Full Press Release Details
Synthetic Blood International, Inc. Joan
Synthetic Blood Announces Major Restructuring
Receives $1 million advance against $12 million convertible note
Announces management and board changes
COSTA MESA, Calif. (November 20, 2007) Synthetic
Blood International, Inc. (OTC/BB: SYBD), a bio-pharmaceutical company, today
announced a significant financing, management and board changes, and important steps
toward successful commercialization of its core product OxycyteTM, a proprietary
perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.
Management and Board Changes
Synthetic Blood announced that Robert
Larsen has assumed the position of interim Chief Executive Officer following the
resignation of Robert Nicora effective today due to family health issues. Mr. Larsen,
who founded the Company in 1990 and served as director and Chief Financial Officer
until his retirement in 2002, will serve until a permanent CEO is recruited and can
assume active management of the Company. Mr. Larsen has also rejoined the Company s
Board of Directors. Mr. Nicora, who has guided the Company s operations since
1998, will remain as a consultant on matters relating to clinical trials and
U.S. Food and Drug Administration (FDA) regulatory requirements.
I deeply regret that family
responsibilities have necessitated this action at this crucial time in Oxycyte s
development, stated Mr. Nicora. I am confident that the talent brought to the
Company by the new board members will help ensure continued financial and
operational support.
Synthetic Blood today also announced the
additional appointments to the Company s Board of Directors of Chris J. Stern,
Doctor of Business Administration, and Richard Kiral, PhD, Vice President of
Research & Development. Mr. Kiral has been with the Company since 1999 and is
responsible for the development of the Oxycyte product. Mr. Stern, best known for his
writings and lectures on management techniques and managing multilingual and
multinational companies, was also elected Chairman. Mr. Stern, an American and Swiss
dual national is Principal and Founder of the Institute for Efficient Management,
which has conducted more than one hundred major strategic consulting projects. He
also serves on a number of boards, has received his MBA from GSBA in Zurich/State
University of New York and a doctorate in business administration from Trinity College & University.
I am impressed with the progress the Company
has made with its preliminary Oxycyte clinical testing and I look forward to assisting
in the completion of clinical trials and the marketing of Oxycyte, stated Mr. Stern. I
would like to take this opportunity to thank Bob Nicora for his many years of service
Synthetic Blood also announced the
appointment of Bruce Spiess, MD, and Ross Bullock, MD, to a new Scientific Advisory
Board. Both physicians were principal investigators of the Virginia Commonwealth
University Reanimation Engineering Shock Center (VCURES) Phase IIa pilot study in
traumatic brain injury (TBI) in which patients who were administered Oxycyte
showed dramatic improvement over conventional therapy for neurotraumatic damage. Drs.
Spiess and Bullock have prepared a protocol for a double blind, placebo-controlled Phase
IIb/III study to compare Oxycyte with present-day advanced therapies in TBI. The study
is expected to enroll 100 to 150 patients at six major neurosurgery centers.
I am delighted to join the Company and
to assist in guiding it through the FDA process, stated Dr. Spiess. If this
controlled study produces similar results to the earlier Phase IIa trial, it will
prove that the application of Oxycyte to brain and spinal cord injury could well be one
of the most exciting advances in the treatment of neurotrauma in the history of medicine.
Dr. Spiess, who was trained at the Mayo
Clinic, is currently a professor of Anesthesiology and Emergency Medicine at the VCU
Medical Center in Richmond, Va. He is also Director of VCURES, a group of more than 40
MD and PhD researchers. He has more than 25 years of experience researching oxygen
delivery to tissues and developing blood substitutes and oxygen therapeutics. Dr.
Spiess has authored six textbooks, more than 25 book chapters, and more than 150 articles
in peer-reviewed journals.
M. Ross Bullock, MD, PhD, a neurosurgeon
at the VCU, is one of the leading authorities in North America on clinical TBI. Among
hundreds of papers and publications, he has coauthored two major sets of clinical
guidelines for the management of TBI and a textbook of head injury pathophysiology and
management. He is the only physician to have served as chairman of both the Neurotrauma
Society and Trauma Section of the American Association of Neurological Surgeons. He
is also a member of VCU s Head Injury research team.
Synthetic Blood today announced that it has
received a loan in the amount of $1 million as an advance against a proposed $12 million
five-year convertible note with 10 percent interest and a conversion price of $0.22 per
share with a lock-up period scheduled to be completed by December 31, 2007. The note
also includes an option to invest another $6.6 million priced at $0.245 on conversion
with a lock up period. This loan is expected to enable the Company to proceed in
preparing sufficient Oxycyte material to move forward with planned additional
pre-clinical and clinical trials that are being funded by the U.S. Navy at VCURES,
under the direction of Dr. Spiess. The balance of these funds is expected to provide
the Company with sufficient capital to complete Phase IIb/III clinical testing, which
management believes is necessary to attract major pharmaceutical licensing agreements.
The investment is being arranged in Europe on behalf of long-time investors in the
The Company also reported that the U.S. Navy s
Office of Naval Research granted a total of $3.1 million to perform basic scientific
research on PFCs in TBI, and $1.3 million for use of PFCs in the treatment and
prevention of decompression sickness (DCS). Additionally, a grant for $1.6 million
is under consideration for the basic science study of PFCs on arterial gas embolism.
These grants followed a review of the Phase
IIa pilot study of Oxycyte in TBI that was conducted at VCURES.
About Synthetic Blood International
Synthetic Blood International is dedicated to
commercializing innovative pharmaceuticals and medical devices in the field of oxygen
therapeutics and continuous substrate monitoring. The company has under
development a blood substitute and a liquid ventilation product, and an implantable
glucose sensor. These products are based upon core technologies that include
biomedical applications for perfluorocarbons, and medical and industrial applications
for biosensors. Each of the product candidates is designed with advantages over
currently marketed products in major markets including acute respiratory distress
syndrome, stroke, myocardial infarction, surgery, trauma, malignant tumors and
diabetes. For further information, visit www.sybd.com.
Safe Harbor Statement The Private
Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking
information made on the Company s behalf. All statements other than statements of