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StemCor will develop the System for Hospira, and Hospira will manage theclinical trial program, leading to commercialization. The System has 510(k)clearance from the U.S. Food and Drug Administration and CE Mark in Europe,and Hospira plans to initiate post-approval clinical use studies in early 2009to support product launch thereafter. Under the agreement, Hospira will marketthe device to Oncologists, Hematologists and other physicians specializing inbone marrow transplantation.
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"We are excited to develop this System's potential in collaboration withHospira, a leading global specialty pharmaceutical and medication deliverycompany," said Vartan Ghazarossian, Ph.D., President and CEO of StemCor. "Thisis a specialized market that varies from country to country, and we arepleased to have a strong distribution partner in both the U.S. and around theworld."
Andrew Robbins, Director of Strategy and Ventures at Hospira, said, "Thisagreement is a step forward as Hospira seeks to provide innovative productsfor the oncology market. Hospira is excited to provide a new device tofacilitate bone marrow harvest, with the goal of improving the donorexperience."
About StemCor's Product
StemCor's proprietary System is designed to rapidly and easily harvestbone marrow in a minimally invasive manner, in the outpatient setting, andwithout general anesthesia. The System consists of an access guide, a poweredhandle that drives a flexible atraumatic shaft through which marrow isaspirated, and an integrated marrow collection container. The shaft gainsaccess to the bone marrow cavity through the access guide to allow the removalof bone marrow through a single entry site. This is in contrast to the currentpractice of bone marrow aspiration through the repeated insertion of a needleinto multiple sites in the iliac crest of the hip, which usually requiresgeneral anesthesia, an operating room, and multiple clinical personnel.Preclinical studies demonstrated the ability of the System to safely harvestlarge volumes of marrow with greater stem cell activity than is contained instandard needle aspirates.
About StemCor Systems
StemCor Systems is a privately held medical device company located in theSan Francisco Bay Area. The company's initial product is a proprietary,minimally-invasive bone marrow collection system. The technology was licensedexclusively from Stanford University.
About Hospira
Hospira, Inc. is a global specialty pharmaceutical and medication deliverycompany dedicated to Advancing Wellness(TM). As the world leader in specialtygeneric injectable pharmaceuticals, Hospira offers one of the broadestportfolios of generic acute-care and oncology injectables, as well asintegrated infusion therapy and medication management solutions. Through itsproducts, Hospira helps improve the safety, cost and productivity of patientcare. The company is headquarted in Lake Forest, Ill., and has more than14,000 employees. Learn more at http://www.hospira.com.Contact: Vartan Ghazarossian, Ph.D. President and CEO StemCor Systems, Inc. 650-321-6884 [email protected]
SOURCE StemCor Systems, Inc.
