SonaCare Medical snagged an FDA OK for its prostate ablation ultrasound device, broadening its international footprint months after ramping up sales for the device in Europe.
The company's Sonablate 450 uses high intensity focused ultrasound (HIFU) in a minimally invasive procedure to destroy prostate tissue without harming surrounding healthy tissue. The device includes a probe with dual transducers that move robotically through the body according to doctors' ablation plans.
SonaCare got its FDA blessing for Sonablate 450 through the agency's de novo clearance pathway, which is reserved for low- to moderate-risk devices that don't have a market equivalent. The Charlotte, NC-based company plans to kick off distribution this month for its product, it said in a statement.
"The FDA regulatory authorization to market Sonablate in the U.S. is a milestone for non-invasive prostate care and a tremendous gain for men's health," SonaCare CEO Mark Carol said in a statement. "Our company is appreciative of the collaborative efforts made on the part of the FDA to bring this technology to the U.S."
In addition to its Sonablate device, which is already approved for use in 49 countries, the company also has an FDA-cleared laparoscopic ablation system, Sonatherm, which allows surgeons to target specific areas while sparing surrounding tissues.
In May 2015, the company dialed up sales for Sonablate in Europe by lending its HIFU equipment to University College London. The move built on SonaCare's previous international efforts, as earlier this year the company sold two of its systems in Mexico, one in Switzerland and another to a urology center in Moscow.
"While Europe has always been a strong market for our technology we have recently been experiencing a surge in volume," SonaCare's VP of international operations Alex Gonzalez said at the time. "Hospitals can now draw on the benefits of HIFU across multiple surgical disciplines, which also leads to an even better return on their investment."
SonaCare is not the only one making waves in the prostate ablation market. In July, startup ProCept BioRobotics roped in $42 million for a pivotal trial of its water-based prostate ablation device.
In August, HistoSonics reeled in $2 million for its image-guided tissue ablation technology, adding to $1.5 million in debt raised in December and $14 million in equity collected between 2009 and May 2014. The Michigan-based company's Vortx Rx System delivers focused ultrasound therapy through a device that is placed on top of the skin, eliminating soft tissue in a targeted area.
- read SonaCare's statement