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Dilon Launches US FDA Cleared Clinical Trial for Use of MarginProbe® in Breast Cancer Surgery

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Dilon Devices, Ltd. today announced the launch of a pivotal clinical trial of the MarginProbe™ intraoperative, real-time, positive margin detection system, following U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) approval of its protocol during breast cancer surgery.

With the FDA IDE approval in place, Dune is launching a nationwide U.S. clinical trial of MarginProbe, which uses Radio Frequency Spectroscopy to characterize breast tissue during surgery to determine the malignancy status of tumor margins. The study will involve more than 600 women in more than a dozen leading medical centers in New York City, Baltimore, Washington DC, Allentown PA and Los Angeles.

Underscoring the benefits of MarginProbe technology, the American Journal of Surgery published in its October issue results of an earlier 300-patient, prospective, randomized, controlled clinical trial that found a 56 percent reduction in repeat lumpectomies with use of MarginProbe. The double-arm study compared surgeons’ ability to detect and remove positive margins during an initial lumpectomy and the resulting reduced rate of repeat procedures. In the MarginProbe group, surgeons applied the probe to the excised lumpectomy specimen and shaved additional tissue according to the device’s readings, which resulted in a 56 percent reduction in the need for repeat surgeries.

Dune recently closed a $15 million Series C investment led by Apax Partners. Apax also led Dune’s two previous financing rounds in 2004 and 2006.

“With its recent IDE, the opening of its European office, the readiness of production, and the recent funding, Dilon Devices is well positioned for introduction of MarginProbe, following our clinical trials and FDA clearance. We are gratified to have received funding given the current world financial situation and believe this underscores the importance of what our technology is bringing to healthcare,” said Dr. Dan Hashimshony, founder and CEO of Dilon Devices, Ltd. “Based on the strength of our ongoing studies and their validation of the benefits of MarginProbe, we look forward to the device’s acceptance within the surgical community. Soon thereafter, we hope to help ease the difficulties experienced by women who receive multiple surgeries for breast cancer.”
Current statistics indicate that between 20 and 60 percent of breast-conserving lumpectomies performed each year in the U.S. necessitate re-excision because clean margins were not obtained in the initial procedures.

The Dune MarginProbe system comprises a sterile hand-held probe and portable console. When the probe tip is applied to an excised lumpectomy segment, radio frequency signals are transmitted into the tissue and reflected back to the console, where they are analyzed using a specialized algorithm to determine tissue status. With streamlined operation and instantaneous results, the technology is designed for easy integration into existing surgical workflow.
About Dilon Devices, Ltd.

Founded in 2002 and headquartered in Caesarea, Israel, Dilon Devices, Ltd. is a privately owned, venture-funded medical device company, backed by Apax Partners. Dune is engaged in the development and commercialization of devices for real-time tissue characterization. Dilon’s devices facilitate complete, therapeutic excisions in surgical oncology procedures. The MarginProbe™ described above is undergoing clinical trials in Israel and the U.S. http://dilon.com

Source:
Jeanne-Marie Phillips
HealthFlash Marketing
http://www.healthflashmarketing.com

Randomized, Controlled Multicenter Trial Demonstrates Safety and Clinical Benefit, Significant Reduction in Repeat Surgeries Enabled by Dune’s MarginProbe®

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Company Opens US Office to Spearhead North American Operations Caesarea, Israel-Jan. 7, 2008 – Dilon Devices announces significant new clinical developments surrounding the company’s novel breast cancer assessment probe, currently in investigational use. Results from a recent randomized clinical trial in 11 medical centers in Israel have underscored the safety and clinical benefit of the system in the intraoperative detection of tumors at the resection margins (positive margins) in specimens of patients undergoing breast conserving surgery. The study compared the performance of 35 surgeons operating on patients with and without the MarginProbe™. Use of the system resulted in a significant reduction in repeat surgeries, which are typically performed in order to surgically correct positive margins found following a patient’s initial lumpectomy. The effect of the MarginProbe™ is especially pronounced in patients with non-palpable lesions. Preliminary results for more than 110 patients with non-palpable lesions showed a 60 percent reduction in repeat surgeries in the study arm that allowed use of the MarginProbe™. These results reflect initial data from the first 200 patients recruited and analyzed in the study. Final results from the entire 300 patient cohort are scheduled for presentation at the annual meeting of the American Society of Breast Surgeons (ASBS) in May 2008 in New York City.

