Friday, November 14, 2008

AugmentRx eyes Europe for launch of injectable tissue filler

By Marc Songini

A regional biotech startup sees Europe as a strategic starting point to revolutionize the bioceramics industry and launch a product line that officials say could be worth hundreds of million of dollars annually.

The company is AugmentRx Medical Inc., based in Shelburne, Vt., and it’s ready to roll, said CEO Stuart Smyth. The company however, needs funding to bring its first product, called Solve, to Europe. Solve is an injectable, non-migratory tissue-bulking material that helps treat urinary and fecal incontinence. After the Solve release, Smyth intends to use the underlying proprietary technology to “revolutionize” the bioceramics industry worldwide.

“It has properties and characteristics that are absolutely unique and useful for such things as hard or soft tissue regeneration or restoration,” Smyth about the technology.

To get Solve to market, Smyth is looking to secure Series A funding of $4 million for the first tranche to cover the animal testing phase and establish manufacturing operations in Europe. He believes it will take perhaps 16 months to start selling to the European market and making “small revenues.” On the other hand, it could take four years to get U.S. Food and Drug Administration (FDA) approval. In August, the company was looking for $3.5 million to start animal testing, but at that time wasn’t discussing its plans for Europe.

In total, Smyth is hoping for $8.5 million in Series A funds, and has several potential investors, Smyth said. “Even though it’s a bad time, I’m still optimistic,” he said.

In the long run, Smyth wants to see a widespread penetration of the AugmentRx platform, which will be licensed through Boston-based medReign Technologies LLC. The bioceramics products prevalent today typically use open-pore spongy cell particles that are brittle and can’t withstand great weight loads. The AugmentRX platform, at its core, uses bioceramic materials such as alumina and zirconia that have been turned into micro-porous spheres with fully interconnected pores, said Smyth. This technology can withstand greater loads and exhibits superior compressive strength than the classic bioceramics, Smyth said. Because the technology is 85 percent porous, human tissue grows into it.

Smyth anticipates that between orthopedics, dentistry, and other applications, the next-generation bioceramics market could be worth more than $350 million a year to his company. In Japan, which shuns inserting animal- and human-based products into the body, this synthetic alternative will be particularly desirable. “Japan will freak out. They’ll love it,” he said.

The potential for AugmentRx’s bioceramics technology is “enormous,” said James Yoo, associate professor for the Wake Forest Institute for Regenerative Medicine, based in Winston-Salem, N.C.

Yoo is also a management consultant with AugmentRx. Doctors can use the AugmentRx product to treat a variety of conditions, and they can easily inject it via a needle without needing repeat treatments, stated Yoo, in an e-mail. Overall, because bioceramics are inert and remain in place long-term in a patient’s body, he anticipates ever wider medical applications for them.
The Solve technology is compelling compared with “today’s legacy generation of inferior human tissue bulking agents,” said David Bradbury, president for the Vermont Center for Emerging Technologies Inc. (VCET). The Burlington-based VCET is a regional incubator whose clients include AugmentRx.

Smyth also founded and headed the Williston, Vt.-based female surgical contraceptive device maker Avalon Medical Corp. In 2003, CooperSurgical Inc. of Trumbull, Conn., purchased the firm.