Arch Therapeutics Inc (ARTH)

[Polyphemus]

It's nice that ARTH acknowledges that there is an market for Class II hemostat devices in GI endoscopy. Cook Medical & BSX are in that market with minor hemostat products (for them) that complement their main products (stents) in this area. 3-D Matrix Medical has a device (Purastat?) very similar to AC5 (self assembling peptide technology also licensed from MIT) that it introduced a few years ago. 3D has established distribution in UK & Europe, publications and revenues. Read about it on the net. Since most GI supplies for endoscopy proceedures come out of MD's pockets when endoscopy is performed outside of hospitals, this can be a large though price sensitive market. Maybe an endoscope company would pick this up as a gap filler in their line. An intro into the GI market can be a positive movement if well executed.

Reading carefully the 'new information' posted earlier about AC5, it seems that ARTH is backing carefully away from absorbable hemostat claims and is positioning AC5 carefully as a sealant with potential light duty as a hemostat. Big difference in market opportunity between sealants and absorbable hemostats. In any case, both are Class III devices, so substantial development funds for a PMA would be required.

Very hard to buy the concept that ARTH has been "in negotiations protected by NDA" with potential distribution partners for 18+ months. Sometimes obtaining a 510(k) is not a bridge to anywhere special.