WINSTON-SALEM, North Carolina — When thinking of biotech and med-tech hotbeds, an automatic assumption is California. But as manufacturing and agricultural industries have waned in the South, innovation continues to gain momentum.

From advances in organ generation to new-age bandages made of glass and bamboo that stop bleeding, the growth of a technology sector in North Carolina, in particular, was on display at this week's Council for Economic Development (Durham, North Carolina) 17th annual Biotech 2008 Conference, co-sponsored by the North Carolina Biotechnology Center (Research Triangle Park) and the North Carolina Biosciences Organization (Research Triangle Park).

"What excites me about all of this is the home-grown companies," said James Hunt, former North Carolina governor whose four-term tenure included the establishment of the North Carolina Biotechnology Center and other tech-based new economy strategies that are now paying off. "In my first two terms, I went around the world recruiting industry. For example, I helped to recruit Glaxo to the area. In those days, we were just trying to bring something in. Now, we're growing our own."

Hunt was a keynote speaker at the event.

The breakthroughs across North Carolina are evident. Two companies that presented at this forum received some level of financial or guiding assistance from one of the above-mentioned organizations:

Entegrion (Research Triangle Park, North Carolina) has just reported FDA 510(k) approval for its wound dressing that's designed to stop blood loss. Stasilon|FR is a hemostatic wound dressing available for use by both medical professionals under prescription and over the counter by consumers to control bleeding resulting from minor wounds.

Pending acceptance of an amendment to the FDA approval, a second version of the technology will be implemented as Stasilon|OR hemostatic surgical pads.

What's really amazing is that these bandages are made out of glass and bamboo.

"Uncontrolled hemorrhaging has always been a problem," Thomas Fischer, PhD, Entegrion's chief science officer and founder, told the CED conference attendees. "Typically wounds are wrapped in gauze bandages, but that doesn't stop the bleeding. Patients go into shock and can die. It's been long known that when blood contacts glass, hemostasis occurs. So we thought, why not use glass as a basis for a bandage?"

But they didn't know what to mix it with. So the inventors worked with a local textile company, Cheraw Mills (Cheraw, South Carolina). "They brought up the idea of bamboo. It slows the flow of blood, allowing clotting to occur. If you add blood to gauze, it passes right through it. Red blood cells stick to the glass and bamboo. Stasilon also dehydrates tissue for vasoconstriction."

In addition to the emergency care applications, Entegrion is studying Stasilon's applications for everything from failed caesarian sections to burns.

Hemorrhage control is achieved via the woven material from glass (silica dioxide) and bamboo (cellulosic rayon) fibers specifically selected for their ability to activate both blood platelets and coagulation proteins, constrict blood vessels, and rapidly wick fluids out of wounded tissues.

Entegrion invented Stasilon in consultation with the Office of Naval Research (Arlington, Virginia) because it also addresses the military's critical need for effective, but low-cost, hemostatic wound dressings, as severe blood loss accounts for 50% of all battlefield deaths.

Switching gears from blood loss to organ failure, Tengion (East Norriton, Pennsylvania) is collaborating with Wake Forest University (Winston-Salem, North Carolina) to create neo-organs and tissues, which are derived from a patient's own cells that are grown on a scaffold or model that is bioresorbable, or can be absorbed by the body.

The neo-organs become functional replacements after being implanted in the patient's body. Since they come from a patient's own cells (autologous cells), there is virtually no risk of rejection from the body's immune system.

Under their agreement, Tengion provides funding to Wake Forest for research conducted at the Wake Forest Institute for Regenerative Medicine under the direction of Anthony Atala, MD, an expert in the field of regenerative medicine and chair of the department of urology at Wake's School of Medicine.

"We have multiple Phase II trials under way now," said Timothy Bertram, PhD, senior VP, science and technology at Tengion. "We take a sample of the patient's own cells and use it to create a new organ for them to replace the failing organ or tissue. The product we generate promotes the regeneration what already exists in the body.

"There are more than 90,000 cases of patients waiting for transplants. While there have been some increased efforts to promote organ donation, they've been less than optimally successful," he told attendees. "By bringing forward neo-tissues and neo-organs, we can address this shortage."

He added: "The cost of procuring an organ is $50,000 just to get the organ. But that cost can go much higher. And then the cost of sustaining the post-implant patient is $100,000 to $500,000 per year. By generating a neo-organ, many of those costs are eliminated or stopped."

Bertram presented pre-clinical efficacy data for the Tengion Neo-Bladder Replacement.

"The Neo-Bladder Replacement was able to achieve functional recovery and a regenerative response that emulated the native bladder," he said. "These data join the existing body of information from the preclinical studies of our first product candidate, the Tengion Neo-Bladder Augment, and underscore the promise and potential of our Autologous Organ Regeneration Platform as a foundation for our pipeline of regenerative medicine products."

The pre-clinical study was a six-month, single-arm study to evaluate the application of Tengion's technology to regenerate an entire urinary bladder. Neo-Bladder Replacements were produced from autologous bladder cells seeded onto a biodegradable scaffold and were then surgically implanted into 23 large mammals.

Tengion's Neo-Bladder Replacement was able to regenerate an entire urinary bladder within six months after implantation. The regenerated bladder wall structure consisted of three layers: urothelium, muscle and serosa by about two months after implantation.

The regenerated bladder wall showed near-native pharmacological and electrophysiological functional responses by six months after implantation.

The company will submit plans to the FDA shortly to initiate human clinical trials in 2009. Tengion also is conducting three Phase II trials of its Neo-Bladder Augment at 12 academic medical centers across the U.S. — one in children with neurogenic bladder due to spina bifida, one in adults with neurogenic bladder due to spinal cord injury and one in adult patients with overactive bladder and urge incontinence.

"We've raised $120 million in venture funding so far," Bertram said. "We anticipate completing Phase II trials in 2008."