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Augmenix Inc. announced the three-year results from the SpaceOAR System Prostate Cancer US Pivotal Clinical Trial in September at the 2016 annual meeting of the American Society for Radiation Oncology (ASTRO).
April 1, 2016 — Augmenix Inc. announced the publication of the SpaceOAR System U.S. Clinical Trial results of the ...
Florida Cancer Affiliates (FCA) is helping to pioneer a new tool aimed to protect prostate cancer patients from the negative effects of radiation therapy.
Augmenix Inc. showcased the SpaceOAR System at the 57th annual American Society of Therapeutic Radiology and Oncology meeting, highlighting robust commercial uptake in the United States. An absorbable hydrogel, SpaceOAR technology is designed to create space and protect the rectum in men undergoing prostate cancer radiotherapy. The device received clearance from the U.S. Food and Drug Administration (FDA) in April 2015 and since then, more than 40 cancer treatment centers in 19 states have adopted it.
Augmenix Inc. announced the publication of the 222-patient pivotal study designed to evaluate safety and efficacy of the SpaceOAR System in men undergoing prostate radiotherapy. By creating space between the prostate and rectum, the SpaceOAR System is intended to reduce the radiation dose delivered to the rectum during prostate radiotherapy. The favorable results from the multi-center, randomized, single-blind study led to the April 1, 2015, U.S. Food and Drug Administration (FDA) clearance of the SpaceOAR System.
Provision Center for Proton Therapy is helping pioneer a new product that will help further protect prostate cancer patients from the effects of radiation therapy. Four patients were injected with SpaceOAR hydrogel, the first product in the United States cleared just last week as a spacer to protect the rectum in men undergoing radiation therapy for prostate cancer. The SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, creating space to protect the rectum from radiation exposure. Provision is the first proton therapy center and the second radiation treatment center nationwide to adopt the product.
Augmenix Inc. announced U.S. Food and Drug Administration (FDA) clearance of the SpaceOAR System, cleared as a spacer to protect the rectum in men undergoing prostate cancer (PCa) radiotherapy. Despite many advancements in PCa radiotherapy, the close prostate-rectum proximity makes it challenging to deliver adequate radiation to the prostate without injuring the rectum (defined as the Organ At Risk - OAR). The SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for PCa.