BIOMD IMPLANTS 10th BOVINE CARDIOCELL TISSUE PATCH
October 10th 2008 08:13
Thursday October 9, 2008
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* ASX, BIOTECHS DOWN: PHOSPHAGENICS UP 14%, STEM CELL DOWN 23%
* BIOMD IMPLANTS 10th BOVINE CARDIOCELL TISSUE PATCH
* ARANA APPOINTS BIOFUSION’S GORDON BLACK DIRECTOR
* ARANA TO BUY BACK 10% OF SHARES
* AUSBIOTECH OKTOBERFEST
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BIOMD
Biomd says it has implanted the tenth patient with its Cardiocel bio-implant in its South African phase II human clinical trial.
Biomd said South Africa had “a high incidence of congenital heart disease”.
The trial’s primary objectives are to evaluate the safety, efficacy and clinical performance of the Cardiocel patch in cardiovascular surgical repair procedures.
Secondary endpoints are the evaluation of its design features, such as handling characteristics, shape and sizing requirements, as well as implant procedures.
The Cardiocel patches will be implanted into 50 patients requiring bio-prosthetic tissue substitution to support repair of atrial and ventricular septal defects, aortic root enlargements and outflow tract reconstructions.
Cardiocel patches are manufactured from bovine pericardium and treated with the Adapt tissue engineering process.
Biomd said patient would have a 12-month post-operative follow-up. Follow-up procedures include echo-cardiographic examinations at six and 12 months to evaluate haemo compatibility, calcification status and the general efficacy and stability of the implant patch.
Selected patients will have magnetic resonance imaging as part of their assessment.
Biomd said the Adapt tissue engineering process allowed for site specific controlled tissue remodeling, allowed stem cell trans-differentiation; removes all RNA and DNA including the alpha Gal Epitope; removed all residual and unbound polymer molecules; removed all calcium binding sites; and produced a stable soft tissue extracellular matrix.
The company said the Adapt tissue engineering process was “a proven multi-factorial approach in tissue engineering technology”.
Biomd said extensive in-vivo studies had shown that enhanced cross-linking mitigated inflammation and tissue erosion.
The Adapt tissue engineering process enabled a soft tissue extracellular matrix to partner with the human body’s natural healing processes to recreate a durable, functional and site specific tissue repair, Biomd said.
The company said that through controlled remodeling, the soft tissue extracellular matrix supported the surrounding tissue until the remodeling process was completed and the graft incorporated by the patient’s own tissue.
Biomd climbed 0.2 cents or five percent to 4.2 cents.
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