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Spectral Medical Inc T.EDT

Alternate Symbol(s):  EDTXF

Spectral develops devices for unmet medical needs. Sepsis occurs in 1.7M Americans/year causing 250K deaths, often caused by endotoxin. Our devices measure and remove endotoxin from the bloodstream. An FDA confirmatory trial is underway. Dialco, a Spectral sub, offers SAMI, a novel instrument for renal replacement, cleared by FDA. Dialco is seeking FDA approval for DIMI a unique home dialysis enabler. These devices have large commercial potential


TSX:EDT - Post by User

Post by mercedesmanon Jan 20, 2023 3:18pm
259 Views
Post# 35236300

Here's my best i-Dialco guess

Here's my best i-Dialco guess(and it shouldn't have to be a guess)
  • Infomed to take the lead on US Distribution efforts (and fund the costs of same)
  • hire the right team, including a new President, based in the US (big $ investment required by Infomed). Maybe this is why they gave up 20% of US
  • FDA and Health Canada approval on dialysate bags (1 year?).  Can't use DIMI without that.
  • resolve tubing sourcing and ramp up production capacity for 2025+  (to service US market)
  • await clarity on US insurance coverage for Home Dialysis
  • start 30 person trial in 2023
  • Sometime after or during the above - take on a Distribution partner (partial monetization). 
  • Expand market for SAMI as a portable device that can be used once PMX approved (alongside Baxter's Prism).   Including for Europe (spectral owns that patent)

Little to no Dialco value reflected (yet) in Spectral SP (despite 30% stake in i-Dialco)

If a Spectral/PMX/EAA deal in consumated in 2023, then i-Dialco gets spun out to Spectral shareholders (= monetization).

All JIMHO

MM
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