Medical Device Daily Executive Editor

SAN FRANCISCO — Cardiovascular firms received particular interest from investors during last week's 24th annual JPMorgan Healthcare Conference here, with small- to mid-sized companies carrying much of the load in the absence of such big hitters as Boston Scientific (Natick, Massachusetts), Johnson & Johnson (J&J; New Brunswick, New Jersey) and Guidant (Indianapolis), those absences doubtlessly keyed to the unfinished business of what has become an auction for the latter firm.

Two companies that attracted sizable audiences to their presentations in the California Room setting at the Westin St. Francis Hotel were drug-eluting stent developer Conor Medsystems (Menlo Park, California) and growth-by-acquisition endovascular firm ev3 (Plymouth, Minnesota).

In introducing Conor Chairman and CEO Frank Litvack, PhD, JPMorgan med-tech analyst Michael Weinstein referred to the company as “one of the more interesting and closely followed companies in the cardiovascular space in some time.“

For his part, Litvack characterized his firm as “an innovative, vascular drug-eluting company,“ adding: “We believe our technology will allow us to push the limits of drug-eluting stents [DES] beyond where they are today.“

That technology features a design focus on drug delivery, with the company's CoStar stent incorporating hundreds of small reservoirs into which drug/polymer combinations can be loaded. That's distinctly different from the other versions of DES on the market or coming to it in the near future, which universally involve a drug coating on a conventional mesh stent.

Those reservoirs on the cobalt chromium stent “allow enhanced control of drug release,“ Litvack said. In addition, the CoStar stent features bioresorbable polymers that are absorbed by the body after the drug is released, which in concert with complete drug discharge “may solve“ the problem of delayed stent thrombosis.

He noted that Conor had “a very busy year“ in 2005, including commercial launch of the CoStar DES in “a few international countries,“ the start of enrollment in the pivotal COSTAR II trial in the U.S., and the presentation of results from three clinical trials — COSTAR I (Cobalt chromium STent with Antiproliferative for Restenosis), PISCES (Paclitaxel In-Stent Controlled Elution Study) and EuroSTAR (EUROpean cobalt chromium STent with Antipro-liferative for Restenosis).

Enrollment in the COSTAR II trial stood at 800 last week, and the company is anticipating completing enrollment of an anticipated 1,700 patients at some 85 clinical sites during 1Q06. The study is a comparison of the CoStar with Boston Scientific's market-leading Taxus Express2 DES.

Litvack said the company's 2006 agenda includes the hoped-for launch of CoStar in Europe and other markets and the advancement of Conor's next two products into clinicals.

Those include a pimecrolimus/paclitaxel-eluting stent, which he said is “the first duel-drug stent“ in development, and a fully bioresorbable stent being developed in a program with Biotronik (Berlin/Lake Oswego, Oregon), which he characterized as in the “feasibility“ stage, but with “a lot of progress“ being made.

Biotronik is Conor's distribution partner in Europe and Latin America, while St. Jude Medical (St. Paul, Minnesota) is the company's partner for Asia Pacific and Japan.

The dual-drug stent involves pimecrolimus, a drug licensed by Conor from Novartis (Basel, Switzerland). Calling it “a very potent anti-inhibitor,“ he said the beauty of the dual-drug approach is that pimecrolimus is a fast-release drug and paclitaxel has a longer release profile.

Speaking from the same podium a day earlier, ev3 President and CEO James Corbett cited his firm's two primary divisions, the CardioPeripheral Division and NeuroVascular Division, the latter including the operations of Micro Therapeutics (MTI; Irvine, California), the remaining minority stake of which was acquired by ev3 in a deal that closed the Friday before the start of the JPMorgan conference (Medical Device Daily, Jan. 10, 2006).

“We're in large and really under-served markets,“ he said, pegging their potential value at $1.6 billion a year and growing by more than 20% annually.

“There is a lot of opportunity for innovation in these spaces in the area between the big companies and small, single-product companies,“ Corbett said. “Part of our strategy is addressing the striking overlap in the area of occlusive disease.“

He said ev3 had introduced 12 new product platforms in the past year, adding that more than 90% of the company's revenues come from products introduced in the past two years.

And, while noting the steady growth of revenues, Corbett pointed out that the company currently has only about a 5% share of the addressable market, so there's ample room for growth.

He pegged the peripheral vascular disease market op portunity alone at $1 billion, with opportunities “in carotids, renals, iliacs, SFAs and tibial/lower leg.“ ev3 has products “that address all these vascular 'beds' — with more on the way,“ Corbett said.

Citing clinicians' shift from surgical to endovascular treatments, he highlighted a variety of products, including the SpideRx embolic protection filter, which he said is “the only filter compatible with users' preferred wires,“ allowing physicians to use any company's guidewire in conducting endovascular procedures.

Corbett cited critical limb ischemia as “a key area of focus“ for the company.

Noting the broad product line ev3 now has in the neurovascular area, he said “we're the only company [with] all the products needed“ to work in that sector, including MTI's Onyx liquid embolic to treat arterio-venous malformations.

“We have the broadest product pipeline“ in the sector, Corbett said, adding: “We compete very well with Boston Scientific“ in neurovascular.

Saying that ev3's expertise is in “leveraging multiple platforms,“ he added, “We have the portfolio to meet endovascular interventionalists' needs.“

Corbett said that the company's biggest growth this year will be outside the U.S., as it expands both its geographic and product reach internationally.

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