Date: Oct 25, 2008 Source: Biospace (
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Menlo Park, CA - StemCor Systems, Inc., a medical device company developing systems for Enabling Regenerative Medicine, announced today that it has signed an agreement with Hospira, Inc. to develop and commercialize StemCor's proprietary System for the harvest of bone marrow.
StemCor will develop the System for Hospira, and Hospira will manage the clinical 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 2009 to support product launch thereafter. Under the agreement, Hospira will market the device to Oncologists, Hematologists and other physicians specializing in bone marrow transplantation.
"We are excited to develop this System's potential in collaboration with Hospira, a leading global specialty pharmaceutical and medication delivery company," said Vartan Ghazarossian, Ph.D., President and CEO of StemCor. "This is a specialized market that varies from country to country, and we are pleased to have a strong distribution partner in both the U.S. and around the world."
Andrew Robbins, Director of Strategy and Ventures at Hospira, said, "This agreement is a step forward as Hospira seeks to provide innovative products for the oncology market. Hospira is excited to provide a new device to facilitate bone marrow harvest, with the goal of improving the donor experience."
About StemCor's Product
StemCor's proprietary System is designed to rapidly and easily harvest bone marrow in a minimally invasive manner, in the outpatient setting, and without general anesthesia. The System consists of an access guide, a powered handle that drives a flexible atraumatic shaft through which marrow is aspirated, and an integrated marrow collection container. The shaft gains access to the bone marrow cavity through the access guide to allow the removal of bone marrow through a single entry site. This is in contrast to the current practice of bone marrow aspiration through the repeated insertion of a needle into multiple sites in the iliac crest of the hip, which usually requires general anesthesia, an operating room, and multiple clinical personnel. Preclinical studies demonstrated the ability of the System to safely harvest large volumes of marrow with greater stem cell activity than is contained in standard needle aspirates.
SOURCE: StemCor Systems, Inc.
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