Spectral Medical Inc. has announced the closing of a C$6.1 million (US$4.553 million) bought deal private placement of 9.0% convertible unsecured senior notes due November 1, 2026. The financing will support the company's Phase III Tigris trial, which is evaluating the PMX product for the treatment of endotoxic septic shock.
The offering was conducted by Paradigm Capital Inc. and involved the sale of 4,553 notes at a price of US$1,000 per note. Each note is convertible into approximately 15,475,647 common shares of Spectral Medical. Baxter International Inc., a leading global medical products company, participated in the financing as part of an amendment to a milestone payment under the distribution agreement for PMX and the Endotoxin Activity Assay (EAA).
The net proceeds from the offering will be used to fund the Tigris Study and for general corporate and working capital purposes. The Tigris study is a Phase III registration trial evaluating PMX for endotoxic septic shock. PMX is a therapeutic hemoperfusion device that removes endotoxin from the bloodstream. It is guided by Spectral's EAA, the only FDA-cleared diagnostic for assessing the risk of developing sepsis.
"We remain encouraged by the continued momentum and pace of patient enrollment in the Tigris study," said Chris Seto, Chief Executive Officer of Spectral Medical. "We are now at 72 patients enrolled, and the study remains on track to reach the important interim milestone of 90 patients enrolled by the end of 2023."
PMX is already approved for therapeutic use in Japan and Europe, where it has been used safely and effectively on over 340,000 patients. Spectral obtained exclusive development and commercial rights in the U.S. for PMX in 2009. In July 2022, the 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.
About the Tigris Trial
The Tigris trial is a pivotal Phase III study designed to evaluate the safety and efficacy of PMX in patients with endotoxic septic shock. The primary endpoint of the trial is mortality at 28 days. Secondary endpoints include improvements in organ function and reductions in the need for vasopressor support.
The study is currently enrolling patients at multiple sites across North America. Spectral anticipates activating three additional trial sites in Q3. The company expects to reach the interim milestone of 90 patients enrolled by the end of 2023.
PMX and Endotoxic Septic Shock
Septic shock is a life-threatening condition that occurs when the body's response to an infection spirals out of control, leading to widespread inflammation and organ damage. Endotoxin, a component of the outer membrane of Gram-negative bacteria, is a potent trigger of the inflammatory cascade in sepsis. PMX works by removing endotoxin from the bloodstream, thereby reducing the inflammatory response and potentially improving outcomes in patients with septic shock.
The EAA is a diagnostic tool that measures the activity of endotoxin in the blood. It is used to identify patients who are at high risk of developing septic shock and who may benefit from PMX therapy.
