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  • Regeneus Extends Reach Of HiQCell® Stem Cell Therapy To Melbourne 0 comments
    Oct 30, 2013 1:04 AM

    Regenerative medicine company Regeneus (ASX: RGS) has started offering its HiQCell® stem cell knee osteoarthritis therapy in Melbourne with the establishment of a new cell-processing laboratory.

    While not long listed on the Australian Stock Exchange, Regeneus has a history dating back to 2007.

    It has also been on a fast track, developing products and generating revenues from its stell cell therapies.

    HiQCell® uses a patient's own stem cells from fat tissue to create the treatment and is considered a surgical procedure, resulting in lower regulatory requirements.

    The treatment is offered by specialist sports and exercise physician Dr Philip Bloom at Bounce Health Group, in conjunction with Linley Clinic Private Hospital.

    The new state of the art laboratory is equipped and staffed by Regeneus.

    "HiQCell® provides a viable treatment option for mid-stage age or impact related OA patients who might otherwise face ongoing debilitating pain, loss of function, the inability to play sport and reduced quality of life," Dr Bloom said.

    Regeneus commercial development Director Steven Barbera added the treatment offered by Bounce Health Group practitioners and the Linley Clinic Private Hospital represented another step in the development of its services.

    It currently offers the treatment through specialists in New South Wales, Queensland and Victoria.

    HiQCell®

    Cell therapy, using a patient's own stem cells from fat tissue, was pioneered by Regeneus and since 2011 has been used to treat more than 350 people and over 800 arthritic joints.

    Its HiQCell® therapy uses a procedure and manufacturing protocol that offers safe cell harvest, optimal cell yield in 60 minutes processing time and the option for storing patient's stem cells for future reinjections.

    The treatment involves harvesting a small amount of a patient's own stem cells from adipose (fat) tissue. The regenerative cells are separated and concentrated before being re-injected in osteoarthritic-affected joints such as knees, hips and ankles.

    The HiQCell® treatment, which reduces inflammation and repairs damaged tissue is carried out under the supervision of the treating medical specialist.

    A recent clinical study has demonstrated its potential disease modifying effect by slowing cartilage degradation with magnetic resonance imaging (MRI) confirming that participants in the HiQCell® treatment group had slower than expected loss of cartilage at the 6 month post-treatment time point.

    In addition, a key cartilage breakdown marker (CTX-II) was found to have stabilised while the inflammation and osteoarthritis biomarker decreased significantly in these participants.

    The latter also represents a discovery that the macrophage inhibitory factor (MIF) can be used to accurately measure the anti-inflammatory effects of stem cell treatments.

    The study showed that the HiQCell treatment was safe and clinically feasible. It was well tolerated by patients and there were no major safety concerns and no joint infections during the course of the study.

    Regulatory Advantage

    The benefit of HiQCell® being considered a surgical procedure, and hence requiring less regulatory oversight in Australia, also extends to other countries with similar regimes.

    These include Japan, Singapore, Canada, South Korea, the UK and other parts of Europe.

    Osteoarthritis

    Osteoarthritis is the number one chronic disease in Australia, which currently affects 4 million people and is expected to affect 7 million by 2050.

    Similar rates of the disease, which has no cure, are also seen in major western countries with ageing populations.

    There is a treatment gap between pain medication and joint replacement procedures with cell therapy the only option to delay or overcome the shortcomings of invasive procedure.

    Future Plans

    Over the next 12 to 24 months, Regeneus plans to expand its treatment footprint and procedure rates in Australia by having treatment hubs in all major Australian capitals with musculoskeletal specialist communities.

    It also plans to launch it in Singapore, Germany and UK, which have similar regulatory frameworks to Australia.

    Regeneus is looking to grow its registry data and extend the use of HiQCell® to new musculoskeletal applications including ain management.

    Plans are also underway to have the procedure reimbursed with the company noting that some procedures have been funded by private insurers.

    Analysis

    In Proactive Investors' view, Regeneus is at the forefront of a massive growth in the regenerative medicine and cell technology industry, currently in its infancy.

    A marker is that its core HiQCell® stem cell knee osteoarthritis treatment initially targets Australia's top chronic disease that current affects 4 million people.

    Osteoarthritis, which was incurable, usually resulted in the need for a hip replacement so there is a real treatment gap and need.

    Regeneus is already earning revenues with fast growth: $1.77 million in 2013, (FY12: $1.25m FY11:$0.785m). This demonstrates how Regeneus is different - very product-focused, developing products and servicing markets with a clear need that generates revenues now from stem cell-related technology products.

    Investors certainly agree, with the company's $10 million IPO raising, closing oversubscribed by $500,000 in September 2013, valuing it now at post money $33 million.

    With every indication that this is just the start after a hiatus after listing not that long ago on the ASX.

    Today's announcement just hints at the growth ahead which sees the HiQCell® now being available in Melbourne, in line with the company's plans to have treatment hubs in all major Australian capitals with musculoskeletal specialist communities.

    HiQCell, is being used in three medical facilities in Sydney and one on the Gold Coast, with more than 700 joints in 335 patients treated so far.

    The company is also looking to leverage the regulatory advantage offered by HiQCell® being considered a surgical procedure rather than a drug to expand its offering to countries with a similar regime to Australia.

    Onward and Regeneus will look to roll out more HiQCell processing labs and day surgeries in Australia, Singapore and Britain.

    With IPO funding and revenues generated, Regeneus has a 2 year funding runway to meet business and R&D
    milestones.

    Comparisons

    Comparisons can be odious, however in the regenerative medicine industry Australia's Mesoblast Ltd. (ASX:MSB; OTC:MBLTY), with its $1.85 billion market cap leads the way and provides a marker for medium to long term ambitions in terms of valuation for Regeneus.

    Regeneus may be new as a public company but its history dates back to late 2007. It was founded by a group of science entrepreneurs with a history at Macquarie University.

    Regeneus is product driven first and foremost. It also sells two products, AdiCell and CryoShot, to treat similar musculoskeletal conditions in dogs and horses.

    With the patient's own cells are used, approval is not required from drug gatekeepers such as the local Therapeutic Goods Administration and the US Food and Drug Administration, as they are technically surgical procedures rather than drugs.

    With few companies operating in the regenerative stem cell space that are listed on global markets, Proactive Investors expects investors will twig to the growth story that is Regeneus.

    Given Regeneus's impressive product pipeline, it is a matter of time.

    nly the patient's own cells are used -- approval is not required from drug gatekeepers such as the local Therapeutic Goods Administration and the US Food and Drug Administration. - See more at: www.theaustralian.com.au/business/compan....dpuf

    nly the patient's own cells are used -- approval is not required from drug gatekeepers such as the local Therapeutic Goods Administration and the US Food and Drug Administration. - See more at: www.theaustralian.com.au/business/compan....dpuf

    Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX "Small and Mid-cap" stocks with distribution in Australia, UK, North America and Hong Kong / China.

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