Navigation Links
Dune Medical's MarginProbe™ Demonstrates Increased Positive Margin Identification Leading to Reduction in Patients Indicated for Re-excision in Landmark Lumpectomy Surgery Trial
Date:4/29/2011

WASHINGTON and FRAMINGHAM, Mass., April 29, 2011 /PRNewswire/ -- Dune Medical Devices, Inc. today announced that the landmark, 664-patient pivotal trial evaluating the MarginProbe™ System met its primary endpoints.  The MarginProbe System provides surgeons with a real time, intraoperative technology to detect microscopically-positive margins on excised tissues. Top-line data from the study were presented at the 12th Annual Meeting of the American Society of Breast Surgeons (ASBS) in Washington, DC. Results showed that, when using MarginProbe in addition to standard of care techniques, there was greater than a three-fold increase in surgeons' ability to identify and immediately resect all positive lumpectomy margins, compared to standard of care techniques alone. This improvement led to a 57 percent reduction in patients who were candidates for re-excision (additional surgery) due to positive margins left un-resected on the lumpectomy specimen.  

A successful lumpectomy requires cancer-free margins at the edges of excised tissue.  However, intraoperative methods currently available to surgeons are limited in their ability to identify microscopically positive margins.  Because of this, patients frequently require re-excision when positive margins are found during pathological examination, normally occurring 2-4 days following lumpectomy.  Re-excision rates for positive margins are reported as high as 30 percent.  

Patients participating in the international, multi-center, controlled trial underwent lumpectomy surgery and were randomized in the operating room to receive either the standard of care (control group), or the standard of care plus MarginProbe (device group). In the device group, MarginProbe was used to measure each margin of the excised lumpectomy specimen. If the device registered a positive reading, additional tissue was immediately resected from the adjacent breast cavity surface.

A primary endpoint of the study was Complete Surgical Resection (CSR), which measured the surgeons' ability to identify and resect all positive margins when present.  Roughly 50 percent of patients had one or more positive margins on the lumpectomy specimen (later determined by pathology), and CSR was successful when all margins were identified and completely resected.  For the device group, the rate of successful CSR was 72 percent, compared to 22 percent in the control group (P<0.0001). Patients who did not achieve successful CSR were considered candidates for re-excision procedures, 42 in the device group compared to 98 in the control group (57 percent reduction, P<0.0001). Of these candidates, 30 patients in the device group and 62 patients in the control group had a re-excision.

"The results of the study are very encouraging," said International Principal Investigator Lorraine Tafra, MD, FACS, Medical Director of Anne Arundel Breast Center, Annapolis, MD. "The ability to accurately identify cancer immediately in the operating room, and have a marked impact on the number of patients who return from surgery with clear margins, suggests that the MarginProbe System has the potential to significantly improve traditional breast cancer surgery outcomes."

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.  

"Despite best efforts, achieving microscopically-clear surgical margins in the operating room has been a persistent challenge," said Dune Medical CEO, Bill Densel. "We are extremely pleased with the positive outcome of the study. These results confirm that our breakthrough technology can benefit patients by providing physicians with the ability to detect cancerous tissues during procedures and immediately react."

Pivotal Study Details

664 women aged 18 years and older, histologically diagnosed with carcinoma of the breast, with non-palpable malignant lesions requiring image guided localization, and undergoing lumpectomy surgery at one of 21 sites in the U.S. and Israel, were enrolled in the study.  Of these women, 596 were randomized in the operating room to one of two evenly distributed groups, either device or control.  In the device group, the MarginProbe System was used in addition to standard of care methods to measure each margin of the excised lumpectomy specimen. If the device registered a positive reading, additional tissue was immediately resected from the breast cavity corresponding to the positive margin. All tissue, in both groups, underwent intraoperative specimen imaging before being sent to routine pathology per standard of care.

A primary endpoint of the study was Complete Surgical Resection (CSR), the rate of patients with one or more positive margins (< 1mm) on the lumpectomy specimen, as determined by histology, in whom all positive margins were identified and immediately resected. In the device arm, the rate of CSR was 72 percent (N=117/163) compared to 22 percent (N=33/147) in the control group (P< 0.0001).  Total tissue volume excised across all surgeries in both groups was similar, with an average of 93cc removed in the device group compared to 85cc removed in the control group.

