Below are some clippings from other news stories which may answer your questions.
Friday June 21 4:26 PM EDT
Fda Informs Spine-Tech That Pma Application Is Approvable
MINNEAPOLIS, June 21 /PRNewswire/ -- Spine-Tech, Inc. (Nasdaq: SPYN), has announced that the Food and Drug Administration
(FDA) has informed the Company that its Pre-Market Approval (PMA) application for the BAK(TM) Interbody Fusion System, which
is designed to stabilize and fuse vertebrae in the lumbar spine, is approvable subject to approval of final product labeling and the
post-approval study protocol. Spine-Tech cannot begin marketing or commercial sale of the device until it receives final FDA approval.
"We are very pleased that the FDA has been so prompt in providing us with this Approvable Letter," said David Stassen, Spine-Tech
president and chief executive officer. "This letter affirms the recommendation of the Orthopaedic and Rehabilitation Devices Advisory
Panel which voted to recommend approval less than a month ago. We expect to provide an initial response to all of the FDA requested
items by the end of next week."
Spine-Tech, Inc., founded in 1991 and based in Minneapolis, designs, develops, manufactures and markets spinal implants and
instruments for the surgical treatment of degenerative disc disease and other spinal conditions.
Wednesday June 19 5:13 PM EDT
Spine-Tech, Inc., Receives Ce Mark Certification
MINNEAPOLIS, June 19 /PRNewswire/ -- Spine-Tech, Inc. (Nasdaq: SPYN), today announced it has received CE Mark
Certification, which signifies that the company conforms with the European Community Medical Device Directive requirements for the
design, manufacturing, servicing and installation of its products.
David Shaw, Spine-Tech vice president of manufacturing operations, stated, "We are very pleased to receive CE Mark Certification,
which allows Spine-Tech to market its products broadly throughout the European Community. This certification assures our customers
and physicians that Spine-Tech's products are designed, manufactured and serviced to 'world class' quality standards."
In Europe, Spine-Tech currently markets its BAK(TM) series of spinal implants and instruments in France, Germany, the United
Kingdom, The Netherlands, Italy and Spain. The company also markets its products in Japan, Korea and Australia. In United States,
the company has clinical trials underway and has filed a Pre-Market Approval Application (PMA) with the Food and Drug
Administration to seek approval to begin marketing the BAK system domestically. On May 23, the FDA Orthopaedic and
Rehabilitation Devices Advisory Panel reviewed and recommended approval of Spine-Tech's PMA application. Spine-Tech cannot
begin marketing or commercial sale of the device until it receives final FDA approval.
Spine-Tech, based in Minneapolis and founded in 1991, designs, develops, manufactures and markets spinal implants and instruments
based on the company's BAK(TM) technology for the surgical treatment of degenerative spinal conditions. The company's BAK
systems are designed to promote spinal fusion while reducing surgical trauma, accelerating patient recovery, improving patient
outcomes and lowering treatment costs.
Thursday May 16 10:48 AM EDT
Robertson, Stephens & Company Issues Research Report on Spine-Tech,
Inc.; Reiterates A Buy Rating
SAN FRANCISCO, May 16 /PRNewswire/ -- Robertson, Stephens & Company analyst Vivian Wohl issued a research report
reiterating her Buy recommendation with an 18 month price target of $45.00 per share on Spine-Tech Inc . Spine-Tech is a
Minneapolis-based company focused on the development of spinal instruments that hold the promise for the less invasive and even
laparoscopic treatment of degenerative disc disease, the most common identifiable cause of chronic back pain.
Wohl's Buy recommendation is based on the company's flagship product, the BAK-L, which is scheduled for review next week by
the FDA Advisory Panel on Orthopedic and Reconstructive Surgery. The EPS estimates for 1997 and 1998 are $0.80 and $1.30,
respectively.
Robertson Stephens & Company is an investment banking and investment management firm focused on emerging growth industries.
The firm's 31 senior analysts provide leading research coverage on over 350 companies.
Thursday May 23 1:19 PM EDT
Fda Orthopaedic and Rehabilitation Panel Approves Spine-Tech Pma
Application with Conditions
MINNEAPOLIS, May 23 /PRNewswire/ -- Spine-Tech(R), Inc. ( Spine-Tech Inc ) has announced that the Food and Drug
Administration (FDA) Orthopaedic and Rehabilitation Devices Advisory Panel today reviewed and recommended approval of the
Company's Premarket Approval (PMA) application for clearance to market the BAK1 Interbody Fusion System with conditions related
to post-market surveillance and labeling. Spine-Tech cannot begin marketing or commercial sale of the device until it receives final
FDA approval.
"We are very pleased with the decision of the Orthopaedic and Rehabilitation Devices Panel," said David Stassen, Spine-Tech president
and chief executive officer. "This decision affirms the outstanding results we have seen in clinical trials and the potential medical
benefits of our BAK technology, products and procedures. Now, we are focusing our efforts on preparing for the introduction of the
BAK system in the United States, pending final FDA approval."
The current PMA application is for the BAK system, which is designed to stabilize and fuse vertebrae in the lumbar (or lower spine),
the region where degenerative disc disease occurs most often. The Company has initiated clinical trials for the BAK/C1 for the cervical
(or neck region), and the BAK/T1 for the thoracic (or chest) region.
Spine-Tech submitted the PMA application in January 1995, and it was amended in August 1995. On October 20, 1995, the FDA
accepted Spine-Tech's PMA application and granted expedited review, a process reserved for breakthrough technologies.
Spine-Tech initiated clinical trials in the United States for the BAK system in April 1992. Since then, more than 1,400 open and
laparoscopic surgical procedures have been performed at 24 medical centers. Clinical results indicate reduced operating time and
hospital stays, improved fusion success rates, superior pain relief and lower costs in comparison to traditional spinal fusion
procedures.
The BAK system is an innovative series of patented implantable devices, proprietary instruments and methods specifically designed
and sized to facilitate fusion of vertebrae in the spine to address degenerative disc disease. The BAK implants are hollow, threaded
cylinders made of titanium alloy that are implanted between two or more vertebrae. Fusion and stabilization results from packing the
cylinders with bone graft and allowing the adjoining vertebrae to grow together through the implant.
Outside the United States, the BAK system has been approved in more than 20 nations.
The company estimates that in the United States more than 200,000 spinal fusion procedures are performed annually to treat back pain
and other spinal conditions. Additional procedures are performed to correct failed spinal fusions. Worldwide, an estimated 400,000
spinal fusion surgical procedures are performed each year. Spine-Tech believes that most spinal fusion patients are candidates for the
BAK procedure.
Spine-Tech, Inc., founded in 1991 and based in Minneapolis, designs, develops, manufactures and markets spinal implants and
instruments for the surgical treatment of degenerative disc disease and other spinal conditions. |
