Arch Therapeutics Inc (ARTH)

[Polyphemus]

Corrections to Misinformation

Vetigel is a verternary device, NOT a Class III device intended for human use. Veternary devices do not require FDA premarket clearance prior to commercialization, only QSR/GMP regulation compliance. Marketers choose the vet market for commercialization when they don't have either a product that could pass FDA muster and be commercially successful or the funds to obtain a PMA.

TRAUMAGEL is a proposed Class II device intended as temporary implant in trauma cases outside the hospital environment. It would not compete with as a surgical hemostat (Class III devices) which require a PMA. Apparaently, Landolini is trying to mimic the earlier (and temporary) success of the HemCon dressing.

Comparing Arch Therapeutics to Cresilon or Suneris implies that Arch will also be a "never was".