Spectral Medical Shares Updates on the Tigris Trial's Progress
Spectral Medical Shares Updates on the Tigris Trial's Progress
In a notable development, Spectral Medical Inc. (TSX: EDT), a company specializing in advanced therapeutics for sepsis and septic shock, has provided an important update regarding its Tigris trial. This Phase 3 study focuses on evaluating the efficacy of Polymyxin B Hemoperfusion (PMX) in treating adults suffering from endotoxemia and septic shock. Recent reports indicate that 136 patients have been enrolled at the end of November.
Challenges Impacting Enrollment
Interestingly, the enrollment process faced significant hurdles in October and November due to Hurricane Helene's impact on the medical supply chain. This natural disaster disrupted the availability of critical intravenous fluids, contributing to a slower than expected patient enrollment rate for the Tigris trial. The production disruptions have led to a scarcity of saline required for PMX treatments.
Continued Commitment to the Trial
Despite these challenges, management remains optimistic. The team is dedicated to finalizing the Tigris trial as swiftly as possible. While the medical supply chain issues have posed difficulties, the Company anticipates that these disruptions will be resolved in the near term, projecting full enrollment by the end of the first quarter of 2025.
Dr. John Kellum, Chief Medical Officer of Spectral, expressed confidence stating, "Even with the saline shortage, our trial sites are remaining proactive and enthusiastic in their efforts to complete the enrollment process. We are optimistic about the engagement at our trial locations and the progress being made with patient screenings."
Upcoming Corporate Update Call
In a bid to further engage stakeholders and the public, Chris Seto, the Chief Executive Officer, alongside Dr. Kellum, will additionally host a corporate update call. This event will include valuable insights into the trial's progress as well as an interactive question-and-answer session.
Conference Call Details
The scheduled conference call will take place on December 16, and everyone interested is encouraged to join. Participants can call in using the provided numbers or click on the designated link for immediate access.
The Significance of PMX in Sepsis Treatment
Spectral Medical is actively pursuing U.S. FDA approval for PMX, its unique hemoperfusion device designed to eliminate endotoxins from the bloodstream—a significant causative factor in sepsis. PMX, which is already approved for therapeutic use in Japan and Europe, has been utilized safely in over 340,000 patients to date.
The Tigris trial stands as a vital confirmatory study comparing PMX in conjunction with standard medical care against standard care alone. The design encompasses a total of 150 patients, allocated in a 2:1 randomization, leveraging Bayesian statistical methods to evaluate outcomes.
Insights into Septic Shock
Septic shock represents a severe complication of sepsis, impacting around 330,000 patients in North America annually. As part of its commitment to advance treatment options, Spectral's Tigris trial will provide essential clinical data that has the potential to transform current practices in managing septic shock.
About Spectral Medical
To summarize, Spectral Medical Inc. (TSX: EDT) continues to innovate in the quest for effective treatments for sepsis. With the promise of PMX and ongoing clinical research, the Company is poised to make a significant impact on healthcare for critically ill patients. For more information, please reach out to their investor relations team.
Frequently Asked Questions
What is the Tigris trial about?
The Tigris trial is a Phase 3 study evaluating the effectiveness of Polymyxin B Hemoperfusion (PMX) in treating adults with septic shock and endotoxemia.
How many patients have been enrolled in the Tigris trial?
As of the end of November, a total of 136 patients have been enrolled in the trial.
What challenges has the Tigris trial faced recently?
The trial has faced enrollment challenges due to the impact of Hurricane Helene, which disrupted the medical supply chain and the availability of critical intravenous fluids.
Who will host the upcoming corporate update call?
CEO Chris Seto and CMO Dr. John Kellum will host the corporate update call, offering insights into the Tigris trial and other developments.
What is the goal of PMX therapy in septic shock?
The goal of PMX therapy is to remove endotoxins from the bloodstream to improve outcomes in patients suffering from septic shock.
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