A Medical Device Daily

InSightec (Tirat Carmel) reported receiving FDA approval for software that the company said "significantly speeds up" the treatment time of its ExAblate 2000 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) system.

The FDA also approved the ExAblate 2000 to be used with a 3.0 Tesla MRI scanner, in addition to the 1.5 Tesla version.

InSightec also reported that Canada's healthcare regulatory body, Health Canada, has granted regulatory approval to the ExAblate 2000 system for the treatment of symptomatic uterine fibroids.

The MRgFUS technology combines MRI — to visualize tissues in the body, plan the treatment and monitor in real time treatment outcome — and high-intensity focused ultrasound to thermally ablate uterine fibroid tissue.

"The system allows the incisionless ExAblate procedure to be performed more efficiently than the conventional method and permits more sonications during the same treatment window," said George Holland, MD, director of MRI at the Lahey Clinic (Burlington, Massachusetts) in an abstract presented at last year's meeting of the International Society for Magnetic Resonance in Medicine (Berkeley, California). "Using this technique, women with fibroids can be treated faster and women with larger fibroids may now be eligible for the outpatient procedure. The more of the fibroid that a physician can treat, the greater the symptom relief."

The new software version uses an "interleaved" mode of treatment whereby the system targets different parts of the fibroid, allowing the recently ablated tissue area to cool while the focus moves onto other areas of the fibroid. This reduces the cooling time required.

Another new feature allows physicians to leverage the beam steering in phased array transducer to maximize the energy in the focal point, allowing significantly more volume to be treated for the same amount of energy applied.

The Lahey Clinic, the University of California at San Diego, Weill Cornell Medical Center (New York) and KNI Imaging (Kalamazoo, Michigan) participated in a 40-patient study to evaluate the new version of the system.

The new version was previously available in Europe and Asia.

"The use of the ExAblate system with a 3 Tesla MRI allows physicians the freedom to use ExAblate with either a 1.5 Tesla or 3 Tesla MRI scanner, allowing busy MRI centers greater flexibility in scheduling use of their systems and allowing women greater access to this non-invasive procedure to destroy their symptomatic uterine fibroids," said William Bradley Jr., MD, PhD, chairman of the University of California at San Diego's Department of Radiology and a professor of radiology at UCSD School of Medicine.

Of the Canadian approval, Jacob Vortman, PhD, president/CEO of InsightTech, said, "This approval expands access to this revolutionary incisionless surgery technology and offers Canadian women an alternative to hysterectomy and other invasive surgeries to treat this condition. Instead of lengthy hospitalizations and weeks of recovery time, the outpatient ExAblate procedure allows women to return home after treatment and get back to normal activities with their families and jobs within two days."

The company said that, to date, more than 2,500 women have been treated with the ExAblate worldwide.

Doctors from the Mount Sinai Hospital and University Health Network Joint Department of Medical Imaging (Toronto) are conducting clinical studies on uterine fibroids, pain palliation of patients suffering from advanced bone metastases and breast tumors using the ExAblate 2000.

InSightec is a subsidiary of Elbit Medical Imagining (Tel Aviv).

2nd accord for Compugen, Biosite

Compugen (Tel Aviv, Israel) reported signing a second agreement with Biosite (San Diego) for the development and commercialization of immunoassay diagnostic products.

Since the companies inked an initial agreement in June 2005, Biosite has been licensed to develop and commercialize immunoassay-based diagnostic products using novel biomarkers discovered by Compugen (Medical Device Daily, June 21, 2005).

Now, in addition to expanding the number of potential diagnostic biomarkers available for selection, Biosite has access to Compugen's increasing inventory of immunoassay biomarkers. The collaboration is expanded to cover cardiovascular, oncology and additional diagnostic areas, the company said.

Compugen will continue to receive milestone payments and royalties from the sale of any products emerging from the collaboration.

BioLine in drug-delivery agreements

BioLineRx (Jerusalem) said it has signed worldwide exclusive license agreements with PolyGene and Efrat BioPolymers for the development and commercialization of their polymer drug delivery system.

BioLineRx will continue the development of the system for delivering chemotherapy to solid tumors, designated BL-4010, and for delivering antibiotics to bone and other infections, designated BL-4011. The company said it plans to submit the project for funding by the Israeli Office of the Chief Scientist through BioLine Innovations Jerusalem under a National Biotech Grant received in November 2004.

"We are looking forward to developing this novel platform for the improved delivery of anti-cancer and anti-infective agents," said CEO Morris Laster, MD.

BL-4010 and BL-4011 are based on a biodegradable polymer, developed by Professor Abraham Domb of the faculty of medicine at Hebrew University of Jerusalem, who is the founder and chief scientist of PolyGene and Efrat BioPolymers. The polymer allows the administration of therapeutic agents to the site of the disease while avoiding systemic side effects.

Unlike currently available drug delivery polymers, the polymer is not water-soluble, therefore allowing slow release of the drug from the polymer at a constant rate at the site of injection.

Sialo Tech IPO raises NIS 32.5M

Israeli start-up Sialo Tech has raised NIS 32.5 million in its IPO held on the Tel Aviv Stock Exchange.

The offering of stocks, warrants and enforced convertible bonds, was held at the minimum price and was slightly oversubscribed by 1.03%, although 80% of the securities were sold in the institutional tender, which was oversubscribed fourfold.

Sialo develops devices for the treatment of temporomandibular joint (TMJ) syndrome and stones in the salivary glands.

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