Augmenix touted data today from a Phase III trial evaluating its SpaceOar hydrogel in men undergoing prostate radiotherapy. The study showed that the company’s device, placed between the prostate and rectum, helps men maintain sexual function and potency following radiation therapy. Data from the trial demonstrated that the SpaceOar device reduced the median radiation dose […]
Augmenix Inc. said today that long-term outcomes data from the company’s phase III clinical trial evaluating its hydrogel spacer, SpaceOAR, was published in the International Journal of Radiation Oncology Biology and Physics. The spacer is designed to separate the rectum and prostate during prostate cancer radiotherapy, according to the Waltham, Mass.-based company. The newly published […]
Augmenix said today it won a category 1 current procedural terminology reimbursement code from the American Medical Association for periprostatic implantation of biodegradable material, covering its flagship SpaceOAR device. The SpaceOar is designed to separate the prostate from the rectal wall during radiation treatment for prostate cancer, Augmenix said. The device is delivered through a small needle […]
Augmenix said today it raised $6 million in a Series E round of funding to support the development of next-gen products and support the company’s SpaceOAR system. The SpaceOar is designed to separate the prostate from the rectal wall during radiation treatment for prostate cancer, Augmenix said. The device is delivered through a small needle as a liquid, […]
Augmenix said last week that a pivotal study of its SpaceOar system was published online in the International Journal of Radiation Oncology•Biology•Physics. The 222-patient pivotal study was designed to evaluate safety and efficacy of the SpaceOar System in men undergoing prostate radiotherapy, the company said. The SpaceOar is designed to separate the prostate from the rectal wall during radiation […]
April 3, 2015 by Mark Hollmer
FDA clearance in hand, Augmenix is formulating U.S. commercial sales and insurance reimbursement plans for a medical gel designed to help protect the rectum during prostate cancer radiotherapy, CEP John Pedersen told MassDevice.com today.
Augmenix said it won CE Mark approval in Europe for its TraceIT fiducial marker and TraceIT gel system radiology marking agents.
Massachusetts-based Augmenix is hoping it can make it to the U.S. market with the $10.8 million funding round it just closed, the company said this month.