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Proxima Therapeutics Files for 510(k) Clearance for MammoSite(R) Radiation Therapy System, Accelerated Treatment for Breast Cancer (PR Newswire)...inserted in the cavity created by surgical removal of the breast tumor.......deliver radiation directly to the tissue surrounding the cavity, where tumors are most likely to recur.......to develop site-specific cancer treatment systems for breast and brain tumors....- Jun 07 8:02 AM ET


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Posted on: 06/07/2001

"Yahoo - Proxima Therapeutics Files for 510(k) Clearance for MammoSite(R) Radiation Therapy System, Accelerated Treatment for Breast Cancer"
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Thursday June 7, 8:02 am Eastern Time

Press Release

SOURCE: Proxima Therapeutics, Inc.

Proxima Therapeutics Files for 510(k) Clearance for MammoSite(R) Radiation Therapy System, Accelerated Treatment for Breast Cancer

ALPHARETTA, Ga., June 7 /PRNewswire/ -- Proxima Therapeutics, Inc., a developer and marketer of site-specific cancer treatments, today announced that it has filed with the United States Food and Drug Administration (FDA) for 510(k) clearance to market its MammoSite RTS internal radiation for accelerated breast cancer treatment.

Proxima submitted data from its recently concluded study to prove safety and performance of the device. The MammoSite RTS is a balloon catheter that is inserted in the cavity created by surgical removal of the breast tumor. The device is designed to deliver radiation directly to the tissue surrounding the cavity, where tumors are most likely to recur. Radiation therapy takes just five days with MammoSite, compared to six or seven weeks with traditional external beam radiation therapy, and avoids the potential side effects of external beam radiation, such as irradiating healthy tissue.

"Accelerated radiation therapy is a significant advance in the treatment of breast cancer, and MammoSite provides an alternative to other methods that are very complicated for doctors and intimidating to the patient," said Robert Kuske M.D., principal investigator of the study and professor of radiation oncology at University of Wisconsin Medical Center. "The rate at which patients entered the study has exceeded our expectations, and we hope that the convenience and simplicity of MammoSite will enable more women with early- stage breast cancer to choose a lumpectomy over losing their breasts with a mastectomy."

The clinical study was conducted at leading cancer centers throughout the country, including Ochsner Clinic in New Orleans, William Beaumont Hospital in Detroit, University of Southern California Medical Center in Los Angeles, Medical College of Virginia in Richmond, Arizona Oncology in Phoenix, Medical College of Wisconsin in Milwaukee, Mount Sinai Hospital in Miami Beach, Texas Cancer Center-Sherman, and Paris Regional Cancer Center in Texas. The study will continue until MammoSite receives FDA clearance, so the treatment is currently available at the participating medical institutions to patients meeting the requirements of the study.

"We look forward to offering breast cancer patients in this country a convenient option for accelerated radiation therapy," said Timothy Patrick, president and CEO of Proxima Therapeutics. "We are very encouraged by the results of the clinical trial and believe that MammoSite will become a preferred method for treating early-stage breast cancer."

About Proxima Therapeutics

Based in Alpharetta, Ga., Proxima Therapeutics, Inc. is a privately held medical device company established in 1995 to develop site-specific cancer treatment systems for breast and brain tumors. In addition to MammoSite, Proxima has developed the GliaSite® RTS, a site-specific radiation treatment for brain tumors that was recently cleared for marketing by the FDA. Proxima's technology may have additional applications for other solid tumors. Additional information is available on the company's web site at www.proximatherapeutics.com .

SOURCE: Proxima Therapeutics, Inc.

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