Axya: A stitch in time

By MARY K. PRATT

Essex County Newspapers

BEVERLY _ A spark of innovation built Axya Medical Inc.

Thomas Egan was working as an engineering consultant back in 1991 when he observed arthroscopic surgery. He saw the doctors trying to knot the sutures through the tiny incision.

"It was just so clumsy. It was such a painful way of doing it," Egan said.

Egan thought there had to be a better way. He drew on his experience with industrial ultrasonic welding and developed the idea of welding, not knotting, sutures together.

That was the start of Axya Medical. Founded in 1996 and based in the Cummings Center in Beverly, Axya is bringing to the medical market technology and devices _ the AxyaStitch and the AxyaWeld _ that eliminate the knots in sutures.

The response as Axya rolls out its innovations has been enthusiastic, according to company officials. For Egan, the success represents almost a decade of work.

"I think there are a lot of people out there who have a good idea. I wrote it down and sent it off to a patent lawyer and got a patent for it," Egan said. He spent $17,000 of his own money on lawyers to get the patent, which was issued in 1995 and lasts for 17 years.

Success didn't come quickly. "I marched it around to a couple of medical-device companies in the area, and they all thought, `That's interesting. Why don't you come back to us when you have a prototype?'" Egan recalled.

Egan said he didn't have the cash or resources to turn his idea into a product; he just wanted to sell the idea. But he haddetermination and kept plugging his idea. That's when he teamed up withinvestors Paul Fenton and George Adaniya. The two initially invested $250,000 to develop a prototype. The National Institutes of Health also gave the new company a $100,000 grant.

Over the past several years, the company also raised money from venture capital sources, including Vector Fund Management, Marquette Venture Partners, Prism Venture Partners, Piper Jaffray Ventures, Delphi Ventures, and Johnson and Johnson Development Corporation.

Financing, though, wasn't the only stumbling block. Some in the medical-device community initially dismissed Egan's idea as having been tried before without success.

"That was our big fear," Fenton said. But a researcher familiar with the past effort reviewed Axya's program in 1996 and confirmed that the company's technology was different and successful.

"That was a tremendous load of our minds, when he gave us his endorsement," Egan said.

The company is billing its AxyaWeld as "the new standard in soft tissue fixation." Axya products can be used with both absorbable and nonabsorbable sutures, depending on a doctor's preference.

Doctors use the small probe-like instrument, the AxyaWeld, to create a suture loop, called AxyaLoop. The suture is ultrasonically welded, which eliminates knot-tying by the surgeon. It has a minimal profile and, according to one study, "no capacity for slippage."

The ultrasonic welding only takes a fraction of a second. "It's an improvement over the current technique," Fenton said. "There are no side effects, no drawbacks. It's relatively safe."

Axya launched its first product in summer 2000, Fenton said. Doctors could use the AxyaWeld on the market late last year for soft tissue repair in open and laparoscopic general surgical and urological procedures.

Axya then moved forward with its AxyaWeld J-Tip, a 4.5mm instrument designed for arthroscopic procedures. Fenton explained that it can work in saline, which will allow doctors to use the instrument in minimally invasive surgery where knotting sutures is particularly challenging. ("It has been described that it's like trying to tie your shoelaces with salad tongs while looking in a mirror," Fenton said.)

Studies done using AxyaWeld have found that the technology and Axya's products live up to their billings. One study published in 1999 said: "It has great potential for soft tissue repair, particularly tendon and ligament repairs."

The study continued: "The technology is easy to use, safe for all tissues, and can be used in open surgery, endoscopic surgery, or arthroscopic surgery." Axya is now working with distributors and is direct-marketing the products, Fenton said. He said he expects that there will be "a rapid adoption" of the new technology among surgeons.

"Doctors are pretty excited about it," said Allan Weinstein, Axya's vice president of sales and marketing. Vince Novak, director of marketing, explained that many doctors would prefer doing surgery through a minimally invasive scope, but the single barrier preventing that is the difficulty in knotting sutures.

"They view our technology as making it an easier transition," he added. Doctors seem very enthusiastic about the new technique, Egan said. When they see demonstrations, "They say, `That's it. There's no knot? The surgeons see the advantage. . It's really consumer driven."

After spending its early years developing AxyaWeld, the company is looking ahead. What's next? "Coming up with more, better and diverse products," Egan said. "The demand is there." Axya received two patents in June 2000 from the U.S. Patent Office; one patent covers a sutureless fixation device and the second covers a sutureless cardiac heart valve.

It has also developed a Bone Anchor System and Kit. Designed to be used with the AxyaWeld instrument, it "utilizes suture material and bone anchors to secure soft tissue structures in surgical procedures where bone anchors are indicated," according to the company.

Fenton said there are about a dozen products in the works. "They're all different, but they all use AxyaWeld technology." As the company developed its new products, it has had to expand considerably: It had 16 employees in early 1999, but had 50 at the end of 2000.

Fenton said the company plans to stay in Beverly as it continues its expansion. As he discussed Axya's future, Egan reflected on the work that has turned the one idea he had back in 1991 into a company. "Having a good idea isn't unique. A lot of people have a good idea and don't get around to doing anything about it," he said.

"People need to take themselves seriously. The trick is to follow through."