FDA grants breakthrough device designation for OncoSil

OncoSil unresectable pancreatic cancer treatment FDA ASX OSL breakthrough device designation
Breakthrough device designation is expected to expedite development and approval of the OncoSil device in the United States.

Medical device company OncoSil Medical (ASX: OSL) has been granted what’s known as breakthrough device designation by the US Food and Drug Administration (FDA) for the treatment of pancreatic cancer in combination with systemic chemotherapy.

OncoSil’s “first in class” medical device is comprised of microparticles containing phosphorus-32, a pure beta-emitter radioisotope that’s implanted directly into a patient’s pancreatic tumour via endoscopic ultrasound guidance.

The device could potentially change how pancreatic tumours are mitigated and thereby improve the armamentarium of tools used by clinicians.

Pancreatic cancer alert

Pancreatic cancer is typically diagnosed when there is a poor prognosis for long-term survival which means most patients do not recover.

According to the World Journal of Oncology, pancreatic cancer is the seventh leading cause of cancer-related deaths worldwide and caused around 430,000 global deaths in 2018.

In other research, the World Cancer Research Fund estimated that the five-year survival rate for all stages of pancreatic cancer combined is approximately 5%.

Taking market dynamics into account, OncoSil said it estimates the global market opportunity for its device in pancreatic cancer exceeds $1 billion.

OncoSil medical device

OncoSil claims its device is a unique platform technology that could be utilised for most solid tumour types, but development has so far focused on liver and pancreatic cancers with application in biliary cancers also a likely eventuality.

The FDA’s breakthrough devices program is a voluntary initiative for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Today’s news of FDA’s designation is a significant milestone for OncoSil considering it will help expedite development and approval of the device in the US market.

Ultimately, the medical device company wants to help patients obtain faster access by expediting device development, assessment, and review while preserving the standards of pre-market approval (PMA).

According to OncoSil, it will now work closely with the FDA to ensure that the proposed PMA evidence development and clinical trial design capture clinically meaningful data required in a post-market setting.

“The granting of breakthrough device designation by FDA of the OncoSil device offers the company many benefits with respect to PMA trial design, device assessment and expedited review,” OncoSil chief executive officer and managing director Daniel Kenny said.

“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 and downstaging tumours to resection with curative intent,” Mr Kenny said.

In it to win it

To qualify for FDA’s specialist program, OncoSil is required to meet several criteria including proving that its device provides more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition.

Also, OncoSil must demonstrate its radioactive isotope represents a breakthrough technology that has no comparative peer or alternative already being marketed in the US.

The FDA is also keen to determine whether the device is in the best interest of patients and whether it’s safe for repeated use. Treatment with the OncoSil device is intended to deliver more concentrated and localised beta radiation compared to external beam radiation.

So far, OncoSil has conducted six clinical studies with amiable results on tolerability, safety and efficacy but is still awaiting CE Mark certification to be fully regulated and permitted in the European Union and the UK.

Director buying

In other news, OncoSil non-executive director Dr Martin Cross acquired 485,000 shares at $0.11 each, for a total consideration of around $56,000 – thereby bringing his total share ownership in the company to 2.5 million shares (worth around $280,000 at current market prices).

Dr Cross is a highly regarded pharmaceutical executive with over 30 years of experience including corporate and industry leadership roles directly influencing healthcare policy and government legislation in Australia and global business management, marketing and sales roles.

Dr Cross also served as chairman of Medicines Australia, the country’s peak body representing the research-based pharmaceutical industry.

This morning’s FDA designation news boosted OncoSil shares by over 21% up to $0.11 going into afternoon trade.

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