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Government of South Australia - Department of State Development

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    30th Sep 2024
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    Local medtech company making significant impact on women’s health

    Early-stage biomedical engineering company SmartFem Pty Ltd was recently awarded a $500,000 Seed-Start grant to commercialise its ‘Victoria Graft System’ – Generation 1 product, which is shown to significantly improve patient outcomes post-surgery for pelvic organ prolapse.

    SmartFem was established in 2012 by South Australian gynaecologist Dr Fariba Behnia-Willison, who commenced development of the Victoria Graft System after synthetic pelvic mesh – previously widely used in pelvic organ prolapse surgery – was withdrawn from market in 2017.

    Native tissue repair is currently the most common surgical option for pelvic organ prolapse, but it has a high failure rate, with 37 to 50 per cent of patients requiring further surgery.

    The Victoria Graft System is a novel method of producing an autologous graft from patient blood. Patients tolerate the graft well, as it uses their own blood, minimising graft rejection while significantly increasing stem cell migration and tissue rejuvenation. The graft also offers mechanical and structural support to the patient.

    SmartFem is positioning as a global leader in women’s health

    Dr Anabela Correia, Director of medical device commercialisation company Inner Maven – which has been engaged to deliver the product to market – says SmartFem is positioning as a global leader in women’s health, with a focus on prolapse and incontinence repair.

    “The Victoria Graft System has been successfully used in more than 400 cases, demonstrating an efficacy rate of more than 90 per cent at up to five years post-surgery,” Dr Correia said.

    “The Seed-Start funding will enable SmartFem to independently evaluate the Victoria Graft System and execute on translation of the product.

    “We essentially want to demonstrate the system works just as well in the hands of independent clinicians and derive similar (or better) patient results.”

    The grant will also support registration of the product with the Therapeutic Goods Administration and the Food and Drug Administration, and potentially CE Mark.

    Data collected from evaluating the Victoria Graft System will inform the research and development of a Generation 2 product, which may contain new materials to strengthen the biomechanical structure of the graft and create new intellectual property.

    “The current product has been in development since 2012, undergoing various refinements, and second-generation products are currently in development,” Dr Correia said.

    “SmartFem may be in a position to address other markets in the future, but for now the focus is on making a significant impact in women’s health.”

    The Victoria Graft System has the potential to improve quality of life for the 40 – 60 per cent of women affected by pelvic organ prolapse.

    It will also create 10 PhD and clinical research jobs and 10 commercial and support jobs, while developing local manufacturing and tissue engineering capabilities, and positioning South Australia as a global leader in regenerative medicine.

    The Seed-Start program equips innovative local startups with grant funding to support the commercialisation of a unique product or service that demonstrates sustainable competitive advantage in national and international markets.

    Part of the Research and Innovation Fund, the program offers $50,000 - $500,000 in matched grant funding to early-stage startups with high growth potential to assist with the costs of delivering a project that will generate significant economic, employment or social benefits for the state.