Risks and Uncertainties
Clinical trials and regulatory approvals
All medical devices developed for market release must undergo a comprehensive registration process with the relevant authority in each individual market. This process includes, where applicable, requirements for preclinical development, clinical trials, registration, approval, marketing, manufacturing, and distribution of new medical devices. Failure to meet these existing or future requirements may necessitate additional clinical studies, product recalls, and may prevent registration approval.
Neola Medical is advancing to clinical validation phase, initiating clinical studies, which will be instrumental in securing registration approval for commercial launch in the USA. The transition to the clinical phase carries inherent risks and uncertainties. These studies are not guaranteed, as any unfavorable results and unforeseen challenges could further complicate the process and impact the timeline for FDA approval and CE marking, potentially leading to increased costs and delays in the commercial launch of Neola®.
Neola Medical plans to submit documentation for FDA approval and CE marking for Neola® in 2025. The Company relies on these approvals for commercial launch. Therefore, the Company needs a functioning capital market to finance product development until this milestone is reached.
Dependence on expertise and key personnel
The Company depends on specialist expertise and key personnel. Loss of such expertise and key individuals could impede the Company’s development.
Intellectual property rights
The Company’s intellectual property rights are protected through patents, patent applications, agreements, and legislation safeguarding trade secrets. Infringement of the Company’s intellectual property rights could harm its operations. Furthermore, patent protection for biomedical and biotechnological companies is uncertain and involves complex legal and technical issues. There is a risk that patents will not be granted for patent-pending inventions and that granted patents will not provide sufficient protection. Additionally, not all developments and technologies can be patented.
Financing and conditions for continued operations
The Company conducts capital-intensive research and development activities. To date, the Company has financed its operations through equity via new share issues and shareholder contributions. The Company’s activities may require additional external financing before generating revenue, and it cannot be guaranteed that the Company will secure the necessary capital. If, for any reason, the Company is unable to continue its operations, this could affect the Company’s ability to realize the reported values of its assets, particularly concerning capitalized development costs and patents, which are based on and dependent upon the conditions for continued operations.