A Medical Device Daily

Sage Medical Technologies (Plymouth, Minnesota) said on Friday that it is “actively raising funds for its Series B financing.” It did not report the amount of that funding.

Sage is an early-stage medical device company developing its core endovascular technology to address two deficits of the aorta. The company is completing animal studies with a plan to initiate human feasibility trials in the 1Q08.

“We are delighted with the rapid progress of our research and development team in producing a functional prototype and its evaluation in animals. The timeline from product sketch to implant has been an impressive six months. Augmenting this is enthusiastic guidance from key opinion leaders in both the cardiology and vascular surgery communities,” said Jagi Gill, the company’s CEO.

The first program the company is focused on is aortic dissection, a condition which develops acutely as a tear in the aortic wall leading to rapid blood loss. Current surgical and medical treatments have a mortality rate of more than 30%. A minimally-invasive approach designed specifically to treat aortic dissections offers a much needed solution to this catastrophic disease.

The company’s technologies combine an ultra-flexible nitinol stent, macro-porous covering to promote vessel healing along with a catheter delivery system. More than 35,000 patients per year in the U.S. would be candidates for use of the Sage system, the company says.

The core technology is also being developed to provide a catheter-based solution to entrap plaque which resides in the aortic arch. Aortic plaque has been documented to contribute to 15%-25% of all ischemic strokes.

Much like the growth in carotid artery stenting to reduce the incidence of stroke for appropriate patients, the safe deployment of the Sage Medical plaque-entrapping stent should reduce the risk of stroke in over 130,000 persons in the U.S. who annually present with aortic arch plaque.

While conventional stent-grafts do not permit for accurate deployment around the aortic arch, the Sage Medical system is designed to enable the endovascular surgeon to do so in a percutaneous manner.

Sage has been in operation since January 2006 in its facility outside of Minneapolis. Emdeon (Elmwood Park, New Jersey) reported that it has begun its previously disclosed tender offer to purchase up to 100 million shares of its common stock at a price per share of $12.25 (Medical Device Daily, Sept. 27, 2006).

The number of shares proposed to be purchased in the tender offer represents about 36% of its currently outstanding shares. The last reported sales price per share of the company’s common stock on the Nasdaq on Sept. 25 was $11.64 a share.

The share repurchase is to be funded out of the proceeds of sale of a 52% interest in Emdeon Business Services (EBS) to General Atlantic, valued at about $1.5 billion. The share repurchase is conditional on the EBS transaction being finalized.

The dealer manager for the tender offer is Citigroup Global Markets. The information aagent for the tender offer is Innisfree M&A Inc. The Depositary is American Stock Transfer & Trust Co. The tender offer will expire on Dec. 4, unless extended by the company.

Emdeon provides business, technology, and information solutions designed to transform both the financial and clinical aspects of healthcare delivery.

In other financing news, Nastech Pharmaceutical (Bothell, Washington) reported that it has filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission, so that it may issue common stock from time to time, up to an aggregate of $125 million.

While the company said it has no current plans to access the capital markets, the shelf registration statement, once declared effective by the SEC, would allow it to expeditiously access capital markets in the future subject to market conditions and the company’s capital needs.

The proceeds of the offering with would used for general corporate purposes, including the funding of clinical research and development programs, the clinical development of product candidates, capital expenditures and working capital needs.

Nastech is a pharmaceutical company developing products based on molecular biology-based drug delivery technologies. Nastech and its collaboration partners are developing products for multiple therapeutic areas including osteoporosis, diabetes, obesity, respiratory diseases and inflammatory conditions.

FDA sets Dec. 7 and 8 for panel meeting on DES safety issues

As promised, the safety of drug-eluting stents (DES) will come under scrutiny from federal health officials and outside experts at a special panel meeting. The expert FDA panel tasked with evaluating cardiovascular devices will meet Dec. 7 and 8, with products by the two manufacturers of U.S.-approved DES devices — Cordis (Miami, Florida) and Boston Scientific (Natick, Massachusetts) — likely to receive the most attention.

The focus of the meeting will be recent reports that DES devices may increase the risk of deadly blood clots. The agency in September promised the meeting after several studies indicated that DES-implanted patients had a higher risk for clots than those implanted with bare metal stents. Both types of devices are designed to keep arteries open after they have been cleared of fatty deposits.

A panel made up of outside experts is expected to make recommendations on whether additional DES studies or labeling changes are needed. The FDA is not required to follow panel recommendations, but they usually carry great weight in the agency’s decisions.

Besides Cordis and Boston Scientific, Medtronic (Minneapolis) and Abbott Laboratories (Abbott Park, Illinois) appear next to seek U.S. approvals. DES devices by several firms are approved for marketing in Europe.

Earlier this month, Prudential med-tech analyst Larry Biegelsen wrote in a research report that only two of the nine members of the panel are interventional cardiologists, the type of doctors who typically prescribe stents. “We believe it likely that the FDA will invite additional experts to participate in the meeting,” Biegelsen wrote in a note to clients. “In our view, these additional experts could have a major impact on the outcome of the meeting.”

— Holland Johnson, MDD Associate Managing Editor