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June 21, 2004
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Affinergy Selects Hyman, Phelps & McNamara, P.C. as Regulatory Counsel for its Platform Coatings Technology
Experienced FDA device experts to assist Affinergy in Clinical and Regulatory Strategy.
RESEARCH TRIANGLE PARK, N.C., June 21, 2004 - Affinergy, Inc., a biomaterial coatings company with unique capabilities to regulate biological processes on the surface of synthetic materials, announced today that it has selected Hyman, Phelps & McNamara, P.C. as regulatory Counsel.
"Medical device coatings are enjoying great commercial success in the marketplace," said Diane B. McColl of Hyman, Phelps & McNamara, P.C. "Early involvement of regulatory advisors is always prudent, but especially important for a platform technology like Affinergy. Our firm looks forward to working with Affinergy along the regulatory pathways of its various product applications."
"Affinergy is proud to be working with preeminent experts in the field of medical device regulations such as Hyman, Phelps & McNamara, P.C. " said Peyton Anderson, CEO of Affinergy. "This is an outstanding firms with deeply relevant expertise. Diane and her team will become integral partners to Affinergy."
About Affinergy
Affinergy's revolutionary "biological glue" is a platform technology designed to greatly improve the performance of medical devices by regulating the biology on their surfaces. Target opportunities include applications include to block biofilm formation, promote specific cell growth, and enable biomolecular immobilization. The coatings technology is highly modular, target-specific, and easy to apply in manufacturing. Affinergy can help medical device suppliers grow sales by differentiating existing devices as well as creating new products. By creating "tunable" bioactive surfaces on medical devices, Affinergy can contribute to the lowering of healthcare costs and improving of patient outcomes.
About Hyman, Phelps & McNamara
Hyman, Phelps & McNamara, P.C. (HPM) is a specialty law firm that advises and represents a broad range of clients on legal issues concerning food, drug, medical device and cosmetic law and regulation. HPM's attorneys counsel and assist clients in gaining government approvals for new products and in developing strategies to support successful marketing in accordance with the requirements of the law and the enforcement policies of FDA. The firm represents clients in federal and state courts, in Congress and before agencies including the U.S. Food and Drug Administration. The firm's clients are as diverse as the regulatory issues they face. They range from individuals and small growth companies with no in-house legal staff to many of the largest U.S. and overseas-based corporations. More detailed information about HPM and its attorneys is available at www.hpm.com.
For more information, visit www.affinergy.com or contact Peyton Anderson at (919) 345-4732.
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