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| Augmenix's SpaceOAR system--Courtesy of Augmenix |
Augmenix is trumpeting results from a study of its prostate cancer spacing device, promising data as the company charges ahead with development for the product after snagging FDA clearance in April.
The Waltham, MA-based company is celebrating positive numbers for SpaceOAR, an injectable gel that moves the rectum away from the prostate during radiotherapy, potentially reducing the risk of injury and long-term effects such as diarrhea, bleeding and pain. In a study with 222 patients, individuals tolerated the spacer well and the extra space cut the average rectal V70 radiation dose from 12.4% to 3.3%, an almost three-quarter reduction compared to the control group.
SpaceOAR was also associated with fewer reports of side effects over the course of treatment and recovery, with a 76% drop in reports of rectal pain during radiation; a 71% reduction in reports of rectal toxicity in the year after radiation; and a 46% drop in reports of individuals with "significant declines" in bowel activity, Augmenix said in a statement. The findings were published electronically in the International Journal of Radiation Oncology•Biology•Physics (Red Journal).
"In the field of prostate radiotherapy, the rectum dose reduction seen in this trial is unprecedented," Dr. Richard Hudes, an oncologist at Chesapeake Urology and a study investigator, said in a statement. "This new ability to safely reduce rectum radiation may enable advanced protocols, like prostate stereotactic body radiation therapy, resulting in significant cost savings, as well as in prostate dose escalation, potentially decreasing cancer recurrence."
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| Augmenix Chairman Amar Sawhney |
The news comes a couple of months after Augmenix scored an FDA OK for SpaceOAR, and almost a year after the company roped in a fresh batch of funding to support product development. Last July, Augmenix roped in $10.8 million in a Series D round to advance its portfolio, including SpaceOAR and TraceIT Hydrogel, an absorbable tissue marker with CT, MRI and ultrasound visibility that helps improve radiation targeting of bladder tumors. TraceIT Hydrogel is already cleared by the FDA and has a CE mark.
But Augmenix could have its work cut out for it as it charges ahead as a solo operation. The company disclosed last year that an option from Varian Medical Systems ($VAR) to acquire the company under a 2011 financing had expired, leaving the company to fend for itself as it looks to generate some upward momentum. But Augmenix Chairman Amar Sawhney is still bullish about the company's prospects, saying at the time that it was "well-resourced to chart an independent path forward."
And the company seems to be on its way to achieving profitability with its recent FDA clearance in tow, Augmenix CEO John Pedersen said in a statement.
"In just two months since receiving FDA clearance, the SpaceOAR System has already been incorporated into several clinical practices across the country," Pedersen said. "We are encouraged by the overwhelming interest from clinicians to receive SpaceOAR hydrogel training and will strive to meet demand and provide support to new customers."
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- get the research abstract