Mofema plans to debut on NewConnect

Mofema plans to debut on NewConnect next year, announced president Leszek Wójcik.
“The plans for next year include a debut on NewConnect. We are trying to create documentation that will allow us to carry out the debut process efficiently, ”said Wójcik during the WSE Innovation Day.

Mofema's most advanced project is the PregnaLIFE24 telemedicine electrocardiotocographic system (eKTG).

The management board announced that the company does not plan to launch the product on its own, and that its potential partners will be large industry players. He sees three possible models for commercialization: selling the entire project after design and development or certification, selling a license through a distributor after certification, or selling a data analysis service through distributors. As the president pointed out, the first and the second models are preferred by the company.

“We have started talks with potential domestic and foreign partners. Due to the fact that we have quite a lot to offer, we recognize that we are at a good stage and at a good level of advancement of these talks, ”assessed Wójcik.

Commercialization is planned for 2023/2024, the company said in the presentation. The management board declared that the main direction for Mofema is the USA.

"We plan to submit a complete application for registration [according to the procedure] 510k for the entire product in Q2 [...]. The goal is to have FDA approval for commercialization of the product in the US sometime at the end of next year," said regulatory director Przemysław Tadla.
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