OncoSil granted FDA Breakthrough Device Designation

By Meagan Evans. Published at Mar 18, 2020, in ASX Biotechs

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.

View Our Investment Portfolios

S3 Consortium Pty Ltd (CAR No.433913) is a corporate authorised representative of LeMessurier Securities Pty Ltd (AFSL No. 296877). The information contained in this article is general information only. Any advice is general advice only. Neither your personal objectives, financial situation nor needs have been taken into consideration. Accordingly you should consider how appropriate the advice (if any) is to those objectives, financial situation and needs, before acting on the advice.

Conflict of Interest Notice

S3 Consortium Pty Ltd does and seeks to do business with companies featured in its articles. As a result, investors should be aware that the Firm may have a conflict of interest that could affect the objectivity of this article. Investors should consider this article as only a single factor in making any investment decision. The publishers of this article also wish to disclose that they may hold this stock in their portfolios and that any decision to purchase this stock should be done so after the purchaser has made their own inquires as to the validity of any information in this article.

Publishers Notice

The information contained in this article is current at the finalised date. The information contained in this article is based on sources reasonably considered to be reliable by S3 Consortium Pty Ltd, and available in the public domain. No “insider information” is ever sourced, disclosed or used by S3 Consortium.

Australian ASX Small Cap stocks | Why Finfeed.com is Australia’s leading small cap publication

Founded seven years ago, Finfeed.com is Australia’s leading and longest standing website for investor and finance news, education and expert opinion.

Published by StocksDigital, Finfeed was created to report daily on the comings and goings of ASX listed stocks in the small cap market.

As the first digital publication dedicated specifically to this space, Finfeed soon became the most trusted publication in the market, quickly garnering over two million page views – a number that continues to rise.

Finfeed.com provides its readers with informative articles that tackle the latest in market moving #ASX small cap news, plus exclusive content you won’t find anywhere else. It is aimed at those with an interest in investing, market education, company performance, start-ups and much more.

Finfeed.com is the only media organisation operating under the strength of a Financial Services License and is backed by leading journalists and analysts all with brands of their own.

The website aims to inform, educate and entertain with content that drills down into the heart of financial matters.

Finfeed is a leading source of investor and market information, with everything investors need to know about how to invest written in a way that anyone can understand. 

Over the years, the website has expanded beyond exclusively reporting on small caps, to profile Australia’s leading ASX listed small, mid and large caps as well as some of the country’s most successful CEOs and business leaders to find out what makes them tick.

Every day you will find fresh content covering:

Fast Facts

Over 4,000 articles published

Over 2.3 Million Page Views and counting

Over 10,000 followers on social media

Subscriber list growing by 2% monthly

Thanks for subscribing!