FINALLY, Some good news
Integrated Surgical Systems Sells Second
Neuromate Stereotactic Robot in U.S.
PR Newswire - July 13, 1998 21:21
FDA Filing Schedule for ROBODOC Revised
DAVIS, Calif., July 13 /PRNewswire/ -- Integrated Surgical Systems, Inc. (ISS)
(Nasdaq: RDOC; EASDAQ), a leading developer of image-directed robotic products
for surgical applications, today announced that it has reached an agreement with the
Chicago Institute for Neurosurgery and Neuroresearch (CINN) for the purchase of one
of ISS' NeuroMate(TM) Stereotactic Robots for clinical neurosurgery. CINN will be
the first institution to use NeuroMate in clinical neurosurgery and the second institution in
the U.S. to install the system. Currently, the University of Texas Health Science Center,
San Antonio, is using NeuroMate in its research for a -free, non-invasive treatment
of depression.
NeuroMate has been cleared for marketing in the United States by the U.S. Food &
Administration (FDA) and in Japan by the Ministry of Health and Welfare, and
carries the CE Mark in Europe.
Leonard Cerullo, M.D., Medical Director for CINN, commented, "NeuroMate is the
state-of-the-art in high-precision, minimally invasive neurosurgery. We expect that our
patients will significantly benefit from the added accuracy and information that
NeuroMate will provide, especially in functional neurosurgeries where the surgical
targets are very small. Other applications, such as neuroendoscopy, look very
promising, as well."
"This sale represents a major milestone, as it will be the first system to be used in the
U.S. for clinical neurosurgery and will bring the worldwide installed base of NeuroMate
Systems to ten. CINN is the largest neurosurgery practice in the Midwest, and has a
reputation for recognizing valuable, early-stage technology and applying it to their
practice. We are very pleased to be associated with such a progressive group, as well
as to be entering the important Chicago area market," said Dr. Ramesh Trivedi,
President and Chief Executive Officer of ISS.
FDA Filing Schedule for ROBODOC(R) System
"Additionally, we continue to make progress on our pre-market application for the
ROBODOC(R) Surgical System's introduction into the United States. We had hoped
to complete this filing in the second quarter; however, the FDA has recommended that
we hold a pre-submission review meeting. The pre-submission review is intended to
expedite the formal PMA process. The preparations for this meeting are complete and
we look forward to continuing our dialogue with the FDA on the submission. We
believe that the pre-submission review process will shorten the time to market in the
United States, and now expect to file our PMA some time in the second half of 1998,"
stated Dr. Trivedi.
The Company
Integrated Surgical Systems, Inc. develops, manufactures, markets and services
computer-controlled, image-directed robotic products for surgical applications.
NeuroMate(TM), ISS' neurosurgery product, is the first robotic technology for use in
stereotactic brain surgery. NeuroMate consists of a robotic arm assembly and a
PC-based positioning system. The product interfaces to popular pre-surgical planning
stations, which are offered by a number of third-party vendors. ISS has installed 10
NeuroMate systems in the U.S., France and Japan, which have supported neurosurgical
procedures on more than 1,800 patients, to date.
ISS also produces the ROBODOC(R) Surgical Assistant System (ROBODOC(R)),
which is designed for orthopedic applications. The ROBODOC(R) System has been
used to perform precise total hip replacement surgeries on more than 2,500 patients
worldwide. ROBODOC is currently being marketed in Europe.
Looks like we will have to wait a little longer BUT this seems very encourageing
Good Luck |
