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The GentleBeam is a low energy x-ray system, with imaging capability, intended for superficial radiotherapy treatments of primary malignant epithelial neoplasms of the skin and keloids. Applications include: (a) basal cell carcinoma; (b) squamous cell carcinoma; (c) Metatypic carcinoma; (d) cutaneous appendage carcinoma (e) Kaposi's Sarcoma; and (f) the treatment of keloids. Keloids are benign fibrous growths that arise from proliferation of dermal tissue typically arising from injuries to skin tissue.

The imaging capability, employed in a non-diagnostic mode, is used to assist the physician in the selection of the correct treatment area. The imaging component is a laser induced ultrasound scanning system used to visualize the layers of skin, including blood vessels, and to make approximate measurements of dimensions in layers of skin and blood vessels, by detecting laser pulse generated ultrasound waves.

The GentleBeam Radiation Therapy System is a mobile low-energy superficial radiotherapy device for treating skin cancer lesions and keloids. The X-ray source, delivers radiation emission in the low energy therapy ranges of 50kV, 70kV and 100 kV (a total of 3 energies) and is held in place by a manually guided robotic arm. The X-ray source uses single target collimators with a fixed SSD. The robotic arm is manually operated by the user and contains no automated functions, its sole purpose is to support the x-ray head and hold it steady so operator can deliver treatment to the patient. It does not move unless hand guided by the operator to position it. The imaging head produces an ultrasound image, generated using laser induced ultrasound (LIUS, branded as Photosonic) imaging technology for acquisition of internal structures of the skin.

The GentleBeam System includes the following major components:

• Preparation Console – Located on the base of the system to enter patient information, perform simulation and imaging.
• Treatment Console – Located outside the room to control radiation delivery.
• Robotic Arm – Holds the treatment head. Buttons on the robotic arm allows operator to position the arm precisely at the treatment site using hand-guided mode. No automated motions happen on the arm. All movement is through manual user movement.
• Treatment Head – Contains the x-ray source and collimated applicator for precise delivery of radiation treatment using a single focal spot. No multiple focal spots are on the applicators.
• Imaging Head – Ultrasound imaging unit for lesion depth measurement.
• Red Diode Positioning Laser - System uses a laser‐pointing apparatus to assist the operator for a visual guide for positioning purposes of the x-ray source, located on the treatment head.
• Collimators/Applicators - Collimators (also called applicators) are used to collimate the X-ray beam output. The layout of each collimator consists of a single field and flattening filter, which is always used for treatment. The system contains the following applicators:
  • 50kV, 5cm SSD, 1.5cm/2cm/3cm/4cm/5cm diameter – single target
  • 70kV, 5cm SSD, 1.5cm/2cm/3cm/4cm/5cm diameter – single target
  • 100kV, 5cm SSD, 1.5cm/2cm/3cm/4cm/5cm diameter – single target
  • QC Applicator for daily quality assurance checks.

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