NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO THE UNITED STATES OF AMERICA OR TO ANY PERSON LOCATED OR RESIDENT IN THE UNITED STATES OF AMERICA, ITS TERRITORIES AND POSSESSIONS, ANY STATE OF THE UNITED STATES OR THE DISTRICT OF COLUMBIA.
TORONTO, May 30, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (TSX:EDT) (the "Company" or "Spectral"), is pleased to confirm the closing of previously announced offering of 9% convertible notes of the Company at a price of US$1,000 per convertible note due on May 1, 2028 for gross proceeds of approximately C$8.5 million (the “Offering”). Paradigm Capital Inc. acted as the underwriter for the Offering. 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.
AboutSPECTRALMEDICALINC.
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 “Bayesianmethods:apotentialpathforwardforsepsistrials”.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
Forward-lookingInformationCautionaryStatement
Information inthis news releasethat isnot current orhistorical factual informationmay constituteforward-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 currentlyavailabletoit.WhiletheseassumptionswereconsideredreasonablebySpectralatthetimeofpreparation,theymay prove to be incorrect. Readers are cautioned that actual results aresubject to anumber of risks anduncertainties, including theavailabilityoffundsandresourcestopursueR&Dprojects,thesuccessfulandtimelycompletionofclinicalstudies,the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals byregulatoryauthoritiesaswellasgeneraleconomic,marketandbusinessconditions,andcoulddiffermateriallyfromwhatis currently expected.
TheTSXhasnotreviewedanddoesnotacceptresponsibilityfortheadequacyoraccuracyofthisstatement.
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