Biopsy for diagnosis of prostate cancer is a sensitive procedure, and millions of biopsies are performed annually worldwide. Around three percent of the procedures cause serious complications such as infections or injuries, which cause great suffering and extensive healthcare costs.
The new biopsy instrument has a needle design that, according to studies, reduces bacterial transmission by up to 96 percent. The design of the needle differs significantly from the old needle technology, which prevents bacterial transmission and allows the needle to travel in a completely straight path through the body to the sample area. This improves the precision and efficiency of prostate biopsies. Xaga's new biopsy instrument is already used clinically today by leading urologists at several American centers, including the renowned Penn State College of Medicine.
“I have seen many men suffer from infections after prostate cancer biopsies with today's biopsy needle design, which is over 50 years old. Today's standard needles can also deviate away from the prostate during sampling. Our technology is developed to both improve diagnostic accuracy and reduce the risk of bacterial transmission that causes infections with a single instrument – with the ambition to contribute to safer, better and more cost-effective care. The FDA approval and the fact that leading American centers are already using our technology are important validations. With the new capital, we can accelerate use in the United States while continuing to work towards CE marking for use and establishment in Europe”, says Andreas Forsvall, senior physician in urology and founder of Xaga Surgical.Following the FDA approval, Xaga Surgical has secured SEK 17 million in new capital from previous owners and investors that will accelerate use in American specialist clinics, as well as increase production capacity and prepare for establishment in Europe. Approval (CE marking) by European authorities is expected later this year. The company has previously raised SEK 30 million in capital from SmiLe Inject Capital and Almi Invest, among others.
“The modern biopsy needle is our first product and there are plans for more types of medical technology that aim to reduce the risk of infection in connection with needle sampling and improve cancer diagnostics,” says Andreas Forsvall.
Source: Xaga Surgical. (2026). New Swedish Biopsy Needle Receives FDA Approval – Secures SEK 17 Million in Capital [Press release]. https://xagasurgical.com/.