Published 1/12/18 in the Daily Record

The GammaPod uses stereotactic radiation to treat breast cancer. It was invented at the University of Maryland School of Medicine. (Submitted photo)

The GammaPod uses stereotactic radiation to treat breast cancer. It was invented at the University of Maryland School of Medicine. (Submitted photo)

A Maryland company can now begin marketing its device, which could change the way breast cancer is treated, after it received government clearance last month.

The Food and Drug Administration granted clearance last month to the GammaPod, a device that could cut the number of radiation sessions breast cancer patients need and possibly even eliminate the need for surgery.

“We want people to know that the Gamma POd is here to help women with early-stage breast cancer,” said Dr. Elizabeth M. Nichols, the principal investigator of a feasibility and safety study submitted by the the University of Maryland School of Medicine as part of the FDA clearance process. “We think this is really the most promising advancement in oncology breast cancer care in the last couple of decades.”

The GammaPod was developed by doctors at the University of Maryland Medical Center and has been commercialized by Xcision Medical Systems, based in Columbia.

Most breast cancer treatments include surgery to remove the cancer from the breast followed by chemotherapy and radiation. That radiation often takes place over a period of six-to-seven weeks as patients receive moderate doses.

The GammaPod uses stereotactic radiation instead to deliver higher doses of radiation to a more specific area. It could reduce radiation therapy to as little as one visit. Doctors believe the doses could be high enough and targeted enough to eliminate the need for surgery.

It is one thing researchers plan to investigate as the pursue further clinical trials this spring.

Stereotactic radiation has been used in the treatment of cancers of the lung, liver and brain. In lung cancer, the therapy currently rivals surgery as a treatment option, Nichols said.

But breast cancer has presented challenges because the breast is composed of soft tissue that tends to move when the patient breathes, especially in a typical treatment setting where a patient is lying on her back with her arms behind her head.

With the GammaPod, a patient lies on her stomach and her breast is placed in an immobilization device made up of a plastic dome. A vacuum-like suction is used to hold the the breast inside the dome.

Because of the clearance from the FDA, Xcision can begin to market the device commercially, said Steve Rubenstein, the company’s vice president of marketing.

“For us, we’re focused on ramping up our sales process and adding another sales person,” he said.

GammaPod will be working with research partners including the University of Maryland Medical Center, University of Texas Southwestern Medical Center in Dallas and Allegheny General Hospital in Pittsburgh.

The clearance marks an important step in the commercialization process for a company that took more than a decade to get to this point.

“The Gamma Pod’s success is the culmination of the extraordinary efforts and innovation taking place within the University of Maryland Medicine,” said Dr. E. Albert Reece, dean of the University of Maryland School of Medicine. “The Gamma Pod illustrates the school’s entrepreneurial spirit and our goal to bring new technologies and new treatments from the research laboratory into clinical practice.”

The device could have an impact on the total cost of breast cancer treatment by reducing the number of radiation treatments necessary, Nichols and Rubenstein said.

“From a financial perspective, if you take a look at hospitals and health care in the industry in general, there’s this greater push to move towards value-based care,” Rubenstein. “For Xcision, we think the GammaPod lines up very well with the goals of value-based care.”

But the impact could also be felt beyond traditional health care costs.

When a patient has to go into treatment every day for six or seven weeks, they also have to take time off work or line up child care. These type of costs can be a phantom toll of treatment.

If the GammaPod can treat women in just one session, it would be a significant improvement in convenience and cost of care, Nichols said.