A Medical Device Daily

Vermillion (Fremont, California) and its collaborators presented data demonstrating that several of the company’s ovarian cancer protein biomarkers could be used to detect early-stage ovarian cancer and to predict survival. These poster presentations were made at the 15th international meeting of the European Society of Gynecological Oncology in Berlin.

The ovarian cancer detection study showed that a panel of biomarkers in combination with CA125 could more accurately identify early stage ovarian cancer than could CA125 alone. CA125 is a commonly used tumor marker for ovarian cancer.

Vermillion said that for stage I disease, the combination correctly identified 80% of the cancers, while CA125 used alone predicted 68%. With stage II ovarian cancer, the Vermillion panel with CA125 identified 88% of the cancers compared to 71% for CA125 alone.

The study analyzed pre-operative serum samples from 231 patients. Vermillion collaborated with Robert Bast Jr., MD, and colleagues from the University of Texas M.D. Anderson Cancer Center (Houston) on this research.

“Ovarian cancer is the most lethal of gynecologic malignancies, and the development of a reliable test for detecting early-stage ovarian cancer could contribute to improving overall survival in patients,” said Bast. “These discoveries promise to improve the ability of blood tests to detect women with early ovarian cancer.”

In the survival study, researchers determined that Vermillion’s seven biomarker panel could accurately and with statistical significance predict women with ovarian cancer who had good prognosis from those who did not. The study used Kaplan-Meier analysis to show that women with a low panel score were “significantly more likely to survive than women with high scores,” independent of the stage of the disease.

Researchers analyzed pre-operative serum samples from 84 patients diagnosed with invasive epithelial ovarian cancer. Vermillion collaborated with researchers from the Oncologic Clinic Rigshospitalet, the University of Copenhagen and the Danish Cancer Society on this study.

“These data further contribute to our robust ovarian cancer diagnostics pipeline, and validation studies are underway in a larger population of women with ovarian cancer with the goal of replicating these results,” said Eric Fung, MD, PhD, chief scientific officer at Vermillion.

In addition to these data, Vermillion also presented results supporting the use of ovarian cancer triage test to distinguish benign from malignant ovarian tumors.

$20 million financing for EDAP

EDAP TMS (Lyon, France), a developer of high-intensity focused ultrasound products for treatment of prostate cancer, has entered into a securities purchase agreement with selected U.S.-based institutional buyers under which the investors will purchase $20 million in unsecured convertible debentures convertible into EDAP’s ordinary shares which will be delivered in the form of American Depository Receipts (ADR) at a conversion price of $6.57 a unit.

The company said proceeds from the financing will be used to fund its ongoing U.S. Phase II/III clinical study of the Ablatherm-HIFU system in the treatment of localized prostate cancer. The study is treating patients at U.S. clinical locations nationwide, with additional centers slated to join.

EDAP said Ablatherm-HIFU has been approved for use in the European Union and has been used in more than 13,000 cases at centers worldwide.

The debentures will mature five years from the date of closing, bearing 9% interest. EDAP may, provided certain conditions are met, elect to pay all or a portion of interest on the debentures in the form of ADRs. The investors also will receive warrants to purchase an additional 1.68 million ADRs at an exercise price of $6.87, which will expire six years from closing.

Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment.

EDAP also is developing the technology for the potential treatment of certain other types of tumors.

Cardiatis reports on 1st FluidSmart case

Cardiatis (Brussels, Belgium) issued a follow-up report on treatment of the first renal artery aneurysm (RAA) patient with its FluidSmart 3-D Multilayer Braided Stent, an investigational device in the European Union, which the company termed “a next-generation technology” for endovascular aneurysm repair.

The procedure was performed by Antonios Polydorou, MD, at the Agios Panteleimon General Hospital of Nikaia (Athens, Greece) in December of last year. The patient, a 78-year-old man, underwent a minimally invasive endovascular procedure that placed a Cardiatis hemodynamic modulating stent to treat a large renal artery saccular aneurysm with side branches.

Follow-up angiogram showed successful deployment and reduction in flow within the aneurysm, with improved flow within the main artery as well as within vital collateral circulation.

Cardiatis said a seven-month follow-up angiogram in July “confirmed reduction in aneurysm size, collapse of the aneurismal sac and preservation and improved flow in vital collateral circulation.” It added that as of the end of October, the aneurysm remained excluded from circulation while branches remain open and functional.