- OncoSil Medical (OSL) has announced that its namesake medical device has been granted breakthrough device designation by the Food and Drug Administration
- This designation will accelerate the development and approval of the medical imaging device in the U.S. market
- The OncoSil medical device is implanted directly into a patient's pancreatic tumour via ultrasound guidance
- The ultrasound then uses high-frequency sound waves to produce detailed images of the lining and walls of specific organs
- Chemotherapy is used in tandem with this device to destroy the cancerous cells
- OncoSil has skyrocketed 35.9 per cent in mid-morning trade with shares currently trading for 12.5 cents each
OncoSil Medical (OSL) has announced that its OncoSil medical device has been granted breakthrough device designation by the FDA.
This designation is a significant milestone for the company as breakthrough designation will accelerate the development and approval of the device in the U.S. market.
The Breakthrough Devices Program (BDP) is intended to speed up the FDA (Food and Drug Administration) review and approval of designated devices that may provide more effective treatment of life-threatening or irreversibly debilitating diseases.
OncoSil will now work closely with the FDA to ensure that the proposed premarket approval (PMA) evidence development and clinical trials capture meaningful data.
"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," CEO 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," he added.
The OncoSil device is designated for the use of treatment of patients with advanced and unremovable pancreatic cancer. This is used in tandem with standard chemotherapy.
Current treatment options for cancerous cells include surgery, radiation therapy, chemoradiation therapy, or chemotherapy.
While surgery may not be an option depending on the location of the cancer, OncoSil's device can still be used to identify the cancerous cell's location.
The OncoSil device is a brachytherapy (treatment of cancer) device that implants a pre-determined dose of beta radiation directly into cancerous tissue.
The beta particles that are emitted by OncoSil travel a short distance in the tissue causing damage to cancer cell DNA.
This locates cancerous cells while chemotherapy is used to destroy them.
OncoSil has skyrocketed 35.9 per cent in mid-morning trade with shares trading for 12.5 cents each at 11:30 am AEDT.