Strategic Addition to Fuel Clinical Research Endeavors
Delphinus Medical Technologies, Inc., developer of SoftVue™, the first automated whole breast ultrasound system to gain FDA clearance using volumetric circular transducer technology, announced that Heather Rone has joined the company as Vice President of Clinical Affairs. Her addition to the Delphinus team is pivotal as the company embarks on a large clinical research program in support of regulatory approval for its non-ionizing breast cancer screening technology.
Ms. Rone comes to Delphinus with a strong background in clinical and regulatory achievements within the medical technology domain. While at U-Systems, Inc., maker of the somo-V automated breast ultrasound systems, she led multiple prospective clinical trials in the U.S. and Europe, enrolling over 18,000 participants that culminated in the first-ever FDA approval for a breast ultrasound screening indication. She was responsible for developing and executing a comprehensive global training program in support of commercialization and educational objectives. Among her many accomplishments, she was instrumental in earning additional regulatory approvals for the technology in the U.S. as well as global markets. After receiving PMA approval, U-Systems was acquired by GE Healthcare in 2012.
Based on her clinical trial proficiency, collaborative approach, and recognized achievements, she has been recruited as a clinical affairs and regulatory consultant for other developing medical technologies, specializing primarily in women’s health. Ms. Rone has co-authored multiple publications and her research has contributed to several published manuscripts in peer-reviewed journals.
From Mark Fochette, president and chief executive of Delphinus, “We’re very pleased to have Heather join our executive team. Her remarkable knowledge, her experience conducting transformational studies, and track record of gaining regulatory indications not realized before, will benefit Delphinus greatly in our clinical research and regulatory strategy efforts. This is going to be a momentous year for us as we broaden our clinical studies program. Heather’s leadership will contribute to our overall objective to offer a best-in-class breast imaging technology that has no radiation or compression, and, based on preliminary studies, has the potential to improve both sensitivity and specificity for breast cancer screening. We know this performance is important particularly for women with dense breast tissue, where breast cancer can be difficult to detect and additional imaging solutions are needed.”
Delphinus is the first to introduce and automated whole breast ultrasound system to integrate ring transducer technology that captures reflection echoes from all directions around the breast and measures transmitted signals coming through the breast, depicted by a color analysis of sound speed and attenuation values. SoftVue™ presents a volumetric cross-sectional image map of the entire breast, providing a consistent and uniform exam without reliance on operator skill and technique.
About Delphinus Medical Technologies, Inc.
Delphinus Medical Technologies, Inc. is a pioneering medical imaging company that has developed SoftVue™, the first circular array transducer technology that has received U.S. Food and Drug Administration clearance. The patented technology is a whole breast ultrasound tomography imaging device that delivers no radiation, requires no compression, and images the entire breast with a single scan. SoftVue is indicated for use as a B-mode ultrasonic imaging system and is not intended to be used as a replacement for screening mammography. Delphinus is capitalized through principal investments by Arboretum Ventures, Ann Arbor, Mich., Beringea, Farmington Hills, Mich., and North Coast Technology Investors, Ann Arbor, Mich. For more information, visit www.delphinusmt.com.
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Delphinus Medical Technologies, Inc.