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.
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"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.
Vartan@StemCorSystems.com
CONTACT: Vartan Ghazarossian, Ph.D., President and CEO of StemCor Systems,
Inc., +1-650-321-4684, Vartan@StemCorSystems.com
