. . .Speaking of sleepers. . . .
If you have been keeping up with one of our longshot penny stocks. . . they have been reporting about selling quite a number of their expensive units. This is keeping their cashflow going while awaiting the FDA decision on their ROBODOC and NEUROMATE systems.
Here is latest news on progress on one of these fronts. . .
Integrated Surgical Systems Announces the Beginning of US Clinical Trials
DAVIS, Calif., Dec. 11 /PRNewswire/ -- Integrated Surgical Systems, Inc. (ISS) (Nasdaq: RDOC; EASDAQ), a pioneer in medical robotics and the world leader in image-directed, semi-autonomous robotic products for surgical applications, announced today that it will initiate the formal clinical trials for the Digimatch (Pinless) ROBODOC(R) Surgical Assistant System for the total hip arthroplasty.
William Bargar, MD, will perform the first surgery, which is planned for the third week in December, at the Sutter General Hospital in Sacramento. The other two sites are scheduled to start the clinical trials in January. The clinical trial, requiring a total of 180 patients, is expected to take five (5) months to complete. All the sites will use the VerSys(TM) line of cementless hip prostheses made by Zimmer, Inc., a subsidiary of Bristol-Myers Squibb (NYSE: BMY).
Once completed, the data from the studies will be submitted to the Food and Drug Administration for clearance under the recently agreed upon 510(k) "de Novo" classification.
THE PRODUCTS:
ROBODOC is the robotic surgery system of ISS that is used for total joint arthoplasties. ROBODOC consists of a robotic arm assembly and a PC-based 3-D planning station called ORTHODOC(R). ISS has installed 37 ROBODOC systems worldwide.
The ISS neurosurgery product, NeuroMate(TM), is the first robotic technology based system for use in stereotactic brain surgery. NeuroMate consists of a robotic arm assembly and a PC-based planning system. NeuroMate also interfaces with other popular planning stations offered by third-party vendors. ISS has installed 16 NeuroMate systems in the U.S., Europe, and Japan.
THE COMPANY:
Integrated Surgical Systems, Inc. develops, manufactures, markets and services computer-controlled, image-directed robotic products for surgical applications. ISS produces the ROBODOC Surgical Assistant System (ROBODOC), which is designed for orthopedic applications. The ROBODOC System has been used to perform successful total hip replacement surgeries on more than 7,300 patients worldwide. ROBODOC is currently being marketed in Europe and the Middle East. NeuroMate(TM), an ISS neurosurgery product, is the first robotic technology for use in stereotactic brain surgery and it has supported to date over 3,000 neurosurgical procedures.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including the timely development and market acceptance of new products and upgrades to existing products, the impact of competitive products and pricing, and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission (SEC).
NOTE: ROBODOC(R) is a registered trademark of Integrated Surgical Systems, Inc. NeuroMate(TM) is a trademark of Integrated Surgical Systems, S.A.
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