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Financings In Brief

This article was originally published in The Gray Sheet

Executive Summary

Paradigm Spine closes $21.5 million financing: Spinal implant firm will use proceeds from $21.5 million financing to build its U.S. sales team and fund its ongoing U.S. clinical trial of coflex, an interlaminar/interspinous "functionally dynamic" stabilization device currently marketed internationally. The 460-subject, multi-center, randomized IDE trial is comparing stabilization with coflex versus fusion with autograft bone and pedicle screw fixation for patients with lumbar spinal stenosis. The financing, announced July 27, was led by Fifth Third Bank, Praefinium Group and Trevi Health Ventures

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New Products In Brief

Sonablate 500 software addition: US HIFU is outfitting its minimally invasive high-intensity focused ultrasound device with a new Tissue Change Monitoring software component that will allow physicians to monitor prostatic tissue changes in real time, the firm announced. According to US HIFU CEO Stephen Puckett, "from a competitive perspective, TCM levels the playing field with MRI systems because TCM gives immediate feedback on what is happening to the tissue during treatment." The software works by sending a radiofrequency signal to a precise site in the prostate before the physician treats it with ultrasound energy, after which another signal is sent that quantifies the change that took place. The results are color-coded and displayed on the Sonablate 500 screen and overlaid on a sagittal image. Sonablate 500 is currently in clinical trials in the U.S. for the treatment of prostate cancer. US HIFU recently secured $5 million in financing to support the studies (1"The Gray Sheet" Aug. 20, 2009)

New Products In Brief

Sonablate 500 software addition: US HIFU is outfitting its minimally invasive high-intensity focused ultrasound device with a new Tissue Change Monitoring software component that will allow physicians to monitor prostatic tissue changes in real time, the firm announced. According to US HIFU CEO Stephen Puckett, "from a competitive perspective, TCM levels the playing field with MRI systems because TCM gives immediate feedback on what is happening to the tissue during treatment." The software works by sending a radiofrequency signal to a precise site in the prostate before the physician treats it with ultrasound energy, after which another signal is sent that quantifies the change that took place. The results are color-coded and displayed on the Sonablate 500 screen and overlaid on a sagittal image. Sonablate 500 is currently in clinical trials in the U.S. for the treatment of prostate cancer. US HIFU recently secured $5 million in financing to support the studies (1"The Gray Sheet" Aug. 20, 2009)

Research In Brief

CT angiography: Computerized tomographic angiography (CTA) is a safe and effective diagnostic method for ruling out serious cardiovascular disease in patients who come to an emergency department with chest pains, according to the lead author of a long-term study of CTA screening presented May 15 at the Society for Academic Emergency Medicine's annual conference in New Orleans. In the study, led by Judd Hollander, University of Pennsylvania, 481 patients who had no evidence of coronary blockage in a CTA scan were followed for one year. None of the patients had a heart attack or required a coronary revascularization procedure during the follow-up, although 11% were rehospitalized for further cardiac testing. "The ability to rapidly determine that there is nothing seriously wrong allows us to provide reassurance to the patient and to help reduce crowding in the emergency department," Hollander said. According to the Medical Imaging & Technology Alliance, previous research has shown that CTA screening saves $2,500 per patient versus admitting the patient to the hospital for more extensive testing. In a MITA press release, Hollander says: "The evidence now clearly shows that when used in appropriate patients in the emergency department, we can safely and rapidly reduce hospital admission and save money.

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