Boston Scientific (NYSE:BSX) announced that published results from an analysis of its SpaceOAR hydrogel spacer revealed safe prostate-rectum separation. Marlborough, Mass.-based Boston Scientific has developed the SpaceOAR since its $600 million acquisition of Augmenix in September 2018. The absorbable polyethylene glycol hydrogel spacer won CE Mark approval in the European Union in 2010 and 510(k) clearance from the […]
Boston Scientific puts up $600m for Augmenix
Boston Scientific (NYSE:BSX) said yesterday that it put $600 million on the table for Augmenix and its SpaceOar device. The deal for Bedford, Mass.-based Augmenix calls for $500 million in up-front cash and another $100 million pegged to sales-based milestones, Boston said. The SpaceOar hydrogel device, which won CE Mark approval in the European Union in 2010 […]
Augmenix wins Japanese reimbursement for SpaceOar hydrogel
Augmenix said yesterday that its SpaceOar hydrogel won national reimbursement in Japan from the Ministry of Health, Labour & Welfare. The Belford, Mass.-based company’s SpaceOar hydrogel is designed to separate the prostate from the rectal wall during radiation treatment for prostate cancer. The product is delivered through a small needle as a liquid, which then solidifies […]
Augmenix touts AMA code, CMS reimbursement for SpaceOar
Augmenix said today that the American Medical Association established a Current Procedural Terminology code for its SpaceOar hydrogel and similar devices, with the Centers for Medicare and Medicaid Services setting a payment rate for procedures with the injectable. The Bedford, Mass.-based company said that the AMA established CPT code 55874 for the periprostatic implantation of biodegradable […]
Augmenix touts more SpaceOar data
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 touts long-term data for hydrogel spacer in prostate cancer patients
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 scores reimbursement code for SpaceOar
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 raises $6m in Series E round
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 touts publication of pivotal SpaceOar study
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 […]
On-X Life Technologies wins expanded labeling indication from FDA | Regulatory news for the week of April 6, 2015
Augmenix wins FDA nod for SpaceOar prostate treatment
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.
