Delphinus Hires Clinical Affairs VP

Delphinus Medical Technologies Inc. has beefed up its management team with a new executive appointment.

The company recently hired Heather Rone as vice president of clinical affairs. Bigwigs claim 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 nonionizing breast cancer screening technology.

Rone has 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 United States and Europe, enrolling more than 18,000 participants that culminated in the first-ever U.S. Food and Drug Administration (FDA) approval for a breast ultrasound screening indication. She also developed and executed a comprehensive global training program in support of commercialization and educational objectives. Among her many accomplishments, Rone was instrumental in earning additional regulatory approvals for the technology in the United States as well as global markets. After receiving pre-market approval, U-Systems was acquired by GE Healthcare in 2012.

Based on her clinical trial proficiency, collaborative approach, and recognized achievements, Rone has been recruited as a clinical affairs and regulatory consultant for other developing medical technologies, specializing primarily in women’s health. She has co-authored multiple publications and her research has contributed to several published manuscripts in peer-reviewed journals, Delphinus executives said.

“We’re very pleased to have Heather join our executive team. Her 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,” Delphinus President/CEO Mark Forchette said. “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 claims it is the first company to introduce an 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. The FDA-cleared 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. SoftVue is indicated for use as a B-mode ultrasonic imaging system and is not intended to be used as a replacement for breast screening mammography.

Delphinus Medical Technologies develops breast ultrasound imaging platforms. The company is funded through principal investments by Arboretum Ventures of Ann Arbor, Mich.; Beringea LLC of  Farmington Hills, Mich.; and North Coast Technology Investors LP, also of Ann Arbor.