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December 15, 2014 Issue

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New Tomography System utilizing Optoacoustics to Visualize the Molecular Composition of Biological Tissues

 

 

Dr. Alexander A. Oraevsky
Chairman & CEO

 

TomoWave Laboratories, Inc.

www.tomowave.com

  

Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – December 15, 2014

 

CEOCFO: Dr. Oraevsky, what is the concept at TomoWave Laboratories?

Dr. Oraevsky: TomoWave Laboratories develops biomedical imaging, sensing and monitoring systems utilizing properties of light and sound most beneficial for visualization of anatomy and molecular composition of biological tissues. We call this concept opto-acoustics. The technology is based on the invention I made about twenty five years ago. The method of optoacoustic imaging uses short pulses of light with colors selected to penetrate deep tissues and to generate ultrasound in hemoglobin of red blood cells and other molecules that can absorb this light. The detected ultrasound signals are used to reconstruct high-resolution tomographic images of internal tissue structures based on the contrast of blood. With this concept, it is possible to see inside of the human organs by listening to the sound of light. Imaging and sensing modalities based on optoacoustic principles are important for healthcare.

 

CEOCFO: How does this concept differ from common methods available today?

Dr. Oraevsky: There are different physical principals that doctors use today to image through the human body. The very first technology was discovered by Wilhelm Röntgen in 1895 and is called x-ray imaging. X-rays penetrate very well straight through the body and can be very useful to visualize hard tissues, such as bones and teeth. Today this method is dramatically improved to visualize different soft tissues in order to detect cancer or find blocked arteries in the heart and brain. For example, screening for breast cancer with mammography utilizes x-rays. Another example of a powerful imaging technology is magnetic resonance imaging (MRI). MRI is much better than x-rays for imaging soft water-containing tissues and thus, it has numerous medical applications.  Another example I should mention is Positron Emission Tomography (PET). PET is different from the first two technologies as it provides images of how tissue functions rather than just anatomical pictures. So, modern medicine has many good imaging methods.  However, these methods are not free from significant limitations. A universal philosophic principle states that “there is nothing bad without something good and there is nothing good without something bad”. Well, the bad part of x-rays is that this radiation is ionizing and can cause cancer and genetic mutations. Yet doctors use it because the benefits outweigh the potential harm. In order to enhance contrast of x-ray imaging in computer tomography (CT) contrast agents are used, which are quite toxic. The same is true for contrast agents used for MRI and PET. Therefore, statistically, a majority of people will benefit from these modalities but some people will suffer. Also, some of these technologies are very expensive and not affordable for small hospitals and clinics. As you can see, there is no ideal imaging technology.

 

TomoWave develops imaging systems that will fill the market need for a very safe and inexpensive imaging modality that can provide simultaneously anatomical pictures and functional information to the physician. Our systems naturally combine optoacoustics with ultrasound, since detectors and electronics used for both methods can be the same. Ultrasound is yet another medical imaging method, which is well established for diagnostic imaging of breast cancer and many other applications. By providing doctors with a modality that they are comfortable with and enhancing it with molecular specificity based on optical contrast, we assure rapid adoption of our technology by the community of medical practitioners, which will be happy to have a solution for certain problems of existing modalities. Combined optoacoustic ultrasonic Imaging systems developed by TomoWave take advantage of the most useful properties of light and sound to give doctors comprehensive medical information about breast tumors with high contrast and high resolution not otherwise available.

 

CEOCFO: Where are you in developing the concept? Do you have products in use?

Dr. Oraevsky: We started 4 years ago when we first developed the Laser Optoacoustic Imaging System (LOIS-3D) for the market of preclinical research systems. Many human diseases can be modeled in a mouse. Therefore, academic, medical and pharma researchers use mouse models to learn biological mechanisms of human diseases such as cancer and to develop drugs and therapeutic methods to cure them. LOIS-3D provides images of the entire animal with emphasis on the medically most important organs, such as vascular circulation network, kidneys, spleen, liver, spine and even the brain.  Since this system does not require regulatory approval by the Food and Drug Administration, we recently launched sales of the Laser Optoacoustic Imaging System (LOIS-3D) and presently arranging for distribution agreements. Simultaneously, we started active efforts towards commercialization of our clinical imaging system, based on the same three-dimensional technology. Currently, this system is in clinical feasibility studies at M.D. Anderson Cancer Center in Houston TX. As a step before application for regulatory clearance, we need to learn what features will be required for detection, diagnostic characterization and assessment of efficacy of breast cancer chemotherapy, and what needs to be improved in the final commercial system so that it could be accepted by doctors, patients and insurance companies.

