Medical Device Daily Contributing Writer

ZICHRON YAAKOV, Israel – Start-up Dune Medical Devices (Caesarea, Israel), which late last month closed a second financing round in which it raised $12.5 million (Medical Device Daily, June 29, 2006), has its eyes on the U.S. market with its hand-held surgical probe that detects cancerous tissue during breast surgery.

Founder and CEO Dan Hashimshony cited the utility of the device: “The surgeon immediately sees if the edges of the tumor are benign. Benign margins indicate that the growth has been removed in its entirety. A final scan indicates with the probe ensures that no cancerous tissue remains.“

He said Dune Medical would be the first company to enter the U.S. with such a product, adding the belief that “our solution is better than other products currently being developed. We can identify positive margins in 75% of all patients, potentially eliminating the need for additional surgery in those cases.“

Hashimshony added that 20% to 60% of the breast-conserving lumpectomies done each year in the U.S. require re-excision because a clear margin was not obtained in the initial procedure.

Dune also received CE-mark certification to market its device, but Hashimshony said that Dune has no plans to market the product in Europe, although it will expand its clinical trials there. “We do not expect any substantial sales in Europe until we receive FDA approval for the probe,“ he said.

Apax Partners invested $11.5 million in the “B“ round, with another $1 million raised from Meditech Advisers and private investors. Apax led the first financing round for Dune in 2004, raising $7.5 million in two stages. Other investors include the Tzina Bio-Perspective Fund and the Reich Family.

Dune came out of the Misgav Technology Center incubator.

$1.3M for TK Signal

In another financing, radiopharmaceutical company TK Signal raised $1.3 million from London institutional investors. TK Signal is a portfolio company of Hadasit Bio Holdings (Jerusalem).

Hadasit Bio owns 28.43% of TK Signal.

The present round is part of the company's pre-IPO process, with a plan to go public on London's Alternative Investment Market within 18 months.

TK Signal develops radio-opaque labeled molecules designed to noninvasively trace cancerous growth for diagnosis or treatment. The company is targeting the epidermal growth factor receptor.

Company co-founder and Chief Technology Officer Eyal Mishani developed the approach in his laboratory at the Hebrew University of Jerusalem. Mishani said TK Signal has developed a series of radiopharmaceutical tracers, each of which identifies a different type of cancer.

The company's shareholders include Hadasit Bio, ProSeed Venture Capital Fund, Yozma Venture Capital, Ofer Hi Tech Ltd. and Rotem Industries Ltd.

CEO Dana Cohen said the money would enable the company to complete pre-clinical trials of its first product, and move onto human trials scheduled for late 2006.

TK Signal has initiated negotiations with regulatory authorities, including the U.S. FDA and Israel's Ministry of Health for permission to mount human trials.

NESS device helps move paralyzed feet

Neuromuscular Electrical Stimulation Systems (NESS; Ra'anana) has launched its NESS L300 device for moving paralyzed feet. The company has obtained CE-mark certification for the device, and will initially market it in Israel and the Netherlands.

CEO Shmuel Shany said, “Analysts estimate the potential market for the device at hundreds of thousands of units a year in the West, of a $1.8 billion market in Europe alone, focused on the one in four people with brain injuries who suffer from drop foot, which prevents normal walking without the use of a cane or walker.“

FDA approval for marketing the device in the U.S. is “expected shortly,“ according to the company. After FDA approval is obtained, sales in the U.S. will be handled by a joint NESS-Alfred Mann subsidiary.

NESS currently markets 180,000 units a year of its NESS H200 for movement activation in paralyzed hands in the U.S., Israel and the Netherlands. NESS Holland, a wholly owned subsidiary, will handle European sales in Europe.

The effects of the electric stimulation by the device seem to stimulate nerves enough so that limited movement is possible even when the patient does not wear the device.

Teuza holds a 34% stake in the company. Other investors include serial entrepreneur Alfred Mann; BG Technologies and Applications, the technology transfer company of Ben Gurion University of the Negev; Johnson & Johnson Development; ABN Amro Capital; Dow Corporate Venture Capital; Life Sciences Partners; and Israel-United States Binational Industrial Research and Development Foundation (BIRD-F).

Mann is chairman of Advanced Bionics and MannKind (Valencia, California), and owns 9.7% of Teuza as well as his direct investment in NESS.

Two years ago, Mann donated a record $100 million to the Technion – the Israeli Institute of Technology – and also set up a joint venture with NESS.

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