Accelerating the fight against pancreatic cancer, the United States Food and Drug Administration (FDA) is set to expedite an FDA application from medtech company OncoSil Medical (ASX: OSL) for their pancreatic treatment device.
The OncoSil(™) device has been granted Breakthrough Device Program (BDP) designation which is only granted to medical devices that may provide effective treatment of life-threatening or irreversibly debilitating diseases. In this case, OncoSil specifically treats pancreatic cancer which cannot be surgically removed (unresectable) in combination with systemic chemotherapy.
“The granting of Breakthrough Device Designation by FDA of the OncoSil™ device offers the Company many benefits with respect to premarket approval trial design, device assessment and expedited review” said OncoSil Medical CEO, Daniel Kenny.
“Breakthrough designation also provides validation of the OncoSil™ 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.”
Having secured BNP status, OncoSil will adjust clinical trial design where BNP designation enables the company to shift some clinical data gathering to the post-market setting which significantly quickens the FDA assessment process, whilst preserving the standards of premarket approval.
To receive BNP status, medical companies must prove that their device represented breakthrough technology where there is no clear alternative device marketed in the United States and it will provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition.
OncoSil™ is a 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 company has faced regulatory roadblocks in Europe for CE Mark approval but has been in regular contact with the British Standards Institute and remains confident of a positive outcome.
Following news of BDP designation from the FDA, shares in OSL rose to an intraday high of $0.145 in morning trade, a rise of 57.6% from the previous day’s close of $0.092.