Augmenix Inc., (http://www.spaceoar.com), a medical technology company that develops, manufactures, and sells proprietary biodegradable hydrogels that separate and protect organs at risk during radiotherapy, announced today that with the support of the American Society for Radiation Oncology (ASTRO) and the American Urological Association (AUA), the American Medical Association (AMA) has granted a Category I, Current Procedural Terminology (CPT) code specifically for periprostatic implantation of biodegradable material.
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SpaceOAR separates the prostate and rectum during radiation treatment, reducing rectal injury (Graphic: Business Wire)
The purpose of CPT is to provide a uniform language that accurately describes medical, surgical, and diagnostic services, and thereby serves as an effective means for reliable nationwide communication among physicians and other healthcare providers, patients, and third parties. The new CPT code is expected to become effective on January 1, 2018 at which time the Category III code, 0438T, will be eliminated.
Following the recent presentation of positive 3 year data from the SpaceOAR Pivotal Clinical Trial at the 2016 American Society for Radiation Oncology Annual Meeting in Boston, MA, AMA granted a Category 1 CPT code for periprostatic implantation of biodegradable material. “This is an important reimbursement milestone for providers who offer this new treatment option to prostate cancer patients,” commented John Pedersen, Chief Executive Officer, Augmenix. “The Category I CPT code will facilitate reimbursement with US government payers and commercial health insurance companies to enable wider access to the innovative SpaceOAR technology."
“SpaceOAR is clearly the most elegant and clinically proven technology for reducing rectal toxicity in the treatment of prostate cancer developed in the past 20 years,” said Steven Kurtzman, MD, President - Western Radiation Oncology Inc. San Mateo, CA. “I consider the product an integral part of my treatment protocol for patients receiving both external beam radiation therapy and brachytherapy.”
About SpaceOAR System
The leading side effects of prostate cancer radiotherapy are collectively known as “rectal toxicity” (diarrhea, rectal bleeding, urgency, pain, etc.), which results from unintended radiation injury to the rectum (the Organ At Risk, OAR). These complications can last for years, significantly impacting patient quality of life (QOL).
Using a minimally invasive procedure, SpaceOAR System is injected as a liquid into the space between the prostate and rectum where it expands the space and then solidifies into a soft hydrogel. The hydrogel remains stable for three months while protecting the rectum during radiotherapy, and then liquefies and is completely absorbed by the body after radiotherapy is complete. The SpaceOAR System is FDA Cleared and is currently being used in the majority of leading cancer centers in the United States. It is also CE marked, approved in Australia and licensed in Canada. See the Instructions for Use for complete information on potential risks, warnings and precautions.
About Augmenix, Inc.
Augmenix, Inc. is a privately held company based in the Boston area focused on the development and commercialization of radiation oncology products using its proprietary hydrogel technology. The company was founded by Incept LLC in 2008 and is funded by several leading venture capital groups. More information about Augmenix and the SpaceOAR System can be found at http://www.Augmenix.com.
CPT is a registered trademark of the American Medical Association.
SpaceOAR is a registered trademark of Augmenix, Inc.
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Last updated on: 09/11/2016
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