OncoSil Medical Ltd (ASX: OSL) is celebrating the treatment of the first 10 patients with the OncoSil device in Spain.
Since treating the first patient in April 2022, four hospital sites have performed the implantation of the OncoSil device, resulting in the first 10 patients being treated within Spain.
The sales team in Spain are continuing to activate additional hospital sites and will be continuing to work with existing sites for additional treatments in the coming months.
We are proud of having achieved this significant milestone in the Spanish market and provide hope to patients who otherwise have a poor prognosis,” OncoSil’s CEO and Managing Director, Nigel Lange, said.
“Our efforts are to further extend our reach into other areas within Spain, the EU and the UK.”
About OncoSil
OncoSil Medical is a medical device company seeking to advance radiation for cancer patients. OncoSil Medical’s lead product, OncoSil is a targeted radioactive isotope (Phosphorus-32), implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound.
Treatment with the OncoSilTM is intended to deliver more concentrated and localised beta radiation compared to external beam radiation. OncoSil Medical has conducted six clinical studies with positive results on tolerability, safety and efficacy. CE Marking has been granted for the OncoSil device which can be marketed in the European Union and the United Kingdom. The OncoSil device has also been classified a Breakthrough Device in the European Union and the United Kingdom.
An Investigational Device Exemption (IDE) has been granted by the United States Food and Drug Administration (FDA) to conduct a clinical study of the OncoSil device aimed at supporting a PMA approval.
In December 2018, the FDA granted Humanitarian Use Designation (HUD) for the OncoSil device for the treatment of unresectable bile duct cancer. In March 2020, the FDA granted Breakthrough Device Designation for the OncoSil for unresectable pancreatic cancer in conjunction with systemic chemotherapy.
Pancreatic cancer is typically diagnosed at a later stage, when there is a poor prognosis for long-term survival. The World Cancer Research Fund estimated that in 2012, 338,000 people globally were diagnosed with pancreatic cancer. The prognosis for patients diagnosed with pancreatic cancer, regardless of stage, is generally poor; the relative five-year survival rate for all stages combined is approximately 5%. The estimated world-wide market opportunity for OncoSil in pancreatic cancer exceeds $3b.