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Ann: Manufacturing Strategy Update and Queensland Government Supp, page-2

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    Analytica Ltd. 222 Bazaar Street, Maryborough, QLD 4650 ABN 12 006 464 866
    pericoach.com analyticamedical.com
    P E R I C O A C H
    ASX ANNOUNCEMENT
    Manufacturing Strategy Update and Queensland Government
    Support
    • Analytica to bring manufacturing responsibility in-house.
    • Queensland Government financial support through grant funding under the Advance Queensland
    Industry Attraction Fund.
    • Phased manufacturing expansion plan over 5 years.
    • Analytica pursuing public health markets for post-natal rehabilitation and aged care prevention.

    6 September 2021. Analytica Ltd (ASX:ALT) wishes to update shareholders on its strategy to manufacture
    and supply its PeriCoach product to meet prospective demand, and financial support offered by the
    Queensland Government under its Advance Queensland Industry Attraction Fund (AQIAF).
    Analytica's commercialisation process for the PeriCoach system to date has followed the path of R&D,
    product development, regulatory clearances, and conducting market research. During this phase, Analytica
    has outsourced manufacturing of the product.
    With positive progress having been achieved on its commercialisation activities, such as the distribution
    agreement in the Middle East across 10 countries and the JV in China, Analytica has conducted a strategic
    review of its manufacturing strategy in contemplation of higher prospective demand for the PeriCoach
    product in North America and Europe currently being pursued.
    Analytica has taken the decision to develop its own manufacturing capability and become the regulatory
    manufacturer-of-record for the PeriCoach product.
    The benefits of bringing the PeriCoach product under Analytica's control include:
    • better supply chain management and regulatory compliance - being better able to manage
    delays in global supply chains and restricted travel during the covid-19 pandemic and to comply with
    regulatory requirements (including new certifications and responsibilities imposed on manufacturers
    following recent rule changes in Europe and Australia regarding software in medical devices);
    • meet potential demand from distribution networks – being better able to meet prospective
    demand for the PeriCoach product for Australian sales and export to the Middle East, European and US
    markets, with appropriate clearances; and
    • market re-engagement – leveraging the 2020 published clinical trial results from the University of
    New Mexico with a clinical trial in peer reviewed publication and subsequent published health economic
    manuscript, Analytica will be well positioned to start re-engaging with the market. For example, it would
    provide the ability to re-commence direct to consumer sales and to continue to pursue deals with public
    health systems and health insurers to address the enormous women’s health issues of rehabilitation of
    post-natal mothers and treatment for post-menopausal women to prevent or delay their entry into

    www.pericoach.com www.analyticamedical.com

    residential aged care.
    An internal manufacturing capacity will require the establishment of an ISO 13485 certified, and US QSR-
    compliant facility of our own.
    Analytica has presented a detailed, staged manufacturing expansion plan over 5 years to the Queensland
    Government which has agreed to provide funding over the Project period under an AQIAF agreement.
    Analytica's proposal to the Queensland Government involves establishing a headquarters in Maryborough,
    Queensland comprising manufacturing, warehousing, a customer support centre, data centre, and
    administration and training support for the production of the PeriCoach e-health system.
    Initially, Analytica will accept supplied components and perform final assembly, quality control testing,
    packaging and product release. As volumes increase the plan allows for plastic and silicone moulding to be
    brought in-house, and at full implementation, electronics manufacturing.
    Analytica’s CEO and COO are experienced in managing medical device manufacturing and have been
    adapting the company’s quality management system for in-house manufacturing over the last 12 months.
    Analytica has pre-arranged for a notified body to conduct an ISO13485 audit of Analytica facilities and
    quality system.
    The AQIAF program was established in 2016 by the Queensland Government to provide financial incentives
    to attract projects assessed to provide significant economic benefits to Queensland. AQIAF specifically aims
    to drive job creation, regional growth, increased innovation and technology and supply chain development.
    Analytica’s plan meets all these objectives.
    “The Queensland Government is committed to encouraging investment in the biomedical and advanced
    manufacturing sectors, and we’re thrilled to be supporting Analytica to execute its manufacturing strategy in
    Queensland.” Treasurer and Minister for Investment Cameron Dick said.
    Analytica Chairman Dr Michael Monsour said “We are excited to be establishing our headquarters,
    manufacturing and call centre operations in Maryborough. We are looking to secure a facility that we can fit-
    out to our specifications within the next 6 months.”
    Grant payments are made retrospectively on the completion of agreed milestones and there is no obligation
    on Analytica to continue the Project should circumstances change, noting the Queensland Government has
    the right to terminate the grant if Analytica is not able to meet the agreed milestones.
    The AQIAF grant is being provided on standard AQIAF terms and conditions. In addition, various project
    specific grant preconditions must be met within 6 months including securing a site in Maryborough, entering
    into fit out contracts, securing Project funding for the first 3 years (including performance bank guarantees
    to the Queensland Government), an approved funding plan for the balance of the Project, continued TGA
    approval for the PeriCoach product, an approved workforce development plan and approved marketing,
    distribution and sales arrangements. Analytica is working constructively towards satisfaction of these pre-
    conditions but there is no guarantee or assurance that these preconditions will be satisfied either at all or on
    terms and conditions satisfactory to the Queensland Government or Analytica or that the grant funding will
    be made available.
 
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