SBIR-STTR Award

This program addresses the development of practical therapeutic ultrasound systems for non-invasive treatment of diseases that present challenging problems to modern health care. The first goal is the provision of a system for palliation and management of metastatic carcinoma in the liver, to benefit patients that are untreatable with current modalities. A practical therapy system will be designed with complete capabilities, incorporating reliable calibration methods, clinical ease-of-use, 3-D aiming, and lesion monitoring. To achieve these objectives, Spectrasonics will adapt its ultrasonic therapy system, which has received FDA Pre- Market Approval for treating refractory glaucoma. The new unit will also integrate a diagnostic imaging device with advanced spectrum analysis capabilities, also having received 510-K FDA approval for ophthalmic applications. Spectral analysis techniques will be used to estimate sub- resolution tissue-scattered properties (e.g., size), and to detect microstructural changes induced by clinical ultrasonic therapy. Tissue Parameter_ Images will be formed to aid in identifying lesion characteristics. The potential exists for developing a methodology to monitor and control, in real time, the course of the high intensity ultrasound treatment which improves significantly the efficacy of this therapy modality.National Cancer Institute (NCI)

This program addresses the development of practical therapeutic ultrasound systems for non-invasive treatment of diseases that present challenging problems to modern health care. The first goal is the provision of a system for palliation and management of metastatic carcinoma in the liver, to benefit patients that are untreatable with current modalities. A practical therapy system will be designed with complete capabilities, incorporating reliable calibration methods, clinical ease-of-use, ultrasonic imaging for aiming, and lesion monitoring. To achieve these objectives, Spectrasonics will adapt its ultrasonic therapy system, which has received FDA Pre-Market Approval for treating refractory glaucoma. The new unit will also integrate a diagnostic imaging device with advanced spectrum analysis capabilities, also having received 510-K FDA approval for general abdominal applications. Spectral analysis techniques will be used to estimate sub-resolution tissue-scatterer properties (e.g., size), and to detect microstructural changes induced by clinical ultrasonic therapy. Tissue Parameter Images will be formed to aid in identifying lesion characteristics. The potential exists for developing a methodology to monitor and control, in real time, the course of the high intensity ultrasound treatment which improves significantly the efficacy of this therapy modality. PROPOSED COMMERCIAL APPLICATION Spectrasonics will market these systems to clinicians and biochemical researchers who wish to investigate a broad spectrum of therapeutic applications including treatments of cancers of the pancreas, prostate, and breast. Ultimately it is anticipated that this methodology will become an accepted minimally invasive alternative to conventional surgery