Optheras continues progress and raises capital for clinical study

The Danish medtech company Optheras, which is developing, commercializing, and expanding the use of a new groundbreaking laser technique to treat superficial bladder tumors without hospitalization or anesthesia, has raised DKK 38 million (USD 6 M) from all existing shareholders to conduct the company’s first clinical study.

The clinical study is intended to demonstrate the core technology’s functionality and compliance, continuing Optheras’ planned progress. Since its founding in 2022, the company has expanded its organization to 22 highly specialized employees, developed a preclinical prototype, and is close to completing a major preclinical in-vivo study. This study uses pathological analyses to compare the safety and efficacy of the company’s adaptive laser technology with conventional laser methods.

“After three busy years at Optheras, we’re ready to take the next step and carry out our first clinical study. We’ve developed our groundbreaking core technology and built a fantastic team, which is now putting the final touches on the preclinical work and creating the right organizational and physical framework for development, quality assurance, and cleanroom production. That’s why we’re also pleased to have raised capital from our shareholders for the next stage of our effort to ensure that patients can avoid anesthesia, hospitalization, potential side effects, and post-treatment,” says Thomas Alkeskjold, CEO of Optheras.

In May 2024, Optheras achieved Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the company’s laser and accompanying disposable fiber for the treatment of Ta low-grade bladder tumors. The voluntary Breakthrough Device Designation program targets medical devices that can provide more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions -and is intended to ensure faster access to medical devices for patients and healthcare professionals by accelerating development, assessment, and review towards premarket and 510(k) approval as well as De Novo marketing authorization.

In recent years, Optheras has worked strategically to validate the company’s market assumptions and has conducted several blinded interviews with U.S. urologists, nurses, and payers, along with follow-up surveys confirming both the need for and interest in the technology and treatment. Furthermore, Optheras has received positive feedback and established constructive dialogue with several industrial players regarding the development and dissemination of the new technology and treatment method.

The treatment is based on adaptive laser technology, operating through optical feedback from tumors inside the bladder. This technology is being developed by Optheras in close clinical collaboration with the urology department at Herlev and Gentofte Hospital. Frequent checkups and treatments make bladder cancer one of the most expensive cancer types for healthcare systems.

In Denmark, approximately 2,000 new cases of bladder cancer are diagnosed annually, and between 6,000 and 8,000 conventional transurethral procedures are carried out each year for the diagnosis and treatment of bladder cancer through procedures involving full anesthesia and hospitalization. Optheras estimates that around half of these procedures could be treated using their effective laser method, pending approval.

The direct annual cost of these procedures for the Danish healthcare system is estimated at DKK 150–200 million, and in the Western world, the number of such procedures is estimated to exceed 1 million annually-corresponding to direct costs of USD 3-5 billion.