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 17, 1997
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
<PAGE>
ITEM 5. Other Events.
On December 5, 1997, SpectraSCIENCE, Inc. announced that it received 510(k)
premarket notification clearance from the United States Food and Drug
Administration for its fiberoptic Reusable Biopsy Forceps. Details of this
announcement are included in the attached Press Release dated December 5, 1997.
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, 1997
SpectraSCIENCE, Inc. For more information please contact:
3650 Annapolis Lane, Suite 101 Brian T. McMahon, Chairman, President & CEO
Minneapolis, MN 55447-5434 Tel: (612) 509-9999 ext 203
Ching-Meng Chew, Vice President & CFO
Tel: (612) 509-9999 ext 201
FOR IMMEDIATE RELEASE
SPECTRASCIENCE RECEIVES 510(k) PREMARKET NOTIFICATION CLEARANCE FROM UNITED
STATES FOOD AND DRUG ADMINISTRATION FOR A FIBEROPTIC REUSABLE BIOPSY FORCEPS
- --------------------------------------------------------------------------------
MINNEAPOLIS, December 5, 1997 - 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 Reusable Biopsy Forceps.
The SpectraSCIENCE(TM) Reusable Biopsy Forceps is designed specifically to
collect tissue samples utilizing minimally invasive endoscopic techniques for
histopathological examination. The reusable forceps is intended for endoscopic
gastrointestinal and urological biopsy applications. The SpectraSCIENCE(TM)
Reusable Biopsy Forceps has an adjunctive feature incorporating a disposable
optical fiber for the transmission of light during tissue biopsy procedures. The
forceps can then be re-used several times after proper sterilization between
patients with a new disposable optical fiber for each use.
Brian T. McMahon, Chairman, President and Chief Executive Officer of the
Company said: "We are very excited about this significant milestone for our
Company. Currently, more than 70% of the standard (non-light transmitting)
biopsy forceps market is in reusable forceps. This 510(k) premarket notification
clearance of the Reusable Biopsy Forceps will greatly complement our previous
510(k) clearance of the Disposable Biopsy Forceps."
The SpectraSCIENCE(TM) Optical Biopsy(TM) System is currently in the final
phase of a multi-center clinical study to detect gastrointestinal cancer. The
study results will be utilized to support an expected submission of a premarket
approval application late first quarter 1998 for the SpectraSCIENCE(TM) Optical
Biopsy(TM) System.
SpectraSCIENCE develops innovative, minimally-invasive medical delivery
systems to facilitate the diagnosis and treatment of a broad range of human
diseases by utilizing advanced spectroscopy, fiber optics, computer hardware and
software.
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