COMPANY:

Prostatype Genomics

"Prostatype Genomics has applied for reimbursement for Prostatype® under an already established regulatory framework (L38293/L38338) with Medicare in the U.S. market, where a reimbursement level has already been established (USD 3,783 per completed test). Prostatype® is designed to address the clinical question of whether a patient should undergo radical treatment or not (typically surgery or radiation therapy) in connection with a prostate cancer diagnosis. Despite the very low mortality rate among low- and intermediate-risk prostate cancer patients, many men are unnecessarily subjected to radical treatment, often resulting in significant lifelong side effects, primarily impotence and incontinence, leading to reduced quality of life."

"Prostatype Genomics announces that previously communicated positive results from a Spanish multicentre study with Prostatype®, have now been confirmed in a scientific journal. The study included 93 patients with prostate cancer at seven Spanish hospitals, where Prostatype® delivered significantly better prognostic performance compared to NCCN®, D'Amico and EAU for both the risk of prostate cancer-specific mortality within 10 years as well as to predict the risk of developing metastasis."

"Prostatype Genomics announces that the company's commercial activities in the U.S. continue to develop in a positive way. The number of selected American urologists at urology clinics/hospitals who have started using Prostatype® clinically for risk classification of established prostate cancer is gradually increasing and now exceeds 10 in total. Furthermore, the company has engaged a billing partner who will handle administration and financial flows linked to reimbursement from Medicare and other healthcare insurance providers. The company's ongoing Medicare application for reimbursement is progressing, and the company is in active dialogue with Medicare to deliver the remaining clarifications requested."

"This newsletter highlights two significant achievements: positive preliminary results in the U.S. study with Prostatype® conducted with leading U.S. institutions, and that the clinical use of Prostatype® in Italy is increasing following the order received by the company in December last year. Additionally, two filmed presentations in the United States and a link to an Italian article about Prostatype® and the company’s collaborator Professor Pierluigi Bove are included."

"Prostatype Genomics is pleased to announce that preliminary results from the study conducted in the United States in collaboration with leading institutions shows promising results. Prostatype® is a genomic test designed to improve risk stratification of patients diagnosed with non-metastatic prostate cancer. The study has a diverse patient population, with a significant proportion of African American patients, which is crucial for ensuring the clinical utility of the test in a patient population with multiple ethnicities."

"Prostatype Genomics AB announces that the results from the health economics study with the company's prognostic genomic test Prostatype® now has been published in the renown scientific journal PharmacoEconomics. The study and a complementary analysis, both conducted by the Institute for Health and Healthcare Economics (IHE), show that Prostatype® can contribute with just over 800 MSEK in annual health economic benefit just in Sweden compared to the method for risk classification of established prostate cancer that is currently being used in Sweden's healthcare system."

"Prostatype Genomics AB announces that the company has compiled and submitted supplementary answers in the final phase of its Medicare application to get the prognostic genomic test Prostatype® approved for reimbursement in the United States. The compilation has been conducted in an efficient manner together with external partners in Sweden and the United States to create optimal conditions to complete the application process and get Prostatype® approved for reimbursement in the near future."

"Prostatype Genomics AB announces that the company's application for inclusion of the genomic test Prostatype® in the federal U.S. healthcare program Medicare's reimbursement system is now in its final phase. A limited number of supplementary questions have been received, and the company is working on compiling the answers which will be submitted to Medicare shortly. The company has thus taken a major step towards completing the application process and getting Prostatype® approved for reimbursement in the near future."

"Prostatype Genomics AB...announces that the Company has received its largest order so far, valued at SEK 1.3 million, from University Hospital Policlinico Tor Vergata in Rome, Italy. The order comprises a low three-digit number of test kits for Prostatype®, the Company's prognostic gene test used for diagnosed prostate cancer. The hospital laboratory where the tests will be analysed has been validated by the Company, which means that testing of Italian patients can be initiated shortly."

"Prostatype Genomics AB announces that the company has obtained certification in accordance with the EU regulation for medical devices for in vitro diagnostics (IVDR), following a comprehensive evaluation process by its notified body TÜV SÜD. The certification asserts that the company's operations within prognostic gene testing for diagnosed prostate cancer meet high standards in safety, quality and performance, and thus constitute an important regulatory milestone."

"Prostatype Genomics AB announces that its wholly owned subsidiary Prostatype Genomics Inc. has submitted its application for the Company's gene test Prostatype® to be approved for reimbursement by the Medicare healthcare system in the United States in line with the previously announced timeline. The Company continues to have Medicare approval in Q4 2024 as a business goal. The application is submitted within the MolDX program for molecular diagnostic tests. The US market is the world's largest single market for prognostic gene tests for diagnosed prostate cancer, with annual sales corresponding to approx. 2 billion SEK."

"Prostatype Genomics AB...announces concrete commercial progress in Spain following the presentation of positive data from a Spanish multicentre study with the genetic test Prostatype® in April. Agreements have so far been signed with around ten private healthcare providers in the country, of which some have started using the test commercially, and negotiations are ongoing with over ten university hospitals and additional private healthcare providers."