SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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): December 16, 1996
SPECTRASCIENCE, INC.
(Exact Name of Registrant as Specified in its Charter)
Minnesota 0-13092 41-1448837
(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation File Number) Identification Number)
3650 Annapolis Lane, Suite 101, Minneaplis, Minnesota 55447
(Address of Principal Executive Offices)
Registrant's Telephone Number, Including Area Code: (612) 509-9999
ITEM 5. Other Events.
On December 16, 1996, SPECTRASCIENCE, Inc. announced that it received
510(k) premarket notification clearance from the United States Food and Drug
Administration for its fiberoptic Biopsy Forceps. Details of this announcement
are included in the attached Press Release dated December 16, 1996.
Signature
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.
SPECTRASCIENCE, Inc.
By /s/ CHING-MENG CHEW
Ching-Meng Chew
Vice President Finance & Administration
Chief Financial Officer
Dated: December 17, 1996
SPECTRASCIENCE, Inc. For more information please contact:
3650 Annapolis Lane, Suite 101 Brian T. McMahon, President & CEO
Minneapolis, MN 55447 Ching-Meng Chew, Vice President & CFO
Telephone: (612) 509-9999
FOR IMMEDIATE RELEASE
SPECTRASCIENCE RECEIVES 510(k) PREMARKET NOTIFICATION CLEARANCE FROM UNITED
STATES FOOD AND DRUG ADMINISTRATION FOR FIBEROPTIC BIOPSY FORCEPS
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MINNEAPOLIS, December 16, 1996 -- SPECTRASCIENCE, Inc. (NASDAQ: SPSI) announced
today that the Company has been notified by the United States Food and Drug
Administration that it has received 510(k) premarket notification clearance for
its fiberoptic Biopsy Forceps.
The SPECTRASCIENCE Biopsy Forceps is designed specifically to collect tissue
samples utilizing minimally invasive endoscopic techniques for histopathological
examination. The disposable product is intended for endoscopic gastrointestinal
and urological biopsy applications. The SPECTRASCIENCE Biopsy Forceps has an
adjunctive feature incorporating a fiberoptic core for the transmission of light
during tissue biopsy procedures. The Biopsy Forceps will be utilized during
clinical studies to further advance the development of the electro-optic and
software components of the SPECTRASCIENCE Optical BiopsyTM System.
SPECTRASCIENCE believes that achievement of this significant milestone is an
important step towards the clinical development of its Optical Biopsy(TM) System
and the generation of revenues worldwide through institutional sales of its
products.
SPECTRASCIENCE is a market driven early growth stage company located in
Minneapolis, Minnesota, which applies advanced spectroscopic diagnostic
techniques to the analysis of specific human tissues associated with important
diseases. The Company believes its technology will significantly impact the
medical market, initially in cardiovascular medicine and the detection of
cancer.
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