The Company: A leading manufacturer of surgical lasers. TMED
manufactures a family of Holmium and Nd.. YAG lasers for use in urology,
orthopedics, ENT surgery, gynecology and general surgery to treat a variety of
diseases and medical conditions.
We became really excited about this situation on July 22, 1999 when the
company received FDA clearance to market its new Side-firing Holmium Laser
Needle!
According to the press release: TMED received clearance from the FDA to
commence marketing its Omnitip Side-Firing Needle, commonly referred to as the
Knight Needle
The principal use of the Knight Needle will be to vaporize a portion of a
herniated lumbar spinal disk in a minimally invasive procedure, reducing the
volume of the disk. When a spinal disk develops a herniation, the resulting
bulge presses against the nerves in the spinal column. This causes lower back
and leg pain, a condition affecting millions of people within the US.
The Knight Needle was developed jointly by TMED and M. Knight, one of the
worlds most renowned orthopedic surgeons. In addition to decompression of
herniated lumbar spinal disks, the Knight Needle has been cleared for sale for
a wide variety of surgical applications, including the incision, excision,
vaporization, ablation and coagulation of tissues in arthroscopy urology,
ear-nose-throat (ENT) surgery, gynecology and general surgery.
The Knight Needle contains a suction/irrigation channel which can be
connected to an external pump, providing surgeons with the ability to withdraw
fluid or administer drugs or fluids of their choice before, during or after the
laser procedure.
THIS IS BIG STUFF! THE MARKET POTENTIAL IS HUGE! THE PROCEDURE OFFERS A MORE
COST-EFFECTIVE CHOICE FOR BACK-SURGERY CANDIDATES. LESS RECOVERY TIME, PAIN AND
ABLE TO RETURN TO WORK MUCH FASTER. INSTEAD OF A 2.5 INCH CUT FROM STANDARD
PROCEDURES ONLY 1/8 TO 1/4 INCH CUT- LESS TRAUMA!!!!
Press Release, July 16, 1999, Trimedyne Inc. (NASDAQ/NMW:TMED) announced the
U.S. Patent and Trade Office has issued U.S. Patent No. 5,913,853 to
Trimedynes 90% owned subsidiary, Cardiodyne Inc.
The patent covers Cardiodynes new Laser Transmyocardial
Revascularization ( TMR) System, which is designed to create
channels in the heart wall, using Timedynes powerful Holmium
cold laser in less than 1/2 second, during diastole, when the heart is
momentarily at rest. The channels enable blood from the chamber to perfuse the
heart muscle and the growth of new blood vessels (angiogenesis), which is seen
around the laser created channels, increases the distribution of blood in the
heart muscle.
Cardiodynes Laser TMR System is fully automated and synchronizes the
channel making procedure with the patients ECG. When the surgeon
positions the device and presses a button, the optical fiber, which is encased
within a short length of syringe needle, pierces the outer portion of the heart
wall without activating the laser. The laser is then activated and the
fiber/needle advances through the remainder of the heart wall into the chamber,
creating the channel. The AutoFire System is designed to also inject genes or a
growth factor to increase the angiogenic effect, if desired, as the
fiber/needle is withdrawn. When the fiber/needle exits the heart wall, bleeding
from the needle puncture is minimal, enabling the procedure to be performed
with a scope through a puncture between the ribs in a minimally invasive,
endoscopic procedure at lower cost.
Cardiodynes patent also covers Laser TMR catheters which can be
inserted into the femoral artery in the groin and advanced through the arterial
system into the heart chamber, enabling the channels to be made less invasively
from the inside of the heart. Cardiodynes extensive patent portfolio
includes three other issued U.S. Patents and four pending U.S. patent
applications.
Press release August 10, 199 - TMED announces Web presence - www.trimedyne.
com. According to the company, spokesman Shane H. Traveller stated,
Trimedyne caters to a broad customer, supplier and investor base. Our goal in
developing our Web site is to provide our customers and investors with current
information on the companys activities in a format accessible by both
English and non-English speaking visitors.
We have worked hard to develop a Web presence that meets the needs of
potential users, while conforming to FDA regulations regarding format and
content. Our Web site is a significant step in that direction.
Customers visiting Trimedynes Web site will have access to a variety
of product information including new product releases, special offers and
promotions. Though the Web site is not presently set up for on-line sales, the
company anticipates adding this feature to a future site. The current Web site
also incorporates links to recent press releases, SEC filings, stock
performance and company profile.
Traveller continued, We are continuing to develop new medical
devices, while filling out our existing product line. Our technology is widely
considered to be the best in the industry and our quality is superb. Management
is focusing on its vision of the future for the medical laser industry.
- Cash as of June 30th - $6.7 milliion
- Total assets - $12.5 million
- Total liabilities - $1.3 million
- Shareholders Equity - $11,300,000
- Book value - $1.03
- NOL - $30 million (company shielded from taxes for a loooong time).
- Management controls 1 million shares.
- Free trading - 9.9 million.
- LTD=0
- 52 week range - .625 - 3.75.
- During January 1994, TMED reached all time high of $18.00.
In our opinion, TMED offers investors a very interesting speculation! They
obviously have cutting-edge technology using laser for surgical procedures.
This, of course, is HOT stuff, figuratively as well as literally!
The company has a great balance sheet with plenty of cash on hand. The market
cap is tiny when one considers the possibilities of laser surgery. The company
has also a few brokerage firms that follow it and have recently commented
onTMED with speculative recommendations. Since we recommended, it has been a
real trading stock. It ran from $1.93 to $3.75 back to $1.875 back to $3.00,
and is now hovering around the $2.375. We would not chase, but would establish
a position at the $2.00 area. This stock is not tightly held, so with almost 10
million shares in the float, it will be very difficult for a large substained
advance unless a corporate alliance is forged with a major drug or medical
company or earnings start to appear.
The largest problem that this company has is that medical insurance
reimbursements only pay a limited amount of money for the listed procedures
that use TMED lasers. That means much more out of pocket for the patient and
less fees for the surgeon. This is a problem. Many surgeons will opt for older
techniques in order to make the GREEN!
From what we have read, TMEDs laser for herniated disks is by far the
answer for such a terrible condition.
The company is also actively working on the introduction of other products
using this laser technique. We see little downside risk near term and possible
huge upside potential over the long term!
Overall: Interesting core holding in the medical industry for speculative
accounts that understand the inherent risk of investing. Note: if the insurance
companies eventually see the overall benefit for these and other laser
procedures, then TMED will most likely fly and most probably be acquired by a
large company.
We intend to monitor TMED in our portfolio for percentage gain performance.
Broker contact: Mike Chesler @ 1-800-890-1629; Corporate # 949-559-5300.
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