ProstaLund AB (publ) announced that the Company has decided to withdraw its 510(k) application and intend instead to submit a "De Novo" application for market approval for the Schelin Catheter® in the US. The background is that ProstaLund applied for a 510(k) application in July 2022. A 510(k) application is based on the fact that there are already similar approved products launched in US.

The FDA has now announced that they do not believe there are similar products (predicate device) to Schelin Catheter® - it is unique. This means that a "De Novo" application, that is an extended application is required to verify the safety and efficacy for the intended use. A De Novo application means an application process that is adapted to low- or medium-risk medical devices where similar products are not available on the US market.

The next phase will include a pre-submission meeting with the FDA to get the agency's preliminary view on how the final application should be designed. This phase is expected to start after the summer. It is estimated that the registration process takes 12 months.

Schelin Catheter® is a unique injection tool that allows urologists to administer drugs into the prostate in a sterile manner through the urethra. Pain relief for most minimally invasive treatments of benign prostatic hyperplasia (BPH/BPE) is usually in local anesthesia injected through the rectum, spinal anesthesia or patients being under full anesthesia during the procedure. It can entail significant risks of severe infections and even full anesthesia is associated with risks and requires large resources in the form of monitoring and beds.

This is avoided when using Schelin Catheter® It takes about 4 minutes per patient to administer anesthetic with Schelin Catheter® before the intended treatment and the patient can go home almost immediately after treatment.