A Medical Device Daily

Kensey Nash (Exton, Pennsylvania) reported that it has acquired substantially all of the assets of IntraLuminal Therapeutics (ILT; Carlsbad, California), a developer of forward guidance systems that cross and recanalize chronic total occlusions (CTOs) in the coronary and peripheral arteries, for $8 million in cash.

ILT commercialized the Safe-Cross system in both the U.S. and Europe and developed a patent portfolio of 19 U.S. and corresponding foreign patents focused on guidance technology in combination with radio frequency energy. The platform technologies have broad therapeutic application for a variety of cardiovascular, surgical, neurological, carotid and men's/women's health procedures.

Kensey Nash said that the assets of ILT are complementary to certain research and development activities that it has initiated for products to treat CTOs. The company said it plans to use the ILT technology as a base platform to develop products to meet the clinical needs of the emerging CTO market.

Kensey Nash said that “thought leaders” have described CTOs as the “last frontier” of interventional cardiology. It is estimated that 30%-50% of people diagnosed with coronary artery disease have at least one CTO, yet they are rarely treated due to the difficult nature of the condition.

By most definitions, CTOs are complete blockages of a vessel that have been present for at least one month and are extremely difficult to cross with conventional guidewire techniques. Often patients are not treated at all or are referred for bypass surgeries, yet if minimally invasive interventional treatment is possible, patient outcomes and one-year survival rates can be significantly improved.

The Safe-Cross system, which received FDA marketing clearance in 2004 (Medical Device Daily, Jan. 13, 2004), is designed to safely cross CTOs using optical coherence reflectometry (OCR) technology as guidance and radio frequency (RF) as an energy source to penetrate the difficult lesions.

According to the company, the Safe-Cross is the only commercialized product that combines forward guidance with a crossing mechanism in a familiar guidewire configuration. The system is designed to give the interventionalist real-time feedback as to the proximity of the crossing wire to the arterial wall plus the capability to use RF power on the tip of the wire to assist in penetrating hardened material within the artery, thus facilitating safe and successful passage and placement of therapeutic devices for recanalization in native coronary and peripheral arteries. The system will be sold through Kensey Nash's direct endovascular sales forces in the U.S. and Europe after a transition period of nine to twelve months.

“We believe that this acquisition of technology will accelerate our internal product development programs targeting the important CTO market and will provide a foundation for the development of further useful tools to treat CTOs,” said Joseph Kaufmann, president and CEO of Kensey Nash.

Kensey Nash provides a range of products into multiple medical markets, primarily in the endovascular, sports medicine and spine markets.

In other dealmaking activity:

• Health information company Ingenix (Minneapolis) said it has agreed in principle to acquire NWH (New York), the parent company of healthcare payer services organization Electronic Network Systems (ENS; Pueblo, Colorado), and has completed the acquisition of Claredi (Salt Lake City), a provider of e-commerce software solutions, implementation and consulting services to the healthcare industry.

Ingenix said it would acquire all of the outstanding shares of NWH for a cash price of $18.24 per share, or about $54 million. Terms of the Claredi transaction were not disclosed.

The NWH transaction, which is subject to NWH stockholder approval and other customary conditions, is expected to close sometime in 3Q06.

“We intend to create the next generation of connectivity by combining ENS and Claredi assets and resources with Ingenix capabilities in coding, claims editing, revenue cycle management and healthcare transaction management,” said Richard Anderson, CEO of Ingenix. “This combination will facilitate the creation of intelligent electronic connectivity tools for use by physicians, hospitals and payers in an open network. Our focus will be to enhance the healthcare system's affordability and usability by providing real-time Internet connections among the participants in healthcare. This will increase efficiency, help physicians get quicker payment of claims and assist payers in reducing the amount of rework and rejected claims.”

Ingenix is a subsidiary of UnitedHealth Group (Minnetonka, Minnesota).

• Grifols (Madrid, Spain) reported the recent acquisition of eight pre-existing plasma collection centers in the U.S. for an undisclosed sum.

This acquisition comes on the heels of acquiring Plasma Care (Cincinnati) earlier this month (MDD, May 2, 2006), which significantly increased the number of Grifols-owned plasma collection centers.

With this more recent addition, the company said it is now one of the largest plasma collectors in the world. The total number of Grifols-owned plasma collection centers now stands at 72.

“Our growth strategy is focused on securing a stable supply of plasma and increasing our throughput in order to meet the needs of this expanding market for years to come,” said Victor Grifols, company CEO.

Human plasma is used to produce a number of life-saving therapies that treat inherited rare diseases such as hemophilia, primary immune deficiencies, genetic emphysema, as well as shock, trauma and burns.

Unlike traditional small molecule pharmaceuticals, the production of plasma therapies begins with the donation of human plasma which is then processed to extract specific therapeutic proteins.

• Cord Blood America (Los Angeles), an umbilical cord blood stem cell preservation company focused, it says, on developing the life saving potential of stem cells “to families nationwide,” reported that its CEO Matthew Schissler, in an interview with Francis Gaskins of World Talk Radio, commented that the company will be “extremely aggressive in mergers, acquisitions and asset purchases” as the stem cell industry consolidates.

“We will be the most aggressive player in the industry in adding companies that are immediately accretive,” Schissler said in the interview.