Optheras receives FDA Breakthrough Device Designation for laser treatment of bladder cancer

Danish medtech company Optheras, which develops, commercializes, and expands the use of ground-breaking laser technology for the treatment of non-invasive bladder tumors without hospital admission and general anesthesia, has received Breakthrough Device Designation status from the U.S. Food & Drug Administration (FDA) for the company’s laser and related single-use fiber for treatment of Ta-LG bladder tumors.

The FDA Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. With the granting of Breakthrough Device Designation status, the FDA has made the determination that there is a reasonable expectation that Optheras’ device, if approved, has the potential to offer a more effective treatment relative to the current standard of care.

The treatment is based on an adaptive laser technology, which is being developed by Optheras with a close clinical collaboration with the department of urology at Herlev and Gentofte Hospital in Denmark. According to one study, regular patient follow-ups and treatments can make bladder cancer one of the most expensive cancer types for the healthcare system[1].

For Optheras, Breakthrough Device Designation status opens access to a closer dialogue with FDA during the development phase and an opportunity to expedite the development, assessment and review during the pre-market review phase by the FDA.

“We are thrilled to have received Breakthrough Device status from the FDA, enabling the possibility of accelerated development of this ground-breaking technology and gentle treatment method. It is a breakthrough for Optheras and great news for the patients who will be able to avoid anesthesia, hospital admission, other potential side effects and aftercare. We look forward to continuing the development of the technology and obtaining the necessary market authorizations in the coming years,” says Thomas Alkeskjold, CEO of Optheras.

Around 2,000 new cases of bladder cancer are diagnosed in Denmark each year, and approximately half are non-invasive and could potentially benefit from treatment with the efficient laser procedure, if approved. Each year, between 6,000 and 8,000 conventional transurethral resections of bladder tumors are completed in the operating theatre with general anesthesia. The direct cost related to these procedures amount to DKK 150-200 million annually in the Danish healthcare system alone, and in the western world, the number of procedures is estimated to exceed 1 million corresponding to direct costs of USD 3-5 billion.

[1] Economic impact of bladder cancer (BC) in the United States (US). Otavio Clark, Tulio Sarmento, Anthony Eccleston, Julia Brinkmann, Renato Picoli, Vamsi Daliparthi, Jorine Voss, Sanjana Chandrasekar, Allison Thompson, and Jane Chang. s.l.: Journal of Clinical Oncology, 2023;41.6.