It was a long time coming, but Delphinus Medical Technologies Inc. started this year off with a big step toward entering the revenue stage.
The Plymouth Township-based company announced Jan. 7 that the U.S. Food & Drug Administration had cleared the company to sell its SoftVue device used to detect breast cancer.
Delphinus formed in 2009, but development of its technology began 10 years earlier at the Barbara Ann Karmanos Cancer Institute in Detroit. Its product aims to more accurately and less painfully detect breast cancer through 3-D ultrasound imaging.
Delphinus’ device looks like a bed with a hole near the top. Patients lie down, with a breast through the hole. The breast is immersed in water and surrounded by a ring containing 2,048 ultrasound sensors, which generate data that are translated into images.
Before the company was spun out of Karmanos, $19 million was spent on research, with money coming from private donors, the Michigan Economic Development Corp., the Susan G. Komen Breast Cancer Foundation, the National Institutes of Health and the National Cancer Foundation.
After the spin-out, Delphinus raised $8 million in a 2010 round led by Ann Arbor-based Arboretum Ventures LLC, with North Coast Technology Investors LP of Ann Arbor and Beringea LLC of Farmington Hills participating.
The same firms joined in a second round of $11 million that closed last September. GE Capital also joined in that round.
With the new FDA blessing in hand, sales are on track to begin at the end of this year, said CEO Mark Morsfield, who replaced William Greenway last October.
The initial price point per machine is $400,000. No volume or revenue targets have been set, but the numbers will be modest at first, Morsfield said. Clients will be hospitals and outpatient clinics.
Miller Technical Services Inc. in Canton Township has been given the contract to make the SoftVue device.
Delphinus will do another round of fundraising as it ramps up manufacturing and sales, but no target for the next round has been decided.
The company employs 26 people, and that number will rise as the company ramps up.