TAURANGA, New Zealand--(BUSINESS WIRE)--Augmenix, Inc., a medical technology company that develops, manufactures, and sells proprietary absorbable hydrogels that separate and protect organs at risk during radiotherapy, today announced that the first patient in New Zealand has been treated with SpaceOAR® hydrogel at the Kathleen Kilgour Centre (KKC) in Tauranga. SpaceOAR hydrogel is the first absorbable spacer designed to separate the rectum and prostate to reduce the risk of long-term side effects after radiation treatment.
“Recent clinical data show that SpaceOAR hydrogel helps to significantly reduce the risk of rectal and urinary side effects and loss of sexual function associated with radiation therapy in the treatment of prostate cancer,” said John Pedersen, CEO of Augmenix. “We are pleased that the first patient to be treated with SpaceOAR hydrogel in New Zealand took place at the Kathleen Kilgour Centre, which prides itself on offering high quality, multi-modality radiation therapy treatment options for men with a diagnosis of prostate cancer.”
Unintended injury to surrounding tissue during radiation therapy can lead to bowel, urinary and sexual symptoms that can affect patient health and quality of life (QOL). With SpaceOAR hydrogel, physicians can help reduce this risk by placing a hydrogel barrier to separate the prostate from adjacent healthy tissue. SpaceOAR hydrogel is initially implanted as a liquid that solidifies into a soft hydrogel that pushes the prostate and rectum apart. It remains stable for three months during radiation therapy and then is gradually absorbed and eliminated by the body.
In January 2017, Augmenix announced three-year post-treatment data from a prospective, randomized, multi-center, patient-blinded clinical trial showing that patients treated with SpaceOAR hydrogel prior to prostate cancer radiotherapy demonstrated significant rectal (bowel), urinary, and sexual benefit through three years of follow up1. During radiotherapy, the spacer resulted in a 73.5% reduction in rectal V70 radiation dose and a 49% reduction in median penile bulb radiation dose in patients treated with SpaceOAR hydrogel compared to men who did not receive SpaceOAR hydrogel (Control). Overall patient wellness at three years was assessed by looking at the percent of patients with clinically significant declines in bowel, urinary and sexual QOL domains combined. Three years after radiotherapy, patients that were not treated with SpaceOAR hydrogel were 8 times more likely to experience significant declines in all three QOL areas (p=0.002). Among men who were sexually potent at baseline, the analysis showed that men in the SpaceOAR hydrogel arm were better able to maintain erections sufficient for intercourse through 3 years of follow-up (p=0.03). Of these men, 66.7% were able to achieve erections sufficient for intercourse at three years compared to 37.5% in the Control arm, a 77.8% relative improvement2.
“KKC is dedicated to providing the best care for our patients and the introduction of SpaceOAR hydrogel for men with prostate cancer is yet another step in achieving this,” said Dr. Leanne Tyrie, Genitourinary Radiation Oncologist and Clinical Director at the Kathleen Kilgour Centre. “The significant decrease in bowel, urinary and sexual side effects following radiotherapy when SpaceOAR hydrogel is utilised, made our decision to incorporate it as part of standard of care for prostate cancer patients very easy.”
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 affect patient health and quality of life during radiotherapy, and for years afterward. SpaceOAR hydrogel is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space, SpaceOAR hydrogel reduces the radiation dose delivered to the anterior rectum.
SpaceOAR hydrogel is approved for use in Australia and New Zealand, cleared by the U.S. Food and Drug Administration and is currently being used in the majority of leading cancer centers in the United States. It has a European Union CE mark and is 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 U.S. company based in the Boston, Massachusetts area focused on the development and commercialization of radiation oncology products using its proprietary hydrogel technology. Focusing initially on protection during prostate radiation therapy, Augmenix next-generation products will address spacing and marking applications throughout the body to improve radiotherapy and interventional oncology procedure outcomes. SpaceOAR is a registered trademark of Augmenix, Inc. More information about Augmenix and the SpaceOAR hydrogel can be found at www.Augmenix.com
About the Kathleen Kilgour Centre (KKC)
KKC opened its doors in Tauranga, New Zealand in October 2014 bringing world class radiotherapy treatment, services and support to the people in the Bay of Plenty and beyond. An amazing team of Radiation Therapy specialist clinicians give cancer patients the chance of survival and fulfilling their dreams and aspirations.
KKC sets a new standard in New Zealand with its innovative design, cutting edge technology, and personalised patient care. Treatment is available to public and privately funded patients. For more information, go to www.kathleenkilgourcentre.co.nz
1) Hamstra D, et al. Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial. Int J Radiation Oncol Biol Phys, Vol. 97, No. 5, pp. 976-985, 2017
2) Hamstra D, et al. Evaluation of sexual function on a randomized trial of a prostate rectal spacer. J Clin Oncol 35, 2017 (suppl 6S; abstract 69)