Spectral Medical has announced a delay in the completion of enrollment for its pivotal Tigris trial, pushing the anticipated submission of its haemoperfusion device, Toraymyxin, to the U.S. Food and Drug Administration (FDA) to early 2025. The delay is attributed to recent medical supply chain disruptions, notably exacerbated by Hurricane Helene.
Impact of Hurricane Helene
According to Spectral's CEO, Chris Seto, the disruptions have significantly impacted the trial's progress. Dr. John Kellum, Spectral’s chief medical officer, specifically cited the national saline shortage resulting from Hurricane Helene as a primary factor. The shortage affects the preparation of the Toraymyxin device for treatment, as saline is essential for its administration.
Tigris Trial Details
The Tigris trial aims to enroll 150 patients and has currently reached 135 participants. This confirmatory trial evaluates Toraymyxin, also known as polymyxin B haemoperfusion (PMX), in treating septic shock. The device functions by removing endotoxin, a toxic substance produced by bacteria, from the bloodstream. Patients in the trial receive Toraymyxin in conjunction with standard care, with outcomes compared against those receiving standard care alone.
Toraymyxin and Sepsis Treatment
Sepsis, a life-threatening condition triggered by the body's response to bacterial products like endotoxin, remains a significant medical challenge. Toraymyxin is already approved for use in Japan and Europe and has received breakthrough device designation from the FDA, highlighting its potential to address this critical unmet need. Spectral Medical acquired the U.S. rights to Toraymyxin from Toray Industries in 2009.
Commercialization Partnership with Baxter
Spectral Medical is actively pursuing partnerships for the potential rollout of Toraymyxin, collaborating closely with Baxter on commercialization activities. This collaboration encompasses branding, pricing, and launch strategies for the product. An amended agreement earlier this year granted Baxter exclusive rights to supply and distribute PMX products for ten years following FDA marketing authorization.
Baxter's Manufacturing Plant Affected
Adding to the complexity, a Baxter manufacturing plant in North Carolina, a major producer of IV bags, was also impacted by Hurricane Helene, further straining the saline supply chain. This plant typically produces 1.5 million bags of IV solutions daily.
Financial Impact
Spectral Medical's Q3 results revealed a 26% increase in revenue, alongside a $9.4 million increase in loss compared to the same period last year. The company's stock on the Toronto Stock Exchange experienced a slight dip following the announcement.
