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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) May 23, 1996
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SPINE-TECH, INC.
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(Exact name of registrant as specified in its charter)
MINNESOTA 0-26116 06-1258314
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(State or other jurisdiction) (Commission File Number) (IRS Employer
of incorporation Identification No.)
7375 BUSH LAKE ROAD
MINNEAPOLIS, MINNESOTA 55439-2029
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (612) 832-5600
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Item 5. OTHER EVENTS.
Spine-Tech, Inc. (the "Company") announced that the Food and Drug
Administration (FDA) Orthopaedic and Rehabilitation Devices Advisory Panel
recommended approval of the Company's Premarket Approval (PMA) application
for clearance to market the BAK-Trademark- Interbody Fusion System with
conditions related to post-market surveillance and labeling. Although the
Company cannot begin marketing or commercial sale of the device until it
receives final FDA approval, it will continue to pursue all actions necessary
to expedite the review and approval process.
Item 7. EXHIBITS.
99. Press Release of Spine-Tech, Inc. dated May 23, 1996.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
SPINE-TECH, INC.
Date: May 29, 1996 By Keith M. Eastman
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Keith M. Eastman
Chief Financial Officer
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EXHIBIT INDEX
No. Exhibit No. Page
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99. Press Release of Spine-Tech, Inc. dated May 29, 1996. 5
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EXHIBIT 99
FDA ORTHOPAEDIC AND REHABILITATION PANEL APPROVES
SPINE-TECH PMA APPLICATION WITH CONDITIONS
MINNEAPOLIS, May 23 -- Spine-Tech-Registered Trademark-, Inc. (Nasdaq:
SPYN) 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 BAK-Trademark- 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/C-TM- for the cervical (or neck region), and the BAK/T-TM-
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 Unites States, the BAK system has been approved in more than
20 nations.
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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, manufacturers and markets spinal implants and instruments for the
surgical treatment of degenerative disc disease and other spinal conditions.
