Preparing for Sonablate’s U.S. market entry
As Carol describes it, “The Sonablate is a transrectal focused ultrasound system. It uses ultrasound to image, treat and assess the treatment all at the same time. We use a focal spot type of treatment where we scan across the target volume and perform real time treatment planning and real time imaging.”
SonaCare’s soon-to-be-submitted Premarket Approval (PMA) application for the Sonablate 450 system is based on data from a multi-center pivotal clinical trial in which the Sonablate treated 100 patients whose prostate cancer returned after radiation therapy
Sonablate 500 system fast facts:
The PMA will seek FDA approval to market the Sonablate for use in performing salvage therapy for recurrent prostate cancer. “This is a huge step for this new technology along a regulatory pathway that has been anticipated for quite some time,” says Mark Schoenberg, MD, chief medical officer for SonaCare and professor of urology at Johns Hopkins University School of Medicine.
“Patients who have undergone radiation therapy for prostate cancer are limited in their ability to get re-radiated, and surgery on these patients is very, very difficult,” Carol notes. “The opportunity to offer a therapy for these patients that has a relatively high success rate in terms of control of disease over the short period, at least, I think is very important.”
The Sonablate 500 system received CE marking in the European Union in 2001 and is used in more than 30 countries outside the U.S. for treatment of primary and focal prostate cancer. More than 100 systems have been installed worldwide and have treated 12,000 patients, including Americans who have sought out the noninvasive therapy at several offshore facilities staffed by U.S. doctors.
The retooled system features an updated mobile console, a redesigned software platform and an upgraded unit for water degassing, circulation and cooling. It comes with two high frequency robotic transrectal probes, each equipped with a dedicated imaging transducer (6.3 MHz) and dual split beam treatment transducers (4.0 MHz.).
Big expectations for the Sonatherm
“We are very bullish on Sonatherm’s potential to find
SonaCare has big expectations for its Sonatherm Laparoscopic Soft Tissue HIFU Probe. “We’ve looked at this technology anew and decided to reinvigorate it,” Carol says. “The device uses ultrasound to image and treat, which is a unique aspect of all of our technology, and we will be incorporating optical imaging into the system. It uses a laparoscopic probe that is designed to be inserted into or up against the tumor that one wants to treat in an invasive fashion and then to treat all the way back to the surface of the probe.”
Sonatherm technology is undergoing redesign to allow it to be deployed in a 12 mm diameter packet that can be inserted through ports used in robotic surgery. SonaCare believes the system could be used to treat kidney, liver and bladder tumors using probes of various sizes. Carol says the redesigned system will undergo preclinical ing during early 2013, and clinical studies could begin later in the year.
A bladder cancer specialist, Schoenberg is enthusiastic about the possibility of having Sonatherm treatments available to his patients. “I spend a lot of my time thinking about how to take care of people that have malignancy of the urinary bladder and planning and executing surgery for those individuals,” he says. “Bladder cancer is a disease which for years has been treated by focally treating the cancer but trying to preserve the bladder for obvious reasons. We have no technology currently that permits us to see inside the tumor that is being treated. So, endoscopic surgery of bladder cancer, to some extent, requires both finesse and a certain amount of guesswork.”
Sonatherm technology on an endoscopic platform could give bladder surgeons added control in real time. “This would be a real advance in taking care of patients,” Schoenberg says. “I’m very hopeful that we can move this into both animal models and, hopefully, clinical trials in humans in the near future for bladder cancer patients.”
Several aspects of Sonatherm technology could ensure its commercial success:
It will be easy to use by the doctors who are caring for the patients who need treatment. “A key benefit of the Sonatherm is that you can put in the hands of the urologist to specifically target urologic organs as opposed to having to involve the radiologist or the interventional radiologist,” Carol says.
Ultrasound-guided focused ultrasound technology is less expensive than MRI-based options. It’s smaller and can be installed in doctors’ offices or in ambulatory surgery centers. Consequently, it could be accessible to a much wider range of patients and physicians.
Because the Sonatherm received regulatory approval as a 510(k) device, the treatments it performs will be covered by insurance. As Carol explains, “This is something that hasn’t happened with HIFU yet, because the technologies cleared to date were approved under the PMA process, and there’s no reimbursement for them.”
Impact on the field of focused ultrasound
Carol believes that successful introduction and commercialization of the Sonatherm could have a favorable impact on the entire field of focused ultrasound. “It will get HIFU out into the public awareness in a way that allows doctors to use it in a cleared fashion and in a reimbursed fashion. We are very bullish on Sonablate’s potential to find a place in the clinical armamentarium of surgeons. This will hopefully lead to greater awareness and receptivity to the use of all forms of HIFU.”
Written by Ellen C., McKenna