“I believe that these data demonstrate the potential utility of the MarginProbe in reducing the patient anxiety and discomfort associated with repeat breast surgeries while reducing the unnecessary use of healthcare resources,” said Dr. Tanir Allweis of Hadassah Hebrew University Medical center, Jerusalem, Israel, an investigator in the study. Simultaneous with this announcement, Dune debuts MarginProbe™ as the trade name for its cancer probe system. The MarginProbe™ core technology, which relies on radio frequency spectroscopy for real-time tissue assessment during surgeries, will also provide a platform for additional surgical oncology applications.

Additionally, the company announces the opening of a New Jersey office to spearhead North American activities. Dune is poised to launch further clinical trials of the MarginProbe™ system in the U.S. in order to acquire data for an upcoming U.S. Food and Drug Administration (FDA) submission.

“The new data is promising. It suggests that the MarginProbe™ facilitates equally safe yet more accurate surgeries and will enable completing the surgical management of breast cancer patients with fewer repeated surgeries,” said Dr. Dan Hashimshony, founder and CEO of Dilon.  The MarginProbe™ consists of a sterile, hand-held probe and portable console. When the probe tip is applied to an excised lumpectomy segment, radio frequency signals are transmitted into the tissue and are reflected back to the console where they are analyzed using a specialized algorithm to determine tissue status.

 

About Dilon Devices, Ltd.

Founded in 2002 and headquartered in Caesarea, Israel, Dilon Devices, Ltd. is a privately owned, venture-funded medical device company, backed by Apax Partners. Dune is engaged in the development and commercialization of devices for real-time tissue characterization. Dilon’s devices facilitate complete, therapeutic excisions in surgical and interventional oncology procedures. The MarginProbe™ described above is undergoing extensive clinical trials in Israel and the U.S.

Press Contact:
Jeanne-Marie Phillips
Health Flash Marketing
888-655-3434
jphillips@healthflashmarketing.com

Dilon Devices Honored with 2007 Frost & Sullivan European Technology Innovation of the Year Award for Novel Cancer Probe

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LONDON – July 18, 2007 – Dilon Devices (Caesarea, Israel) has been honored with the 2007 Frost & Sullivan European Technology Innovation of the Year Award in surgical oncology for its novel intraoperative breast cancer probe. Using Radio Frequency (RF) Spectroscopy, the innovative device provides physicians during surgeries with the malignancy status of breast cancer margins in real-time.

Following lumpectomy, cancer patients found to have positive (malignant) surgical margins typically require a second surgery, with added expense and trauma, to reshave
tumor sites for additional tissue removal. The Dune handheld probe holds significant promise to reduce re-excision procedures, improve patient outcomes and minimize surgical expenses.

“Dune’s real-time tissue probe and portable console have the potential to satisfy a major unmet surgical oncology need,” notes Frost & Sullivan Research Director Girish Solanki. “The device provides doctors with simple, real-time determination of margin malignancy status at the desired locus while the patient is still in the operating room. It helps improve
surgical accuracy, allowing doctors to meet procedure goals more easily without the need for a second surgery.”

“Today, breast conservation surgery aims to excise tumors completely, along with a rim of surrounding healthy tissue. However, determining the status of this tissue is difficult, and a large number of women must undergo a re-excision to achieve desired surgical results. This is because an accurate and reliable method for accessing margin status intraoperatively has not existed until now. The Dune probe fills an important need,” adds Solanki.

A recent study found that the Dune probe detected 86 percent of positive tumor margins that were otherwise missed by current standard of care, potentially allowing surgeons to reshave the tumor cavity and eliminate an additional surgery. In a second recent study, the device identified 2O out of 21 DCIS sites as verified by post-operative pathology reports. DCIS is a hard-to-detect non-invasive form of breast cancer.

“Among the probe’s multiple advantages are intraoperative detection of positive resection margins in breast conservation surgery and the quantification of dozens of measurement points within minutes, along with simple operation supporting current breast surgical workflow,” says Solanki. Venture capital investments from Apax Partners and other investors have allowed Dilon to advance its technology development and obtain regulatory certifications such as the CE mark for marketing in Europe. In addition, the funding has allowed the company to conduct ongoing clinical studies in US. The investments have also advanced Dilon’s efforts to initiate development of additional products for the Dune RF platform, aimed at other important surgical applications. London Frankfurt Paris Silicon Valley New York Tokyo Mumbai Singapore Beijing Studies with the Dune probe at medical institutions such as the Anne Arundel Medical

Center in the U.S. have demonstrated the success and reliability of this device in helping surgeons evaluate the impact of surgeries in real-time in the operating room. Such
functionality makes the device a significant breakthrough in this arena. “Dilon is proud to have been selected to receive the prestigious Frost & Sullivan Award,” comments Dan Hashimshony, CEO and founder of Dilon. “As studies in the U.S. and Israel continue to underscore the benefits of our technology, we welcome this additional validation of our product’s benefits from this internationally recognized organization.”

