Swedish medical technology company Xaga Surgical has raised SEK 17 million (€1.6 million / $1.8 million) following FDA 510(k) clearance for its next-generation prostate biopsy instrument, as the company accelerates commercialization in the United States and prepares for European market entry.
The Helsingborg-based startup has developed a novel biopsy needle designed to improve the safety and accuracy of prostate cancer diagnostics by significantly reducing the risk of bacterial transmission during biopsy procedures.
The new funding, provided by existing investors and shareholders, will support expanded adoption across U.S. specialist clinics, increased manufacturing capacity, and preparations for CE marking in Europe.
Modernizing a 50-Year-Old Medical Procedure
Prostate biopsies remain the standard method for diagnosing prostate cancer, with millions of procedures performed worldwide every year. However, traditional biopsy needles have changed little in decades and can lead to complications including infections, bleeding, and inaccurate sampling.
According to Xaga Surgical, approximately 3% of prostate biopsy procedures result in serious complications, creating significant costs for healthcare systems and unnecessary suffering for patients.
The company’s newly developed biopsy instrument addresses both safety and precision.
Its redesigned needle architecture reduces bacterial transmission by up to 96%, according to clinical studies, while maintaining a straighter path to the target tissue during sampling. The improved trajectory is intended to increase biopsy accuracy and reduce the risk of missed cancer lesions.
FDA Approval Opens the U.S. Market
Receiving FDA 510(k) clearance marks a major commercial milestone for the Swedish startup.
The biopsy system is already being used by leading urologists at several U.S. medical centers, including Penn State College of Medicine, providing early clinical validation ahead of broader market expansion.
Founder and urologist Dr. Andreas Forsvall said the technology was developed after witnessing complications associated with conventional biopsy devices throughout his clinical career.
“I have seen many men suffer from infections after prostate cancer biopsies using today’s biopsy needle design, which is more than 50 years old. Our technology is designed to improve diagnostic accuracy while reducing bacterial transmission with a single instrument.”
He described the FDA clearance and early clinical adoption as important validation of the technology’s potential to improve patient outcomes.
Funding to Expand Commercial Adoption
The newly secured SEK 17 million investment will allow Xaga Surgical to increase production, expand commercialization across the United States, and prepare for its European launch once CE marking is obtained.
The company expects European regulatory approval later this year.
Prior to this financing, Xaga Surgical had already raised approximately SEK 30 million from investors including SmiLe Inject Capital and Almi Invest, supporting the development of its proprietary biopsy platform.
Building a Broader Infection-Prevention Platform
While the FDA-approved prostate biopsy needle is Xaga Surgical’s first commercial product, the company sees broader opportunities beyond prostate cancer diagnostics.
According to Forsvall, Xaga plans to develop additional medical technologies aimed at reducing infections associated with needle-based procedures while improving diagnostic performance across other areas of healthcare.
As hospitals worldwide continue to prioritize patient safety, infection prevention, and more precise cancer diagnostics, Xaga Surgical is positioning itself as a new player in minimally invasive medical technology—combining clinical innovation with practical improvements to one of urology’s most common procedures.
