Business Profile: Zenalux

NCTechNews is publishing a series of business profiles to highlight innovation and entrepreneurism throughout North Carolina. Today we are featuring Zenalux, a biomedical diagnostics start-up in Research Triangle Park.

Q: When was your company founded and why?
A: The company was founded in 2006 to develop products on optical tissue spectroscopy research being carried out at Duke University. 

Q: What are your company’s core products or services?
A: Our core product is the Zenascope™, a patent-protected, photonic system that quickly and non-destructively measures important biological endpoints including hemoglobin concentration, hemoglobin saturation, and scattering (a measure of cell density and necrosis); however the system can easily be tuned to include additional absorbers of interest.

Current customers use the system primarily to monitor response to therapy and also to discriminate between benign and malignant tissue. This unique product enables improved diagnosis, better treatment, and ultimately cost reduction in the health care system. Application areas include accelerating feedback in drug discovery, head and neck cancer detection, response to therapy, breast tumor margin assessment, and cervical cancer detection.

Q: Who are some recognizable members of your leadership team?
A: Dr. Jesko von Windheim, CEO – CEO and founding member of Zenalux, Dr. von Windheim has played an integral role in a number of start-up companies based on networking, photonics, and semiconductor technologies, including Unitive Electronics, Inc., Cronos Integrated Microsystems, and Nextreme Thermal Solutions, Inc.

Dr. Nirmala (Nimmi) Ramanujam, Founder – Dr. Ramanujam is Associate Professor of BME, Director of the Tissue Optical Spectroscopy Laboratory at Duke University and founder of Zenalux Biomedical. Dr. Ramanujam developed the Zenalux technology at the University of Wisconsin, Madison and moved to Duke University to apply it in clinical settings. She was named as one of the top 100 young innovators in technology by MIT, named a DOD Era of Hope Scholar for Breast Cancer research, and won the Global Indus Technovators award from MIT. She is a member of the DOD Breast Cancer Research Program Integration Panel where she is involved in vision setting and allocating funds for breast cancer research, and is also a fellow of the Optical Society of America.

Mark W. Dewhirst, DVM, PhD, Advisor – Dr. Dewhirst is the Gustavo S. Montana Professor of Radiation Oncology and Director of the Radiation Oncology Program of the Duke Comprehensive Cancer Center. He also holds appointments in the Departments of Pathology and Biomedical Engineering at Duke and in the Department of Anatomy Pathology and Radiology at the School of Veterinary Medicine at North Carolina State University.

Q: Who are your company’s competitors and what are your differentiators?

A: Several personal pulse oximeter technologies exist to monitor arterial oxygen saturation, pulse rate, and perfusion index. These sensors are conventionally attached to the fingertip, the ear lobe, or the hollow of the ear.  In contrast, the Zenascope measures oxygen and hemoglobin concentration across all vasculature, enabling diagnostics in any tissue.  Furthermore, unlike these systems, the Zenascope can easily be tuned to measure other absorbers present in the tissue (for example: beta-carotene, melanin). More complex measurements are available with laboratory portable systems that typically rely on infrared (IR) spectroscopy with sensors attached to forehead; however, these measurements are constrained because IR is limited to dimensions exceeding 1-2 cm.  Because the Zenscope operates in the visible spectrum, it can measure in millimeter dimensions, making it ideal for measurements on the tissue surface.  Finally, the Zenascope’s advantage over all these systems is in its ease of use and low cost to achieve quantified results.

Q: Does your company develop new technologies or re-apply existing technologies to solve a problem?
A: Zenalux develops new technologies based on proprietary algorithms and standardized (off-the-shelf) measurement hardware to achieve uv-vis spectroscopy in turbid media.  This enables a host of new applications for uv-vis spectroscopy in non-ideal, scattering conditions, including tissue spectroscopy for medical diagnostics and measuring response to therapy.

Q: Who are your customers?
A: Current customers include Duke University, Roswell Park Cancer Institute, and Tulane University. Generally, customers include pre-clinical researchers in cancer detection and monitoring therapy.

Q: What problems does your company solve?
A: Zenalux’s goal is to make optical spectroscopy easy for medical practitioners who are interested in real-time, non-destructive biological tissue diagnostics. Our products provide effortless translation of uv-vis tissue spectra into quantified biological endpoints to enable the medical professional to focus on medical applications of the technology.

Q: Please share any examples of situations where your products or services achieved a positive result for clients. 
A: The 49-channel Zenascope (C49) is now in a 200 patient clinical study for breast tumor margin assessment at Duke University

For Roswell Park Cancer Institute, the Zenascope is being evaluated to detect oral cancers at an early stage.  The system integrates imaging capabilities with spectrographic data, giving medical teams better visualization of cellular changes and tumor margins.  The system is helping the Roswell team advance research on approaches for differentiating diseased cells from healthy tissue.

Roswell is also applying the technology in interstitial photodynamic therapy applications (PDT). The Zenascope’s real-time monitoring of oxygen and drug levels during surgery may be a key enabler in translating PDT technology into widespread clinical use.  In this case the Zenascope was customized to measure drug levels as well as standard biomarkers (oxygen, blood concentration and scattering levels). 

Researchers at Tulane are utilizing the Zenascope™ system to monitor renal ischemia during partial nephrectomy in large animal models, and to monitor physiological changes in tissue in response to investigational therapeutics in cancer and regenerative medicine. The ability of the system to provide rapid feedback and its ease-of-use have allowed Tulane to track tissue oxygenation in individual animals over time, and has provided another set of useful endpoints for their work.

Q: What new products or services or services will you be rolling-out in 2014?
A: We recently announced an enhancement to the Zenascope—the addition of a high resolution camera to the system, which provides the ability to record both video and still shots, with white-light or blue-light illumination sources. With the addition of these new capabilities, there are now four functions available with the original Zenascope PC1 system – basic quantitative spectroscopy, pressure sensing, imaging, and illumination.

Q: What makes your company relevant to the future of your industry?
A: The total market potential for Zenalux products in cancer detection and response to therapy is >$1 billion annually.  In conjunction with its beta-customers, Zenalux has identified a number of unmet needs that the Zenascope addresses in the clinic.  Specifically these include:  breast tumor margin assessment, oral cancer (or pre-cancer) detection, response to photodynamic therapy and cervical cancer detection in low resource environments.  As an example, in the US approximately 40,000 new cases of oral cancer are detected annually; however, these cases tend to get caught in advanced stages leading to almost 8,000 deaths annually from oral cancer.  For this reason, an effective early screening technique is highly desirable.  As another example, cervical cancer affects the lives of 500,000 women worldwide each year, and results in more than 270,000 deaths. Approximately 85% of these cases occur in the developing world. Unfortunately, the number of cervical cancer deaths is still rising, with estimates that the rates will increase by 25% over the next 10 years.  These are two specific examples where the Zenascope has the potential to have a major impact by delivering low cost, fast diagnostics at the point of care.

Q: Where can people go to find out more information?


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