Optheras A/S, a medical device company focused on advancing minimally invasive bladder cancer treatment, announced today that its ATLAS platform (Automatic Targeting Laser Ablation System) has been accepted into the U.S. FDA Total Product Life Cycle (TPLC) Advisory Program Pilot (“TAP Pilot”), administered by the agency’s Center for Devices and Radiological Health (CDRH).
The acceptance, confirmed by the FDA CDRH Office of the Center Director on July 28, 2026, follows Optheras’ request for enrollment in TAP Pilot program for the ATLAS System proposed indications for use covered under its 2024 Breakthrough Device Designation.
Being accepted into the TAP Pilot gives us a structured, ongoing line of engagement with FDA as we advance ATLAS toward our pivotal trial and regulatory submission. It also provides opportunities for early engagement with Non-FDA stakeholder including patient groups, clinicians, payers and Centers for Medicare & Medicaid Services (CMS)
Thomas Alkeskjold, CEO and co-founder of Optheras.
He continues: “It reflects the strength of the regulatory groundwork our team has built alongside our Breakthrough Device Designation, and it gives us an added layer of alignment with the Agency as we move through the next stages of clinical and regulatory development.”
Optheras is an innovative medtech company founded in 2022 by experts from the Danish laser industry and the urology department at Herlev and Gentofte Hospital where a research group has worked since 2014 on the development of ground-breaking laser technology for the potential treatment of non-invasive bladder tumors without hospital admission and general anesthesia.
Based on results of scientific research, clinical trials and good practical experience, the team behind the technology, T&W Medical and three business angels have founded Optheras A/S with a view to further develop, commercialize and expand the use of the laser treatment. Optheras has 13 employees and offices in Birkerød.
The ATLAS System’s acceptance into the U.S. FDA TAP Pilot Program follows its 2024 Breakthrough Device Designation, placing Optheras among a limited number of companies to receive both recognitions.
Participation in the TAP Program establishes structured, ongoing engagement with the FDA through the device’s regulatory development and review process
