StemCor Systems Receives CE Mark For MarrowMiner(TM) System For Bone Marrow Collection

Main Category: Bones / Orthopedics
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 11 Sep 2008 - 0:00 PDT

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StemCor Systems, Inc., a medical device company developing systems for Enabling Regenerative Medicine(TM), announced that the Company has received the CE (Conformite European) Mark for its MarrowMiner System. The MarrowMiner System is a minimally invasive device used to harvest adult stem cells from the ilium (pelvis), and represents next-generation technology for use in bone marrow transplants, for accelerating bone healing in spinal fusions and other orthopedic procedures, and an expanding array of clinical applications utilizing bone marrow-derived cells. The CE Mark indicates that the product complies with the appropriate quality and safety standards to be commercialized in the EU, and furthers StemCor's goal of becoming a global company.

"We are excited that this regulatory authorization gives us the ability to commercialize StemCor Systems' technology in the European Union. The use of adult-derived stems cells is expanding rapidly, especially in spine fusion and other orthopedic procedures. We are pleased to be able to offer this novel device to physicians outside of the US, whereby bone marrow can be harvested in a more facile and relatively atraumatic way compared to traditional methods," said Vartan Ghazarossian, Ph.D., President and CEO of StemCor Systems.

About the MarrowMiner

The proprietary MarrowMiner 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 MarrowMiner 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 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 and recent clinical studies demonstrated the ability of the MarrowMiner to safely harvest marrow with significantly higher stem cell activity than is contained in standard needle aspirates.

StemCor Systems, Inc.
http://www.stemcorsystems.com

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