Frontline Defense

Oregon Company Expands Production Of High-Tech Bandage To Support U.S. Army

By Elizabeth Sharpe

Severe hemorrhage causes fifty percent of all deaths on the battlefield where soldiers are vulnerable to bullets and shrapnel from rocket-propelled grenades or land mines. That's why the U.S. Army wants more hemostatic bandages from HemCon, a four-year old start-up company in Tigard, Ore. The Army is even willing to foot the bill to build HemCon a bigger facility and get better equipment so that a minimum of 60,000 bandages can be shipped to Iraq, Afghanistan, and other combat zones before the end of the year.

What makes the HemCon bandage such a hot item? It's one of the best products on the market right now, says Ronald Palmer, product manager for the U.S. Army Medical Materiel Development Activity at Fort Detrick in Frederick, Md. The HemCon bandage works better than the traditional gauze bandage and tourniquet, used by army medics since the time of the Civil War, according to HemCon and U.S. army officials.

The key ingredient to the bandage is chitosan, a natural polymer derived from the exoskeleton of crab, shrimp, and other crustaceans. When the bandage is applied with pressure to a severe external wound for several minutes, blood cells, which have a negatively charged surface, are attracted to positively charged chitosan surfaces. When the red blood cells touch the chitosan, they fuse to it, and a blood clot forms. The bleeding stops, and the bandage adheres tightly to the wound, so the soldier can be moved without more bleeding.

The $6-million advance to improve the Tigard facility is part of a $29-million contract that HemCon signed with the Department of Defense in 2004. The facility will increase, from a little over 12,000 sq ft to nearly 40,000 sq ft, by September 2005, says John Morgan, president and CEO of HemCon. Plus, the number of employees, currently at 41, is expected to more than double. Two freeze dryers will also be added. These machines crystallize the chitosan gel, a critical component of the bandage production.

The crystalline structure of the chitosan is key to its ability to stop bleeding, says Kenton Gregory, HemCon co-founder and director of the Oregon Medical Laser Center at the Providence St. Vincent Medical Center in Portland, Ore. But manufacturing each bandage with the same crystalline structure is about as easy as making 800 snowflakes look exactly alike. Not all pass muster, says Gregory. Many have to be thrown out.

Still, HemCon officials remain optimistic. Within two months of start-up, HemCon secured Federal Drug Administration (FDA) approval for the hemostatic bandage, the only product HemCon currently sells. HemCon started shipping the bandages in March 2003, just prior to the U.S. invasion of Iraq. But they couldn't produce the bandages fast enough for the military's needs.

The company's expansion means dramatic increases for bandage production, says Morgan. Currently, the company can produce around 14,000 bandages a month at 100 percent yield. But achieving that perfect yield means the production process needs to be further studied and refined, says William Wiesmann, HemCon co-founder and chairman. Wiesmann is a 21-year veteran of the armed services as a surgeon, and was the director of combat casualty care for the U.S. Army Medical Research and Materiel Command in Frederick, Md.

Morgan says HemCon is also looking into making the bandage available on the home front, too, in hospital emergency rooms where severe bleeding is not so uncommon, in bullet wounds or even difficult pregnancies, for example.

But it is on the battlefield where unique conditions demand a light and lightning-quick bandage that medics can use to stop bleeding, says Lieutenant Colonel Ian Wedmore, who has been on two tours of duty in Iraq and is a surgeon at Madigan Army Medical Center in Tacoma, Wash. He collected 44 reports from medics in Iraq and Afghanistan who used the HemCon bandage. The results are soon to be published in the Journal of Trauma. Wedmore said the dressing stopped bleeding, while traditional means using a cotton gauze bandage or a tourniquet did not.

Medics also recommended making the bandage smaller, more flexible, and with a backing that can be seen by soldiers at night. Gregory says HemCon is listening, and a newer version of the bandage is due out in the next few months.

Two other hemostatic agents are of interest to the military. Z-Medica's powder-like QuickClot can be poured onto a bleeding wound. It's a third of the cost of the HemCon bandage and some say it is preferred by the Marines. The American Red Cross is working on a hemostatic device made of fibrin and thrombin, proteins that coagulate the blood. But it is more sensitive to battlefield conditions and costs about ten times more than HemCon's bandage.

Wiesmann expects the FDA will soon approve the HemCon bandage as anti-bacterial. But HemCon won't stop there. They want FDA approval for a chitosan-based bandage for internal bleeding for use in vascular or orthopedic surgery, for example. Gregory says the bandage could decrease bleeding during surgery, and the need for transfusion, which means decreased cost and a decreased potential for disease and infection caused by transfusions. Wiesmann says a temporary internal-use bandage (one that cannot be left in the body after surgery) could be available by 2006.

Elizabeth Sharpe is a science writer and editor at University of Washington Engineered Biomaterials (UWEB), a National Science Foundation Engineering Research Center.

Images:

Top: Severe hemorrhage causes fifty percent of all deaths on the battlefield. Photo: Corbis

Middle: HemCon's expansion means more bandages will be produced for soldiers deployed to Iraq and Afghanistan. Photo: HemCon, Inc.