Regulatory press release

COMMERCIAL BREAKTHROUGH: Prostatype® ready for sale in the U.S. market worth SEK 2 billion annually

Prostatype Genomics AB (“Prostatype Genomics” or the “Company”) hereby announces its most significant commercial milestone to date: the entry strategy for the U.S. market, with the genetic test Prostatype® now available for sale in the USA. Additionally, the genetic test Prostatype® is already in clinical use with its first patients.

As part of the U.S. strategy, Prostatype® have undergone a process of preparation, development, and market penetration in the U.S. This entry includes several already achieved milestones before the Company intends to obtain Medicare approval for reimbursement in Q4 2024. Being commercially available is a major leap forward and a prerequisite for the Medicare approval.

“The scalability and general technology of our genetic test, Prostatype®, are well-suited from a business model perspective for the U.S. market, which is why we have also shifted our focus and strategy to the states. We are close to tapping into a major market, and with Prostatype® being ready for sale, we are even closer to reaching the major milestone of obtaining Medicare approval in Q4 2024. The feedback we have received from American urologists has been overwhelmingly positive, and we are confident in the successful implementation and active use of our genetic test”, says Fredrik Rickman, CEO of Prostatype Genomics.

The next milestone, also being a pre-requisite for Medicare approval, is the completion of interim data with focus on the Afro-American population from the ongoing validation study in the U.S., expected in Q2-Q3 2024.

For more information, please contact:
Fredrik Rickman (Persson), CEO Prostatype Genomics AB
Telephone: +46 (0)73 049 77 01

About Prostatype Genomics AB
Prostatype® is a genomic test that is available to patients and treating urologists as a complementary decision basis for the question of treatment or no-treatment of prostate cancer. The test was developed by a leading research group at Karolinska Institute and is provided by Prostatype Genomics AB.