The Betaglue team has identified an area of unmet need and has developed a novel solution for the prevention of the complications occurring during percutaneous biopsy procedures in soft tissues, such as hemorrhage, pneumothorax (PNX) or tumor seeding.
The biopsy solution is a novel kit composed of an in-situ polymerizing surgical glue (Class III) and a proprietary delivery system (Class I) that allows the application of the glue in the biopsy needle tract while simultaneously retracting the biopsy introducer.
The special mechanism ensures that the amount of glue is predetermined and uniformly distributed, so as to minimize its dependence on the users. The system integrates well with the biopsy procedure as it is currently performed, making the adoption in the clinical practice very easy.
The biopsy market is well established. The performance of biopsies to evaluate lesions is a widespread and well accepted clinical practice in the world, being essential for completing a diagnostic process and/or selecting adequate oncological treatments.
Over 18 million biopsy procedures were performed in US, EMEA, Australia and New Zealand in 2018, with an expected growth rate of 6% per year.
Existing therapies have severe limitations. Although biopsy procedures are very common, they may potentially lead to serious complications: between 20% to 33% of the patients who undergo a lung biopsy develop complications, with prolonged hospital stay and additional costs for the health systems3.
Complications after liver biopsy range from pain to vascular phistulae to serious hemorrhagic events in around 9% of the cases4.
There are no treatments that can prevent biopsy procedure complications, which can only be treated once they arise: for instance, chest drainage is applied in case of PNX and endovascular embolization after liver hemorrhage, both leading to prolonged hospitalization and sizeable increase in the costs for National Health Systems.
The biopsy system from Betaglue works.
One hundred and eighty one patients undergoing ultrasound-guided liver biopsy or radiofrequency ablation for liver tumors were treated at a single institution with the device in order to seal the biopsy needle tract. No decrease in hemoglobin level or other complications were observed at the time of the procedure, nor signs of tumor seeding after 6 months of follow-up5.
Forty patients undergoing CT-guided lung biopsy were enrolled in a multicenter study and treated with the device. The results show a consistent ability of the device to prevent PNX or other hemorrhagic complications in a very sizeable manner (5.0% rate of complications, CI: 0.0%-11.7%)6.
1- Custom Research Study “Biopsy procedure data for target geographies” MartesandMarkets (2019)
2- “Biopsy Devices Market” – The InSight Partenrs (2020)
3- Heerink WJ et Al. Eur Radiol (2017)
4- Norman Oneil Machado, IntechOpen (2011)
5- Izzo F et al., Infectious Agents and Cancer (2015)
6- Study on the Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Procedures Using the MIPP-Kit Device (MIPP-PNX1). Betaglue, Data on file