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 of Vascular Diseases and Surgery. "This clinical trial represents a unique opportunity to evaluate a novel biologic treatment for 'no-option' CLI patients and reinforces Ohio State Medical Center's leadership role in the clinical evaluation of these important technologies to improve the delivery of care for our patients."

Ultimately, Arteriocyte expects this technology to benefit many of the 750,000 individuals suffering from Critical Limb Ischemia in the United States. CLI is caused by a severe blockage of peripheral arteries that significantly impairs blood flow to the extremities, causing chronic tissue degeneration and necrosis. It is estimated that 150,000 individuals lose a limb due to this disease each year(1).

Arteriocyte's Chief Executive Officer, Don Brown shared, "We're thrilled to have the green light to initiate this next important step in the clinical development program for the Magellan MAR01™ technology. It represents yet another achievement in our public-private partnership with Ohio's Third Frontier Program, and their support of our development of Magellan based cellular therapies for the treatment of cardiovascular and critical limb ischemia patients."

About Arteriocyte

Arteriocyte, a leading clinical stage biotechnology company, is dedicated in developing novel stem cell products and medical devices for unmet research and clinical needs. Arteriocyte leverages its expertise in stem cell and tissue engineering in order to develop a broad portfolio of cell based therapeutics to improve patient outcomes. In October of 2007, Arteriocyte partnered with DW Healthcare Partners and Comerica to create Arteriocyte Medical Systems Inc., in order to commercialize and distribute novel medical devices and point of care surgical solutions to address serious unmet medical needs in cardiac, orthopedic and vascular surgeries. Today, Arteriocyte Medical Systems manufactures and distributes the Magellan® Autologous Platelet Separator System worldwide.

Reference

(1) Ramsey SD NK, Blough D, et al. : Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care 22:382-387, 1999


'/>"/>
SOURCE Arteriocyte, Inc.
Copyright©2010 PR Newswire.
All rights reserved

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:6/23/2016)... 2016  The Biodesign Challenge (BDC), a university competition ... harness living systems and biotechnology, announced its winning teams ... New York City . The ... projects at MoMA,s Celeste Bartos Theater during the daylong ... senior curator of architecture and design, and Suzanne ...
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, the Industry Network ... Supplyframe Design Lab . Located in Pasadena, Calif., the Design Lab’s mission is ... projects are designed, built and brought to market. , The Design Lab is ...
(Date:6/23/2016)... ... June 23, 2016 , ... In a new case report ... detail how a patient who developed lymphedema after being treated for breast cancer benefitted ... change the paradigm for dealing with this debilitating, frequent side effect of cancer treatment. ...
(Date:6/23/2016)...  Blueprint Bio, a company dedicated to identifying, protecting ... has closed its Series A funding round, according to ... "We have received a commitment from Forentis Fund that ... meet our current goals," stated Matthew Nunez . ... complete validation on the current projects in our pipeline, ...
Breaking Biology Technology:
(Date:6/9/2016)... in attendance control systems is proud to announce the introduction of fingerprint attendance control ... right employees are actually signing in, and to even control the opening of doors. ... ... ... Photo - ...
(Date:6/2/2016)... The Department of Transport Management (DOTM) ... million US Dollar project, for the , Supply ... Enrolment, and IT Infrastructure , to ... implementation of Identity Management Solutions. Numerous renowned international vendors participated ... was selected for the most compliant and innovative ...
(Date:5/24/2016)... Ampronix facilitates superior patient care by providing unparalleled technology to leaders of the medical ... premium product recently added to the range of products distributed by Ampronix. ... ... ... Ampronix News ...
Breaking Biology News(10 mins):