News | April 01, 2014

Frost & Sullivan Recognizes Sensus for Development of Low-Energy Radiotherapy Systems for Skin Cancer

Products have demonstrated safety, clinical efficacy and potential for widespread adoption to treat dermatological and oncological conditions, says analyst

April 1, 2014 — Based on its recent analysis of the non-melanoma skin cancer therapy market, Frost & Sullivan recognized Sensus Healthcare LLC with the 2014 North American Frost & Sullivan Award for New Product Innovation Leadership. Sensus uses a technique known as superficial radiation therapy (SRT) in its two low-energy X-ray devices, SRT-100 and SRT-100 Vision.

Competing products use electron beams ranging from 1 to 12 mega electron volts (MeV), or decaying isotope-based emitting sources. Patients are typically subjected to radiation levels many times the energy required for non-melanoma skin cancer treatment, with only a part of the energy being delivered to the surface of the skin. The SRT-100 and SRT-100 Vision use kilovoltage X-rays in the 50 to 100 kilo volts (KV) energy range. The radiation is delivered completely to the surface of the skin, without affecting the underlying healthy tissue and cells. SRT is ideal for irradiating tumorous growths at depths of between 0.5 mm and 5 mm.

The systems are small footprint and portable devices, similar in size and design to an ultrasound instrument. The SRT-100 Vision integrates high-resolution ultrasound imaging and laser positioning capabilities to help with the accurate localization, characterization and topology of lesions. This, in turn, will ensure optimal energy dosage, treatment fractionation and depth of beam penetration.

"SRT-100 and SRT-100 Vision utilize a noninvasive approach that does not leave scars and therefore eliminates the need for additional follow-up procedures, such as skin grafting and cosmetic reconstructive surgeries," said Frost & Sullivan Research Analyst Bhargav Rajan. "There is no loss of skin and/or sensation, and since it is a non-contact procedure, it is painless. The entire procedure lasts only seconds for each treatment fraction, compared to surgeries and other procedures, which take hours and additional recovery time."

A retrospective assessment of more than 1,700 patients who were treated for basal cell carcinomas (BCC) and squamous cell carcinomas (SCC) using SRT-100 showed a 98 percent cure rate over two years, and a more than 95 percent cure rate over five years. These remarkable cure rates are comparable with those obtained using current clinical standards.

"SRT-100 has come to be considered medically necessary and/or an adjunctive procedure for the treatment of non-melanoma skin cancers and non-oncological skin conditions such as keloids," said Rajan. "Due to its record for safety, efficacy and low risks, it is covered by most insurance companies and Medicare for oncological and non-oncological procedures."

The U.S. Food and Drug Administration (FDA) recently granted 510(k) clearance to the SRT-100 for treating keloids (collagen-based non-malignant scars). With this regulatory approval, SRT-100 and SRT-100 Vision can now be used to treat non-oncological conditions (keloids) and pre-oncological conditions such as actinic keratosis.

For more information: www.frost.com

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