OncoSil Medical obtains CE Mark and breakthrough device designation for its pancreatic tumour isotope
Medical device company OncoSil Medical (ASX: OSL) has announced that it has finally received the CE Mark from the British Standards Institute (BSI) for its proprietary OncoSil device – a means of treating locally advanced pancreatic cancer (LAPC) in combination with chemotherapy.
The company said OncoSil is a first in class medical device comprising microparticles containing phosphorus-32, a pure beta-emitter radioisotope, implanted directly into a patient’s pancreatic tumour via endoscopic ultrasound guidance.
According to the medical device company, this initial approval serves as a major milestone and opens the door for the device to be marketed and sold within the EU and the UK.
Being passported into both territories is a significant achievement considering the ongoing Brexit negotiations and the potential for the two regions to diverge on their respective trade policies in the coming years.
“Designation of the OncoSil device as a breakthrough device is a validation of our platform technology which can be used to treat multiple solid tumour types such as liver, biliary duct and of course pancreatic cancer,” said Daniel Kenny, chief executive officer and managing director of OncoSil.
“Having secured CE Marking approval, our focus is now on multiple registration filings in jurisdictions which recognise CE Marking certification,” he added.
Mr Kenny also confirmed that the current COVID-19 pandemic had left OncoSil’s regulatory pathway “unaffected” although he did confirm the pandemic would impact the company’s launch preparedness, including delaying OncoSil’s European debut.
The company expects disruptions due to limited hospital access in the coming months for new site initiation and training as well as shipping and logistical disruption.
With operations in multiple regions secured, OncoSil announced it will “immediately commence” multiple registration filings in key ASEAN and APAC markets which recognise CE Marking certification.
A key aspect of OncoSil’s approval from the BSI is that its device has been designated as a “breakthrough device” which means it has been proven to deliver clinical benefit to patients for unmet medical needs which are life-threatening, and for which current medical alternatives are insufficient or carry significant risks.
BSI’s approval also means that OncoSil is now officially licenced as a breakthrough device in the EU, the UK as well as the US.
To achieve its multi-region certification, OncoSil generated “compelling clinical data” as part of a PanCo study. To support its case, the company provided a detailed comparative analysis, or what’s known as “naïve in-direct treatment comparison” of the PanCO results with state-of-the-art treatment for unresectable locally advanced pancreatic cancer (LAPC).
According to OncoSil, state-of-the-art treatments included a broad range of clinical studies of systemic chemotherapy as well as induction chemotherapy and consolidated chemo-radiotherapy regimens supported in clinical guidelines for the treatment for unresectable LAPC.
Having obtained its cornerstone clinical data and comparative analysis, OncoSil declared the results confirm that the OncoSil device, when combined with contemporary systemic chemotherapy regimens, demonstrates multiple facets including excellent local disease control, prolonged overall survival, an encouraging rate of surgical resection and prolonged progression-free survival.
OncoSil’s device was shown to create a higher disease control rate, marked tumour volume reduction and, possibly most importantly from a commercial perspective – superior outcomes to comparable alternatives.
The OncoSil device recently being granted breakthrough device designation from the US Food and Drug Administration (FDA).
Shares in OncoSil Medical were up over 22% to $0.165 in early morning trade.