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Harvest Technologies Announces Interim Study Results From Critical Limb Ischemia Trial in Chennai India
Date:4/1/2009

PLYMOUTH, Mass., April 1 /PRNewswire/ -- Harvest Technologies Corp. (www.harvesttech.com) announced today that the interim study report was completed for the first thirty (30) patients in the clinical trial of patients suffering with non-reconstructable critical limb ischemia due to advanced thromboangitis obliterans, commonly referred to as Buerger's Disease.

The trial is being conducted at Sri Ramachandra University in Chennai India and is designed to evaluate the therapeutic effect of a composition of nucleated bone marrow cells prepared using the Harvest SmartPReP System. The study is being led by principal investigator Prof. K. S. Vijayraghavan, Head of Vascular Surgery. Harvest's SmartPReP System is a point-of-care device for concentrating a patient's own (autologous) bone marrow stem cells in approximately 15 minutes.

Prof. Vijayraghavan stated, "This study has very important implications for treating this patient population, because they are young (average age 45) and have limited access to any revascularization options. The trial was the first of its kind to be approved by all regulatory bodies in India," and was conducted in accordance with the significant risk provision of the Investigational Device Exemptions Regulations (21 CFR Part 812); the Protection of Human Subjects Regulations, including Subpart B Informed Consent of Human Subjects (21 CFR Part50); the Institutional Review Board Regulations (21 CFR Part 56).

Patients enrolled in the trial were treated with a composition of concentrated bone marrow nucleated cells, termed BMAC. A total of 240 mL of marrow aspirate was processed using the point of care SmartPReP System (Harvest Technologies, Plymouth, MA) to yield 40 mL of treating volume. The patients were divided
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SOURCE Harvest Technologies Corp.
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