New ally on the operating table?

Product to stem bleeding faces tough obstacles

An entrepreneur, a doctor, and a team of researchers at MIT are trying to make surgery a less bloody proposition. They say surgeons spend about half their time in the operating room trying to manage bleeding, using sponges, clamps, sutures, glues, and substances that promote clotting. When those means fail, it's usually curtains for the patient.

But getting the technology from the research lab into the operating room won't be a cinch for Arch Therapeutics Inc., a Cambridge company formed two years ago to try to commercialize what seems like a breakthrough in blocking bleeding.

In April, Arch Therapeutics signed a deal to license the technology from the Massachusetts Institute of Technology, and it is hoping to test it in larger animals later this year (so far, it has only been tested on rodents). The company hasn't yet raised outside venture capital funding - though its founders say that's all part of the plan.

An MIT researcher, Rutledge Ellis-Behnke, had a eureka moment in 2001. He was trying to develop a substance that would help foster the regeneration of damaged nerve tissue, using protein fragments known as peptides. But during one surgical procedure, Ellis-Behnke noticed that the animal stopped bleeding after he applied the substance. He and his colleagues assumed the animal died; they were wrong. They soon realized that the transparent peptide gel had an interesting side effect: It seemed to halt bleeding within a few seconds, and then break down safely once an incision had healed.

When the peptides come into contact with blood, they appear to assemble into fibers, forming a na noscale barrier that stanches bleeding. Terrence Norchi, a Natick doctor who serves as Arch Therapeutics' chief executive, compares it to "a liquid Saran Wrap or Tyvek." Another benefit is that the gel doesn't seem to spark an immune system response. It also may be possible to apply the gel to an area before surgery, and cut through the gel - controlling the bleeding before it has a chance to get out of hand.

Steve Kelly, a onetime tech entrepreneur, spotted the research as a volunteer reviewing grant applications for MIT's Deshpande Center for Technological Innovation, which aims to shepherd new ideas out of the lab and into widespread use. After building and selling several big networking companies to buyers like Siemens AG and IBM Corp., Kelly decided to shift into medical entrepreneurship.

"It felt like incremental innovations in networking just weren't going to have a big impact," he says.

Instead, he found himself gravitating toward business concepts with more "social benefit"; his first venture in that vein was Myomo Inc., a Boston company that sells a device to help patients recovering from a stroke regain the use of their arms.

Several months before the peptide research was published in the journal Nanomedicine in October 2006, Kelly incorporated the company (originally called Clear Nano Solutions Inc.) and later linked up with Norchi.

Compared with Myomo, which developed a product for a particular subset of stroke sufferers, the peptide gel felt big. Not only might it stop bleeding, but it also seemed to have some potential in patching ruptures that sometimes occur during surgery. "It's disruptive, and there's a large market for it," Kelly says, "but the risk involves the business strategy: What kind of use do you focus on first?"

They decided to develop a product aimed at helping surgeons better control bleeding - a market that is expected to reach $621 million by 2010, according to the market research firm Frost & Sullivan. But the firm notes that surgeons can be skeptical and slow to adopt new products.

Dr. Joseph Madsen, a neurosurgeon, says adoption of Arch Therapeutics' gel, if it can win approval from the Food and Drug Administration, "would depend on surgeons' impression of its efficacy and safety, and whether they thought it was extremely expensive or not."

But Madsen, who practices at Children's Hospital Boston, adds that he keeps an open mind about new products. He says surgeons "take great pride in having a clean, bloodless field." Many of the products they use, however, either take a lot of time to prepare in advance or can't be left inside the patient, unlike the product Arch Therapeutics is developing. Preventing blood loss, Madsen adds, "is a good way to prevent complications of other kinds."

Kelly and Norchi say they haven't been actively chasing venture capital investors, choosing instead to bankroll the start-up themselves until they've gathered more data, which may allow them to hand over a smaller piece of the company to investors.

They're focusing, Norchi says, on "getting the composition of the gel right; it's a matter of tweaking it."

Kelly adds that another key is making sure it can be manufactured at a price that's competitive with other products surgeons use to cope with bleeding.

"So much of the success of this will be a function of the economics and the cost of goods," he says.

Until Arch Therapeutics can show that its gel works in larger animals - and eventually in humans - many investors will regard it skeptically; another nifty science fair project that requires more real-world proof.

"It's an intriguing top-level story - just apply it and it stops bleeding," says medical entrepreneur Amar Sawhney, who has looked at Arch's technology.

"I've been around long enough to know that nothing does that. Bloodless surgery is a good claim to make," Sawhney says, throwing down a verbal gauntlet to the entrepreneurs at Arch to show they can make good on that claim.

Scott Kirsner can be reached at kirsner@pobox.com.