Harvest Technologies Corporation Granted CE Mark for Expanded Clinical Indication for Treatment of No-Option Critical Limb

    Harvest Technologies Corporation Granted CE Mark for Expanded Clinical
         Indication for Treatment of No-Option Critical Limb Ischemia

  PR Newswire

  PLYMOUTH, Massachusetts, Nov. 19, 2012

PLYMOUTH, Massachusetts, 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 CorporationPlymouth, MA 02360(877) 842-7837

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

Website: http://www.harvesttech.com
Contact: Michele Sullivan, Director of Marketing, Harvest Technologies
Corporation, +1-508-732-7500
Press spacebar to pause and continue. Press esc to stop.