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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: April 9, 1997
BIODYNAMICS INTERNATIONAL, INC.
(Exact name of Registrant as specified in its charter)
FLORIDA 0-16128 59-3100165
(State or other jurisdiction) (Commission File Number) (IRS Employer
Identification No.)
10500 UNIVERSITY CENTER DRIVE, SUITE 130, TAMPA, FLORIDA 33612
(Address of principal executive offices) (Zip Code)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (813) 979-0016
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ITEM 5. OTHER EVENTS
On March 28, 1997, BIODYNAMICS INTERNATIONAL, INC. (the "Company") announced
that the Japanese Ministry of Health banned all uses of human dura mater,
including the Company's Tutoplast(R) dura mater. This ban does not include
other human tissues processed by the Company. Since Japan is a significant
market for the Company, revenues will be impacted.
On March 31, 1997, the Company announced that it has executed an agreement with
Musculoskeletal Transplant Foundation (MTF) of Edison, New Jersey for the
recovery of dura mater tissue. This agreement has the potential to greatly
increase the supply of Tutoplast(R) dura mater to the surgical community.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
EXHIBITS
(a) & (b) None.
(c) 99.1 News Release - Japanese Ministry of Health Bans Use of
Human Dura Mater
99.2 News Release - Biodynamics International, Inc. and
Musculoskeletal Transplant Foundation Sign Dura Mater
Recovery Agreement
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.
Date: April 9, 1997 Biodynamics International, Inc.
/s/ Karl H. Meister
--------------------------------
Karl H. Meister
President and
Chief Executive Officer
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EXHIBIT INDEX
99.1 News Release - Japanese Ministry of Health Bans Use of Human Dura
Mater
99.2 News Release - Biodynamics International, Inc. and Musculoskeletal
Transplant Foundation Sign Dura Mater Recovery Agreement
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EXHIBIT 99.1
[BIODYNAMICS INTERNATIONAL, INC. LETTERHEAD]
NEWS RELEASE
RELEASE: Immediate NASDAQ: BDYN
CONTACT: Robert Sicignano
(813) 979-0016 Ext. 238
JAPANESE MINISTRY OF HEALTH BANS USE OF HUMAN DURA MATER
- - --------------------------------------------------------------------------------
TAMPA, FLORIDA - (March 28, 1997) - Biodynamics International, Inc. announced
today that in response to a recommendation from the United Nations World Health
Organization (WHO), the Japanese Ministry of Health is banning all uses of
human dura mater, including the Company's Tutoplast(R) dura mater. Since Japan
is a significant market for the Company's tissues, revenues from that country
will be affected. The ban does not include other human tissues processed by
Biodynamics and distributed in Japan.
Company President and CEO, Karl H. Meister, stated, "The essential flaw in
WHO's recently announced recommendation is that it has rejected dura mater
generically and failed to consider the extensive safeguards and product safety
history that Biodynamics brings to its tissues, including dura mater. These
safeguards include extensive donor screening and testing, the patented
Tutoplast(R) viral inactivation process and Good Manufacturing Practices as
mandated by the FDA's regulation of dura mater as a 510(k) medical device. It
also is important to note that no transmission of any disease has occurred
since the introduction of the Tutoplast(R) process of preserving human tissues
in the early 1970's."
Biodynamics will lodge a strong protest with WHO and ask that their statement
be revised to reflect the record of safety of its human dura mater tissue. The
Company will also request reinstatement of Tutoplast(R) dura mater by the
Japanese Ministry of Health.
Biodynamics International, Inc. is a world leader in safe bioimplants for
tissue repair, with offices in Tampa, Florida and Erlangen, Germany, processing
and manufacturing facilities in Alachua, Florida and Neunkirchen, Germany and
worldwide distribution.
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EXHIBIT 99.2
[BIODYNAMICS INTERNATIONAL, INC. LETTERHEAD]
NEWS RELEASE
RELEASE: Immediate NASDAQ: BDYN
CONTACT: Robert Sicignano
(813) 979-0016 Ext. 238
BIODYNAMICS INTERNATIONAL AND MUSCULOSKELETAL TRANSPLANT
FOUNDATION SIGN DURA MATER RECOVERY AGREEMENT
- - --------------------------------------------------------------------------------
TAMPA, FLORIDA - (March 31, 1997) - Biodynamics International, Inc. today
announced that they have executed an agreement with the Musculoskeletal
Transplant Foundation (MTF), Edison, New Jersey, for the recovery of dura mater
tissue. Under the terms of the agreement, MTF recovery organizations will
commence the recovery of dura mater throughout the United States, following the
strict guidelines of the U.S. Food & Drug Administration (FDA) and the American
Association of Tissue Banks (AATB), effective immediately.
Biodynamics will process these tissues utilizing the Company's proprietary and
patented Tutoplast(R) process for distribution in the U.S. market.
Tutoplast(R) processed bioimplants have been used safely for over 25 years in
more than 750,000 patients. Many consider the Tutoplast(R) process as the
"gold standard" for the production of safe, high-quality bioimplants. Dura
mater is a regulated medical device with 510(k) clearance from the U.S. Food &
Drug Administration.
"The execution of this agreement with MTF, the largest tissue recovery
organization in the U.S., has the potential to greatly increase the supply of
Tutoplast(R) dura mater to the surgical community," Karl H. Meister,
Biodynamics' CEO stated. "Tutoplast(R) dura mater has long been considered the
allograft of choice in neurosurgical applications for wound closure."
Biodynamics International, Inc. is a world leader in safe bioimplants for
tissue repair, with offices in Tampa, Florida and Erlangen, Germany, processing
and manufacturing facilities in Alachua, Florida and Neunkirchen, Germany and
worldwide distribution.
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