No safety concerns were noted in the study.  Events were similar across both study groups.

About the MarginProbe™ System

The MarginProbe System enables real time detection of cancer at or near the surface of excised tissue specimens during surgery for breast cancer. This simple and immediate assessment of the surgical margins allows surgeons to immediately excise additional tissue, potentially saving a second procedure.

The MarginProbe System is commercially available in Europe.  It is an investigational device in the United States.

About Dune Medical Devices

Dune Medical Devices was founded in 2002 by Dr. Dan Hashimshony to realize the extraordinary medical potential of its proprietary cancer detection technology. Offering surgeons and radiologists the real time ability to identify cancerous tissues and react immediately, this technology holds promise for a broad range of surgical and diagnostic applications. The MarginProbe System is Dune's first commercial product.  

Dune Medical Devices is a privately-held company, financed by Apax Partners. It has offices in the U.S., Israel, and Switzerland. For more information, please visit www.dunemedical.com.


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

Related biology technology :

1. SAFC Hitech(TM) Successfully Demonstrates Device-Quality GST Precursors For Phase Change Memory Applications
2. SuperGens MP-470 Demonstrates Clinical Tumor Regression When Combined with Standard of Care Chemotherapy
3. EntreMeds ENMD-2076 Demonstrates Tumor Regression in Human Colon Cancer Model
4. Vaxart Demonstrates Efficacy of Oral Avian Flu Vaccine in Preclinical Studies
5. Study From the University of Texas M.D. Anderson Cancer Center Demonstrates That AHCC(R) is Safe in Combination With Most Chemotherapeutic Agents
6. RVX-208 Data Demonstrates Increase in Functional HDL Particles
7. Antheras Varespladib Demonstrates Significant Anti-Inflammatory Effect and LDL Reduction in Patients With Coronary Heart Disease
8. Human clinical study demonstrates superior Neptune Krill Oil NKO(R) pharmacokinetic profile
9. Sparta Systems Demonstrates Global Enterprise Quality Management Leadership at TrackWise(R) Connection User Conferences
10. Epilepsia Study Demonstrates New Add-on Antiepileptic Drug Vimpat(R) (lacosamide) Significantly Reduces Partial-Onset Seizures in Adults With Epilepsy
11. First Multiple Dose Clinical Trial of TorreyPines Therapeutics Oral Compound NGX426 Demonstrates Compound Is Safe and Well-Tolerated
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... , February 4, 2016 - New FDA action ... - New FDA action date of July 22, ... July 22, 2016   - ... in the past decade indicated for the treatment of signs and symptoms of ... has the potential to be the only product approved in the U.S. in ...
(Date:2/4/2016)... Beike Biotechnology, the Shenzhen ... ceremony in late 2015 to mark their successful combined ... --> --> The ... Cell Therapy" was hosted by the Shenzhen Cell Bank ... of Beike Biotechnology Co., Ltd. Shenzhen,s ...
(Date:2/4/2016)... EDISON, N.J. , Feb. 4, 2016 ... company focused on the development and commercialization of targeted ... BIO CEO & Investor Conference 2016, to be held ... and Source Capital Group,s 2016 Disruptive Growth & Healthcare ... on February 10-11, 2016. James Sapirstein ...
(Date:2/4/2016)... 4, 2016 Strasbourg, France ... --> Strasbourg, France , to the ... PharmaVentures is pleased to announce that it acted as an ... unit in Strasbourg, France , to the ... --> --> Transgene (Euronext: TNG), a member ...
Breaking Biology Technology:
(Date:2/1/2016)... 2016  Today, the first day of American Heart ... develop a first of its kind workplace health solution ... In the first application of Watson ... ), and Welltok will create a new offering that ... analytics, delivered on Welltok,s health optimization platform. The effort ...
(Date:1/28/2016)... Synaptics (NASDAQ: SYNA ), a leading developer of human interface ... 31, 2015. --> --> ... percent compared to the comparable quarter last year to $470.5 million. ... million, or $0.93 per diluted share. --> ... of fiscal 2016 grew 9 percent over the prior year period ...
(Date:1/25/2016)...   Unisys Corporation (NYSE: UIS ) today announced ... International Airport, New York City , to help ... to enter the United States using passports ... pilot testing of the system at Dulles last year. The ... during January 2016. --> pilot testing of the ...
Breaking Biology News(10 mins):