Allied Healthcare Group (ASX: AHG) has generated over A$5.4 million in revenue so far this financial year, marking an 8% increase for the year to date, and is on track for more than $7 million in sales for the full 2013 financial year.
Importantly, this signals strong growth in revenue which will increase even further with the nearing commercial rollout of the company's cardiovascular tissue patch, CardioCel®, in the U.S.
Allied expects full regulatory approval of CardioCel® in at least one jurisdiction in 2013.
During the March quarter, Allied filed its 510(NYSE:K) marketing approval submission with the FDA for CardioCel®.
The U.S. is the largest global market for regenerative medicine and gaining approval gives Allied commercial entry.
Allied is now advancing its pre-commercial launch activities in preparation of approvals and launching CardioCel® in overseas markets.
The company's cash balance was $3.77 million at the end of the March quarter following a successful A$4.6 million capital raising.
This will provide the company with sufficient capital to achieve its major milestones, including the initial approval and launch of CardioCel® and the initiation of the first clinical study for the DNA vaccine program.
CardioCel® continues to be used in patients to treat and repair congenital heart defects via the Authorised Prescriber Scheme in Australia.
Additionally, surgeons based in Melbourne and Brisbane have now been approved to use CardioCel® in patients.
This was supported by additional data from a phase two extension study which showed patients progressing well four years after receiving CardioCel®, with these patients showing no signs of calcification - a unique feature of the CardioCel® product.
Typically, calcium build-up at the site of repair can be seen within six months post-surgery with existing marketed products.
Allied anticipates additional early access approvals at key centres in Australia in the coming months.
During the March quarter, Allied also announced positive results from its regenerative tissue franchise in the areas of hernia repair, pelvic floor repair and stem cell seeding.
These results support the existing work with CardioCel® and show the potential for the company to build a strong pipeline of products in the regenerative tissue area.
Allied also further invested in its DNA vaccine programs, led by Professor Ian Frazer, as the lead herpes vaccine advances towards clinical trials expected to start in the first half of 2013.
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