Spectral Medical will have to wait to submit an application to the US Food and Drug Administration (FDA) for its haemoperfusion device after the company pushed back enrollment completion in a pivotal trial to early next year.
Announcing its Q3 financial results, Spectral’s CEO Chris Seto said that “recent medical supply chain events” negatively impacted enrolment, meaning the finalising of enrolment has been shifted “into the early 2025 timeframe”. Spectral highlighted the impact of Hurricane Helene – a tropical cyclone that hit the US in September – on the enrolment delay.
Shares in the Toronto-listed company opened 1.7% down compared to the pre-announcement market close. Spectral has a market cap of $160.3m.
Spectral’s chief medical officer Dr John Kellum said: “We experienced some disruptions due to Hurricane Helene – mainly the national saline shortage [required to prepare the device for treatment]. Our clinical team is focused on trial site support and is working to help resolve this issue.”
Canada-based Spectral has so far enrolled 135 patients out of the 150-patient target in the trial. Named Tigris, the study is a confirmatory trial evaluating Toraymyxin for the treatment of septic shock. The company’s device is being administered with standard of care, with results pitted against those from patients who receive standard of care only.
Also known as a polymyxin B haemoperfusion (PMX), Toraymyxin is a haemoperfusion device that removes endotoxin, a toxic substance produced by bacteria, from the bloodstream. Sepsis is a life-threatening condition caused by the body’s response to bacterial products such as endotoxin.
PMX is already approved in Japan and Europe and has won breakthrough device designation from the FDA. The company gained US rights for the technology from Toray Industries in 2009.
Spectral has been eyeing up partnerships for the potential rollout of the therapy and said that it has been “working closely with Baxter” on commercialisation activities. This includes branding, pricing and launch strategy for the product. The two companies amended an existing agreement earlier this year, resulting in Baxter having exclusive rights to supply and distribute PMX products for ten years following FDA marketing authorisation.
Incidentally, a Baxter manufacturing plant, a significant producer of IV bags in the US, was hit by Hurricane Helene. The company’s North Cove plant in North Carolina, which produces 1.5 million bags of IV solutions daily, was flooded due to the storm.
Spectral’s Q3 results included a 26% rise in revenue, coupled with a $9.4m increase in loss compared to Q3 of last year. The company reported a 54% revenue increase earlier this year.
