StemCor Systems Receives FDA Clearance for Bone Marrow Harvesting System

    MENLO PARK, Calif., Oct. 31 /PRNewswire/ -- StemCor Systems, Inc., a
 medical device company developing systems for Enabling Regenerative
 Medicine(TM), announced today that it has received 510(k) clearance from
 the U.S. Food and Drug Administration (FDA) to market its MarrowMiner(TM)
 for the harvest of bone marrow.
     (Logo: http://www.newscom.com/cgi-bin/prnh/20071030/STEMCORSYSTEMSLOGO)
     "Regulatory clearance of StemCor's MarrowMiner is a major
 accomplishment for the Company as we develop the necessary tools to
 extract, process and deliver bone marrow-derived adult stem and progenitor
 cells," said Vartan Ghazarossian, PhD, President and CEO of StemCor
 Systems. "The MarrowMiner is the first minimally-invasive system for the
 collection of bone marrow, making marrow extraction faster, safer and more
 comfortable. Physicians will now be able to use this system to collect
 marrow from healthy donors for bone marrow transplantation, as well as from
 patients who are to be treated with their own marrow-derived cells, for an
 expanding array of current and emerging regenerative medicine
 applications."
     "We believe this novel and innovative system addresses a large unmet
 clinical need to gain access to sufficient adult-bone marrow derived cells
 in a safe, convenient and reliable manner," said Paul Yock, MD, Weiland
 Professor of Medicine and Bioengineering and Director, Program in
 Biodesign, Stanford University. "This technology meets a key need to access
 a patient's own cells for use in treating a variety of diseases and
 conditions."
     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 studies demonstrated the ability
 of the MarrowMiner to safely harvest large volumes of marrow with
 significantly higher stem cell activity than is contained in standard
 needle aspirates.
     About Bone Marrow
     Bone marrow is a rich source of both adult stem and progenitor cells.
 Marrow-derived stem cells have been utilized extensively for over 40 years
 in the field of bone marrow transplantation, primarily for the treatment of
 a wide array of cancers and hematologic diseases for which over 60,000
 transplants are performed each year. Orthopedic procedures, such as spinal
 fusions and the treatment of non-union fractures, also commonly utilize the
 patient's own bone marrow. More recently, marrow-derived cells are showing
 promise in the treatment of a widening array of diseases and conditions.
     About Regenerative Therapies
     Regenerative medicine focuses on the ability to repair or regenerate
 damaged, diseased or aging tissues, and is rapidly emerging as the next
 frontier in medicine. Regenerative therapies have the potential to provide
 effective therapies for millions of patients worldwide suffering from a
 wide array of diseases, including cardiovascular, neurologic, and
 orthopedic diseases and diabetes. A critical aspect of many regenerative
 therapies is the ability to collect the patient's own stem cells, and later
 process, select and deliver these cells to a target organ.
     About StemCor
     StemCor Systems is a privately held medical device company located in
 the San Francisco Bay Area developing enabling technologies for
 regenerative medicine. The company's initial product is the MarrowMiner, a
 proprietary, minimally-invasive bone marrow collection system. The
 technology was invented by Daniel Kraft, MD, and was licensed exclusively
 from Stanford University. Clinical studies are now underway to evaluate the
 potential of the bone marrow collection system to obtain sufficient and
 high quality marrow-derived cells.
      Contact:  Vartan Ghazarossian, PhD
                President and CEO
                StemCor Systems, Inc.
                650-321-6884
                Vartan@StemCorSystems.com
 
 

SOURCE StemCor Systems, Inc.