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What's Next for Cardiovascular Systems?

This article was originally published in Start Up

Executive Summary

Cardiovascular Systems beat out 119 other suitors for the right to purchase publicly traded biopharma company, Replidyne, which had fallen on hard clinical times, or, more precisely, to acquire the company's place on the public markets. But now what? With CVS headed toward the public market, it will be interesting to see how the company is valued by public investors after its merger is complete. This month, we survey small cap medical device companies that are in similar situations to see how they're faring on the public markets.

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Peripheral Vascular Disease Grows at Double-Digit Rates, Waits for Solutions

New technologies are wanted for peripheral artery disease, which affects 12 to 14 million people in the US, two to three million of them serious enough to warrant intervention, according to "US Markets for Interventional Peripheral Vascular Disease Management Products and Technologies," a report recently issued by Windhover-Elsevier. In addition to peripheral arterial disease, approximately eight million people in the US suffer from chronic venous insufficiency, of whom more than three million develop venous ulcers. Aortic aneurysms affect another two million people in the US, and the prevalence is increasing due to the increasing number of the elderly. But one of the largest serious problems in peripheral vascular disease that has few solutions is deep vein thrombosis (DVT). In the US approximately 25 million suffer from this condition and two million more are diagnosed each year. DVT brings the danger of pulmonary embolism and death. These and other categories in peripheral vascular disease are forecast to grow by double-digit rates, including mechanical atherectomy systems, chronic total occlusion crossing systems, and endovascular cryotherapy systems.

The Top Device Stories of 2008

As 2008 draws to a close, In Vivo takes stock of the major events affecting the medical device industry in 2008. Two stories continue to unfold; how the new Obama administration will control national health spending, and the financial crisis that hit the US and global economies. The latter is already taking its toll on medtech. Financial markets crashed, and so did public device companies. M&A dwindled as the year went on, with some notable--and surprising--exceptions, and the downturn is driving VCs to invest either extremely early or late. In other stories: the Department of Justice continued probing into physician conflict of interest matters, this time focusing on the influential Cardiovascular Research Foundation. Also from Washington, the 510(k) process is under review, and 2009 may see changes that make the process of demonstrating safety and effectiveness more costly for device companies. CMS instituted payment reforms affecting hospitals, although this may be good news for medtech companies offering products to help curb hospital-acquired infections and medical errors. The news was good in diabetes--for devices, not pharmaceuticals--with positive outcomes from a major trial on continuous glucose monitoring and two new markets opening up in diabetes for device manufacturers. The regulatory agency delivered some positive news to companies in cardiac rhythm management and neurostimulation too. And second generation drug-eluting stents found a market more receptive than it was a year ago.

The Top Device Stories of 2008

As 2008 draws to a close, In Vivo takes stock of the major events affecting the medical device industry in 2008. Two stories continue to unfold; how the new Obama administration will control national health spending, and the financial crisis that hit the US and global economies. The latter is already taking its toll on medtech. Financial markets crashed, and so did public device companies. M&A dwindled as the year went on, with some notable--and surprising--exceptions, and the downturn is driving VCs to invest either extremely early or late. In other stories: the Department of Justice continued probing into physician conflict of interest matters, this time focusing on the influential Cardiovascular Research Foundation. Also from Washington, the 510(k) process is under review, and 2009 may see changes that make the process of demonstrating safety and effectiveness more costly for device companies. CMS instituted payment reforms affecting hospitals, although this may be good news for medtech companies offering products to help curb hospital-acquired infections and medical errors. The news was good in diabetes--for devices, not pharmaceuticals--with positive outcomes from a major trial on continuous glucose monitoring and two new markets opening up in diabetes for device manufacturers. The regulatory agency delivered some positive news to companies in cardiac rhythm management and neurostimulation too. And second generation drug-eluting stents found a market more receptive than it was a year ago.

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