Firm gets FDA approval for system to aid implant radiation therapy
SAVOY — Over the last 25 years, Everette "Clif" Burdette has shepherded several medical devices to market, many of them focused on treating cancer.
His current company, Acoustic MedSystems of Savoy, recently got 510(k) clearance from the U.S. Food and Drug Administration for the RadVision system.
That system is a software-based product that aids in the administration of implant radiation therapy.
That kind of therapy is used to treat prostate and breast cancers and, to a limited degree, head and neck cancers.
In the minimally invasive treatment, doctors implant low-dose radioactive "seeds" — radioactive sources that look like small grains — in targeted areas to kill cancer cells. The seeds eventually decay.
The system can also be used in conjunction with high-dose radiation treatments of localized cancers.
RadVision helps in planning the dosages and providing image-guided delivery of the therapy.
What makes it different from other systems on the market, Burdette said, is it provides real-time feedback on the true dosage, as well as the true location of the implanted seeds.
Using RadVision, medical professionals can "re-optimize" the treatment during the procedure, if needed, he said.
RadVision has been used in test settings at several research institutions, and it will be used on patients at two clinical sites for the first time later this month. The two sites are the Johns Hopkins Hospital in Baltimore and Brigham and Women's Hospital in Boston.
Both locations were test settings for RadVision, as was Queen's University in Kingston, Ontario.
Burdette said he expects RadVision to be used in 10 to 20 centers before the company moves to a broader marketing strategy for the device.
At some point, the system is likely to be marketed by Acoustic MedSystems in one of three ways:
— Through partnership with a much larger company;
— Working through a distributor; or
— Direct sales by Acoustic MedSystems.
No price has been set yet for RadVision, but Burdette said depending on the configuration, it could range from the mid-$10,000s to the $100,000 range.
Burdette said the concept for RadVision dates back many years, but work on the product started about six years ago stemming from a grant from the National Institutes of Health.
Acoustic MedSystems is also working on technologies that Burdette says could have broader use than RadVision.
One is TheraVision, a thermal therapy system for which Acoustic MedSystems is preparing to seek FDA approval. The company describes it as "ablation system instrumentation," with ablation referring to the removal of cancerous tissue, sometimes by using intense heat.
Work on TheraVision stemmed from research done at the University of California, San Francisco, by Professor Chris Diederich, chief scientific advisor of Acoustic MedSystems. The device itself has come to fruition only in the last three or four years, Burdette said.
The company has also developed an array of Acoustx ultrasound therapy probes, catheters and needles that can be used in conjunction with TheraVision.
According to the company, 22 patents have been issued and 23 patents are pending covering the TheraVision and Acoustx technologies.
The Acoustic MedSystems name has been around since 1997, but it wasn't activated as a full-fledged company until 2004, Burdette said.
The firm was located at 206 N. Randolph St., C, until 2011, when it moved to the former Board of Certified Safety Professionals building at 208 Burwash Ave. in Savoy.
Today Acoustic MedSystems has 11 full-time employees as well as four full-time contractors. It also has subcontracts and support people at several universities and research institutions.
Burdette's history in the medical device field predates Acoustic MedSystems. He initially came to Champaign-Urbana in 1984 to help start Labthermics Technologies, which used spin-off technology from the University of Illinois.
That company developed ultrasound thermal therapy devices that are still in use today. In 1993, Burdette went to work for Dornier Medical Systems for four years and continued to be based locally.
In 1998, he founded Burdette Medical Systems, which developed a treatment planning and guidance system for prostate seed implants. That company was purchased by St. Louis-based Computerized Medical Systems four years later.
Burdette, who received a doctoral degree in medical physiology from Emory University in Atlanta, had joint appointments at Emory and Georgia Tech before coming to Champaign-Urbana.
Cancer treatment was of great professional and personal interest to him because friends and family members had been touched by the disease.
During one 18-month period, cancer afflicted 14 family members, friends and associates, including a long-term employee, Burdette said.
"I felt like I had been run over by a large roller machine," he said.
During nearly three decades of developing medical devices, Burdette said he learned it's a field that requires dedication and mastery of many different areas, including user ergonomics, biocompatibility, design of analog and digital electronics and an understanding of regulatory agencies.
He said he learned from his Labthermics years not to underestimate a company's capital needs.
"I did better with Burdette Medical Systems and much better with Acoustic MedSystems," he said.
Acoustic MedSystems, which does a lot of contract and grant work, is largely self-funded, Burdette said. The company has not had to borrow or depend on institutional investments, he added.
The company is also doing development work in women's health for a much larger company. That work could lead to manufacturing, possibly resulting in the hiring of five to 15 people, depending on volume, he said.
Business: Develops medical devices, including ultrasound and radiation systems for treatment of localized cancers.
Location: 208 Burwash Ave., Savoy
Staff: 11 full-time employees, plus four full-time contractors
Founder, president and CEO: Everette "Clif" Burdette
History: Active since 2004, though the name dates farther back.
Products: RadVision, a system for image-guided treatment of localized cancer that recently received clearance from the Food and Drug Administration; also in the product pipeline are two other technologies, TheraVision and Acoustx.