Diagnostics & Imaging Week Contributing Writers

Start-up Dune Medical Devices (Caesarea, Israel), which late last month closed a second financing round in which it raised $12.5 million, 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 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.

Xpert EV assay released by Cepheid

Cepheid (Sunnyvale, California) last month reported the European release of the Xpert EV (enterovirus) Assay for clinical diagnostic use on the company's GeneXpert System. The assay, released under the European Directive on In Vitro Diagnostic Medical Devices, is designed to aid clinicians in the detection of EV-associated meningitis.

Enteroviruses cause 90% of all viral meningitis cases. Currently, patients who present with meningitis symptoms must undergo treatment for bacterial meningitis until culture-based test results are available, generally in two to three days.

The Xpert EV assay is designed to detect EV RNA in cerebrospinal fluid by reverse-transcription real-time polymerase chain reaction. The test can help physicians rule-in viral infection in less than three hours. Cepheid said rapid results available through use of the assay may assist in determining antibiotic use and hospitalization decisions, and may help reduce the utilization of other more expensive diagnostic modalities such as MRIs, CTs and X-rays.

"Rapid molecular viral diagnosis of a benign disease that does not require treatment, but initially causes concern, is of unquestionable advantage," said Helene Peigue-Lafeuille, MD, PhD, professor of virology and head of the virology department at the Hospital of Clermont-Ferrand in France. "The timely availability of additional diagnostic information may be of benefit to both the patient and the community because of its impact on health economics, the needless consumption of drugs and, as a result, resistance to antibiotics."

The Xpert EV assay is the fifth in a planned menu of CE IVD mark products scheduled to be released in Europe for use on the GeneXpert and SmartCycler Systems during 2006, Cepheid said.

Cosmetic counters to get skin-imaging devices

Procter & Gamble (P&G; Cincinnati) said it plans to place SIAscope skin-imaging devices from Astron Clinica Ltd. (Cambridge, UK) at Olay counters in several countries this year, enabling consumers to increase their understanding of what makes their skin look younger.

For the first time, consumers at retail will be able to observe what is happening beneath the surface of their skin, and learn how their skin's outward appearance is directly affected, Astron Clinica said.

The Olay Skin Tone Analysis System, powered by Astron's SIAscopy technology, will be used as a counseling tool at the point of sale for consumers who are shopping for skin care products.

SIAscopy enables those in the medical, pharmaceutical and cosmetics industries to visualize up to 2 mm beneath the surface of the skin using both a hand-held scanner and a digital camera. Users include dermatologists, plastic surgeons and in Australia, general practitioners.

Astron Clinica said use of the system would give women the opportunity to see beneath the surface of the skin on their face and compare it to the skin on their inner forearm, an area seldom exposed to the rigors that faces are exposed to. The comparison will help show the damage that the face has suffered through time, sun and other environmental factors.

Originally used for the early identification of malignant melanoma, the SIAscope (SIA standing for Spectrophotometric Intracutaneous Analysis) allows observation of the skin below the surface, mapping the condition and distribution of melanin, hemoglobin and collagen.

P&G researchers have been working with SIAscopy in the laboratory as a research tool for several years, and wanted to adapt the technology so that consumers could benefit.

$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 non-invasively 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 preclinical 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.

Various countries testing VScan test kits

Medical Services International (MSI; Edmonton, Al-berta) said earlier this month that it would begin shipping its VScan HIV test kits into several European countries that are now doing their own testing rather than wait for MSI to get CE-mark approval.

The company said preliminary testing by departments of health in several European countries has resulted in test data from the VScan HIV test kit that "exceeded expectations." It said those countries have decided to complete the necessary testing for regulatory approval themselves through their departments of health.

MSI said that upon successful completion of the testing of the VScan HIV test kits by the departments of health, it would receive clearance to begin selling VScan HIV test kits in those countries.