- OncoSil Medical has secured G-BA approval for a fully funded trial to evaluate its OncoSil device.
- Successful results from the clinical trial are anticipated to lead to public insurance reimbursement funding of the device for all patients in Germany.
- The device targets patients with Locally Advanced Pancreatic Cancer.
- Revenue receipts from the device provision during the study would aid revenue growth.
Shares of OncoSil Medical Ltd (ASX:OSL) rallied by nearly 14% to AU$0.041 in the morning trading session following the release of a significant update on OncoSilTM device. The medical device company has secured approval for a fully funded trial in Germany to evaluate its OncoSil device.
OncoSil Medical is focused on advancing radiation for cancer patients. The company’s lead product is OncoSil™, a targeted radioactive isotope (Phosphorus-32) implanted directly into a patient’s pancreatic tumours through an endoscopic ultrasound.
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G-BA approves trial in Germany
Today, the company announced to have received approval from the Federal Joint Committee (G-BA) for conducting the trial to assess the OncoSil device compared with chemotherapy in the treatment of Locally Advanced Pancreatic Cancer (LAPC).
The OncoSil™ device has a Breakthrough Device designation in the US, UK and Europe with a CE mark in Europe and the UK.
Potential benefits from the trial
- The comparative trial will represent remarkable opportunity for OncoSil to improve the current body of evidence.
- Successful results from the G-BA clinical trial are expected to aid in securing public funding to treat patients in Germany with unresectable locally advanced pancreatic cancer.
- OncoSil will also get additional device sales revenues for the provision of OncoSil™ during the study.
The commencement and funding of a clinical trial follow the receipt of a “Positive Status 1” classification under the innovation funding (NUB) program. The G-BA decision and the classification under the NUB program are expected to remarkably boost the profile of the OncoSil™ device with Key Opinion Leaders and stakeholders in the German market and throughout the EU and the UK.