Frost & Sullivan’s Technology Innovation Award is bestowed upon a company (or individual) that has carried out new research, which has resulted in innovation(s) that have or are expected to bring significant contributions to the industry in terms of adoption, change and competitive posture. This award recognizes the quality and depth of a company’s research and development program as well as the vision and risk-taking that enabled it to undertake such an endeavor.

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.

 

About Dilon Devices

Founded in 2002, Dilon Devices is a private, Israel based venture-funded company engaged in the development and commercialization of hand-held devices that employ patent-protected radio frequency (RF) spectroscopy to characterize tissue malignancy on-contact and in real-time. Dune’s devices are designed to enable surgeons to intraoperatively obtain clear margins and facilitate complete, residual-free therapeutic excisions in one procedure. Visit: www.dunemedical.com

About Frost & Sullivan

Frost & Sullivan, a global growth consulting company, has been partnering with clients to support the development of innovative strategies for more than 40 years. The company’s
industry expertise integrates growth consulting, growth partnership services, and corporate management training to identify and develop opportunities. Frost & Sullivan
serves an extensive clientele that includes Global 1000 companies, emerging companies, and the investment community by providing comprehensive industry
coverage that reflects a unique global perspective and combines ongoing analysis of markets, technologies, econometrics, and demographics. For more information, visit www.awards.frost.com London Frankfurt Paris Silicon Valley New York Tokyo Mumbai Singapore Beijing

For further information, please contact:

Frost & Sullivan
Sandra Holze, Promotions Co-ordinator, Best Practices
T: +44 20 7915 7866, sandra.holze@frost.com

Dilon Devices
Jeanne-Marie Phillips
President
HealthFlash Marketing
Stamford, CT 06902
203-363-0347
jphillips@healthflashmarketing.com

Dilon Devices Raises $12.5 M – The Round was Led by Apax Partners and Included Meditech Advisers and Private Investors

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Israeli start-up Dilon Devices Ltd., which develops surgical oncology technologies and products, has closed a second financing round in which it raised $12.5 million. The latest round was led by Apax Partners which invested $11.5 million, with a further $1 million raised from Meditech Advisers and private investors. Apax also led the previous financing round for Dune in 2004 in which $7.5 million was raised in two stages. According to data produced by IVC online, the company’s investors also include the Tzina Bio-Perspective Fund and the Reich Family. Dune was founded under the auspices of incubator Misgav Technology Center.

Dune has developed a hand-held surgical probe that enables detection of cancerous tissue during the course of breast surgery. Founder and CEO Dr. Dan Hashimshony said, “When a surgeon removes a growth, he scans it with the probe to verify whether it has benign margins, which will indicate that the growth has been removed in its entirety, or whether it has cancerous margins, which will indicate that cancerous tissue still remains in the body. Once the growth has been completely removed, he scans the area with the probe to ensure that no cancerous tissue remains.”

Globes: Are there any other products in the market that use different means to perform such real time examinations?

Hashimshony:”There are no such products on the market. There is one product currently in the development stages, but we will be the first company to enter the US market and the solution we offer is, I think, better than other products currently being developed.”

Published reports indicate that from 20-60% of the breast-conserving lumpectomies performed each year in the US, necessitate re-excision because a clear margin was not
obtained in the initial procedure. In a study presented at the annual conference of the American Society of Breast Surgeons (ASBS), researchers reported that Dune’s probe can identify positive margins in 75% of all patients, potentially eliminating the need for additional surgery in those cases.

In a related development, Dune also announced it had also won EU CE Mark certification for its device. The CE Mark indicates that the product is safe to use and that it does detect cancerous tissue. It now remains to be seen whether surgeons will be able to use the device to reach decisions regarding whether or not additional surgery is required.
Despite obtaining the CE Mark Certification, Dune has no plans to market the product Dilon Devices Ltd. P.O. Box 3131 Caesarea Industrial Park, Israel 38900 Tel: (972) 4 617-8000 Fax: (972) 4 627-0642 www.dunemedical.com info@dunemedical.com | All contents © 2006 Dilon Devices. All rights reserved. in Europe in the near future, but will expand its clinical trials there to prove its efficacy. “We do not expect any substantial sales in Europe until we receive US Food and Drug Administration (FDA) approval for the probe, so we will therefore deal the launch until we get it,”said Hashimshony. “We have already had a small amount of sales for clinical trial usage. We expect FDA approval by the beginning of 2008.”

Published by Globes [online], Israel business news – www.globes.co.il – on June 29, 2006
© Copyright of Globes Publisher Itonut (1983) Ltd. 2006