OncoSil’s Shares Seem To Be On A Recovery Mode Post Some Constructive Discussion With BSI On CE Marking Application

  • Mar 29, 2019 AEDT
  • Team Kalkine
OncoSil’s Shares Seem To Be On A Recovery Mode Post Some Constructive Discussion With BSI On CE Marking Application

OncoSil Medical Limited (ASX: OSL) is a medical device company seeking to advance radiation for cancer patients. The company is focused on localised treatments for patients with pancreatic and liver cancer. The company has a lead product, OncoSil™, which is implanted directly into the pancreatic tumours of the patient via an endoscopic ultrasound.

The company today, on 29 March 2019, provided an update on the CE Marking application after its constructive discussion with the senior management of British Standard Institute (BSI).

After the Clinical Oversight Committee has given an unfavourable assessment of the company’s CE Marking application, the company has had initial discussions with BSI. The conversation with BSI remained constructive, and the company is now having a better understanding of the issues.

The CE Marking File is currently put on hold subject to a meeting between the company, the Clinical Oversight Committee and BSI, and a final CE Marking determination is yet to be made. BSI has given confirmation that the meeting will be held as soon as practicable.

The company is of the belief that it meets all the requirements for CE Mark certification as per BSI directives, AIMDD regulations and MEDDEV requirements since it has made all the necessary submissions and currently looking forward to the upcoming meeting with BSI and the Clinical Oversight Committee.

As per the previous notice of the company as on 25 March 2019, the Clinical Oversight Committee has determined that OncoSil has demonstrated insufficient clinical benefit to recommend approval and the Clinical Oversight Committee will send the recommendation to BSI’s Medical Device Group for the final decision.

On the operational front, the primary focus of the company during the six-month period is to make progress related to its application for CE Marking of the OncoSil™ device in the European Union, development in its EU launch and early commercialisation strategy, and clinical progress in the United States of America market with the OncoPaC-1 clinical study.

On the financial performance front, the company has reported revenues from ordinary activities of ~$1.93 million in 1H FY19, an increase of 6.3% from the previous comparing period. The loss from ordinary activities after tax attributable to the owners of the company stood at ~$5.14 million as compared to ~$4.53 million in 1H FY18, an increase of 13.6% from the prior corresponding period.

The cash and cash equivalents and financial assets balance stood at $13.0 million as of 31 December 2018. The company received a R&D tax incentive refund of $4.3 million during the half year period.

On the price-performance front, the stock of OncoSil Medical Limited is trading at $0.055, an increase of ~37.5% during the day’s trade, with a market capitalisation of ~$25.23 million (AEST 03:13 PM). The stock has generated a negative YTD return of 77.14% and generated negative returns of 80.0% and 77.78% over the past six months and three months period, respectively. Its 52-week high price stands at $0.255, and 52-week low price stands at $0.021 with an average trading volume of ~ 1,894,897.


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