SPECTRAL MEDICAL

PMX (TORAYMYXIN™ PMX-20R)

Endotoxin Removal

Polymyxin B Hemoadsorption (PMX)

PMX is a Polymyxin B extracorporeal direct hemoadsorption column which is highly effective in removing endotoxin in the bloodstream.

Clinically available since 1995*
More than 340,000 treatments performed worldwide
Reproducible clinical benefits
As of 2019, more than 200 scientific papers and peer reviewed articles available

Polymyxin B Hemoadsorption

PMX

*PMX has been approved and marketed by Toray Industries in Europe and Japan since 1994 and 2002 respectively, and has been used safely on more than 340,000 patients worldwide.

PMX is available in Canada where Spectral holds the exclusive rights for its distribution. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock.

The Tigris Clinical 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.

The trial methods are detailed in “Bayesian methods: a potential path forward for sepsis trials”.

PMX

Patient Selection

PMX is indicated for patients with Sepsis and endotoxemia or suspected gram negative infection.

Recent data suggests that the best patients for PMX therapy have the following characteristics:

• Septic shock requiring continuous vasopressor support
• EAA ≥0.60 and <0.90
• Multiple Organ Dysfunction (MODS>9)

The graphic describes the decision making process that should be followed to prescribe PMX hemoadsorption therapy.^[2]

[2] Polymyxin B hemoperfusion in endotoxemic septic shock patients without extreme endotoxemia: a post hoc analysis of the EUPHRATES trial. Intensive Care Med. 2018 Dec;44(12):2205-2212. doi: 10.1007/s00134-018-5463-7. Epub 2018 Nov 23.

PMX

Clinical Benefits

The only double blinded, randomized trial of PMX (The EUPHRATES Trial) demonstrated that PMX cartridge therapy increased both ventilator free and renal replacement therapy free days.

Additionally, patients who received PMX therapy had a greater increase in mean arterial pressure as well as a decreased requirement for vasopressors.^[3]

[3] Effect of Targeted Polymyxin B Hemoperfusion on 28-Day Mortality in Patients With Septic Shock and Elevated Endotoxin Level: The EUPHRATES Randomized Clinical Trial. JAMA. 2018 Oct 9;320(14):1455-1463. doi: 10.1001/jama.2018.14618.

A group of patients with baseline EAA™ results between ≥0.60 and <0.90 at randomization, treated with PMX, had a 28 day mortality of 26% as compared to 37% in patients who did not receive PMX (p<0.05, n=194). In the same population, patients who received PMX had a 90 day mortality of 30% as compared to 41% in patients who did not receive PMX (p<0.04, n=194).

Source: Polymyxin B hemoperfusion in endotoxemic septic shock patients without extreme endotoxemia: a post hoc analysis of the EUPHRATES trial. Intensive Care Med. 2018 Dec;44(12):2205-2212. doi: 10.1007/s00134-018-5463-7. Epub 2018 Nov 23