Four Firms Apply For Medicare New-Tech Add-On Payments
This article was originally published in The Gray Sheet
Executive Summary
Four manufacturers are seeking new-technology payments for their devices in the fiscal year 2009 inpatient payment rule, despite industry's frustration with CMS' process for granting the add-on payments
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Financings In Brief
TherOx raises $30 million: Privately held developer of the DownStream SuperSaturated Oxygen Therapy system for adjunctive treatment of acute myocardial infarction raises $30 million from DAG Ventures and other investors. A PMA application for the device is pending. Downstream is designed to reduce infarct size and preserve heart muscle after a severe heart attack by super oxygenating a patient's blood for direct re-infusion to oxygen deficient tissue after a patient has already been treated with balloon angioplasty and a stent. Based in Irvine, Calif., the firm reported results last October from its pivotal, 300-patient AMIHOT II trial, including a statistically significant 6.5% reduction in infarct size using the device. Other potential applications for the technology include ischemic stroke, cancer and wound healing, according to the company (1"The Gray Sheet" Dec. 3, 2007, p. 15)
Financings In Brief
TherOx raises $30 million: Privately held developer of the DownStream SuperSaturated Oxygen Therapy system for adjunctive treatment of acute myocardial infarction raises $30 million from DAG Ventures and other investors. A PMA application for the device is pending. Downstream is designed to reduce infarct size and preserve heart muscle after a severe heart attack by super oxygenating a patient's blood for direct re-infusion to oxygen deficient tissue after a patient has already been treated with balloon angioplasty and a stent. Based in Irvine, Calif., the firm reported results last October from its pivotal, 300-patient AMIHOT II trial, including a statistically significant 6.5% reduction in infarct size using the device. Other potential applications for the technology include ischemic stroke, cancer and wound healing, according to the company (1"The Gray Sheet" Dec. 3, 2007, p. 15)
Four New-Tech Bonus Payment Applicants Plead Their Case To CMS
SynCardia Systems says its CardioWest artificial heart qualifies for CMS bonus payments for new, innovative technologies even though the device was FDA-approved in 2004, highlighting a gray area in CMS' process for granting such payments