Allied Healthcare (ASX: AHZ) is the recipient of the biotech industry's Janssen 2013 Emerging Company of the Year award in recognition of its achievements this year.
"We are very proud and excited to receive industry recognition that highlights the strong progress that our company has made, particularly over the last 12 months," chief executive officer Lee Rodne said.
"With growing revenues, bringing our lead regenerative tissue product CardioCel® to market in Europe and initiating the Group's Phase 1 study for its lead vaccine targeting a treatment for Herpes, it has been a very exciting year."
The company has had a string of successes recently.
Its closely watched herpes therapeutic vaccine trial is progressing well with no safety issues reported as yet, fulfilling the key objective of the current trial.
Participants in the trial run by Professor Frazer and his Coridon science team in Brisbane are currently on their third dose of the vaccine to prevent transmission of as well as treat herpes simplex virus 2 (HSV-2).
The trial is also expected to provide the first indication of the vaccine's protective and therapeutic effect in humans
Allied has a 50.1% share in Coridon.
The company's CardioCel® cardiovascular tissue patch has also expanded its reach this month after an additional eight surgeons - the entire cardiac department at The Prince Charles Hospital in Brisbane - received approval to use it to repair and treat heart defects in adult patients.
Notably, its ongoing Phase II extension study has also hit a milestone with five patients monitored over a five year period post-surgery showing no sign of calcification, a major issue with other existing tissue products.
Supporting this, no signs of calcification have been seen in a further six patients monitored over four years and eight beyond three years.
CardioCel® has also received its CE mark in Europe, allowing it to be marketed for use in both children and adults.
Other milestones include:
- Growing revenues to $7.4 million, with the C=company also being awarded a 5-year contract worth over $2 million to implement its leading edge infusion management systems into a Queensland Hospital;
- CardioCel® granted early access at key centers in Australia, allowing cardiac surgeons to repair congenital heart defects. Fourteen heart surgeons have now been approved to use CardioCel in paediatrics and adults via this scheme and have completed over 75 successful open heart procedures using CardioCel®;
- Lodged its FDA 510(k) marketing application for CardioCel® and expect US marketing approval in the first half of 2014;
- In November 2012, CardioCel® showed superiority over autologous tissue in a heart valve repair model. The results showed that heart valves repaired with CardioCel® tissue did not calcify while facilitating strong regeneration around the valve tissue;
- The company also announced positive results in the comparative study with ADAPT prepared tissue in pelvic floor reconstructions and hernia repair. This showed that ADAPT® prepared tissue is superior to existing products with strength equal to that of synthetic materials and suitable for pelvic floor and hernia repair;
- Allied's regenerative medicine division was awarded a $1.9M grant from Commercialisation Australia to prepare and launch CardioCel® into global markets; and
- Successful initial preclinical results of Professor Ian Frazer's next HPV vaccine targeting a treatment against the human papillomavirus (HPV) and cervical cancer.
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