Cellda Prostate for cancer diagnosis - regulatory and market evaluation

Purpose and goal

The project consists of two parts. For the specified markets, the potential for the product Cellda® Prostate is evaluated, and potential partners for collaborations are identified. The goal is to further develop the company´s market strategy. The regulatory documentation for Cellda® Prostate is reviewed and supplemented. The aim is for it to be finalized in preparation for an upcoming clinical performance study and before submitting a certification application.

Expected effects and result

After the project, markets with the greatest potential for Cellda® Prostate have been prioritized and basis for starting collaborations with other actors as well as for funding of the company has been created . The regulatory documentation has been reviewed, areas for development and improvement have been identified and addressed. The overall expected results are that the project has contributed to Cellda® Prostate being ready for CE-proposal and has expanded knowledge of priority markets.

Planned approach and implementation

Hired consultants and experts will work with the company´s operational team to implement the project. The project manager calls joint project meetings to plan and follow up activities, identify tasks and reporting. The project manager ensures that the project´s implementation, results and conclusions are documented and implemented as well as that competence transfer is ensured.