A Medical Device Daily

Edwards Lifesciences (Irvine, California), a manufacturer of heart valve technologies, and 3F Therapeutics (Lake Forest, California) said they have restructured the development and supply agreements between Percutaneous Valve Technologies (PVT; Fort Lee, New Jersey) and 3F Therapeutics, established prior to Edwards’ acquisition of PVT in early 2004.

At the time of its acquistion by Edwards, PVT was an early-stage company engaged in the development of a catheter-based (or percutaneous) heart valve.

Under terms of the new agreements, Edwards will pay 3F Therapeutics $25 million and will obtain the right to self-manufacture all components of its percutaneous heart valves and to apply, it said, “the entire array of Edwards’ capabilities and materials,” including its Perimount heart valve technology, to those products.

Edwards also may apply any technologies developed for its percutaneous program in all other applications and is free to market any of those products.

3F Therapeutics will have co-exclusive, royalty-bearing licenses to select Edwards patents related to minimally in-vasive, beating heart, surgical valve replacement and venous valve systems aimed at tricuspid valve regurgitation associated with congestive heart failure.

Edwards said it expects to take the majority of the $25 million as a special charge in the current quarter.

“We are pleased to complete the restructuring of these agreements, which provide for a continued access to the intellectual property required in surgical, beating-heart valve replacement products based on the 3F Aortic Bioprosthesis, model 1000,” said Walter Cuevas, president and CEO of 3F Therapeutics. “In addition, the restruc- turing of this agreement will provide 3F Therapeutics with a significant source of new capital, enabling us to achieve our clinical development and operating goals.”

He added that the transaction also frees up human resources within 3F that were previously dedicated to manufacturing Edwards products.

Tm Bioscience (Toronto), which focuses on the commercial genetic testing market, reported signing an agreement to supply the Emory Genetics Laboratory at Emory University (Atlanta) with Tag-It ASR(x) reagents for use in its Ashkenazi Jewish Panel (AJP) gene assay. The assay detects gene mutations associated with Tay-Sachs disease, Canavan disease, Familial dysautonomia, Gaucher disease, Bloom syndrome, Fanconi anemia, Neimann-Pick disease, and Mucolipidosis Type IV.

“Emory Genetics Laboratory is one of the largest academic diagnostic laboratories in the southeastern U.S. and its Molecular Genetics Laboratory offers a comprehensive suite of genetic assays,” said Greg Hines, president and CEO of Tm Bioscience.

“We are seeing growing demand for genetic screening across the state of Georgia,” said Dr. Kasinathan Muralidharan, director of the Molecular Genetics Laboratory at Emory. “Incorporating the Tag-It reagents from Tm Bioscience will help us [provide] a multi-disease panel that will produce fast results, with high throughput and a minimum of operator time.”