17 Dec 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Australia's Allied Healthcare Group has successfully completed an oversubscribed strategic placement which raised $1.7 million, and has also launched a share purchase plan (SPP). The placement, targeting sophisticated investors and institutions, and the SPP are priced at $0.02.
Funds raised from the placement and SPP will be used primarily to support the preparation of the company's CardioCel heart patch prior to its imminent launch. Allied expects CardioCel will receive marketing approval in the first half of 2013 in at least one global jurisdiction.
Allied has existing and growing revenue that is forecast to be over $7 million this financial year. Approval of CardioCel would represent a major inflection point for Allied as it is expected to result in a significant increase in global revenue for the company. Allied is expecting to also submit CardioCel's 510K marketing approval application with the FDA in the 1st quarter of 2013.
"CardioCel is on the cusp of global approvals so we need to ensure we maximise the impact it has in the market with extensive pre-launch preparation of the product," said Allied Healthcare Group, MD, Mr Lee Rodne.
The company is seeking initial approval for the use of CardioCel in the repair and reconstruction of congenital heart disease (CHD) defects in infants and children. Once CardioCel receives its initial approval, Allied will aim to expand the applications for the product in additional cardiovascular areas, such as adult heart valve repairs and reconstructions.