elevator Pitch.....as evidenced by the news today on the Protocol Amendment ...
...is gettgin more succinct and up to date....
"About Spectral Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 200,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”), is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use."
However...
my only question is...is the 330,000 a conservative estimate given more recent developments?
Why do I ask?
1. It's based on CDC figures released on Sepsis from years ago, when there is evidence that the incidence of Sepsis has been growing steadily for the past 3 - 5 years (even pre-Covid).
2. Does the 330,000 severe sepsis figure really include Canadian data as it was derived from the 1.7million a US number?
3. What is the impact of Covid on the number of expected Sepsis cases in NA?
Taking into account the above, are the numbers likely to be 20 % higher...50 % ? higher?
And if so, wouldn't that translate into a much higher target market and much higher revenues?
Jus' asking
MM