AION Diagnostics Inc, a nano-diagnostics company developing medical imaging agents, has announced positive preliminary results of a pilot study showing the high intravascular contrast enhancement of modified porous silicon (mpSi) in reduced dose amounts.
The trialled intravascular contrast agent is based on the same formulation as AION's Marking Agent, a medical device to be registered under the CE Mark in Europe and via the 510(K) route in the US.
'These interim results provide an excellent advancement to consolidate AION's position in the ultrasound imaging sector. Ultrasound is a powerful imaging technique that can be used in a wide variety of settings, including surgical, outpatient, emergency room and community healthcare environments. Ultrasound avoids the need for expensive and radiation-emitting modalities, and provides clinicians with a practical solution for early detection of cardiovascular disease and cancer,' said Dr. Anna Kluczewska, President and CEO of AION.
mpSi is also visible under other key imaging modalities namely MRI, CT, x-ray and optical imaging.
The European contrast media market, inclusive of all imaging modalities, generated revenues of EUR1.02 billion in 2006 with an expected CAGR of 7.2% for 2006-2013.
Current ultrasound contrast agents have a short imaging life due to their inherent fragility and rapid removal from the blood stream. The physical stability of mpSi particles overcomes this issue, offering advantages with increased length of time available to clinicians in performing examinations. The stability of mpSi particles will also allow clinicians to use higher resolution imaging than is possible with conventional contrast media because of their fragility, which translates to better contrast and improved visualisation of anatomical detail.
The high visibility of mpSi at low dose is of vital importance in molecular imaging applications due to the necessity to image minute clusters of diseased cells.
In the in vivo study, a bolus injection of mpSi in saline suspension was administered intravenously. Ultrasonographic imaging of the vasculature and heart indicated that the mpSi showed high echogenicity and produced strong contrast enhancement with no change in vital signs or evidence of acute cardiovascular or respiratory adverse effects. Silicic acid is a natural by-product of silicon and mpSi metabolism, with both silicon and silicic acid levels naturally occurring in humans.
This data supports results obtained for AION's Marking Agent registration filing.
Posetd 15th May 2007