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BIOMD
Biomd says 10 South African children have received its Cardiocel biomaterial patch during
open-heart surgery with no related adverse events.
Biomd said the results came from the six monthly follow-up examinations of the first 10
patients in its phase II human clinical trial of the repair of high risk and complex cardiac
defects.
Cardiocel is a biomaterial patch made from bovine pericardial tissue and treated with the
company’s Adapt tissue engineering process.
The company said the six month post-surgical examination included echocardiogaphy
assessment, blood biochemistry and a detailed clinical cardiovascular assessment.
Results from the first 10 patients showed no patch-related clinical adverse affects in any of
the patients; no patient related thrombo-embolic events; no dehiscence with any implant
patch; no flow obstructions; and minimal traces of non-significant mild calcification was
observed in some patients.
Biomd said post-operative performance of the implants was evaluated in terms of
thrombo-embolic events, immunological reactions, inflammation or endocarditis,
dehiscence from the surrounding tissue, degeneration or absorption of the implant and reoccurrence
of the pre-surgical anatomical defect, thickening of the implanted graft
surfaces obstructing flow patterns and aggressive calcification of the implant.
Biomd said the early results “clearly show within this chronically ill patient group, that the
biomaterial performs to expectations when implanted in a demanding cardiac environment
and creates no adverse effects”.
The company said the Cardiocel biomaterial patch trial was being conducted by the head
of the Department of Cardiothoracic Surgery at Universitas Hospital in Bloemfontein,
Professor Francis Smit, with the primary objectives being the evaluation of safety, efficacy
and clinical performance.
Subsequent follow-up examinations will be undertaken at 12 months post-operatively.
Biomd said 29 patients had been implanted with the Cardiocel biomaterial patch.
“Due to the excellent results obtained from the six month examinations to date and having
regard to the health funding crisis currently being experienced in South Africa, the
company has agreed with the investigators to conclude the trial upon implantation of the
30th patient,” Biomd said.
Biomd managing director Michael Bennett said the results were “very encouraging” and
provided the impetus for the commercial production of the Cardiocel patch.
“These preliminary results are a re-confirmation … of our significant pre-clinical findings
and we believe they will be sustained through to the 12 month assessments,” he said.
Biomd was up 4.5 cents or 128.6 percent to eight cents.