Ukraine and are continuing clinical
trials in Ukraine for comprehensive human testing. We began this
clinical work in May 2000. To date we have completed more than 2,500
successful human surgeries at Ukraine hospitals. We are currently
negotiating with a group of private investors and international
medical device companies, who are familiar with our company's need
additional development funds.

In 2002 we formed Live Tissue Connect, Inc., a Delaware corporation,
through which we propose to develop our Tissue Bonding technology. We
own 86 percent of Live Tissue Connect, Inc.

We estimate that in excess of $2.5 million have been expended in
developing the project and that $2.5 million of additional funds must
be expended to bring this product to market. We estimate that the
first surgical equipment will be manufactured in the U.S. during the
next 12 months for FDA and US clinical work now that the U.S. patent
applications are approved and patents are issued.

We successfully demonstrated live tissue welding on porcine models in
demonstrations during May, June and September of 2004 for the medical
community in Louisville, Kentucky, New York, Massachusetts and Ohio.

This project is still in the development stage, even though the
Ukrainians have created a finished prototype product and a line of
more that 20 surgical instruments. Improvements in the instruments are
possible, and testing on live tissue of humans to U.S. testing
standards is required. Approval of the process and equipment by the
Federal Drug Administration is required.
Howard McCollister - 02 Dec 2004 01:48 GMT
> I'm tempted to buy stock in a speculative company whose principal
> product is described below. I don't know enough to know if it is a big
[quoted text clipped - 80 lines]
> standards is required. Approval of the process and equipment by the
> Federal Drug Administration is required.

There is no "Federal Drug Administration". I strongly suspect a scam, and a
bad one. No disrespect intended toward Ukrainian health scientists, whom, as
we all know, are the world's leaders in breakthrough health technologies,
not to mention the robust financial.health of the medical research
establishments in that part of the world.

HMc
 
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