Galil Medical Receives FDA Clearance For Its Cryotherapy CryoHit(TM) Device For The Treatment Of Breast Fibroadenoma

YOKNEAM, Israel, November 29 /PRNewswire-FirstCall/ -- Galil Medical announced today that its CryoHit product family received FDA clearance for the treatment of breast fibroadenoma. Fibroadenoma is palpable, non cancerous breast lumps. It is the most common benign tumor of the breast and the most common breast tumor in women less than 40 years of age, affecting millions of women worldwide. These tumors are usually removed by surgical excision under local anesthesia in an operating theater. With Galil's minimally invasive cryotherapy, the procedure can be performed at the clinic or outpatient bases resulting in short recovery and superb cosmetic results.

(Logo: http://www.newscom.com/cgi-bin/prnh/20051129/193984 )

Galil's state-of-the-art high-resolution minimal invasive cryotherapy technology involves the application of sub-zero temperatures to freeze and ablate benign and malignant tumors, resulting in necrosis of the target cells. Galil's system utilizes several types of disposable 17-gauge CryoNeedles, capable of creating diverse sizes and shapes of ice-ball allowing the physician to match the ice ball to the shape of the tumor.

The CryoHit product family has FDA clearance since 1998 for wide range of cancerous and benign conditions including general surgery, thoracic surgery, gynecology, oncology, and urology applications. Galil's cryotherapy technology has been widely used worldwide for the treatment of prostate, kidney cancer and liver cancer.

During the cryo procedure, single or multiple 1.47 mm needles are directly inserted to the tumor under ultrasound guidance and accurately placed in the center of the tumor. Thermal sensors may be used for temperature monitoring. Guided by ultrasound, the doctor freezes the tumor while visualizing the ice ball coverage to ensures accurate and complete ablation without damaging adjacent tissue. The procedure typically takes less than half an hour and the patient released home immediately after the procedure. No incision or stitches are required.

"Galil Medical's cryotherapy technology offers real minimally invasive treatment to many women worldwide, who until now may have undergone open surgery to remove benign lumps from their breast." Said Mr. Yaron Tal, Galil Medical's President & CEO. "We view the FDA clearance to this application as an important milestone in Galil's commitment to provide innovative minimally invasive cryo treatments for women".

Galil Medical Ltd. designs and develops minimally invasive cryotherapy technology for various clinical applications. Galil's technology involves freezing and thereby ablating diseased tissue in a technique commonly referred to as cryotherapy. Galil's technology offers an alternative treatment to open surgery for a wide range of cancerous and benign conditions including prostate and renal cancer, liver cancer, breast benign & malignant tumors, uterine fibroids, cardiac arrhythmia, pain management, etc'.

Galil was founded in 1997 by Rafael Development Corporation Ltd (RDC) and Elron electronic industries Ltd . Galil holds 25% of Oncura, a market leader of minimally invasive treatments for urology applications (www.oncura.com).

Its headquarter, R&D and manufacturing facilities are based in Yokneam, Israel. www.galilmedical.com Contact information: Livnat Ben-Zur, VP Business Development, Email: Livnat@galil-medical.co.il, Phone: +972-4-9591080

CONTACT: Contact information: Livnat Ben-Zur, VP Business Development,Email: Livnat@galil-medical.co.il, Phone: +972-4-9591080