 

CEOCFO: When you are working for regulatory approval, will it be for specific procedures?

Dr. Oraevsky: Typically, the FDA looks for a specific indication. They would not approve general use, even though it is possible in some countries to use a medical device for whatever doctors believe it is useful for, given, of course, that it is safe. In the U.S. however, and to a lesser extent in Europe, the developer needs to define exactly how doctors will use the system. We believe the first applications will be diagnostic imaging and guiding therapeutic interventions of breast cancer. Breast cancer is a very large problem for women worldwide. In the United States, one out of eight women develops breast cancer over their lifetime. Breast cancer is a horrible disease taking 40,000 lives prematurely every year. As I mentioned earlier, the state of art modalities for diagnostic imaging of breast cancer have significant drawbacks. What is most disturbing to me is that young women with genetic predisposition to breast cancer do not have an opportunity to detect the disease early, when it is much easier to cure. Due to lack of x-ray contrast, only women over 40 can be screened with mammography. Optoacoustic imaging integrated with ultrasound will solve the problem by providing information to the physician without ionizing radiation and without toxic contrast agents. It is noteworthy that a laser optoacoustic ultrasonic imaging system will reduce the cost of breast cancer care. With accurate noninvasive imaging technology, the number of unnecessary expensive invasive procedures, called biopsies, will be reduced. While all chemotherapy drugs have bad side effects, none of them is guaranteed to be effective. Therefore, it is important to rapidly assess whether a specific chemotherapy method will be effective for a given breast cancer patient. Regulatory approval for these two applications will open a very large multi-billion dollar market.  

 

CEOCFO: When first presenting your system to the medical community, do they understand the concept?

Dr. Oraevsky: The clinicians with whom we work are quite excited about this technology. Today, due to multiple publications and presentations by the community of biomedical optoacoustic researchers, the medical community is well aware of optoacoustic tomography and the importance of optoacoustic biomarkers, such as hemoglobin and oxy-hemoglobin, for diagnostic imaging of cancer and assessment of its aggressive growth. However, twenty years ago, it was surprising to the medical community that they could obtain high resolution images from the depth of tissue using only light and sound. In the early 1990s, there was only a small community that believed in this technology. Gradually, we were able to convince funding agencies to support development of optoacoustic systems and demonstrate their capabilities in a variety of biomedical applications. Today, if you search the internet for key words “optoacoustic imaging” or “photoacoustic imaging” (both are accepted terms describing the same technology), you can find about four hundred researchers worldwide that dedicate their careers to development of optoacoustic imaging and sensing. Governments along with private entities invest significant funds in this technology. Many awards have been made to the members of our community, but every year researchers bring more surprises, demonstrating what this technology can do.

 

CEOCFO: Are you seeking partnerships or funding?

Dr. Oraevsky: Commercialization of a medical device is very expensive. TomoWave is funded today, but appreciating the notion that “time is money” we are actively looking for additional funding to expedite the process. TomoWave has a partnership with Seno Medical Instruments of San Antonio, Texas. Seno acquired my early patents and commercializes the first generation system for qualitative diagnostic imaging of breast cancer. TomoWave is moving forward with the next generation of a quantitative full 3D view tomography system. We are developing a pipeline of new systems being open for partnerships with companies that can take a specific medical application to the next level. With such a wide platform technology as the laser optoacoustic ultrasonic imaging, there is a place in the market for many large and small medical imaging companies.



 

“TomoWave Laboratories develops new tomography systems to enable doctors to see inside of the human organs by listening to the sound of light.”- Dr. Alexander A. Oraevsky


 

TomoWave Laboratories, Inc.

For more information visit:

www.tomowave.com

 

Contact:

Alexander A. Oraevsky

1-713-270-5393

AAO@TomoWave.com
 


 

 



 

 


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