Navigation Links
Arteriocyte Receives FDA Approval to Move Forward with Critical Limb Ischemia Trial
Date:1/28/2011

CLEVELAND, Jan. 28, 2011 /PRNewswire-USNewswire/ -- Arteriocyte®, a leading clinical stage biotechnology company with offices in Cleveland, Ohio and Hopkinton, Massachusetts that develops proprietary stem cell and tissue engineering based therapies, announced today approval from the Food and Drug Administration (FDA) to initiate a Phase I clinical trial using its Magellan MAR01™ technology in the treatment of Critical Limb Ischemia (CLI). The FDA Investigational Device Exemption (IDE 14522) allows Arteriocyte and its clinical partners to initiate evaluation of concentrated marrow injections (using the Magellan MAR01™ technology) in improving perfusion in ischemic tissue in affected limbs of patients with CLI who are not eligible for revascularization surgery.

(Logo: http://photos.prnewswire.com/prnh/20100624/ALOGO)

The Magellan technology combines a rapid bedside tissue concentration device and sterile surgical disposables that produce platelet rich plasma from blood and bone marrow aspirations in approximately 15 minutes and was FDA approved through the 510(k) process for use as deemed appropriate by surgeons. The Magellan MAR01™ technology enables the rapid "closed system" concentration of aspirated bone marrow, yielding an injectable tissue rich in platelets, hematopoietic stem cells and mesenchymal stem cells, commonly viewed as key components in tissue repair. The company is developing MAR01™ for use as a clinical treatment for Critical Limb Ischemia, and plans to initiate additional clinical trials evaluating MAR01™ in cardiovascular disease, and the clinical setting of orthopedics and tissue repair during 2011.

Patient enrollment for the phase I safety study will begin immediately at The Ohio State University Medical Center (as the first clinical site), under the direction of Dr. Michael Go, Assistant Professor of Surgery in the Division
'/>"/>

SOURCE Arteriocyte, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Arteriocyte Named Top Biotech Start Up Venture by the Ohio Venture Association for 2010
2. 3SBio Inc. Receives SFDA Approval for TPIAO Label Extension for the Treatment of ITP
3. Soligenix Receives FDA Orphan Drug Designation for RiVax™ for the Prevention of Ricin Intoxication
4. Regenicin Receives Positive Feedback at OneMedForum Conference
5. Neogens Rapid Test for Salmonella enteritidis Receives FDA Approval
6. Regenicin COO Receives Citizenship Award from VFW Post 1 in Colorado
7. Foundation Venture Capital Group Company Receives $8.2 Million DoD Contract
8. Teysuno™ (S-1) Receives CHMP Positive Opinion for Approval as First-Line Therapy for Advanced Gastric Cancer
9. Quest Diagnostics® Care360™ EHR Receives ONC-ATCB 2011/2012 Certification
10. Pittsburgh-based BIOSAFE Receives EPA Registration and Enters Into Commercialization Agreement with Union Springs Pharmaceuticals
11. PharmAthene Receives FDA Clearance to Reinitiate Clinical Testing of Valortim®
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... The 6th Annual Arrowhead Personalized and ... 29-30 in San Francisco, CA. This year’s conference brings ... and clinicians focused on addressing and solving the significant ... twelve years since the sequencing of the human genome, ... pharmacogenetic information in the label and molecular diagnostics have ...
(Date:8/20/2014)... Calif. , Aug. 20, 2014 /PRNewswire-iReach/ -- ... the transformative collaboration between the school,s bioengineering department ... part of the Intel® Software Academic Program, UCSD,s ... sciences and the human body.  ... The study exhibits the work of Dr. ...
(Date:8/20/2014)... 20, 2014 WriteResult®, a leading provider ... it has expanded its myPROpad™ ePRO tablet with the ... one of the most widely used and well-respected Patient ... status. The EQ-5D is used during clinical trials and ... that can be used to demonstrate Health-Related Quality of ...
(Date:8/19/2014)... One of the major limitations in ... vascular supply. Nutrient and gas transport throughout synthetic ... for successful regeneration and integration into the patient’s ... vascularization and promote angiogenesis in a variety of ... and architecture, and enhancing scaffolds with stem cells. ...
Breaking Biology Technology:6th Annual Personalized and Precision Medicine Conference Bringing Together Thought Leaders to Discuss Clinical Implementation, Dx Reimbursement, Big Data, and Sequencing 2Intel and University of San Diego Bioengineering Department Release Case Study on Health Sciences Research 2EQ-5D™ Assessment Now Available for iPad 2Vascularization in Tissue Engineering Highlighted at 12th New Jersey Symposium on Biomaterials Science 2
... elected mayor of Colorados largest city, businessman John Hickenlooper invited ... was to ceremoniously bury the hatchet of intra-regional rivalry and ... metropolitan area, or not at all. , ,Every suburban ... a near-unanimous effort to pass a $4.7-billion mass transit initiative ...
... data quality firm Firstlogic for about $69 million ... second quarter. , ,Firstlogic is a privately held firm that ... sure their data is as correct as they need to ... call centers, web sites, customer relationship management systems, and business ...
... settled with a Belgian company that sued last September ... virus genotyping technology from Innogenetics, for undisclosed financial terms. ... Aril 2004 Third Wave forged a deal under which ... line of products in Europe. It was Third Wave's ...
Cached Biology Technology:Economic collaboration in Denver sets tall goal for Wisconsin 2Economic collaboration in Denver sets tall goal for Wisconsin 3
(Date:8/20/2014)... Oklahoma Medical Research Foundation a five-year, $14.5 million grant ... effects on humans. , For 10 years, OMRF ... the human immune response to anthrax bacteria as part ... funding came soon after anthrax-laced letters killed five and ... of Sept. 11, 2001. , The long-term goal ...
(Date:8/20/2014)... athletes who have suffered concussions ready to return to ... that high school athletes who head back on the ... significant regression in their abilities to simultaneously walk and ... in changes in their balance and/or altered walking speed, ... the 12 had returned to activity in less than ...
(Date:8/20/2014)... Biting into a chili pepper causes a burning spiciness ... Scientists exploring the chili pepper,s effect are using their ... kinds of pain, which can be caused by inflammation ... compound, which is being tested in clinical trials, in ... Tafesse and colleagues explain that decades ago, scientists had ...
Breaking Biology News(10 mins):$14.5 million grant awarded to continue anthrax studies 2Recovery reversal seen in Oregon study of returning concussed athletes 2Recovery reversal seen in Oregon study of returning concussed athletes 3
... March 30, 2012 The Phoenix Community Alliance (PCA) ... Genomics Research Institute (TGen), with its most prestigious award. ... City Starr Award for his work in improving the ... studying diseases such as Alzheimer,s, diabetes and many types ...
... FL, March 30, 2012 The National Institutes of Health ... the role of a pathway in the development and maintenance ... immune system and turns normal disease fighting cells into cancers. ... part of our white blood cells. John Cleveland, ...
... Bethesda, MD FASEB MARC (Maximizing Access to ... for the 2012 American Society for Clinical Investigation/Association of ... April 27-29, 2012. These awards are meant to ... scientists into the mainstream of the basic science community ...
Cached Biology News:Phoenix Community Alliance honors TGen's Dr. Jeffrey Trent 2Scientists win $2 million to study new pathway in development and maintenance of lymphoma 2