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LifeCell Implements ClearOrbit to Automate Process to Meet Rigorous FDA Label Tracking Requirements


AUSTIN, Texas -- March 16, 2005 -- Gemini Simplified Interface Software Automates Complex Workflow and Labeling for Processing, Shipping, and Tracking Acellular Tissue Grafts.

ClearOrbit(R), the leading provider of real-time supply chain execution (SCE) software solutions, today announced that LifeCell has implemented ClearOrbit’s Gemini Simplified Interface(TM) (G.SI(TM)) and Compliance Label Manager(TM) (CLM(TM)) to automate key processes within LifeCell’s Oracle(C) Process Manufacturing(TM) (OPM(TM)) module. Based in Branchburg, NJ, LifeCell (NASDAQ: LIFC) is a leader in the development and commercialization of human-derived tissue products for use in reconstructive, urogynecologic, and orthopedic surgical procedures.

Because LifeCell develops, manufactures, and distributes products made from human-derived tissue, the FDA heavily regulates LifeCell’s operations. During its product preparation processes, which are supported by OPM, LifeCell is required to record and store highly detailed data generated by its patented, multi-step operations. To supplement OPM with sophisticated trace, track, and control capabilities, LifeCell implemented ClearOrbit’s G.SI for OPM and CLM products. G.SI provides RF mobile automation and bar code scanning of key operations within OPM to improve data accuracy and efficiency. Compliance Label Manager provides a sophisticated rules engine to facilitate adherence to FDA product labeling requirements (LifeCell manages over 130 unique label formats). CLM also includes RFID tagging capabilities for more advanced item tracking.

Today, LifeCell uses ClearOrbit for direct integration to its Oracle enterprise data model to automate inbound, manufacturing, and outbound shipping processes. Using ClearOrbit, LifeCell obtains real-time visibility as the company receives donated tissues (in the form of human skin), prepares the skin through highly controlled clean-room processes, and ships the processed grafts for use in advanced surgical procedures. Because of the opaque packaging used to protect the individual grafts, LifeCell implemented ClearOrbit’s Compliance Label Manager to dependably match individual packaged grafts with the correct packaging components and provide multiple labels for tracking the tissue through preparation, shipping, and individual surgical procedures.

“Generating custom labels as we track our products through the manufacturing and packing processes is difficult enough,” said Hugh Hansard, Vice President of Information Services for LifeCell,“ but to be able to integrate that data to Oracle Process Manufacturing without integrating separate databases was a key to our choice of ClearOrbit.”

“An increasing number of companies in regulated industries, such as LifeCell, are using ClearOrbit to leverage their Oracle OPM data without costly custom coding through our off-the-shelf software solution with integrated bar code and RFID labeling capabilities,” said Tom Dziersk, President & CEO of ClearOrbit

About LifeCell

LifeCell is a leader in the development and commercialization of human-derived tissue based products for use in reconstructive, urogynecologic and orthopedic surgical procedures. The Company’s patented technology produces a unique regenerative human tissue matrix -- a complex three-dimensional structure that contains an array of proteins, growth factor binding sites and vascular channels -- that provides a complete template for the regeneration of normal human tissue. LifeCell’s current products include: AlloDerm(R), for plastic reconstructive, general surgical, burn and periodontal procedures; Cymetra(R), a particulate form of AlloDerm suitable for injection; Repliform(R), for urogynecologic surgical procedures; GraftJacket(R), for orthopedic surgical procedures; and AlloCraft(TM)DBM, for bone grafting procedures. LifeCell markets AlloDerm for plastic reconstructive, general surgical and burn applications through its direct sales organization. The Company’s strategic sales and marketing partners include: Boston Scientific for Repliform, Wright Medical Group, Inc. for GraftJacket, Stryker Corporation for AlloCraftDBM and BioHorizons for periodontal applications of AlloDerm. The Company’s ongoing research and product development strategy is focused on extending the utilization of its regenerative tissue matrix into new markets and the application of its core technology to other tissues. Visit the LifeCell website at

About ClearOrbit

Since 1994, ClearOrbit has assisted more than 275 clients in automating and controlling their supply chain execution processes. ClearOrbit extends enterprise systems value with proven Supply Chain Execution (SCE) and Collaborative Supply Management (CSM) software solutions that allow customers to fully leverage their investment in enterprise applications while also gaining additional value by incorporating their trading partners into their supply chains. ClearOrbit products work within the existing enterprise system to leverage a “single version of the truth,” expanding rather than duplicating functionality to eliminate inefficiencies in the supply chain. By using the customer’s data model, ClearOrbit delivers on the promise of Enterprise Resource Planning (ERP) systems such as Oracle (NASDAQ: ORCL) and SAP (NYSE: SAP) with fully integrated supply chain execution and collaboration solutions that address “last mile functionality” issues inherent in most ERP systems. ClearOrbit customers include Cisco Systems (NASDAQ: CSCO), JDS Uniphase (NASDAQ: JDSU) and Texas Instruments (NYSE: TXN). See how enterprise systems can reach a higher level at or call us at 800-324-5143.


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