Mahwah, NJ, December 9, 2003
Lions Gate Investment Limited (Lions Gate) (LGIV.OB) announced
today the closing of a private placement with commitments totaling approximately
$8.5 million, as described below, and the simultaneous stock-for-stock
merger with DOBI Medical Systems, Inc. (DOBI Medical). The combined company
will operate under the name DOBI Medical International and will assume
and execute DOBI Medicals business plan as its sole business. Lake
Worth Ventures, Inc., owned by one of the founders of DOBI Medical and
its largest shareholder, participated in the transaction. Shares will
be listed on the Over-the-Counter (OTC) Bulletin Board initially under
its existing symbol. The company currently plans to apply for listing
of its shares on the American Stock Exchange.
DOBI Medical Systems, Inc. is an advanced technology medical
imaging company developing a new means for the improved diagnosis of cancer
through the detection of vascular changes (angiogenesis) associated
specifically with malignant tumors.
DOBI Medicals first application of the technology is the ComfortScan
system, a non-invasive, non-ionizing medical imaging system designed to
assist physicians in the detection of breast cancer at the earliest stages
of development. The ComfortScan system is intended to achieve this
by providing new, physiology-based imagery of vascular changes not readily
Phillip C. Thomas, DOBI Medicals Co-Founder and Chief Executive
Officer, stated, The private placement and merger transactions are
significant to DOBI Medical for three reasons. First, it allows us to
accelerate and complete product development and the rollout process for
the ComfortScan system outside the United States. Second, it allows
us to commence the fifth and final module of the Companys FDA Pre-Market
Application, which is expected to take approximately six to nine months
to complete once formal clinical investigational testing has begun. Module
Five is currently expected to be submitted to the FDA by mid 2005 with
FDA review expected to commence immediately thereafter. Finally, we believe
that completion of these transactions demonstrates strong market support
for the DOBI Medical technology and the significant potential for the
product and our approach to cancer identification.
About the Private Placement Transaction
The private placement was completed and will close in two tranches, the
first of which closed today and resulted in gross proceeds to the company
of approximately $5.5 million. The remaining $3.0 million in committed
investor funding will be drawn down subject to the satisfaction by the
Company of certain operating milestones.
The securities sold by Lions Gate in the private placement
and the merger have not been registered under the Securities Act of 1933,
may not be sold in the United States absent registration pursuant to the
Securities Act, and are subject to certain lock-up provisions. The Company
expects to file a registration statement for these securities by April
The ComfortScan System and Angiogenesis
Angiogenesis is a natural occurrence in the body. In cases where cancer
is involved, the growth of new blood vessels occurs around, and in support
of, a malignant tumor. This process is vital, since without it, these
tumors remain small and largely harmless. When a woman discovers a lump
within her breast, it has likely been developing for a number of years,
as cancerous tumors often take many years to become palpable.
DOBI Medicals ComfortScan system is a light based,
digital-imaging system that uses high-intensity light-emitting diodes
(LEDs) and gentle external pressure to highlight areas of vascular
development common to malignant tumors in the breast. The technology is
based on detecting tumor angiogenesis, or vascular change, which is the
process whereby a cancerous growth surrounds itself with a dense network
of tiny blood-filled capillaries. These vascular "feeding tubes"
provide oxygen and nutrients to active tumors and are unique physiologic
"markers" that can reveal the presence of cancer.
ComfortScans high-intensity light-emitting diodes
transmit red light through the breast, recording approximately one image
per second via a CCD camera for 45 seconds. If the light encounters an
angiogenic (and thus potentially cancerous) region of the breast, it is
absorbed by hemoglobin differently than normal portions of the breast.
As a result, the
ComfortScan system focuses on dynamic functional imaging (i.e., what is
occurring within the tissue in near real-time) rather than a singular
morphological image (i.e., a static anatomical snapshot showing anatomical
details at a single point in time) such as those created by mammography.
These unprecedented images provide the physician with new, physiologic
information which may be associated with cancer development.
The initial application of the ComfortScan system is as
an adjunct to mammography and physical exam. The ComfortScan system has
been designed and is being tested to show that it provides high levels
of specificity in detecting benign lesions within the breast, thus 1)
reducing the number of false positives generated by current techniques
and, 2) potentially reducing the high number of breast biopsies or other
downstream testing now being performed.
Forward Looking Statements
This release contains certain forward-looking statements,
relating to the business of DOBI Medical, which can be identified by the
use of forward looking terminology such as believes, expects,
or similar expressions. Such forward looking statements involve known
and unknown risks and uncertainties, including uncertainties relating
to product development, regulatory actions or delays, the ability to obtain
or maintain patent or other proprietary intellectual property protection,
market acceptance, physician acceptance, third party reimbursement, future
capital requirements, competition in general and other factors that may
cause actual results to be materially different from those described herein
as anticipated, believed, estimated or expected. Certain of these risks
and uncertainties are or will be described in greater detail in our filings
with the Securities and Exchange Commission. DOBI Medical Systems is under
no obligation (and expressly disclaims any such obligation) to update
or alter its forward-looking statements whether as a result of new information,
future events or otherwise.