Navigation Links
Harvest Technologies Corporation Granted CE Mark for Expanded Clinical Indication for Treatment of No-Option Critical Limb Ischemia
Date:11/19/2012

PLYMOUTH, Mass., Nov. 19, 2012 /PRNewswire/ -- Harvest Technologies, a leader in advancing cellular therapies, is pleased to announce CE Marking for an expanded clinical indication for its SmartPReP®2 Bone Marrow Aspiration Concentration System (BMAC®2) product.

The British Standards Institution (BSI), a notified body under the Medical Device Directive, has awarded a certificate indicating that the Harvest SmartPReP2 Bone Marrow Aspiration Concentrate System (BMAC2) is intended to be used at point-of-care for the safe and rapid preparation of autologous nucleated cell concentrate from Bone Marrow Aspiration (BMA) for administration into ischemic tissues of the affected limb due to No-Option Critical Limb Ischemia.

This is the first time an autologous point-of-care cellular therapy company has presented sufficient clinical evidence for a notified body to grant approval to promote a specific product for this clinical use.  

This certification comes after BSI's extensive review of clinical data from nearly 50 clinical trials and investigations, including data using Harvest Technologies BMAC2 System.  Previous studies have shown that critical limb ischemia (CLI) patients that have tissue loss (gangrenous or ulcer wounds) are at severe risk for amputation.  Harvest studies have shown that the use of the BMAC2 system significantly reduces that risk and is a viable option for limb salvage. The Harvest studies have also been able to show improvement in rest pain for patients with severe rest pain.  

"We are pleased about the expansion of our claims.  This indication provides a significant treatment option that can improve the quality of life for approximately 800,000 European patients annually that progress to end stage critical limb ischemia," said Gary Tureski, President and CEO, Harvest Technologies Corporation. "The clinical evidence from our European studies is so compelling that we committed to and are currently enrolling patients in a US FDA pivotal trial."  

Harvest Technologies is the leading Cellular Therapy global manufacturer that develops point-of-care products to process and concentrate multiple biologics.  These include high-density platelet rich plasma (APC), bone marrow aspirate concentrate (BMAC®) and adipose tissue.  The company is headquartered in Plymouth, Massachusetts.  It is one of several subsidiaries of Terumo Corporation of Japan that is focused in cellular therapies and biologics.  For more information, visit www.harvesttech.com.

Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with $5 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures, and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures, and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use.

Harvest Technologies Corporation
Plymouth, MA  02360
(877) 842-7837

Harvest, SmartPReP and BMAC are registered trademarks of Harvest Technologies Corporation.  Terumo® is a registered trademark of Terumo Corporation.


'/>"/>
SOURCE Harvest Technologies Corporation
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Harvest Technologies Corporation reicht Patentverletzungsklage gegen ThermoGenesis Corporation ein
2. Harvest Technologies Corporation Files Patent Infringement Complaint against ThermoGenesis Corporation
3. Innovative Hematology and Flow Cytometry Technologies and Emerging Markets
4. Acuo Technologies Selected in Department of Defense Award to Deliver Vendor Neutral Archive for U.S. Army and U.S. Navy Medical Commands
5. Medisafe 1 Technologies Signs the $7MM Perpetual License Agreement
6. TNI BioTech, Inc. Signs Exclusive Distributor Agreement for Federal Republic of Nigeria with G-Ex Technologies/St. Maris Pharma & GB Pharma Holdings LLC
7. Filtrona Porous Technologies präsentiert neue medizinische Schäume und einzigartige Faserprodukte für saubere Arbeitsumgebungen auf MEDICA / COMPAMED-Messe
8. Beyond Lucid Technologies Receives Funding From Dalmore Investments
9. Filtrona Porous Technologies Introduces New Medical-Grade Foams And Unique Fiber Products For Clean Environments At MEDICA / COMPAMED Trade Fair
10. Medical Marijuana Inc. Portfolio Company CanChew BioTechnologies Inc. Announces Final Three Days for Market Survey and Free Product Trial Registration
11. SafeCode Drug Technologies Launches New Website With Product Video Demonstrating the Worlds Next Generation Application for Drug Safety Administration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... June 24, 2016 Dehaier Medical Systems Ltd. ... which develops, markets and sells medical devices and wearable ... signed a strategic cooperation agreement with Hongyuan Supply Chain ... Chain") on June 20, 2016, to develop Dehaier,s new ... cooperation agreement, Dehaier will leverage Hongyuan Supply Chain,s sales ...
(Date:6/24/2016)...   Pulmatrix, Inc ., (NASDAQ: PULM ... announced today that it was added to the Russell ... comprehensive set of U.S. and global equity indexes on ... milestone for Pulmatrix," said Chief Executive Officer Robert ... progress in developing drugs for crucial unmet medical needs, ...
Breaking Medicine Technology:
(Date:6/25/2016)... Lewisville, TX (PRWEB) , ... June 25, 2016 , ... ... in the United States, named Dr. Sesan Ogunleye, as the Medical Director of its ... be the facility Medical Director of our new Mesquite location,” said Dr. James M. ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, ... at Work award to iHire in recognition of their exemplary accomplishments in worksite health ... annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. ...
(Date:6/24/2016)... ... 24, 2016 , ... Those who have experienced traumatic events may suffer from ... avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid this ... coping following a traumatic event. , Trauma sufferers tend to feel a range of ...
(Date:6/24/2016)... ... June 24, 2016 , ... The ... in Dallas that it will receive two significant new grants to support its ... PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists for ...
(Date:6/24/2016)... ... 2016 , ... Comfort Keepers® of San Diego, CA is excited to announce ... program to drive cancer patients to and from their cancer treatments. Comfort Keepers ... of life and ongoing independence. Getting to and from medical treatments is one ...
Breaking Medicine News(10 mins):