Dr. Kendall Waters (SVMI) shared “A Medical Imaging Device Start-up Story” at Bio2DeviceGroup.org on February 21. 2012

Coronary Heart Disease or CHD is a market that is growing due to obesity and other lifestyle changes.  In theUS, more than 16M people suffer from CHD.  This is a condition in which plaque builds up inside the coronary arteries.  These arteries supply oxygen rich blood to the heart muscle and when plaque builds up, it limits the flow of the blood to the heart muscle.  This plaque can also rupture and cause a clot which can become large and completely block blood flow through the coronary artery.  The major challenge is that we are unable to effectively predict when plaque will lead to clinical events.

There are several current tools in the market.  X-ray angiography is one dynamic tool.  Through the catheter, a contrast medium is introduced to enable seeing in the blocked area.  However, it is challenging to see through the soft tissue and the vessel wall.  Angioplasty is done to open the vessel, where a balloon is passed into the artery through the catheter and is inflated to treat a narrowed or blocked artery.  Intravascular (IVS) ultrasound devices enable seeing the amount of plaque present.  Most common use of IVS is to optimize stent deployment to avoid stent thrombosis, specifically for drug eluting stents which were introduced into the market in 2000.  Another adjuctive device is Optical Coherence Tomography or OCT.  Based on optical signal acquisition and processing method, OCT captures micrometer resolution, three dimensional images from within the biological tissue.  OCT provides great imaging very rapidly but it offers limited penetration and requires a greater amount of injecting of the contrast medium, though interventional cardiologists that use OCT do not think it is too much.

Silicon valleyMedical Instruments is working on a next generation High-Definition Intravascular Ultrasound Imaging device that integrates powerful imaging with better coronary catheter that will enable better image at faster speed and more convenience, compared to the products currently available.  Waters than discussed the historical timeline and the challenges of managing the talent through the roller coaster ride of the startup that brought the company to the stage it is at currently.  SVMI expects FDA approval in late 2012.



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