Spectral Medical Inc. Announces Closing of Additional US$1 Million Convertible Notes
July 22 2024 - 8:00AM
Spectral Medical Inc. (TSX:EDT) (the "
Company" or
"
Spectral") is pleased to announce the closing of
an additional non-brokered offering of US$1 million of 9%
convertible notes of the Company (the “Notes”) at a price of
US$1,000 per convertible note due on May 1, 2028 (the
“
Offering”).
The Notes were sold to one of the Company’s
largest shareholders pursuant to the exercise of their
anti-dilution pre-emptive rights relating to the closing of the
offering of the approximately C$8.5 million offering of Notes that
was completed on May 30, 2024.
“We are pleased to have one of our largest
shareholders exercise their participation rights and invest more in
the Company at such an exciting phase in our business,” said Chris
Seto, CEO of Spectral. “The combination of a strong balance sheet
and the current pace of patient enrollment has us well positioned
as we close in on completing the Tigris trial and FDA
submission.”
The net proceeds from the Offering are expected
to be primarily used by the Company on its Phase III registration
trial (Tigris) for its PMX treatment for endotoxemic septic shock
and for general corporate and working capital purposes.
The securities have not been, and will not be,
registered under the United States Securities Act of 1933, as
amended (the "U.S. Securities Act"), or any U.S.
state securities laws, and may not be offered or sold in the United
States without registration under the U.S. Securities Act and all
applicable state securities laws or compliance with the
requirements of an applicable exemption therefrom. This press
release does not constitute an offer to sell or the solicitation of
an offer to buy securities in the United States, nor may there be
any sale of these securities in any jurisdiction in which such
offer, solicitation or sale would be unlawful.
About SPECTRAL
MEDICAL INC.
Spectral is a Phase 3 company seeking U.S. FDA
approval for its unique product for the treatment of patients with
septic shock, Toraymyxin™ ("PMX"). PMX is a
therapeutic hemoperfusion device that removes endotoxin, which can
cause sepsis, from the bloodstream and is guided by the Company’s
Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic
for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and
Europe and has been used safely and effectively on more than
340,000 patients to date. In March 2009, Spectral obtained the
exclusive development and commercial rights in the U.S. for PMX,
and in November 2010, signed an exclusive distribution agreement
for this product in Canada. In July 2022, the U.S. FDA granted
Breakthrough Device Designation for PMX for the treatment of
endotoxic septic shock. Approximately 330,000 patients are
diagnosed with septic shock in North America each year.
The Tigris Trial is a confirmatory study of PMX
in addition to standard care vs standard care alone and is designed
as a 2:1 randomized trial of 150 patients using Bayesian
statistics. Endotoxic septic shock is a malignant form of sepsis
https://www.youtube.com/watch?v=6RANrHHi9L8.
The trial methods are detailed in
“Bayesian methods: a
potential path forward
for sepsis
trials”.
Spectral is listed on the Toronto Stock Exchange
under the symbol EDT. For more information, please visit
www.spectraldx.com.
Forward-looking Information
Cautionary Statement
Information in this news release that is not
current or historical factual information may constitute
forward-looking information within the meaning of securities laws.
Implicit in this information, particularly in respect of the future
outlook of Spectral and anticipated events or results, are
assumptions based on beliefs of Spectral's senior management as
well as information currently available to it. While these
assumptions were considered reasonable by Spectral at the time of
preparation, they may prove to be incorrect. Readers are cautioned
that actual results are subject to a number of risks and
uncertainties, including the availability of funds and resources to
pursue R&D projects, the successful and timely completion of
clinical studies, the ability of Spectral to take advantage of
business opportunities in the biomedical industry, the granting of
necessary approvals by regulatory authorities as well as general
economic, market and business conditions, and could differ
materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for
the adequacy or accuracy of this statement.
For further
information, please
contact:
Ali Mahdavi |
Chris Seto |
Capital Markets & Investor
Relations |
CEO |
Spinnaker Capital Markets
Inc. |
Spectral Medical Inc. |
416-962-3300 |
|
am@spinnakercmi.com |
cseto@spectraldx.com |
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