Which Trick Pony will get recognized first?... by "strategic partners" and then by the financial Markets, including the all important US investor? ....
1. PMX/EAA
Addressing Unmet Need in Treatment of Endotoxemic Septic Shock
– Precision treatment utilizing EAA diagnostic and PMX therapeutic device
– Addressable US market of ~US$1.6 billion p.a.+
– No FDA approved sepsis solution in the market… Spectral has no competitor
– De-risked Phase III FDA confirmatory trial – De-risked commercialization
– entered into an exclusive distribution agreement with Baxter in Feb/20
– FDA Breakthrough Device Designation for PMX granted Jul/22
or ...
2. Dialysis
Disruptive Technology for the Dialysis Device Market
– Remove operational complexity from dialysis treatments for both patients and providers
– Addressable US market anticipated to grow to ~US$13 billion by 2026
– Recurring revenue model – installed dialysis device and consumables per treatment
– Multiple End Markets – address patient needs across the dialysis spectrum
o SAMI device: acute market (ICU dialysis and supports PMX therapeutic); and DIMI device: chronic market (dialysis in clinics, skilled nursing facilities and in-home)
o Clear regulatory pathway: o SAMI: already FDA cleared and Health Canada approved o DIMI: Requires FDA regulatory trial for target addressable market for in-home use
Or will both be scooped up by a (one or more) savvy multi-Billion $ US Congolmerate (s), bent on securing their future by tackling Sepsis (where there are no competitors) and /or the paradigm shift to Home Care and Home Dialysis...that also happens to improve patient outcomes?
MM