OncoSil granted FDA Breakthrough Device Designation
Hey! Looks like you have stumbled on the section of our website where we have archived articles from our old business model.
In 2019 the original founding team returned to run Next Investors, we changed our business model to only write about stocks we carefully research and are invested in for the long term.
The below articles were written under our previous business model. We have kept these articles online here for your reference.
Our new mission is to build a high performing ASX micro cap investment portfolio and share our research, analysis and investment strategy with our readers.
Click Here to View Latest Articles
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.
General Information Only
S3 Consortium Pty Ltd (S3, ‘we’, ‘us’, ‘our’) (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 and is for informational purposes only. Any advice is general advice only. Any advice contained in this article does not constitute personal advice and S3 has not taken into consideration your personal objectives, financial situation or needs. Please seek your own independent professional advice before making any financial investment decision. Those persons acting upon information contained in this article do so entirely at their own risk.
Conflicts of Interest Notice
S3 and its associated entities may hold investments in companies featured in its articles, including through being paid in the securities of the companies we provide commentary on. We disclose the securities held in relation to a particular company that we provide commentary on. Refer to our Disclosure Policy for information on our self-imposed trading blackouts, hold conditions and de-risking (sell conditions) which seek to mitigate against any potential conflicts of interest.
Publication Notice and Disclaimer
The information contained in this article is current as at the publication date. At the time of publishing, the information contained in this article is based on sources which are available in the public domain that we consider to be reliable, and our own analysis of those sources. The views of the author may not reflect the views of the AFSL holder. Any decision by you to purchase securities in the companies featured in this article should be done so after you have sought your own independent professional advice regarding this information and made your own inquiries as to the validity of any information in this article.
Any forward-looking statements contained in this article are not guarantees or predictions of future performance, and involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, and which may cause actual results or performance of companies featured to differ materially from those expressed in the statements contained in this article. S3 cannot and does not give any assurance that the results or performance expressed or implied by any forward-looking statements contained in this article will actually occur and readers are cautioned not to put undue reliance on forward-looking statements.
This article may include references to our past investing performance. Past performance is not a reliable indicator of our future investing performance.