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 in transrectal prostate biopsy* (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 CE marked
Clinical value
For the urologist
Built to improve precision by reducing needle deviation while also reducing bacterial transfer by 96% in transrectal prostate biopsy*.
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% in transrectal prostate biopsy* 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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Reduces bacterial transfer by 96% in transrectal prostate biopsy*
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% in transrectal prostate biopsy*.
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
EU CE Mark (MDR)
CE certification for the Forsvall Biopsy Needle System (MDR 783940), enabling commercial use across the EU and EEA Member States.
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