Timeline

2023

First commercial shipment of Imagio^® is delivered for clinical use in the United States.
Neoadjuvant Feasibility study results, showing promise in detecting vessel and oxygenation changes in the breast to indicate treatment response, are shared at the San Antonio Breast Cancer Symposium (SABCS) conference.
Health experts from the University of Texas Southwestern Medical Center presented an analysis at the Radiological Society of North America 2023 (RSNA 2023) that supports the cost-effectiveness of using opto-acoustic/ultrasound with AI technology as found in the Imagio^®.

2022

Seno receives supplemental premarket approval (PMA), which includes a new ultrasound probe that incorporates the latest technology to improve ergonomics, from the Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA).
Seno shares preliminary results at the European Society of Breast Imaging (EUSOBI) Congress of their CONFIDENCE Registry Study to substantiate the efficacy of the Imagio^® System in a real-world setting and the ability for OA/US to benefit physicians and patients worldwide.
Seno publishes, "Optoacoustic Imaging with Decision Support for Differentiation of Benign and Malignant Breast Masses: A 15-Reader Retrospective Study," in the American Journal of Roentgenology.

2021

Seno is granted premarket approval (PMA) for its groundbreaking diagnostic breast cancer imaging technology by the Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA).

2019

Seno announces the first commercial shipment of its Imagio® Opto-Acoustic/Ultrasound (OA/US) Breast Imaging System to a hospital in The Netherlands.

2018

The company publishes information related to the annual cost of false-positive breast biopsies exceeding $2 Billion.
A pivotal study related to opto-acoustic (OA/US) imaging’s ability to downgrade benign breast masses is featured on the cover of Radiology.

2017

The company publishes data that demonstrates that opto-acoustic breast imaging delivers critical diagnostic and prognostic information about tumor subtypes.
Prospective European Clinical Trial data indicates Imagio® Opto-Acoustic Breast Imaging System demonstrates ability to downgrade risk classification of benign breast masses.
Ann Waterhouse appointed to VP of Quality Assurance and Regulatory Affairs and Steve Miller appointed as SVP of Engineering.

2016

First commercial exhibit of Imagio® OA/US technology at European Society of Breast Imaging in Paris.
Announces interim results from the company’s multicenter, European MAESTRO post-market surveillance and clinical follow-up study. The data were presented at a clinical symposium at the Annual Scientific Meeting of the European Society of Breast Imaging (EUSOBI) in Paris, the second largest conference in the world dedicated to breast cancer imaging. “We look forward to the delivery of the first Imagio® OA/US systems in the Netherlands, UK and Germany early next year,” Seno CEO Tom Umbel said.
Tom Umbel named Chief Executive Officer. Mr. Umbel takes the helm from Tom Miller, Seno Medical’s President, who was serving as interim CEO following the departure of founder Janet Campbell.
Completes active enrollment of subjects in its international MAESTRO post-market surveillance clinical study.

2015

Announces results of the 100 subject PILOT study, conducted as the initial part of a larger U.S.-based, multicenter PIONEER pivotal study of more than 2,000 subjects, presented at the annual meeting of the Radiological Society of North America (RSNA) in Chicago.

2014

Sells $34.6 million of a $39 million Series C equity funding round from existing investors with the lead investment from MedCare Investment Funds.
Presents two analyses of outcomes from a U.S. Feasibility Study of its investigational Imagio® breast imaging device at the annual meeting of the European Congress of Radiology 2014.
Receives the CE Mark for Imagio® in Europe.
Completes active enrollment of subjects in its U.S.-based PIONEER Pivotal Study of Imagio®. The study was designed to determine if this technology will provide information to the physician to determine if a woman may avoid negative biopsies. This information will serve as the basis for the company’s Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA).

2013

CEO Janet Campbell wins a Gold Stevie® Award for Female Entrepreneur of the Year in the 10th annual Stevie Awards for Women in Business 2013. Ms. Campbell received the honor in the consumer products category representing companies with 11 to 2,500 employees.
Enrolls first 100 patients in its Pivotal Study of Imagio®.
Announces preliminary information from a feasibility study of its Imagio® breast imaging device. Data presented at the annual meeting of the Radiological Society of America (RSNA) and at the San Antonio Breast Cancer Symposium (SABCS).

Earlier Historical Milestones

2009: Receives the 2009 North American Medical Imaging Emerging Company of the Year Award from Frost & Sullivan for its opto-acoustic imaging technology.
2008: Receives remaining $1 million from the Texas Emerging Technology Fund (TETF). Award is one of the largest investments the State of Texas had made to date to a private company.
2008: Receives the prestigious Super Star Award from the San Antonio Technology Accelerator Initiative (SATAI) in recognition for their entrepreneurial development of cutting edge technology in the region.
2008: Forms a research partnership with the University of Prince Edward Island and Ryerson University of Toronto to develop new biomedical applications for Seno’s opto-acoustic imaging technology.
2008: Signs licensing agreement with VisualSonics, a world-leader in preclinical high-frequency ultrasound, for the exclusive rights to Seno’s Opto-Acoustic small animal imaging (preclinical) technology.
2007: Announces completion of its Series A Preferred Stock offering, receiving aggregate proceeds in the amount of $6 million from the offering.
2007: Announces its participation in the In3 Medical Device Summit. Attendees include some of the biggest dealmakers in the medical device industry, including members of the healthcare investment community.
2007: Receives $2 million award from the Texas Emerging Technology Fund (TETF). Funding allows the company to further develop its life saving technology for cancer imaging and detection and moves it closer to the global marketplace.
2007: Introduces new platform technology using opto-acoustics for small animal functional imagingat the Joint Molecular Imaging Conference in Providence, Rhode Island.
2007: The Joint Molecular Imaging Conference unites medical professionals and scientists with state of the art technology. Scientists and researchers from around the world will have the opportunity to learn about the Imagio® research device that uses Seno’s patented laser opto-acoustic imaging technology.
2006: Receives more than $3 million to launch commercial operations. Funding will allow the company to further develop patented laser opto-acoustic breast imaging technology for commercial use by doctors and hospitals around the world.
2005: Seno Medical Instruments, Inc. was founded in September 2005. The company purchased opto-acoustic prototypes and proprietary test equipment, the core patent, and other associated intellectual properties from Dr. Alexander Oraevsky and Fairway Medical Technologies in exchange for stock. Dr. Oraevsky, the father of medical opto-acoustics, had validated the science through grants from such nationally recognized institutions as the National Institutes of Health (NIH), the National Cancer Institute (NCI) and the Department of Defense (DOD), and he continues to provide advice and support to Seno for future applications of this technology.