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Medical Device Manufacturers Take Technologies Abroad, Design for International Markets First Before Commercializing Devices in U.S.

67 WALL STREET, New York - August 2, 2013 - The Wall Street Transcript has just published its Medical Devices Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs and Equity Analysts. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

Topics covered: Orthopedics and Cardiovascular Medical Devices - Medical Device Innovation and Consolidation Trends - Cardiac - Health Care - Affordable Care Act - Continued Pricing Pressure - Aging U.S. Population

Companies include: DexCom, Inc. (DXCM), Endologix Inc. (ELGX), STAAR Surgical Company (STAA), Nxstage Medical, Inc. (NXTM) and many more.

In the following excerpt from the Medical Devices Report, an expert analyst discusses the outlook for the sector for investors:

TWST: What is going on in the medical device space from a business perspective at this point?

Mr. Cooley: I think we've seen quite a bit of change, or potential change, over the course of the last two years. And what we're seeing now within the industry is I think players settling in, if you will, and moving forward under what we now have with the Affordable Care Act and a little bit more strenuous FDA environment. And basically what that means is that medical device manufacturers I think are increasingly focusing on truly step-function-type changes that can demonstrate not only improved clinical benefits but also some material cost savings.

I also think what's really unique to our industry that we haven't really seen over the last 15 to 20 years is, we are increasingly seeing medical device manufacturers take their technologies abroad and effectively design them for the international markets first and then subsequently look to commercializing those devices here in the States.

TWST: What's caused that change? Why look overseas?

Mr. Cooley: I really think it's a function of two key points. The first being uncertainty on the regulatory front and specifically looking at what the U.S. Food and Drug Administration, or the FDA, requires in terms of getting a product approved now under the old 510(k) or PMA pathways, and then secondly it's reimbursement.

We are increasingly not seeing more favorable reimbursement for new technologies coming into the space at a premium, so where you are thinking about higher upfront development costs and subject reimbursement, manufacturers are increasingly moving abroad where they have a faster pathway, especially in Europe through the CE mark process and a defined reimbursement rate. It is just easier to define the return...

For more of this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs, portfolio managers and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.