Infection
Bacterial transmission through needle punctures presents significant infection risks in vastly different areas such as prostate cancer diagnostics, amniocentesis or cortisone joint injections. The hollow standard needle and current biopsy needles (image left) brings bacteria into sterile tissue and introducing a risk of infection. Needle punctures for vascular access for cancer treatments and nutrition can lead to infections as well as a standard needle puncture in an immunosupprimented individual. Rising antibiotic resistance in combination with advanced modern medicine has led to a situation where a novel medical needle is desperately needed. Xagas needle technology reduces the infection causing bacterial transfer by up to 96%1.
Top image shows the collection of fecal matter between the needle parts in a Tru-Cut needle, introducing colon bacteria into the prostate1, one of the problems adressed by Xagas needle technology.
Cancer diagnosis
Most solid cancers such as breast, kidney, liver and prostate-cancer are diagnosed from a tissue sample collected by a biopsy needle. A biopsy needle must hence collect tissue from the exact intended location.. Xaga Surgical biopsy needles are designed to improve on-target biopsy, aiming to improve cancer diagnostics.
Bottom image shows prostate biopsy seen on an ultrasound screen. The Yellow line indicates the intended needle path, the red actual path of a tru-cut needle. Needle deviation is addressed by Xaga.
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.
A revolution in medical needles - The Forsvall fluid needle is designed to reduce the risk of infection in common needle punctures. Aiming to replace the cannula or hypodermic needle invented in 1844. We researched how needle induced infections occur and designed a needle to help prevent them.
Our novel needle is designed to significatly reduce the transfer of bactiera currently causing millions of global infections annually1. It works for both injection and aspiration of fluids, aiming to seamlessly replace the cannula in punctures with risk of infection.
* Awaiting regulatory clearance - needles are not for sale
1 Xaga Surgical estimate based on available scientific data
Implantation metastasis is the growth of secondary cancers along the needle path after a biopsy. It is not uncommon in biopsy of sarcomas (ref) and liver metastasis from colorectal cancer (ref). It is described and feared to be a future problem in transperineal prostate biopsy (ref).
We believe one mechanism of cancer spread may be cancer cells dropped in the needle tract by the current tru-cut needle upon retraction of the needle. Current biopsy needles have an open chamber allowing for this mechanism. Xaga biopsy needle designs have a closed needle chamber aiming to adress this risk.
A study is being intiated.
Image trucut needle and Xaga needle.
Current biopsy needles can collect 5-25 mm biopsy cores, multiple biopsies are used. Current cancer diagnostics is hence based on fragments of the target organ and part of valuble information is lost.
The Forsvall double needle project by Xaga Surgical aims to allow for any length biopsy, the first ever biopsy instrument allowing for full organ biopsy. This will allow give a new dimension of information in biopsy. From fragments to full insight into organ pathology!
A window to a new world of cancer diagnostics, with the possibility to improve diagnostics of 25 million biopsies annually.
The Forsvall Port Needle aims to replace the currently used Huber needle (invented 1946) in subcutaneous venous ports. The Forsvall port needle is designed to reduce the risk of infection currently affecting around 100.000 patients1,2 to an estimated hospital cost o about 5 Bn USD/year3. We researched why these infections occur and designed a needle aiming to prevent them.
The Forsvall Port needle has an open and a closed state, allowing it to be used as a Huber needle but designed to reduce bacterial transfer.
Background info: A subcutanous venous port is a device placed under the skin and connected to the central venous system. It allows the use of chemotherapy in cancer treatment, nutrition when you can not eat and simple blood testing in chronically ill patients. Bacterial transfer into ports may cause very serious or deadly sepsis.
The first image shows The Forsvall Port Needle. The second image shows a Huber needle connected to a Subcutansous Venous Port (SVP). The SVP has direct connection to the patients central blood circulation. The Forsvall port needle aims to help prevent bactieral transfer into ports.
* Late stage prototype - needles are not for sale
1 Xaga estimates >2 million ports/year.
2 Infection risk 4,5-5%; Teichgräber UK, Kausche S, Nagel SN, Gebauer B. Outcome analysis in 3,160 implantations of radiologically guided placements of totally implantable central venous port systems. Eur Radiol. 2011 Jun;21(6):1224-32. doi: 10.1007/s00330-010-2045-7. Epub 2011 Jan 5. PMID: 21207035.
3 Cost estimated to 48.000 USD/blood stream infection ; Center of Disease Control and prevention (CDC): https://www.cdc.gov/infectioncontrol/pdf/strive/CLABSI101-508.pdf
Aiming to reduce the risk of infection and improve cancer diagnostics in one biopsy instrument, Xaga introduces the Forsvall Biopsy system. Based on years of RnD in the clinic, at Lund University and Xaga it is both no different from currently available biopsy systems - yet a revolution.
Compared to currently available biopsy systems we introduce a very subtle design improvement to the needle tip. The result is a reduction of infection causing bacteria by 96%1 and a needle that moves straight in tissue2. In prostate biopsy we envision it to improve both transperineal and transrectal prostate biopsy as well as having the potential to improve accuracy in all soft tissue biopsy. In essense it aims to be safer for the patient, better for the doctor and cost effective for the buyer.
Top image: The Forsvall Biopsy System. Bottom image shows the Forsvall Biopsy Needle tip on top and the currently used Tru-cut needle below. These tip design changes reduce bacterial transfer by 96% and aims to improve cancer diagnostics.
* Awaiting regulatory clearance - needles are 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
Xagas needles all share the closed tip design. When moving in tissue there are in the closed state, eliminating bacterial collection inside the needle. In the open state they work just like current needles.
Xaga biopsy system and double needle are biopsy needles aiming to go beyond infection prevention but also make cancer diagnostics safer and better. Unique features include
perfectly balanced needles moving straight in tissue hitting the target, closed biopsy chamber aiming to reduce the risk of cancer spread. The double needle also aims to improve tissue collection and open a new world of pathology with full organ biopsies!
Xaga's innovative products are currently in the process of obtaining regulatory clearance for use beyond clinical trials.
To stay informed and receive updates once these products are cleared and available for use, please click the link below to provide your contact information.
.PNG)