- Imagion Biosystems have boosted to a peak of 240 per cent this morning after the company broke news of special recognition from America’s Food and Drug Administration
- FDA’s ‘Breakthrough Designation’, has been awarded to the company’s developing ‘MagSense’ radio-technology
- The device is aimed at reducing unnecessary surgeries during HER2 breast cancer biopsies, by reading special nanoparticles in the patient’s body
- The FDA recognition means the MagSense system will receive priority and special communication between Imagion and the FDA during development and final reviewing
IBX shares rocketed to a 240 per cent premium this morning following announcement of an FDA breakthrough.
Imagion Biosystems’ ‘MagSense’ radio-technology system received ‘Breakthrough Designation’ from the American Food and Drug Administration.
The company broke the news to shareholders this morning in an ASX media release.
The company’s MagSense device is designed to read for HER2 breast cancer. The HER2 cancer is classed as such for containing a protein called human epidermal growth factor receptor 2 – a protein that promotes growth of the deadly cells.
“The FDA’s designation of our MagSense technology and HER2 test as a Breakthrough Device is a significant step in our clinical development program,” Executive Chairman Bob Proulx said.
MagSense reads the tiny nanoparticles in the targeted cancer-bearing area of the body. These nanoparticles bind to the registered cancer cells after a practitioner administers the patient with a special injection.
The nanoparticles circulate through the blood flow and bind to targeted cancer cells, if present. When successful, the radiology MagSense device will reveal cancer cells in the body.
Bob Proulx says the FDA recognition puts the company’s technology ahead in the industry seeking to make biopsies more efficient.
“Qualifying as a Breakthrough Device will allow us to expedite our dialog with the agency and validates that our MagSense technology is not just another medical device but, indeed, represents a transformative opportunity for healthcare and could improve the standard of care for staging HER2 breast cancer,” he said.
What does this FDA recognition mean?
When a device receives the FDA Breakthrough title, it’s recognised as a special priority between the developer and the FDA agency.
This takes effect throughout the device’s development and grants it special priority during the review process.
Only select special products can qualify for this FDA title. It must be recognised as providing a more effective treatment or diagnosis for life-threatening human diseases and conditions.
Imagion Biosystems’ goal with MagSense is to eliminate unnecessary surgeries during the HER2 breast cancer biopsy procedure.
Currently, the company is in discussions with the FDA and unspecified clinical study institutions to undertake a ‘first-in-human’ MagSense trial.
Share prices in IBX closed at two-cents-a-piece yesterday. As of 11:20am AEST, the shares are sitting at six cents each. Today, the company’s market cap is valued at $6.474 million.