Source: Spectral Medical Inc.
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  • Spectral Medical (EDT) announced that the US Food & Drug Administration has granted Breakthrough Device designation for the company’s Toraymyxin (PMX) device
  • Toraymyxin is a therapeutic hemoperfusion device that removes endotoxin from the bloodstream
  • The Breakthrough Devices Program is designed to provide patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review
  • Spectral Medical is focused on the development and commercialization of a treatment for septic shock
  • Spectral Medical Inc. (EDT) is up 28.29 per cent on the day, trading at C$0.435 per share at 10:15 am ET

Spectral Medical (EDT) announced that the US Food & Drug Administration has granted Breakthrough Device designation for the company’s Toraymyxin (“PMX”) device.

Toraymyxin is a therapeutic hemoperfusion device that removes endotoxin, which can cause septic shock.

The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving the statutory standards consistent with the FDA’s mission to protect and promote public health.

Dr. John Kellum, Chief Medical Officer of Spectral, commented on the news.

“For over 50 years the medical scientific community has sought a treatment for sepsis, yet today, no specific therapies are available. A new therapy showing survival benefit for the most severely affected patients would indeed be a breakthrough technology and we are pleased to see that the FDA agrees.”

“We are entering an era of personalized medicine for critical illnesses,” continued Dr. Kellum. “By breaking up sepsis into subsets that have specific molecular pathogenesis, we believe our strategy targeting endotoxemic septic shock, characterized by high levels of endotoxin in the bloodstream, is far more likely to succeed, where other non-specific therapies have failed time and again. Our goal is to show a large difference in mortality when an anti-endotoxin therapy is applied to carefully selected patients with high endotoxin activity in their bloodstream. Moreover, we have a diagnostic test already in clinical use to identify these patients. We believe this combination of an advanced diagnostic with a specific therapy represents the future of sepsis care.”

Chris Seto, CEO of Spectral, added,

“We are honored and grateful to the FDA for granting Breakthrough Device status for PMX. While our clinical trial is still underway, clinical data both within and outside the trial are highly encouraging and we believe PMX has the potential to provide hope for patients suffering from this devastating illness, as endotoxin often leads to multiple organ failure and death. Approximately 120,000 patients each year suffer from endotoxemic septic shock, with an estimated 50 per cent mortality rate. In turn, we estimate this translates to a $1.6 billion annual market for PMX in the U.S. alone. Our current TIGRIS Phase 3 confirmatory trial is continuing to progress, with over a quarter patients out of a planned 150 patients randomized to date. We also believe this trial is significantly de-risked given the prior clinical data from our EUPHRATES trial. Importantly, we believe this Breakthrough Device designation will help accelerate review by the regulators upon completion of the TIGRIS trial. Moreover, we continue to work closely with Baxter, our exclusive commercial partner in the U.S. and Canada, in order to prepare for commercialization, assuming the trial is successful, and we receive regulatory approval.”

Spectral is a Phase 3 company seeking U.S. FDA approval for Toraymyxin, a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream.

Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum.

Spectral Medical Inc. (EDT) is up 28.29 per cent on the day, trading at C$0.435 per share at 10:15 am ET.

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