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, CEO John Pedersen told MassDevice.com today.

“We are rolling the technology out in a responsible way, focusing on physician training,” Pedersen said in a telephone interview. “Our goal is to train 20 to 30 centers this year in using the technology.”

The Waltham, Mass.-based company this week won de novo clearance from the FDA for its SpaceOar System, which is designed to separate the prostate from the rectal wall during radiation treatment for prostate cancer. SpaceOar is delivered through a small needle as a liquid,d then solidifies into a soft gel that expands the space between the prostate and rectum during radiotherapy. The substance then liquefies and is absorbed and cleared from the body in the patient’s urine, according to Augmenix.

Pedersen told us that obtaining reimbursement for SpaceOar could take about 2 years, noting that the company is going for a Category I CPT code because SpaceOar does not appear to fit under existing reimbursement codes options. In the interim, a reimbursement-consulting firm has advised Augmenix that while it won’t have a national coverage policy, it can rely on miscellaneous codes on a case-by-case basis. Discussions with the Centers for Medicare & Medicaid Services and private payers are ongoing, he said.

Typically, the patient population for prostate cancer is older men, with 70% falling under Medicare and the rest covered by private insurance, Pedersen said.

The SpaceOar System, which won CE Mark approval in the European Union in July 2010, is commercially available in Europe and Australia. Augmenix raised a $10.8 million Series D round last July to help support the final stages of its bid for FDA approval.

Pedersen, who joined Augmenix last December, said he brought on a sales and marketing team that is trained and “ready to go.” More than 20 people work for the company domestically; distributors are used to sell SpaceOar abroad. Founder Amar Sawhney remains as chairman (a serial entrepreneur, Sawhney is also president & CEO of Ocular Therapeutix (NSDQ:OCUL), a company he co-founded that also uses hydrogel technology).

Pedersen said that he views SpaceOar as “game-changing” because it offers a new way to treat prostate cancer with radiation without “dosing the rectum and creating unacceptable levels of rectal toxicity.”

Prostate cancer patients face limited choices, he explained: Surgery, which can cause erectile dysfunction and urinary side effects; or radiation therapy, which can leave patients with issues ranging from rectal bleeding to bowel inflammation and more.

Researchers tested the SpaceOar System in a prospective, randomized clinical trial involving 222 patients at 20 U.S. sites.* They generated a 99% success rate for gel placement, creating an average 0.5 inches of space between the prostate and rectum. Patients experienced a 74% reduction in rectal V70 radiation exposure, according to the company. This, in turn, left subjects with 76% less rectal pain during radiation treatment and 71% less rectal toxicity 15 months after treatment. Crucially, there was also a 46% reduction in patients reporting a negative impact on their bowel/quality of life 1 year after radiation treatment.

Augmenix is also developing uses for the hydrogel spacing concept in treating other cancers, Pedersen said.

*Correction, April 3, 2015: Due to a reporter’s error, this article originally mis-stated the risk and number of patients in the Augmenix clinical trial. Return to the corrected sentence.