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Seno making strides with cancer-detection technology
May 7, 2014

Leaders of Seno Medical Instruments — Medical Director Dr. A. Thomas Stavros (left), CEO and Founder Janet Campbell-Clark and President Tom Miller — show the company's Imagio optoacoustic imaging system, designed to diagnose breast cancer. (Photo: Kin Man Hui / San Antonio Express-News)

By Patrick Danner, San Antonio Express-News

SAN ANTONIO - Executives of San Antonio's Seno Medical Instruments Inc. have spent nearly nine years working on a novel way to improve the process of detecting breast cancer.

It's been a long grind, but Seno recently has made some significant strides that are getting it closer to achieving its goal of commercializing a technology called optoacoustics imaging. It combines lasers and ultrasound to diagnose breast cancer.

"The last time a new technology was developed in this field was 20 years ago," said Seno CEO and founder Janet Campbell-Clark. "So this is big."

Last month, Seno's Imagio optoacoustic imaging system received regulatory approval to be sold in Europe. The company is evaluating when it will enter the European market.

In the United States, a clinical study of Imagio launched last fall to offer - if everything goes according to plan - evidence that could lead to Food and Drug Administration approval. About 1,500 of the 2,000 targeted participants have been enrolled. The study is expected to be completed in 2016.

Seno recently raised more than $35 million in a private securities offering that will, in part, support the study. The pivotal study is underway at 16 imaging centers and hospitals around the country - including the Cancer Therapy & Research Center at the University of Texas Health Science Center.

It was the third round of funding for Seno, which has raised in total almost $70 million from 140 investors. The company employs 62 people.

About 1.7 million women undergo surgical and core needle breast biopsies each year in the U.S. But they are expensive and painful, and more than 80 percent reveal noncancerous tumors.

During a biopsy, a needle is inserted in the breast and a tissue sample is taken. Patients often have to wait three or four days to learn whether the suspicious mass is cancerous, said Dr. Stephen Grobmyer, director of surgical oncology at the Cleveland Clinic. It is one of the locations participating in the clinical trials of Imagio.

"Every woman who goes through that process is faced with all kinds of anxiety and fear," Grobmyer said.

If Imagio's technology is validated in the study, it could assist physicians in determining whether to recommend biopsies.

That could mean a significant reduction in the number of biopsies, as well as a decrease in the number of negative biopsies, said Campbell-Clark, the SENO CEO.

"We would save billions to the health care system," she added. Not to mention a lot of angst for patients.

"There are a lot of reasons to be excited about the (Imagio) technology," Grobmyer said. "We're encouraged by the preliminary results."

Campbell-Clark was inspired to launch Seno after the death of her mother from lung cancer.

Campbell-Clark, who has worked her entire career in the medical-device field, traveled the country in 2005 to acquire a technology that she said would "make a difference."

The optoacoustic technology Seno acquired was developed by Dr. Alexander Oraevsky, a Russian-born researcher based in Houston. He received more than $15 million in grants from the National Institutes of Health, the Defense Department and other sponsors for research into optoacoustics. He is a Seno director.

The Imagio looks like a piece of heavy office equipment, complete with a keyboard, touchpad and computer screen - along with a handheld probe. The system weighs about 750 pounds but is portable.

"We call her the Fat Girl," Campbell-Clark said. "We'd like to get her down to 600" pounds so it's easier to maneuver around. Still, she said she can push it while in high heels.

The Imagio provides a unique blood map in and around suspicious breast masses. But unlike other imaging methods, patients aren't exposed to potentially harmful radiation or injections of contrast agents.

Just how much Imagio would cost hasn't been determined. But Campbell-Clark said will it fall between $500,000 and $1.5 million.

Imagio is considered a platform technology, meaning it potentially could be used to detect other types of cancer, such as thyroid and lymph nodes, said Dr. A. Thomas Stavros, Seno's medical director.

"The potential uses are myriad," he said.

Seno's lead investor is MedCare Investment Funds, a private investment company based in Nashville, Tenn., that focuses on innovative services and technologies in the health care field.

"The possibility that this is much more than just a breast-imaging technology is one of the reasons that the management team and the investors are optimistic about the future of (Seno)," said Dr. Harry R. Jacobson, who is chairman of both MedCare and Seno.

MedCare was started by Dr. James R. Leininger, who also founded San Antonio wound-care company Kinetic Concepts Inc. in 1976. KCI is regarded as San Antonio's most successful home-grown company in the health care field.

 

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