Our FEP-BY serial HIFU therapy system is an ultrasound-guided ablation system that is used for the non-invasive treatment of malignant and benign solid tumors. Our system is designed to destroy tumors by using HIFU waves to instantly raise the temperature of the targeted tumor tissue to between 60°C and 70°C (140°F and 158°F). Our HIFU therapy system was approved by the State Food and Drug Administration (the "SFDA") of the People’s Republic of China ("PRC") in 1999 to treat liver, breast and kidney tumors, solid tumors in the pelvic cavity or on bone, and tumors in the four limbs or superficial tissues. To date, over 40,000 tumor patients have received treatment using our HIFU therapy system in the PRC. Treatment using our system is performed without anesthesia and does not cause significant discomfort, skin-burn or hemorrhage.

In July 2007, the U.S. Food and Drug Administration (the "U.S. FDA") granted us conditional approval for our Investigational Device Exemption ("IDE") application on our HIFU therapy system. We plan to begin a clinical trial at the University of Washington in 2008 on patients with pancreatic cancer. In October 2007, we received official approval from the Korean Food and Drug Administration (the "KFDA") to market our HIFU therapy system in Korea for the treatment of liver cancer, pancreatic cancer and uterine fibroids.

Main Features

HIFU Brochure

• Non-invasive procedure
  Treatment performed with our HIFU therapy system does not require incisions or transfusions, thus minimizing the risk and complications associated with invasive procedures.
• Minimal side effects
  The large aperture of the transducer produces less intense ultrasound waves at the point of skin penetration, significantly reducing the likelihood of skin burns and collateral damage to healthy body tissue.
• High degree of safety
  Treatment can be performed without anesthesia and does not cause significant discomfort, skin-burn or hemorrhage.
• Treatment for broad range of tumors
  Our patented two-transducer system enables our HIFU therapy system to target a wide range of tumors including liver, breast and kidney tumors, solid tumors in the pelvic cavity or on bone, and tumors in the four limbs or superficial tissues.

	Video: FEP-BY HIFU Therapy System

System Composition

Integrated transducers Our HIFU therapy system is equipped with two transducers, which enable the patient to be treated in the supine, side or seated positions. Each transducer consists of HIFU transmitting sources and drive circuits that enable the transducer to move in six directions on the X, Y and Z axis with millimeter precision. Each transducer has a concave spherical surface with a 37cm aperture. Only one transducer is used at a time.

	Ultrasound emitter The high intensity ultrasound is produced with a 251 element sparse array high power ultrasound emitter. The HIFU transmitting sources generate high frequency ultrasound waves, which converge from a wide angle to focus on a designated focal point inside the body. The transmitting surface of the array is coated with silica gel.

	Ultrasound imaging system The ultrasound imaging system is an ultrasonic system that creates a computer image of the tumor that guides the physician in monitoring and targeting the ultrasound waves. The probe that captures the image of the tumor can monitor the patient from many angles and can be controlled automatically by a computer or manually by the physician.

Patient treatment table and seat The table and seat frames are adjustable and can be rotated to facilitate treatment of tumors located in different parts of the body. The middle section of the patient treatment table can be removed to install a treatment seat so that the patient can sit while undergoing treatment for tumors in the pelvic cavity. The patient’s position depends on the location of the tumor.

Control station The control station consists of our proprietary software program, a computer, a monitor and peripheral equipment. The control station allows the operator to select automatic or manual treatment, as well as the duration of each ultrasound emission and other treatment parameters. If the operator inputs an unsafe ultrasound shot duration or treatment parameter, a built-in safety mechanism causes the HIFU therapy system to terminate its operation immediately.

Conduct structure Ultrasound energy does not transmit in a straight line through air. Our HIFU therapy system contains a conduct structure to introduce linear ultrasound waves into a patient’s body. An airtight silicon film fitted over the face of the HIFU transducer is filled with degassed water to provide an acoustic path between the HIFU transducer and the patient. Ultrasound gel is used on the surface of the silicon film for coupling with the patient.

	Water treatment system The water treatment system is a stand-alone system used for degassing and heating the ultrasound-patient coupling water.

	Power supply cabinet The power supply cabinet houses the circuitry for driving the ultrasound, ultrasound drive power box and isolation transformer. It also provides power to all components of the HIFU system.

Technical Specifications

• Operating frequency: 1.1MHz±15%
• Focal dimensions: ≤ 3mmx3mmx10mm
• Acoustic focal intensity: ≥ 1,000W/cm²
• Maximum electrical power: 2,000W
• Transducers: Upper and lower transducers
• Convergence method: Multi-element array and concave self-focusing
• Convergence angle: 80°
• Maximum probe movement: 100mm
• Transmission method: Pulse
• Pretreatment preparation: No anesthesia needed

Technical Data of Transducers and Treatment Bed

Upper Transducer

• Up and down movement: 280mm
• Left and right inclination: ±18°
• Front and back inclination: ±5°

Lower Transducer

• Up and down movement: 150mm
• Left and right inclination: ±5°
• Front and back inclination: ±5°

Treatment Bed

• Size: 1,980mm x 700mm
• Vertical movement: 120mm
• Horizontal movement: 120mm
• Front and back inclination: ±5°

top