OncoSil granted FDA Breakthrough Device Designation
OncoSil Medical Ltd (ASX:OSL) today announced that the OncoSilTM device has reached a significant milestone, receiving Breakthrough Device Designation by the US Food and Drug Administration (FDA) for the treatment of unresectable locally advanced pancreatic cancer in combination with systemic chemotherapy.
OncoSilTM is a targeted radioactive isotope (Phosphorus-32) that’s implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound. The treatment by this device delivers more concentrated and localised beta radiation compared with external beam radiation.
OncoSil Medical is now well positioned to accelerate its device development plans in the US as the Breakthrough Device Designation will expedite development and approval of the OncoSilTM device in the country.
The OncoSilTM device represents breakthrough technology and offers significant advantages over existing approved or cleared alternative treatments.
Daniel Kenny, CEO and Managing Director of OncoSil Medical said, “The granting of Breakthrough Device Designation by FDA of the OncoSilTM device offers the company many benefits with respect to PMA trial design, device assessment and expedited review.
“Breakthrough designation also provides validation of the OncoSilTM device as it represents a novel technology that has the potential to provide clinically meaningful benefits to patients in terms of increased Overall Survival (OS) and downstaging tumours to resection with curative intent.”
US FDA Breakthrough Device Designation
The Breakthrough Devices Program (BDP) is intended to expedite the FDA review and approval of designated devices that may provide more effective treatment of life-threatening or irreversibly debilitating diseases.
The BDP is intended to assist patients gain faster access by expediting device development, assessment, and review, while preserving the standards of premarket approval.
The company will now work closely with the FDA to ensure that the proposed premarket approval (PMA) evidence development and clinical trial design captures clinically meaningful data required in the post market setting.
To qualify for FDA Breakthrough Device Designation a company must demonstrate that its device meets the following criteria:
- Device provides more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition
- Device represents breakthrough technologies
- No approved or cleared alternative device is currently marketed in the US
- Device offers significant advantages over existing approved or cleared alternatives
- Device availability is in the best interest of patients
OncoSilTM device – unique platform technology
OncoSilTM is a first in class medical device comprising Microparticles containing Phosphorus-32 (P-32), a pure beta-emitter radioisotope, implanted directly into a patient’s pancreatic tumour via endoscopic ultrasound guidance.
The OncoSilTM device is a unique platform technology that could be utilised for most solid tumour types. Focus to date has been on liver (HCC) and pancreatic cancer and will move shortly into biliary cancers.
CE Mark Update
OncoSil also reported that it continues to await the CE Marking decision from BSI. BSI has confirmed that the CE Marking certification process is in its final phase.
The company remains confident of a positive CE Mark decision and will update the market immediately once this decision is made.
A CE Mark approval will open the way for the company to sell the device in the European Economic Area. It will also trigger multiple registration filings in many Asia-Pacific countries that recognise the CE Mark as part of the overall approval process.