FREEDOM TO OPERATE: GREEN LIGHT FOR REMaST LAUNCH IN EUROPE

In the first quarter of 2025, Hemera completed a comprehensive Freedom to Operate (FTO) analysis for the European market, with fully favorable results. The study confirmed that REMaST technology can be developed, manufactured, and commercialized without infringing on third-party intellectual property rights, such as existing patents.
This strategic milestone significantly reduces the risks associated with market entry, providing strong assurances to both the company and potential investors.
The confirmation of full freedom to operate marks a key step toward the future commercialization of REMaST in Europe.

NEW R&D ADVANCEMENTS: REMaST’S MECHANISM OF ACTION REVEALED AT THE MOLECULAR LEVEL

Thanks to the most recent experimental data, Hemera has taken a significant step forward in the scientific understanding of REMaST, now able to describe its functionality at the molecular level.

This new evidence paves the way for strategic developments on multiple fronts: it will be possible to expand the current phenotypic characteristics of REMaST, with the goal of improving and enhancing its therapeutic effectiveness in treating neurological disorders. In addition, it lays the groundwork for exploring potential synergies with other pharmacological products and, just as importantly, for assessing the extension of REMaST applications to therapeutic areas beyond neurology. This is a key result that strengthens Hemera’s technological platform and significantly broadens its potential for clinical innovation.

 

REMaST READY FOR NEXT CLINICAL STEPS: TEST VALIDATION COMPLETED

Hemera has taken a decisive step forward in the development of REMaST by completing the validation of analytical methods in accordance with EMA and ICH Q2(R2) guidelines. Custom tests were developed to assess the product’s safety, identity, and efficacy, filling a gap where no standard protocols existed on the market. The validated methods enabled the definition of quality controls and acceptance criteria, based on analysis of at least five production batches. These include biological, functional, and phenotypic parameters—such as the ability to stimulate axonal growth.

In parallel, Hemera worked with qualified partners to define and validate the entire production process, including biological reagents. This achievement strengthens the scientific and regulatory foundation of REMaST in preparation for its first clinical use.