A Revolution in prostate biopsy
The Forsvall Biopsy Needle (above) vs. the standard Tru-Cut needle (below):
- Built to travel straight in tissue to significantly improve precision
- The patented needle design reduces bacterial transfer by 96% vs Tru-Cut needle* (bacteria collected between needle parts - se arrow)
- Based on years of R&D – it is both no different in clinical workflow from currently available instruments – yet revolutionary in practice
- FDA 510(k) and ISO 13485
Clinical value
For the urologist
Built to improve precision by reducing needle deviation while also reducing bacterial transfer by 96%*.
For the pathologist
High quality biopsies from the intended location enable greater confidence and improved workflow efficiency.
For the payor & insurer
Designed to reduce complications and improve efficacy without any workflow changes
For the patient
Prostate biopsies face two main challenges - infection and missed cancers. The Forsvall Biopsy Instrument reduces bacterial transfer by 96%* and helps urologists hit the target.
Comments about the Forsvall Biopsy System
Unique features
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The Forsvall Biopsy Gun
The Forsvall Biopsy Gun is solid and well balanced. This gives the operator a comfortable and luxurious tactile feel during the biopsy procedure.
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The Forsvall Biopsy Needle
Built to travel straight in tissue, reducing needle deviation to significantly improve precision. Reduces bacterial transfer by 96%* while collecting non-inferior biopsies**.
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Reduced bacterial transfer by 96%*
Comparison of the tip of a Tru-Cut needle and the patented Forsvall Biopsy Needle, please note the opening between Tru-Cut needle parts where bacteria are collected*.
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On target technology by addressing deviation
Forsvall Biopsy Needle trajectory and target collection vs Tru-cut (orange), in-vitro studies***. Deviation affected by tissue density and distance travelled.
*PMID: 33999753
**PMID: 33999764
***A.Forsvall, M. Utter, M. Wagenius, A0758 – Precision in targeted prostate biopsy: A comparative in-vitro study of a novel needle design vs. Tru-Cut needle, European Urology, Volume 87, Supplement 2, 2025, Page S1595, ISSN 0302-2838,
https://doi.org/10.1016/j.eururo.2025.09.3944
The Science
Xaga Surgical´s primary goal has been to transition from identifying problems to delivering effective solutions, which has culminated in our first breakthrough development - the Forsvall Biopsy System. The scientific foundation underpinning these advancements are being explored further with several new products in development.
The Forsvall Biopsy System
- Built to travel straight in tissue, reducing needle deviation to significantly improve precision.
- The patented needle design also reduces bacterial transfer by 96%*.
Developed in hospital by urologists - for urologists. The Forsvall Biopsy Gun is solid and well balanced. This gives the operator a comfortable and luxurious tactile feel during the biopsy procedure.
Based on years of R&D – it is both no different in workflow from currently available biopsy systems - yet revolutionary in practice. Our aim is to improve biopsy diagnostics and to supply the best prostate Biopsy System available.
- One purpose: Prostate biopsies
- One gauge size: 18G
- One needle length: 25 cm
- One reusable biopsy gun
~4 million prostate biopsies globally per year
~1 million prostate biopsies in the US per year
Certificates & Awards
U.S. FDA 510(k)
Clearance for the Forsvall Biopsy Needle System (K242128) registration for use in the U.S.
ISO 13485:2016
Ensuring the highest standards of quality and safety in medical devices
Best paper
By Engineering & Urology Society, AUA Annual Meeting 2025, Las Vegas
Top ten most promising global startups
In urology by AUA | Innovation Nexus, AUA Annual Meeting 2024, San Antonio
Best abstract
By International Prostate Cancer Update 2023, Vail, Colorado