Nova Eye USA Sales Growth Opportunity
Key Risks –
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- Specific
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Specific Risks (cont.)
Health Insurance
Reimbursement risk
Regulatory and Legislative
Risk
Intellectual Property
Infringement
The Company derives revenue from sales of our products to physicians and surgery facilities, which typically bill all or a portion of the costs and fees associated with our products to
various third-party payors, including Medicare and Medicaid in the USA, private commercial insurance companies, health maintenance organisations, and other healthcare-related
organisations. Medical reimbursement systems vary significantly from country to country, with some countries limiting medical centres' spending through fixed budgets, regardless of
levels of patient treatment, and other countries requiring application for, and approval of, government or third-party reimbursement. As a result, access to adequate coverage and
reimbursement for procedures in which our products are used by third-party payors is essential to their acceptance and adoption by patients, facilities and physicians. These third-
party payors continually review new and existing technologies for possible coverage and can deny or reverse coverage for new or existing products and procedures, and there can be
no assurance that third-party payor policies provide coverage, or will continue to provide coverage, for procedures in which the Company's products are used.
Nova Eye's business is subject to numerous laws and regulations in Australia and overseas. Changes in these laws and regulations, including their interpretation or enforcement, that
affect, or will affect, the Company's business or products, including changes in accounting standards, tax laws and regulations, environmental or climate change laws, restrictions or
requirements related to product content, labelling and packaging, regulations or accords, trade rules and customs regulations, could adversely affect Nova Eye's financial results.
Failure adhere to various regulatory requirements and any regulatory action or enforcement may adversely affect Nova Eye's financial position.
Obtaining and maintaining approvals from regulatory bodies or other third parties can involve significant time and expense, and delays in obtaining approvals or adapting to changes
to laws and regulations may adversely impact Nova Eye's operations.
Nova Eye's commercial success depends at least in part on its ability to operate without infringing, misappropriating or otherwise violating the trade marks, patents, copyrights and
other proprietary rights of others. Nova Eye cannot be certain that the conduct of its business does not and will not infringe, misappropriate or otherwise violate such rights. As Nova
Eye gains greater visibility and market exposure as a public company, third parties may allege that Nova Eye's products, services or activities infringe, misappropriate or otherwise
violate their trade mark, patent, copyright or other proprietary rights in an attempt to gain a competitive advantage. Defending against allegations and litigation could be expensive,
take significant time and divert management's attention. Nova Eye may also be required to pay substantial damages or be subject to court orders prohibiting the Company and its
customers from selling certain products or engaging in certain activities.
If Nova Eye operates its business in a way which infringes, misappropriates or otherwise violates the trade marks, patents, copyrights and proprietary rights of others, this could have
a material adverse impact on the Company's business, financial condition and results of operations.
Nova Eye's intellectual property is important to its success and any unauthorised use of any of the Company's intellectual property may result in the Company needing to commence
litigation to protect those intellectual property rights which may incur significant costs. In addition, a failure to properly protect intellectual property rights may adversely affect the
Company's business and reputation. There can be no assurances that the Company will be able to register or protect new intellectual property it develops in the future or prevent the
unauthorised use of its intellectual property.
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