- Spectral Medical (TSX:EDT) has received Health Canada’s Interim Order, allowing the use of the company’s PMX product to treat COVID-19
- The Health Minister determined that there is an urgent public need for the importation or sale of PMX
- Spectral will provide the therapeutic PMX cartridges for free
- PMX has already demonstrated strong action against other viral pandemics, including avian flu and swine flu
- Spectral’s share price is up 11.94 per cent, and is currently trading for C$0.75 per share
Spectral Medical (TSX:EDT) has received Health Canada’s Interim Order, allowing the use of the company’s PMX product to treat COVID-19.
Specifically, Health Canada’s Interim Order expanded the already approved indications of Spectral’s Toraymyxin hemoperfusion cartridge, also called PMX.
The Health Minister determined that there is an urgent public health need for the importation and sale of PMX.
The Interim Order allows PMX to be used to treat COVID-19 patients. This applies particularly to those with acute respiratory failure, diffuse alveolar damage, difficulty breathing and hypotensive shock.
A recently announced supplemental IDE approval from the US FDA stated that Spectral will provide the cartridges for free.
PMX has already seen action against other viral pandemics, including avian flu (H5N1) and swine flu (H1N1). These diseases, like COVID-19, also result in acute respiratory distress syndrome (ARDS). The use of PMX against these viruses improved chest x-ray results, improved lung function and successfully weaned patients off ventilators.
Spectral’s Vice President of Clinical Development, Debra Foster, said that the improvements may have been the result of endotoxin removal.
“Endotoxin is the primary driver of the cytokine storm. There is reliable evidence that removing endotoxin by the PMX cartridge reduces circulating levels of cytokines.
“Increased levels of endotoxin activity, as measured by our FDA-approved Endotoxin Activity Assay (EAA) has been identified in COVID-19 patients in Japan, Italy, and the US,” she said.
Spectral’s CEO, Dr Paul Walker, said that the company was very happy with the issuance of Health Canada’s Interim Order.
“There is growing evidence from ICU physicians that endotoxemia is playing a role in the progression to septic shock and death in patients with this severe viremia.
“PMX not only provides the opportunity to save lives, it could also relieve stress on scarce critical care devices, like ventilators. We continue to assess how Spectral’s entire product portfolio may aid in fighting the COVID-19 pandemic,” he concluded.
Spectral’s share price is up 11.94 per cent, and trading for C$0.75 per share, as of 10:57am EST.