September 24, 2017 7:54 PM ET

Healthcare Equipment and Supplies

Company Overview of Seno Medical Instruments, Inc.

Company Overview

Seno Medical Instruments, Inc., a medical imaging company, engages in the development and commercialization of opto-acoustic technology to improve the process of diagnosing breast cancer. It offers Imagio, an opto-acoustic breast imaging system to provide physicians with vital information needed to determine whether or not a suspicious mass is cancerous. The company was founded in 2005 and is headquartered in San Antonio, Texas.

5253 Prue Road

Suite 315

San Antonio, TX 78229

United States

Founded in 2005

Phone:

210-615-6501

Fax:

210-615-6508

Key Executives for Seno Medical Instruments, Inc.

Chief Executive Officer and Director
Age: 61
Special Advisor
Chief Financial Officer
Chief Medical Officer and Medical Director
Senior Vice President of Engineering
Compensation as of Fiscal Year 2017.

Seno Medical Instruments, Inc. Key Developments

Seno Medical Instruments Appoints Steve Miller as SVP of Engineering

Seno Medical Instruments, Inc. announced the appointment of Steve Miller as SVP of Engineering. Mr. Miller previously served as the Vice President of Product Realization at FUJIFILM SonoSite, with headquarters in Bothell, Washington. Mr. Miller has dedicated the majority of his 30-year career to the development of innovative medical imaging products that affect patients and customers. He is personally an inventor on more than 30 patents, while leading teams that received more than 200 patents. Mr. Miller was responsible for taking new concepts to volume production, including engineering, manufacturing, supply chain, and product management at SonoSite.

Seno Medical Instruments, Inc. Announces Interim Results from Multicenter, European Maestro Post-Market Surveillance and Clinical Follow-Up Study

Seno Medical Instruments Inc. announced interim results from the company's multicenter, European MAESTRO post-market surveillance and clinical follow-up study. The results demonstrate the potential of its Imagio opto-acoustic (OA) breast imaging system to provide physicians with vital information needed to determine whether or not a suspicious mass is cancerous, with the goal of reducing the rate of negative biopsies. The data were presented at a clinical symposium at the Annual Scientific Meeting of the European Society of Breast Imaging (EUSOBI) on September 24, 2016 in Paris. There are over 1.6 million biopsies performed annually and recent reported data noted an 81% "false positive" rate of biopsy procedures - the portion of biopsies that do not lead to breast cancer surgery. Seno Medical's Imagio breast imaging system, which received its CE Mark in 2014, has the potential to reduce negative biopsies by 43%. Seno Medical is targeting their PMA submission for the Imagio system to the U.S Food and Drug Administration by the end of 2016. MAESTRO, a controlled, multi-center, observational, post-market surveillance and clinical follow-up study, was designed to assess the diagnostic value (specificity and sensitivity) of Opto-Acoustics to conventional diagnostic ultrasound (CDU) in suspicious masses classified as BI-RADS 4a and 4b. Investigators first performed CDU to reach a diagnosis and decision to biopsy followed by an Imagio OA examination. Two hundred female subjects with undiagnosed suspicious masses enrolled in the study. The interim analysis of 78 subjects found that following the use of Imagio system, radiologists downgraded BI-RADS categories of the internal ultrasound control-classified BI-RADS 4a masses to BI-RADS 3 or 2 in 75% of cases, and BI-RADS 4b masses to either BI-RADS 3 or 2 in 37.5% of cases. The interim results also showed that Imagio OA also increased specificity to over 43%, with no significant loss in sensitivity. Importantly, clinicians were able to reduce the rate of false-positive diagnoses by 20% for the last 48 subjects evaluated in the study. Final results from the MAESTRO study are expected to be announced in early 2017. Enrollment for a U.S. trial of more than 2,000 patients has been completed and results will be announced in the latter half of 2017. Seno Medical's Imagio system co-registers and fuses opto-acoustics, a technology based on "light-in and sound-out," with diagnostic ultrasound - (OA/US). The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Cancerous tumors grow relatively quickly and require significant amounts of blood and oxygen, so a network of blood vessels grows around cancerous masses. The Imagio OA/US breast imaging system provides real-time images of these networks and a map of relative oxygen-rich or oxygen-depleted blood. Unlike other functional fusion technologies, Imagio uses no x-rays (ionizing radiation) or injectable contrast agents or radio-isotopes to obtain its information, thereby reducing the patient's exposure to any potentially harmful aspects of imaging.

Seno Medical Instruments, Inc. Appoints Eric Davis as Chief Financial Officer

Seno Medical Instruments, Inc. announced the appointment of Eric Davis as Chief Financial Officer. Mr. Davis previously served as the Chief Financial Officer and Corporate Treasurer at CeloNova BioSciences, Inc. Mr. Davis brings more than 20 years of financial and operational leadership with extensive domestic and international experiences.

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