An Israeli company's biodegradable 'balloon' radically reduces the negative side effects of radiation in cancer treatment.
By Desmond Bentley
The main drawback of radiation therapy for cancer patients is that it harms healthy tissues surrounding a malignant tumor under radiation bombardment.
Now the Israeli company BioProtect has come up with a unique biodegradable "balloon" that physically separates cancerous and healthy tissues during radiation therapy for prostate cancer.
BioProtect's CEO, Amir Shiner, says the company's trademarked ProSpace represents a breakthrough in its field. "We're bringing a new product to the market," he says. "There's a clear clinical need for this product in view of the support by numerous publications for escalating radiation doses to prostate cancer patients undergoing radiation therapy. It makes the therapy far more effective."
In a multi-center, international study involving 26 prostate cancer patients, ProSpace was shown to significantly reduce the radiation reaching the rectal wall and consequent associated complications. It therefore allows for radiation at high doses without ill effects, meaning more efficient treatments with fewer treatment sessions at lower cost.
How does it work?
Made from biodegradable polymers, which have a proven safety record, the ProSpace device is filled with saline and implanted using the minimally invasive, well-established technique of transperineal insertion commonly used at outpatient centers.
The balloon remains inflated throughout the radiation therapy treatment. It then dissolves and reabsorbs into the body within three to six months, eliminating the need for removal. Patients involved in the trial reported that they felt no discomfort or pain from the implanted balloon, aside from mild and temporary discomfort at the access area at the perineum.
Because radiation therapy is a well-established, effective and widely accepted form of treatment for many types of cancer, it is expected that the BioProtect device can be used to implement safer and more effective radiation therapies for a variety of cancers.
"There's a strong need to have such a protection device," says Shiner, noting that BioProtect is not alone in this market. "There is one company that provides a gel product that is injected for the same need. Competition is always good - the feedback we've received from physicians is that they far prefer our product. It has a clear advantage in that it is reproducible. Due to its reproducible shape and size, and well-defined boundaries under a CT scan, it helps the doctor to administer the treatment effectively."
In October 2010, ProSpace received the CE Mark, ensuring that it conforms to European regulatory requirements. BioProtect is now establishing a marketing network in Europe. "In April we started in Italy, and have now signed distribution agreements in five European countries," reports Shiner. "We're in the middle of a soft-launch process in those countries, and are negotiating to expand further in Europe, where we already have initial sales."
Last July, the ProSpace device received Israeli Health Ministry approval for marketing. In January, the company will launch a study utilizing its balloon for an innovative radiation therapy protocol at several medical centers in Israel.
In the United States, the company has already carried out a pilot study for the Food and Drug Administration and is now discussing with the FDA further clinical requirements to obtain clearance, says Shiner.
"We're a small company, based in Kfar Saba. Our R&D team and manufacturing are on site, while we are strongly focused on clinical activities, marketing and sales," he adds.
The company has already raised funds from three groups of investors: Xenia Venture Capital, which operates the technological incubator in Kiryat Gat where the company began as a startup; Virginia Life Science Investments, which invests in several Israeli healthcare companies; and the JumpStart NJ Angel Network. "We also have other private investors," notes Shiner. "Currently, we're working on more significant fundraising to take us to the next stage."