Navigation Links
FDA Formally Accepts Dune Medical's MarginProbe™ System Pre-Market Approval (PMA) Application and Grants Expedited Review Status
Date:5/16/2011

FRAMINGHAM, Mass., May 16, 2011 /PRNewswire/ -- Dune Medical Devices, Inc. today announced that the U.S. Food and Drug Administration (FDA) formally accepted for filing the company's Pre-Market Approval (PMA) application for the MarginProbe™ System.  The FDA's actions mean that the PMA application was sufficiently complete and ready for substantive review.  Additionally, the FDA believes MarginProbe represents a breakthrough technology that may offer a clinically meaningful advantage, and, since there is no legally marketed alternative device, confirmed that the PMA application has been granted expedited review.

"We're extremely pleased that the FDA has accepted the MarginProbe System PMA application and granted expedited review," said Dune Medical CEO Bill Densel.  "Our mission is to develop a range of applications that allow physicians to detect cancer in targeted tissue in real time, and react immediately.  This milestone with MarginProbe brings us one step closer to providing surgeons with an intraoperative technology that detects microscopically positive margins in patients undergoing surgery for breast cancer."

The PMA submission includes data from the pivotal study recently presented Friday, April 29 at the 12th Annual Meeting of the American Society of Breast Surgeons (ASBS) in Washington, DC.

Successful breast conserving surgery requires cancer-free margins at the edges of excised tissue.  However, real time, intraoperative methods currently available to surgeons are limited in their ability to identify microscopically-positive margins.  Because of this, patients frequently require re-excision procedures, which are reported to take place in up to 30 percent of patients.  Readmissions for re-excision to obtain clear margins have been shown to increase cost and emotional distress for patients, as well as have the potential for more scarring and deformation at the surgical site.  

About the MarginProbe™ System

The MarginProbe System provides real time, intraoperative detection of cancerous tissue at the edges of excised breast tissue, thereby enabling surgeons to immediately resect additional tissues.  In clinical studies as an adjunct to standard of care, it has been shown to improve a surgeon's ability to achieve a complete resection of the disease, leading to lower rates of re-excision procedures.  The MarginProbe System is commercially available in Europe.  It is an investigational device in the United States.

About Dune Medical Devices

Dune Medical Devices is a private medical device company developing applications for the real time detection of cancerous tissues during surgical, interventional, and diagnostic procedures.  As a stand-alone platform or in combination with imaging modalities, Dune's breakthrough technology will provide physicians with information that has the potential to improve procedure success rates, better outcomes, and lower costs. Founded in 2002 by Dr. Dan Hashimshony and financed by Apax Partners, the Company has offices in the U.S., Europe, and Israel.  For more information, please visit www.dunemedical.com.


'/>"/>
SOURCE Dune Medical Devices, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. PharmaNet and Anapharm Europe Formally End Joint Venture
2. Paul Meade Accepts Invitation to Speak at AACE Annual Meeting
3. FDA Accepts Investigational New Drug Application for ARI-3030MO; First in Man Clinical Trial to Begin During First Quarter of 2011
4. NYSE Amex Accepts China Shenghuos Compliance Plan for Continued Listing
5. The European Medicines Agency Validates and Accepts Cell Therapeutics Marketing Authorization Application for Pixuvri™
6. The SCOOTER Store Accepts Medicare Contracts
7. FDA Accepts Aricept® Patch (Donepezil Transdermal System) NDA for Review
8. FDA Accepts Sanofi Pasteur File Submission for Novel Influenza Vaccine Delivered by Intradermal Microinjection
9. FDA Accepts Sanofi Pasteurs Application to Expand Indication of Menactra® Vaccine to Infants and Toddlers
10. Talecris Biotherapeutics CEO Accepts 2010 Ernst & Young Entrepreneur Of The Year Award on Behalf of Employees and Patients
11. FDA Accepts Once Daily 23 mg Aricept(R) Extended Release NDA for Review
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2017)... , Jan. 14, 2017  Johnson & Weaver, LLP ... of purchasers of Zimmer Biomet Holdings, Inc. (NYSE: ... through October 31, 2016 (the "Class Period"). Zimmer ... and markets orthopaedic reconstructive products, such as knee and hip ... ...
(Date:1/13/2017)... , January 13, 2017 Constant research ... AIDS will collectively contribute to the demand for western blotting ... a value of US$ 551.0 Mn by 2016 end. Developing ... the most lucrative markets for western blotting, whereas ... globally. ...
(Date:1/13/2017)... YORK , January 13, 2017 ... equities to see how they have fared at yesterday,s ... ), Galena Biopharma Inc. (NASDAQ: GALE ), ... These companies harness cellular and biomolecular processes to develop ... reduce our environmental footprint, feed the hungry, use less ...
Breaking Medicine Technology:
(Date:1/16/2017)... OR (PRWEB) , ... January 16, 2017 , ... ... author, editor, attorney, science teacher, http://www.ageofautism.com/legal , Sharon Kleyne, America’s leading ... Kent Heckenlively to her nationally syndicated radio program, The Sharon Kleyne Hour Power ...
(Date:1/16/2017)... IL (PRWEB) , ... January 16, 2017 , ... ... (iaedp) organized to provide first-quality education and high-level training standards to an international ... spectrum of eating disorder problems. As a way to further its mission at ...
(Date:1/16/2017)... ... January 16, 2017 , ... San Francisco dentist, Dr. ... the latest in 3-D scanning device which is capable of taking digital impressions of ... in dentistry, such as CAD CAM restorations , in terms of speed, efficiency ...
(Date:1/16/2017)... , ... January 16, 2017 , ... NexTec Group has ... group of 100 organizations honored for their accomplishments in the field of midmarket financial ... industry leadership and recognition, and innovation. Selection is not based on revenue and those ...
(Date:1/15/2017)... CINCINNATI, Ohio (PRWEB) , ... January 15, 2017 ... ... their applications, Gensuite’s Community Outreach is a program that strives to better communities ... in each global locations’ community. It also provides the opportunity for team members ...
Breaking Medicine News(10 mins):