Date: Oct 31, 2013 Author: press release Source: PR Newswire (
click here to go to the source)
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
