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

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

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:
(Date:11/25/2015)... 2015  The total global healthcare industry is expected to ... Latin America has the highest projected growth ... Japan ), is second with growth projected at ... increased healthcare expenditure. In 2013-2014, total government funded healthcare was ... 2008-2009 to 41.2% in 2013-2014. In real terms, out of ...
(Date:11/25/2015)... 25, 2015 AAIPharma Services Corp./Cambridge Major ... at least $15.8  Million to expand its laboratories ... . The expansion will provide additional office ... growing demands of the pharmaceutical and biotechnology markets. ... will provide up to 40,000 square feet of ...
(Date:11/25/2015)... Kitov Pharma ceuticals ... biopharmaceutical company focused on the development of therapeutic candidates ... announced the closing of its previously announced underwritten public ... each representing 20 ordinary shares of the Company, and ... and warrants were issued in a fixed combination of ...
Breaking Medicine Technology:
(Date:11/26/2015)... Toronto, ON and Cambridge, ON (PRWEB) , ... ... ... announced today the availability of a real-time eReferral system for diagnostic imaging in ... CTs, ultrasounds, X-rays, mammography, BMD and Nuclear Medicine tests directly from their electronic ...
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare International, Inc., the first ... annual Employee Benefits Conference. The Employee Benefits Conference was hosted by the International ... November 11th, 2015. The conference was held at the Hawaii Convention Center in ...
(Date:11/25/2015)... IN (PRWEB) , ... November 25, 2015 , ... ... water accessible for all, Water For Empowerment ™ attracts volunteers together who ... clean water by empowering women as key stakeholders in the process. The non-profit ...
(Date:11/25/2015)... ... November 25, 2015 , ... Dr. John Pierce, Medical ... more about hair loss treatment with the Capillus272™ Pro laser therapy cap. FDA cleared ... thicker and fuller hair, without the need for surgery, prescription pills, or topical foams. ...
(Date:11/25/2015)... ... 25, 2015 , ... Lakeview Health, a Jacksonville-based drug and ... sobriety and show through pictures what a positive difference it makes. The social ... the hashtag #FacesOfGratitude on their Facebook, Twitter, and Instagram accounts. Short stories ...
Breaking Medicine News(10 mins):