• Resources
  • Blog
  • Journalists
  • Log In
  • Sign Up
  • Data Privacy
  • Send a Release
Cision PR Newswire: news distribution, targeting and monitoring home
  • News
  • Products
    • Overview
    • Distribution by PR Newswire
    • Cision Communications Cloud®
    • Cision IR
    • Sponsored Placement
    • All Products
  • Contact
    • General Inquiries
    • Request a Demo
    • Editorial Bureaus
    • Partnerships
    • Media Inquiries
    • Worldwide Offices

 

When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All News Releases
      • All Public Company
      • English-only
      • News Releases Overview

      • Multimedia Gallery

      • All Multimedia
      • All Photos
      • All Videos
      • Multimedia Gallery Overview

      • Trending Topics

      • All Trending Topics
  • Business & Money
      • Auto & Transportation

      • All Automotive & Transportation
      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation
      • Auto & Transportation Overview

      • View All Auto & Transportation

      • Business Technology

      • All Business Technology
      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • Business Technology Overview

      • View All Business Technology

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Financial Services & Investing

      • All Financial Services & Investing
      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • Financial Services & Investing Overview

      • View All Financial Services & Investing

      • General Business

      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News
      • General Business Overview

      • View All General Business

  • Science & Tech
      • Consumer Technology

      • All Consumer Technology
      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • Consumer Technology Overview

      • View All Consumer Technology

      • Energy & Natural Resources

      • All Energy
      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities
      • Energy & Natural Resources Overview

      • View All Energy & Natural Resources

      • Environ­ment

      • All Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • Environ­ment Overview

      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • All Heavy Industry & Manufacturing
      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • Heavy Industry & Manufacturing Overview

      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • All Telecomm­unications
      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • Telecomm­unications Overview

      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • All Consumer Products & Retail
      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • Consumer Products & Retail Overview

      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Health

      • All Health
      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • Health Overview

      • View All Health

      • Sports

      • All Sports
      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • Sports Overview

      • View All Sports

      • Travel

      • All Travel
      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • Travel Overview

      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • All Policy & Public Interest
      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy
      • Policy & Public Interest Overview

      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • All People & Culture
      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • People & Culture Overview

      • View All People & Culture

      • In-Language News

      • español
      • português
      • Česko
      • Danmark
      • Deutschland
      • España
      • France
      • Italia
      • Nederland
      • Norge
      • Polska
      • Portugal
      • Россия
      • Slovensko
      • Suomi
      • Sverige
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • Sponsored Placement
  • All Products
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • PR Newswire: news distribution, targeting and monitoring
  • Send a Release
    • ALL CONTACT INFO
    • Contact Us

      888-776-0942
      from 8 AM - 10 PM ET

  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • All Products
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR

New Interim Results Support Imagio® Opto-Acoustic (OA) Breast Imaging System's Potential to Reduce Negative Biopsies

Company Plans to Deliver First Imagio® Opto-Acoustic (OA) Breast Imaging Systems to Select Markets in Europe in Early 2017


News provided by

Seno Medical Instruments, Inc.

Sep 24, 2016, 07:00 ET

Share this article

Share this article


SAN ANTONIO, Sept. 24, 2016 /PRNewswire/ -- Seno Medical Instruments, Inc. (Seno Medical), the company pioneering the development of opto-acoustic technology as a tool to improve the process of diagnosing breast cancer, announced today 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), the second largest conference in the world dedicated to breast cancer imaging, on September 24, 2016 in Paris. 

"The interim results from MAESTRO add to the growing body of clinical evidence showing that the Imagio opto-acoustic diagnostic tool increases physicians' confidence when differentiating and classifying malignant and benign breast tissue," said the study's principal investigator Ruud Pijnappel, MD, PhD, Radiologist, University Medical Center, Utrecht, NL, who presented the interim analysis. "The improved accuracy that is possible with this technology could help women avoid painful biopsy procedures that sometimes follow false-positive diagnoses."

There are over 1.6 million biopsies performed annually1 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.2  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. 

"The interim results of the MAESTRO study are promising and could help physicians reliably and safely assess suspicious masses to deliver optimal treatment for each patient," said Tom Umbel, CEO of Seno Medical Instruments. "We look forward to the delivery of the first Imagio OA/US systems in the Netherlands, UK and Germany early next year."

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.

About Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno's Imagio breast imaging system fuses opto-acoustic technology with ultrasound to generate functional and anatomical images of the breast. The opto-acoustic images provide a unique color map in and around suspicious breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of the two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno believes that Imagio images will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. Seno's platform technology may also address other disease applications in organs other than the breast, as well as assessing other breast problems, such as early response to neoadjuvant chemotherapy or hormonal treatments of breast cancer. To learn more about Seno's opto-acoustic imaging technology and applications, visit www.SenoMedical.com

About EUSOBI Annual Scientific Meeting
The EUSOBI Annual Scientific Meeting consists of plenary lectures, workshops, symposia, poster sessions and technical exhibitions.  The conference attracted renowned international speakers who shared their latest information and perspectives on emerging technologies in the breast cancer imaging space.

About Breast Cancer
According to the American Cancer Society, an estimated 246,660 new cases of invasive breast cancer, along with 61,000 new cases of non-invasive (in situ) breast cancer, will be diagnosed in U.S. women in 2016. An estimated 40,450 women in the U.S. are expected to die in 2016 from breast cancer. Only lung cancer accounts for more cancer deaths in women.3

Media Contact
Erich Sandoval
Lazar Partners Ltd. 
Tel: +1 917-497-2867
Email: [email protected]

_________________________

1 J Womens Health, September 2014, Vol. 23:S1.

2 An Actuarial Analysis of Breast Cancer Screening and Follow-on Diagnostics in a Commercially Insured Population.(2014).Millman, Inc., NY.http://www.milliman.com/uploadedFiles/insight/2014/actuarial-analysis-breast-cancer-screening.pdf

3 U.S. Breast Cancer Statistics | Breastcancer.org. (2016). Breastcancer.org. http://www.breastcancer.org/symptoms/understand_bc/statistics

SOURCE Seno Medical Instruments, Inc.

Related Links

http://www.SenoMedical.com

Modal title

Contact Cision

  • Cision Distribution 888-776-0942
    from 8 AM - 9 PM ET

  • Chat with an Expert
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices

Products

  • Cision Communication Cloud®
  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • For Small Business
  • All Products

About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Become a Channel Partner
  • Careers
  • COVID-19 Resources
  • Accessibility Statement
  • Asia
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Mexico
  • Middle East
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

My Services

  • All New Releases
  • Online Member Center
  • ProfNet

Contact Cision

Products

About

My Services
  • All News Releases
  • Online Member Center
  • ProfNet
Cision Distribution Helpline
888-776-0942
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2022 Cision US Inc.