Medical Devices Today

Devices Pique Private Equity's Interest

Reprinted from IN VIVO, April 2008

The spate of recent carve-outs from Boston Scientific has private equity and venture capital investors hungry for similar deals from across the industry. But device companies don't seem to be serving up much.

Summary

• Boston Scientific's strategy to divest non-core assets is feeding private equity investors hungry to do deals in the medical device industry.

• Private equity investors face a challenge in convincing other large medical device companies to make big deals, but smaller ones are getting done.

• Avista Capital Partners sees big opportunity in the spinouts of its two BSX divisions.

• TriVascular2, working in endovascular AAA repair, illustrates the promise—and challenges—of development-stage buyouts.

Boston Scientific Corp. has spent the last year carving itself up like a Thanksgiving turkey. The company—still working through a bloated feeling brought on by its $27 billion acquisition of Guidant Corp.—is slicing off the less desirable pieces of dark meat to a combination of private equity investors and strategic buyers, leaving itself with what it hopes will be the choice favorable stent and CRM businesses, the white meat so to speak. Click here to purchase this article or review the current issue.

Paragon Medical Sets Up Export Production Base In Changzhou

Reprinted from PharmAsia News, May 19, 2008

Paragon Medical, a leading U.S. original equipment manufacturer for the top global medical device suppliers, has selected Changzhou High-tech District as its strategic location to invest in China. As a key export production base for Asia Pacific, the Changzhou facility will mainly manufacture class I orthopedic devices, class I implant components and other metal medical devices. Most of the products will be distributed to the overseas market. (Click here for more - Chinese Language)

"American Paragon Medical Sets Up Export Production Base In Changzhou" - hc360.com (5/13/08)

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Agappe Diagnostics Of India Expects 300 Percent Growth This Year

Reprinted from PharmAsia News, May 19, 2008

India's Agappe Diagnostics says it expects a 300 percent growth over the rest of this year, three times the percentage growth of the previous year. Agappe attributed the expected gains to an appreciating euro and high prices in Western countries. Agappe's managing director, Thomas John, said his firm expects to acquire technology to help it take advantage of India's lower manufacturing costs. John said the past year's situation of an appreciating euro and high Western production costs caused problems in reducing prices, but the technology aspect was expected to be an offset. (Click here for more)

"Agappe Diagnostics Eyeing 300 Percent Growth" - Economic Times (India) (5/17/08)

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At-A-Glance: Device Deals, Alliances, Financing and Acquisitions - April/May 2008

Medical Devices Today has provided a roundup of the most recent device and dignostics deals, mergers and alliances from April and May from Windhover Information and FDC Reports’ Device Deals Database. Our proprietary database is designed for medical technology professionals and investors that need to stay current on the latest industry alliances, financing, mergers & acquistions and other strategic partnerships.

Click here to view At-A-Glance: Device Deals, Alliances, Financing and Acquisitions - April/May 2008

The deals database provides expanded information, including:

- Comprehensive Deal Records
- Complete Financial Information
- Extensive Company Profiles
- Access to important SEC Documents
- Links to related articles

Find out more about what our Device Deals Database and Strategic Transactions Database can do for you.

Contact: James DeFalco at: +1 (203) 838-4401 x104 or jdefalco@windhover.com.

Medtronic Debuts Vision 3D Cardiac Devices

Brief Reprinted from "The Gray Sheet," May 19, 2008

Medtronic unveils its latest line of wireless implantable cardiac devices at the Heart Rhythm Society annual scientific sessions May 14-17 in San Francisco. The first devices to launch on the new Vision 3D wireless device platform are four implantable cardioverter defibrillators (ICDs) and two cardiac resynchronization therapy defibrillators (CRT-Ds), FDA-approved in April and expected to be commercially available in the "coming months." Additional Vision 3D platform products, including pacemakers and bi-ventricular pacemakers, will follow, the company said. Vision 3D technologies include Complete Capture Management to capture data from the right atrium and both ventricles of the heart, and adjust stimulation to patient needs. Other available Vision 3D features include: Conexus wireless telemetry via the CareLink network; the PainFree shock reduction feature, including ATP (anti-tachycardia pacing) During Charging; MVP managed ventricular pacing to reduce unnecessary pacing; and OptiVol to measure fluid levels in the thoracic cavity. Vision 3D "creates synergies across the platform so there's a common foundation across all the devices," Medtronic explains.

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Legal Issues Abound For Device Marketers In The Blogosphere

This article is reprinted from "The Gray Sheet" – May 12, 2008

Tapping into the blogosphere could give medical device companies unprecedented access to patient and physician customers, but using blogs for marketing purposes carries a raft of legal responsibilities as well.

"You can be very cavalier about this venue, and shouldn't be," Mark DuVal, who specializes in drug and device law at DuVal and Associates in Minneapolis, told "The Gray Sheet." "From a legal, regulatory standpoint, it can be kind of a minefield."

The potential legal danger zone encompasses not only blogs, but also social networking sites, message boards and other types of interactive, so-called "new media."

Neither FDA nor the Federal Trade Commission, the main regulators of device advertising and promotion, have developed specific guidance on manufacturer use of new media, though both say blogs and other sites fall within their increasing scrutiny of Internet marketing.

Product Liability Insurers Raise The Bar On Risk Management

This article is reprinted from "The Gray Sheet" – May 5, 2008

Device firms large and small must do even more to satisfy commercial insurers than what the government requires. In fact, FDA may be of limited concern to companies faced with plaintiffs' suits and escalating premiums, device industry insurance experts say.

Commercial plans provide key protections for companies, such as product liability policies that defend firms and pay on their behalf when negligence claims are made. They can also head off future lawsuits by showing firms where their vulnerabilities lie. Yet companies are often so focused on FDA compliance that they ignore liability issues, according to device and diagnostics insurance firm Medmarc (see chart: "¹Product Liability Insurance 101").

"Companies get lulled into believing that if they get that FDA stamp of approval, everything's going to be fine," said Sara Dyson, loss control manager at Medmarc. "Regulatory compliance needs to be your floor, not your ceiling. You absolutely need to comply, but you can't stop there."

"There's always a product liability problem lurking around the corner that the FDA's quality regulations aren't going to address," Dyson told "The Gray Sheet."