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On 31 January 2019, Medical device company, OncoSil  Medical Limited (ASX:OSL) has released its quarterly activities & Cash Flow Report for the December quarter. According to the companyâs Chief Executive Director Daniel Kenny, the company made excellent progress on multiple fronts during the quarter. The company has reached an important milestone in the US, with the FDA (Food and Drug Administration) confirming that the data from the companyâs non-US PanCO clinical study satisfies the safety requirements to proceed to a full pivotal study in the US under an Investigational Device Exemption (IDE). Following this release, the share price of the company uplifted by 5.882% as on 31 January 2019.
In the OncoPaC-1 Clinical Study, the company was granted an Investigational Device Exemption (IDE) by the FDA in July 2016. The IDE was initially granted on the condition that a safety assessment is conducted based on data obtained from 20 US patients before the Company could proceed with a full pivotal study. After the submission of clinical data from the PanCO study, the FDA has confirmed that the Company has successfully met the safety requirements. This has allowed the Company to proceed to conduct a pivotal study in the US in a larger population.
The company has now successfully completed patient recruitment for the US OncoPaC-1 clinical study, with nine patients enrolled. All the patients have been successfully implanted with the OncoSil TM device.
While conducting the PanCO clinical study, a total of 10 patients were re-staged, and they have undergone surgical resection with curative intent. Currently, the resection rate for the PanCO study is 24 percent with eight out of the ten resections with reported R0 surgical margins which is a strong predictor of improved survival.
Although surgical resection rate is not a pre-specified study objective, these findings are very encouraging. The resection rate represents an important clinical milestone as they suggest the potential for âdown-stagingâ selected patients from an initially inoperable to surgically resectable state when the OncoSil ⢠device is used in combination with chemotherapy.
Till now, the company has provided two extensive clinical and technical reports, the first report was provided in May and the second in October. These reports outline the device design, clinical performance and safety of the OncoSil device to the British Standard Institute (BSI) in support of CE Marking Certification. Since the submission of these reports, the Company has engaged extensively with BSI to support its review process.
At the end of the December quarter, the company had Cash outflows from operations is $3.1 million. As at 31 December 2018, the company had cash and cash equivalent of $13,037k.
In the last six months, the share price of the company decreased by 22.73 percent as on 30 January 2019. OSLâs shares traded at $0.180 with a market capitalization of circa $107.22 million as on 31 January 2019. It has a 52-week high of $0.255 and a 52-week low of $0.115.
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