— Novilase minimizes the loss of surrounding breast tissues and reduces retreatment rates
MOUNTAIN VIEW, Calif., Sept. 2, 2014 /PRNewswire/ — Based on its recent analysis of the early-stage breast tumor treatment device market, Frost & Sullivan recognizes Novian Health, Inc. with the 2014 North America Frost & Sullivan Award for Technology Innovation Leadership. Novian Health has greatly improved the treatment of breast fibroadenoma and malignant tumors with its proprietary technology, Novilase® Laser Therapy. This innovative tool is a reliable, accurate, and easy-to-control ultrasound-guided thermo ablation device that performs minimally invasive surgery on breast tumors.
The procedure performed using Novilase leaves only two nicks, measuring approximately 0.3 cm in length and, unlike lumpectomies that result in substantial cosmetic damage, causes minimal scarring. Novilase is FDA 510(k) cleared and can ablate multiple fibroadenomas in a 30-minute outpatient procedure, allowing patients to return to their normal routine immediately. By eliminating the need for general anesthesia y, Novilase can potentially help patients save up to 30 percent of the costs they would have otherwise incurred during a traditional lumpectomy process.
"The major components of the Novilase system are the image-guided probes that enable the physician to target the exact location of the fibroadenoma or malignant tumor," said Frost & Sullivan Research Analyst Madhumitha Rangesa. "The temperature and laser delivery can be monitored in real time for optimal treatment results. The entire system is on a mobile cart that houses a Class IV laser source, in addition to disposable laser and thermal probes."
The probes are connected to a probe guide that varies the ablation radius if a smaller ablation zone is required. Once the probe is inserted into the malignant breast tumor or fibroadenoma, a fiber thread from the laser source is placed into the probe. A parallel temperature probe allows the physician to observe and control the temperature from the monitor. The tumor undergoes instantaneous cell death when the temperature at the periphery of the ablation zone reaches 60 degrees C; the cells will also die if the temperature is maintained over 51 degrees C for several minutes.
Over the course of several months following the procedure, the body’s natural tissue healing process rebuilds the region where the tumor had been present. The technique results in minimal scarring, with no tissue loss since the breast tissue grows in uniformly covering the entire region that was ablated.
The laser ablation system is sized comparably to present-day ultrasound equipment and is portable to a large extent. This mobility encourages usage in rural areas, and can even be used by technicians with little training.
Significantly, Novian Health has proactively fostered strong relationships with regulatory bodies for its practice of documenting and validating its technology through multiple clinical trials. Additionally, its multicenter studies in the United States, France, and Great Britain will further validate the product, as having diverse populations undergo the Novilase Laser Therapy will result in a robust database of patient responses.
Novian Health has followed a strict patent application process and currently has 10 United States patents, 57 European patents (of which 27 are designs), and multiple international patents.
"In the future, once the Novilase procedure receives approval for treating malignant tumors, the company will have multiple collaborative options. The product can be released along with imaging products since imaging companies already have a strong foothold in the same sphere of diseases," noted Madhumitha. "Additionally, the company can collaborate with breast centers and clinics where breast tumor removal procedures are not commonly practiced."
Following the success of Novilase treatment for breast cancer, Novian Health is striving to extend its application to other types of cancers such as liver, skin, and prostate cancers. Overall, pursuing the necessary regulatory approvals and having established a strong IP portfolio, the company is now firmly entrenched as a technology leader in the breast cancer therapy market.
Each year, Frost & Sullivan presents this award to the company that has demonstrated uniqueness in developing and leveraging new technologies, which significantly impacts both the functionality and customer value of new products and applications. The award lauds the high R&D spend on innovation, relevance to the industry, and positive impact on brand perception.
Frost & Sullivan Best Practices awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify industry best practices.
About Novian Health, Inc.
Novian Health Inc., based in Chicago with a subsidiary in Evry, France, is a privately held medical device company with proprietary technology for the treatment of tumors using Interstitial Laser Therapy. Developed as an alternative to surgery, the company’s technology uses parametrically controlled heating for the ablation of tumors. Image-guided treatment of breast tumors is the first application of the technology, with the potential for Novilase to treat tumors elsewhere in the body. Novian Health has received U.S. FDA 510(k) clearance for the treatment of benign breast tumors. For more information, call (312) 266-7200 or access www.novianhealth.com.
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