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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 : May 20,1997
BIODYNAMICS INTERNATIONAL, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
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FLORIDA 0-16128 59-3100165
(STATE OR OTHER JURISDICTION) (COMMISSION FILE NUMBER) (IRS EMPLOYER IDENTIFICATION NUMBER)
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1719 ROUTE 10, SUITE 314, PARSIPPANY, NEW JERSEY 07054
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE
1-201-359-8444
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ITEM 5. OTHER EVENTS
On May 20,1997, Biodynamics International Inc., announced that the Italian
Government has imposed a moratorium on all shipments of human dura mater,
including the Company's Tutoplast (R) dura mater. The moratorium on shipments is
pending an investigation by the European Health Authorities (CPMP) into the
safety of dura mater transplants for neurosurgical procedures. As a result of
this moratorium, the Company's revenues and cash flow will be impacted.
Company President and CEO Karl H. Meister commented that "Our efforts to
compensate for the lost revenues as a result of the moratorium by the Italian
authorities and the previously announced Japanese recall are progressing
encouragingly. Additionally, our investors have continued their financial
support and advanced the Company working capital pending the placement of
permanent capital. We are also continuing our efforts to have the respective
regulatory authorities recognize the scientific evidence supporting the safety
of the Tutoplast(R) processed tissues and exempt the Company from their action."
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
Exhibit No.
99.1 News Release - Italian Government Stops Human Dura Matter
Shipments
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, there unto duly authorized.
Date: May 22, 1997 Biodynamics International Inc.
/s/ Karl H. Meister
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Karl H. Meister
President and Chief Executive Officer
/s/ Nicholas A. Frungillo, Jr.
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Nicholas A. Frungillo, Jr.
Chief Financial Officer
EXHIBIT INDEX
99.1 News Release - Italian Government Stops Human Dura Mater Shipments
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EXHIBIT 99.1
NEWS RELEASE
RELEASE: IMMEDIATE NASDAQ: BDYN
CONTACT: Nicholas A. Frungillo, Jr.
(201) 359-8444
ITALIAN GOVERNMENT STOPS HUMAN DURA MATER SHIPMENTS
Parsippany, New Jersey-May 20,1997- Biodynamics International Inc. announced
today that the Italian Government has imposed a moratorium on all shipments of
human dura mater, including the Company's Tutoplast(R) dura mater. The
moratorium on shipments is pending an investigation by the European Health
Authorities (CPMP) into the safety of dura mater transplants for neurosurgical
procedures. As a result of this moratorium, the Company's revenues and cash flow
will be impacted.
Company President and CEO Karl H. Meister commented that "Our efforts to
compensate for the lost revenues as a result of the moratorium by the Italian
authorities and the previously announced Japanese recall are progressing
encouragingly. Additionally, our investors have continued their financial
support and advanced the Company working capital pending the placement of
permanent capital. We are also continuing our efforts to have the respective
regulatory authorities recognize the scientific evidence supporting the safety
of Tutoplast(R) processed tissues and exempt Biodynamics from their action."
Biodynamics International Inc. is a world leader in safe bioimplants for tissue
repair, with its offices in Parsippany, New Jersey and Erlangen, Germany and
processing and manufacturing facilities in Alachua, Florida and Neunkirchen,
Germany.
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