Augmenix, Inc. Announces Aetna’s Positive Coverage Decision for the SpaceOAR® Hydrogel Procedure for Men with Prostate Cancer

BEDFORD, Mass.--()--Augmenix, Inc. is pleased to announce that Aetna, Inc, the third largest commercial health plan provider in the United States, published an update to their Clinical Policy Bulletin 0926 which states that Aetna considers transperineal periprostatic placement of biodegradable material (SpaceOAR hydrogel) medically necessary for reducing rectal toxicity in men undergoing radiotherapy for prostate cancer. The full policy can be found at http://aet.na/2nZn2Kg.

“This positive coverage decision for SpaceOAR hydrogel is a major milestone for Augmenix and prostate cancer patients”

Aetna is a leading diversified health care benefits company, serving over 23 million medical members. Aetna’s mission is to build a healthier world by helping people realize their best health.

“This positive coverage decision for SpaceOAR hydrogel is a major milestone for Augmenix and prostate cancer patients,” said John Pedersen, CEO and President of Augmenix. “Patients covered by Aetna who are suffering from prostate cancer and seeking a treatment option that maintains their long-term quality of life will now have greater access to the SpaceOAR hydrogel procedure. We look forward to additional private insurers initiating reimbursement in the coming months.”

About SpaceOAR Hydrogel
Radiation therapy in the treatment of prostate cancer can cause unintended radiation injury to adjacent healthy tissue (Organs At Risk). This injury can lead to a range of bowel, urinary, and sexual symptoms that can negatively affect patient health and quality of life during radiotherapy, and for years afterwards.

In recent years, radiation oncologists have considered use of “spacing” techniques to reduce the risk of radiation injury to surrounding tissue during radiotherapy. SpaceOAR hydrogel reduces the radiation dose delivered to the anterior rectum and reduces the risk of injury.1 Injected as a liquid into the space between the prostate and rectum, SpaceOAR hydrogel pushes the structures apart and then solidifies into a soft hydrogel, which maintains space for approximately three months during radiation therapy then liquefies and is completely absorbed by the body.

SpaceOAR Hydrogel, is cleared by the U.S. Food and Drug Administration (FDA) and is currently being used in many leading cancer centers throughout the United States. It has also received CE Mark approval in Europe, is approved in Australia and Japan, and is licensed in Canada. To date, over 20,000 patients worldwide have benefited from the SpaceOAR hydrogel procedure.

See the Instructions for Use for complete information on potential risks, warnings, and precautions. For more information, visit SpaceOAR.com.

About Augmenix, Inc.
Augmenix, Inc. is a privately held company based in the Boston area and focuses on the development and commercialization of radiation oncology products using its proprietary hydrogel technology. Focusing initially on protection during prostate radiation therapy, their next-generation products will address spacing and marking applications throughout the body to improve radiotherapy and interventional oncology procedure outcomes. SpaceOAR hydrogel is a registered trademark of Augmenix, Inc. More information about Augmenix and the SpaceOAR hydrogel can be found at http://www.SpaceOAR.com.

1. Hamstra D, et al. Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys; 2017 Volume 97, Issue 5, Pages 976–985.

Contacts

Augmenix, Inc.
April Renzella, 781-902-1621
ARenzella@Augmenix.com

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Release Summary

Augmenix, Inc. announces Aetna’s positive coverage decision for the SpaceOAR® Hydrogel procedure for men with prostate cancer.

Augmenix, Inc.