Augmenix, a medical technology company that develops, manufactures, and sells proprietary absorbable hydrogels that separate and protect organs at risk during radiotherapy and interventional procedures, announced that the first patients have been treated with SpaceOAR hydrogel at the Chaim Sheba Medical Center in Tel Hashomer, Israel. SpaceOAR hydrogel is an absorbable prostate-rectum spacer that reduces rectal injury during prostate radiotherapy.
“We are excited to offer our patients this new, innovative technology to significantly reduce risks of prostate cancer radiotherapy,” said Zvi Symon, from the Chaim Sheba Medical Center. “SpaceOAR hydrogel will provide meaningful long-term benefits, improving overall quality of life for our patients.”
“We are extremely pleased to bring our innovative SpaceOAR hydrogel to physicians and patients in Israel,” commented John Pedersen, CEO of Augmenix. “Our growing body of clinical evidence demonstrates that SpaceOAR hydrogel significantly reduces the risk of rectal and urinary toxicities and loss of sexual function associated with prostate cancer radiotherapy. SpaceOAR hydrogel is making a significant difference in the lives of men around the world.”
Radiation therapy in the treatment of prostate cancer can cause unintended injury to adjacent healthy tissue, which can lead to bowel, urinary and sexual symptoms that can affect patient health and quality of life. With SpaceOAR hydrogel, physicians can place a hydrogel barrier to separate the prostate from surrounding healthy tissue.
In January 2017, Augmenix announced three-year post-treatment data from a prospective, randomised, multi-centre, patient-blinded clinical trial showing that patients treated with SpaceOAR hydrogel technology prior to prostate cancer radiotherapy demonstrated significant rectal (bowel), urinary, and sexual benefit through three years of follow up. Overall patient wellness at three years was assessed by looking at the percent of patients with clinically significant declines in all three quality of life (QOL) domains (bowel, urinary and sexual). Fully 20% (1 in 5 patients) of men in the control arm had clinically significant declines in all three QOL areas compared to only 2.5% (1 in 40 patients) of men in the SpaceOAR hydrogel arm (p=0.002). Among men who were potent at baseline, the analysis showed that SpaceOAR hydrogel treated men were better able to maintain erections sufficient for intercourse through three years of follow-up (p=0.03). Of the men treated with SpaceOAR hydrogel, 66.7% could achieve erections sufficient for intercourse at three years compared to 37.5% in the control arm, a 77.8% improvement.