A Medical Device Daily

Edwards Lifesciences (Irvine, California) reported that it has completed the sale of certain assets related to its LifeStent product line to C.R. Bard (Murray Hill, New Jersey).

The deal, first reported late last year ((Medical Device Daily Dec. 10, 2007), includes cash payments of about $74 million upon closing and up to another $65 million on the achievement of certain milestones, including FDA approval of LifeStent products for a superficial femoral artery (SFA) indication and the transfer of LifeStent device manufacturing).

For 2007, this business represented about $30 million in sales, according to Edwards.

Bard said that its Peripheral Vascular division in Tempe, Arizona, will assume marketing responsibility for the product and will immediately begin marketing the products globally.

Edwards said it would provide transition services for up to two-and-a-half years following closing.

About 150 employees may be affected by the end of the transition, Edwards said, but that it will be working “very closely with all of these employees” to find them new positions, either within Edwards, with Bard or elsewhere.

Edwards recently completed the one-year follow-up of 206 patients in its RESILIENT trial, which is comparing the LifeStent device to standard percutaneous transluminal angioplasty (PTA) in the treatment of SFA and proximal popliteal stenotic disease. Edwards said it will continue managing the RESILIENT trial for the next two and a half years.

At one year, the PTA-plus-stenting arm of the study demonstrated clear superiority, with 80% primary patency, compared to 38% patency in the PTA only arm. These results were highly statistically significant (p<0.0001), the company said. Additionally, in the SFA, the LifeStent device was found to have a low fracture rate of only 2.9% at one year.

Edwards has submitted a pre-market approval application to the FDA, and it said it is currently responding to the agency’s follow-up questions.

The LifeStent product family is available in the U.S. for biliary indications only.

Bard develops technologies in the fields of vascular, urology, oncology and surgical specialty products.

Edwards develops products to treat heart valve disease, peripheral vascular disease and other critical care technologies.

In other dealmaking activity:

• Foundation Radiology Group (FRG; Pittsburgh), a radiology provider using board-certified radiologists to interpret diagnostic images for hospitals 24 hours a day, reported that it has acquired Oryx Medical Services (Roanoke, Virginia), a provider of radiology practice management solutions for healthcare institutions on the east coast. Terms were not disclosed.

FRG said the acquisition is a step in its plan to build a nationwide network of radiology physician groups to provide 24/7/365 diagnostic imaging services.

Brandon Chan, CEO and chairman of FRG, said, “we are very pleased to add the capabilities of Oryx Medical Services to our organization, and to have [Dr. Gerald] Johnson join us as senior VP of sales and marketing. His contacts, expertise and knowledge of our industry will significantly enhance our capabilities.”

Johnson said, “with FRG’s resources and industry-leading technology, I am confident that we will enhance the service levels and quality of the patient care that we deliver to our clients.”

FRG also said that it has appointed Brandon Smith, formerly with TeraRecon (San Mateo, California), as VP of program management.

Timothy Pisula, COO of FRG, said, “with these key additions to our management team, our sales, implementation and client support methodology is now positioned to significantly enhance revenue growth, client and patient satisfaction.”

FRG says that its mission is to provide “the preeminent national diagnostic imaging, radiology service bureau and physician practice group network.”

• SGV Medical Supplies (Van Nuys, California), a mail order supplier of, reported that it has closed the deal acquire the ostomy supply business from a Philadelphia, Pennsylvania-based medical supply company. The financial terms were not disclosed.

The Philadelphia company, unnamed, said that it sold the ostomy supply business to focus its resources on other DME.

SGV said it made the purchase “to further fulfill its mission to be a resource to ostomates nationally” and will seek other transactions.

• Regeneration Technologies (RTI; Alachua, Florida) and Tutogen Medical (Alachua) reported that special meetings of stockholders have been set to vote on the proposed merger of the companies. The deal, described as a stock-for-stock exchange, was first disclosed last November (MDD, Nov. 14, 2007).

The waiting period imposed by the Hart-Scott-Rodino Antitrust Improvements Act applicable to the merger expired on Jan. 7. The companies said they plan to mail proxy materials in connection with the merger to stockholders on or about Jan. 25.

Tutogen shareholders will receive 1.22 shares of newly issued RTI common stock in exchange for each share of Tutogen common stock they own. Upon completion of the merger, RTI stockholders will own about 55% of the combined company and Tutogen stockholders will own 45%.

The combined company will be a provider of sterile biologic solutions worldwide, with a mix of implants and distributors. The merged company is expected to benefit from cost synergies and enhanced opportunities for revenue growth and increased profitability.

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