The Forsvall Biopsy System looks and functions just as any biopsy system on the market today. However it aims to introduce two major advantages compared to currently available biopsy needles.
It reduces infection causing bacterial transfer by 96%1, aiming to significantly reduce the risk of infection in biopsy, especially developed for transrectal and transperineal prostate biopsy.
It’s unique and patented design allows it to travel straight in tissue – aiming to hit a suspected cancer more central and hence collect a more representable biopsy2. These improvements aims to making it the tool of choice in MRI-first modern prostate cancer diagnostics, regardless if transperineal or transrectal route is preferred by the urologist.
* Awaiting regulatory clearance - The Forsvall Biopsy System is not for sale
1 Forsvall A, Fisher J, Cardoso JFP, Wagenius M, Tverring J, Nilson B, Dahlin A, Bratt O, Linder A, Mohanty T. Evaluation of the Forsvall biopsy needle in an ex vivo model of transrectal prostate biopsy - a novel needle design with the objective to reduce the risk of post-biopsy infection. Scand J Urol. 2021 Jun;55(3):227-234. doi: 10.1080/21681805.2021.1921023. Epub 2021 May 17. PMID: 33999753.
2 Please see videopresentation 2, Research section.
Prostate biopsy is done to diagnose or monitor prostate cancer. It can be made in two ways, transrectal or transperineal, interestingly the same needle is used.
Both methods has problems with infections (caused by bacteria collected by the biopsy needle) and needle deviation leading to missed diagnosis.
The Forsvall biopsy system by Xaga Surgical aims to both improve patient safety and cancer detection in prostate biopsy, regardless if transperineal or transrectal technique is used. Reducing infection causing bacterial transfer by 96% and aiming to hit the cancer better than today it is the technique of the future.
Most cancers are diagnosed using a biopsy needle. But to diagnose a cancer, the needle must first hit it and collect tissue from it. If the needle deviates it risk moving away from the tumor, affecting diagnostic accuracy. The Forsvall neeldes patented streamlined design with a balanced tip creates a needle that is engineered to move straight in tissue. Designed to hit the target.
Ultrasound image of prostate biopsy. Yellow line shows the expected needle trajectory. The red line shows a common needle trajectory of the tru-cut needle. This deviation is due to the tru-cut needle design and has been adressed in the Forsvall Biopsy System.
The second image shows the Forsvall Biopsy Needle tip. The patented needle design allows for a streamlined, balanced tip with needle parts supporting each other - eliminating the factors that makes the current needle (below) to deviate in tissue.
1 Forsvall A, Fisher J, Wagenius M, Broman C, Korkocic D, Bratt O, Linder A. Prostate biopsy quality and patient experience with the novel Forsvall biopsy needle - a randomized controlled non-inferiority trial. Scand J Urol. 2021 Jun;55(3):235-241. doi: 10.1080/21681805.2021.1921024. Epub 2021 May 17. PMID: 33999764.
Current biopsy needles designed in 1960s are not designed to be preventive against infection.
Now antibiotic resistance is a global problem and bacterial transfer into sterile tissue may cause life threatening infections. Almost 100.000 men are hospitilized due to a severe infection caused by biopsy needles each year. All Xaga Surgicals needles are designed to be preventive against infections. Infections are caused by bacterial transfer by the needle, Xaga surgical is (to our knowledge) the only company in the world to adress this problem.
The Forsvall biopsy system needle design reduced the infection causing bacterial transfer by >99% in proof of concept test. In a real world simulation of prostate biopsy bacterial reduction was 96% and in a clinical trial tissue collection and patient experience was non inferior to current needles.
The Forsvall biopsy system aims to be a replacement product for current biopsy systems. Safer for the patient, better for the doctor and cost effective for the user.
The Double needle is a patent pending product under development at Xaga Surgical. It aims to take cancer diagnostics one step further. It aims to give the pathologist a whole new perspective by offering full organ length biopsy. Combinded with MRI it aims to allow a direct connection of the biological findings at cell and gene level with modern diagnostic technology, a vital link in future cancer diagnostics.
The biopsy needle is the cornerstone of tissue collection for diagnosing suspected cancers and other diseases. It's astonishing that in a world of emerging biomarkers, AI, and highly competitive MRI and PET scans, the most critical diagnostic tool has stagnated at a 1960s level. At Xaga Surgical, we're committed to changing that. Our mission is to propel the biopsy needle into the modern era, revolutionizing diagnostics for a healthier future.
At Xaga Surgical, we're dedicated to strengthening the weakest link in modern cancer diagnostics. Our vision for biopsy products is clear:
Safer for the patients: Reducing infections and improving cancer diagnostics.
Better for the doctor: A needle that works with you, not against you.
Cost-effective for the buyer: Ensuring affordability total cost.
Cost-saving for society: Reducing the burden of healthcare costs.
Profitable for the producer: Sustaining innovation and progress.
How do we achieve this vision? By making simple yet elegant and significant improvements in needle design that elevate cancer diagnostics and minimize the risk of infections. Simply elegant - as it should be.
Infection and improved cancer diagnostics adressed in one product!
Cost effective, safe and no change in workflow.
The future of prostate biopsy.
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