Regeneus (ASX:RGS) is poised to help accelerate the return of injured players to their careers after the Australian Football League granted case-by-case approval for the use of its HiQCell® stem cell therapy.
Importantly, the AFL's decision is not a general approval for stem cell therapies but only for HiQCell®.
The treatment has also received clearance as an approved therapy from the Australian Sports Anti-Doping Authority (ASADA) for use with athletes who participate in sporting competitions subject to the WADA Anti-Doping Code.
This approval is notable given that HiQCell® will be used to treat high performance athletes in an environment with increased scrutiny and concern about performance enhancing substances.
HiQCell has already been used to treat a number of elite and high-profile athletes across several sporting codes including the National Rugby League.
It has already undergone a double blind placebo-controlled safety trial and is the subject of an independent ethics approved registry study.
The decision by the AFL gives injured AFL players with conditions that are unresponsive to existing treatments an additional option.
"It's pleasing that HiQCell has been approved under the new AFL Prohibited Treatments List released in March 2014," Regeneus commercial development director for human health Steve Barbera said.
"This recent decision by the AFL demonstrates a further level of compliance, specifically for players within that sporting code."
The HiQCell treatment involves harvesting a small amount of a patient's own stem cells from their adipose (fat) tissue.
The regenerative cells are then separated and concentrated before being re-injected in osteoarthritic-affected joints such as knees, hips and ankles.
It has undergone the highest level of clinical scrutiny - a double blind placebo-controlled safety trial.
This demonstrated that HiQCell is safe and treatment reduces pain and halts cartilage degradation in arthritic joints.
In addition to the placebo-controlled trial, the ongoing effect of HiQCell is being tracked in over 380 patients in an independent ethics approved registry.
A recent registry update demonstrates that patients are maintaining significant improvements at 2 years post-treatment.
At 2 years post treatment, 14 of 17 patients reported more than a 30% reduction in pain. These had experienced an average pain reduction of 84%.
Regeneus had in the June quarter put in place new initiatives that are resulting in increased enquiries and HiQCell treatments in Sydney and Melbourne.
- A direct patient engagement strategy that encompasses outbound marketing communications and a dedicated HiQCell website including patient enquiry portal and customer relationship management system;
- A HiQCell processing centre at the new East Sydney Private Hospital. On 18th June 2014, HiQCell was the first procedure performed at the new state-of-the-art hospital and five HiQCell treating medical practitioners (TMPs) are now accredited at the facility;
- Three additional Melbourne-based TMPs licensed to perform HiQCell;
- HiQCell being made available to treat neuropathic pain following the publication of the positive results of the study in the Journal of Pain Research in May 2014.
The company is also on track to launch the treatment in Singapore in the fourth quarter of 2014 and is in discussions with potential UK medical partners.
Regeneus' HiQCell® stem cell therapy has received a major boost with the Australian Football League approval allowing its use to treat injured players on a case-by-case basis.
This validates its potential to treat elite sports patients and accelerate their return from hard to treat injuries and continue their playing careers.
The regenerative therapy has also received clearance from the Australian Sports Anti-Doping Authority.
It also follows on its usage to treat a number of elite and high-profile athletes across several sporting codes including the National Rugby League.
Proactive Investors considers this is a tipping point for HiQCell® application and useage. As well as a market value accretive development.
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