The G-BA is designing a test study on the “OncoSil” therapy
17.05.2022 11:06
OncoSil Medical Ltd announces that the Federal Joint Committee (G-BA) has decided to evaluate the endoscopic injection implantation of 32P-labeled microparticles in irresectable, locally advanced pancreatic tumors in a test study.
The basis for this decision is the granting of NUB status 1 by the Institute for the Hospital Remuneration System (InEK). This allows hospitals and health insurance companies to individually agree on a NUB fee for OncoSil™ therapy as part of a test study. This study is currently being designed by the G-BA. The evaluation of OncoSil™ technology as potentially positive and the decision to fund a clinical trial will allow the company to significantly expand the current evidence base for OncoSil™ therapy.
The ethics committees of the participating clinics are centrally supported by the University Hospital of Cologne, which has registered as the central ethics body in the OSPREY patient register. “We hope that the trial study confirms the potential of this therapy and that an additional treatment option will be available for this patient group in the foreseeable future,” said Univ.-Prof. Michael Hallek, Director of the Clinic for Internal Medicine and the CIO Aachen Bonn Cologne Düsseldorf.
The company expects that the positive results of the clinical study will lead to long-term success of this therapeutic procedure in the longer term. Successful completion of the study should also lead to the approval of public funding for the treatment of patients with locally inoperable advanced pancreatic cancer and to similar study programs within the EU.
The OncoSil™ implant has CE Mark in Europe and the UK and receives Breakthrough Device status in the US, Europe and UK.
“The G-BA has created the possibility for the medical use of the OncoSil™ treatment while simultaneously including patients suffering from pancreatic cancer in a clinical study in Germany. That's a great success. I am confident that this therapy will be available to suitable patients in Germany in the future. Positive results of the study will lead to funding for OncoSil™ treatment for all patients with locally advanced pancreatic cancer - especially because OncoSil™ technology is an additional treatment option for patients with a life-threatening disease with few treatment options and a poor prognosis." , explains Nigel Lange, CEO and Managing Director of OncoSil Medical.
Pancreatic cancer
In Germany, almost 20,000 people develop pancreatic cancer every year. Because it goes for a long time without any noticeable symptoms, it is often only diagnosed at a late stage, when the prognosis for long-term survival is already very poor. The five-year survival rate is approximately 10 %, making it one of the lowest survival rates for cancer.