Sunday, October 6, 2013

What's Arch Therapeutics Got That Cytomedix and Baxter International Don't? (BAX, ARTH, CMXI)

To give credit where it's due, Cytomedix, Inc. (OTCBB:CMXI) and Baxter International Inc. (NYSE:BAX) have both helped shape the landscape of the hemostasis (bleeding control) market with their products, AutoloGel and TISSELL, respectively. Arch Therapeutics Inc. (OTCBB:ARTH) has proverbially taken their concepts "up a notch", however, and its direct solution to a problem that CMXI and BAX can't quite solve may make ARTH the hottest trading candidate in the hemostasis space.

Hemostasis is the deliberate control, well, stoppage, of unwanted blood flow. It's usually part of the process following surgeries, though it can become part of the stabilization regimen for traumatic injuries. Either way, the need for stopping uncontrolled blood flow is exactly what it seems... uncontrolled bleeding is dangerous, with risks possibly including death.

The technology to control bleeding has come a long way from stitches, bandages, and prayers. It's become something of a science, and more recently, some might even say science fiction.

Take the Autolegel System from Cytomedix, for instance. The fibrin matrix gel is bioactive, harnessing a patient's natural healing power and directing that person's own "chemistry" (platelets) to more effectively self-seal a wound. Being a gel and applicable anywhere, it's a fairly versatile approach too, putting CMXI on the proverbial map. Problem: AutoloGel is only intended for topical use.

The same goes for TISSEEL, from Baxter International. TISSELL is also a fibrin-based hemostasis agent, and could be regarded as the standard within the wound-care sliver of the healthcare industry. It can be used as the primary means of wound-closure, or as an adjunct, and it's also approved for most open-wound purposes.... post-surgery, and trauma. Better still, TISSELL from BAX is a gel-like substance applied as a spray or spread, so is effective on any shape of wound. Again, though, it's only approved for topical use.

Arch Therapeutics Inc. has one-upped both TISSEEL and the AutoloGel System, with a substance simply called AC5.

AC5, like the two products it's most commonly being compared to, is also a gel. Unlike its competitors' products, however, Arch Therapeutics' product is taking aim at internal wounds... the kind created by laparoscopic surgery, the kind that don't seal up with other hemostasis agents, and the kind that don't really lend themselves to sutures or cauterization (two process that can invite pain as well as infection).

Just for the sake of clarity, post-laparoscope surgical hemostats agents exist. Most of them are salt or saline-based. They don't adhere well, however, and can crumble and/or fall apart long before the body heals it wounds. That's not even the big selling point for AC5, however. No, what really separates AC5 from the competition is that the gel 'sets up' clear - so clear, in fact, that a surgeon can see through, and cut through it, to perform a procedure with the bleeding-control measure already in place exactly when the surgery is over. Preclinical studies have shown AC5 achieves hemostatis in a matter of seconds, as opposed to minutes for other bleeding-control approaches.

ARTH is still in the development stages with the AC5 gel, but anticipates being in human clinical trials by 2014. As veteran biomedical traders can attest though, progress toward key milestones can be enough to drive a stock upward. And, this story is really, really compelling. Small cap speculators may want to consider taking on a position.

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