A Medical Device Daily

bioMérieux (Marcy L'Etoile, France), a leader in the field of in vitro diagnostics, has reported the opening of a subsidiary in the United Arab Emirates. A hub for its operations in the Middle East, bioMérieux's 39th subsidiary will be based in Dubai.

Active in the region for more than 25 years, bioMérieux said it has established a leading position in the United Arab Emirates diagnostics market through its exclusive distributor, Al Hayat Pharmaceuticals, with which it will continue to work closely.

"This new subsidiary will be the hub for our Middle East commercial team. With 20,000 healthcare professionals in Dubai HealthCare City and international centers of excellence such as Harvard Medical School and Mayo Clinic, there are exciting opportunities in the UAE health economy," said bioMérieux CEO Stéphane Bancel. "[Our] solid business model allows us to continue our international expansion, a key factor for future growth and sales diversification."

Dubai HealthCare City, where the bioMérieux subsidiary is located, has the goal of becoming the leading center in the region, filling a gap in healthcare services in the zone between Europe and Southeast Asia.

bioMérieux said it will bring its expertise as a world leader in diagnostics for healthcare associated infections (HAI) to local hospitals and universities to build HAI management programs.

The Dubai subsidiary also will provide field support to bioMérieux's customers and distributors in the region. Emphasis will be placed on training and a bioMérieux training center is planned, which will provide training on optimal product use and high-level scientific conferences on key pathologies.

bioMérieux provides reagents, instruments and software used for diagnosing infectious diseases and providing what it terms "high medical value results for cardiovascular emergencies and cancer screening and monitoring." It has a presence in more than 150 countries through 39 subsidiaries and a network of distributors.

Hemopurifier safety study completed

Aethlon Medical (San Diego) reported the completion of a human safety study conducted at Fortis Hospital (Delhi, India). The primary objective of the study was to evaluate the safety of the Aethlon Hemopurifier in health-compromised end-stage renal disease (ESRD) patients who require kidney dialysis.

The Hemopurifier is a first-in-class device that Aerthlon said assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins.

"In addition to demonstrating safety, the study provided the opportunity to observe changes in viral load in ESRD patients infected with hepatitis-C virus (HCV)," the company said.

In the study, six ESRD patients received a series of three, 4-hour Hemopurifier treatments every other day during the course of one week. The treatment regimen mirrored the patient's normal kidney dialysis schedule, which allowed for the inclusion of the Hemopurifier without disrupting dialysis treatment.

Blood chemistry and general health of the patients were monitored throughout the study, and at the conclusion of the study, the sole reported adverse event was hemolysis, which was observed in a total of four treatments, three of which occurred in the same patient.

The physicians administering the study reported that the incidence of hemolysis did not cause any follow-on health concerns. No other adverse events have been reported in a total of 42 Hemopurifier treatments administered in human studies.

Aethlon previously completed a 24-treatment study at Apollo Hospital, also located in Delhi.

In mid-September, Aethlon reported robust viral load reductions in tested HCV patients that completed the three Hemopurifer treatment protocol. The outcomes were derived from consolidated viral load values of all three patients. The values resulted in an average viral load reduction of 60% when measured three days after final Hemopurifier treatment, the company said, and an 82% reduction when measured seven days post-treatment.

"With the Fortis study complete, we will update our investigational device exemption on file with the FDA and request permission to initiate human studies in the U.S.," said Aethlon Chairman/CEO James Joyce. "Additionally, we are preparing to launch a four-week HCV treatment case study that could trigger early commercialization in India, and we have initiated discussions with potential partners to evaluate the clinical opportunity for our Hemopurifier in the European Union."

Canadian distributor named by EraGen

EraGen Biosciences (Madison, Wisconsin) said it has appointed Inter Medico (Markham, Ontario) as the exclusive distributor of the company's molecular diagnostic products in the Canadian market.

Inter Medico will distribute several EraGen molecular tests that recently received Health Canada approval for marketing as in vitro diagnostics. The approved tests are performed on the company's MultiCode RTx real-time PCR (polymerase chain reaction) system.

The company said the system "simplifies and enhances traditional real-time PCR, providing workflow, time-to-result, and flexibility benefits to clinicians and laboratories."

"EraGen's entry into the Canadian market commences our planned expansion into lucrative, rapidly-growing molecular diagnostics markets outside of the U.S.," said Irene Hrusovsky, MD, president/CEO of EraGen. "As we begin that expansion, we are pleased to partner with Canada's leading medical diagnostics distributor. Inter Medico has a strong track record of introducing innovative technologies to the Canadian diagnostics market and we look forward to a successful, productive partnership. We expect to seek Health Canada approval for additional EraGen tests and will bring them to market through Inter Medico upon approval."

Hitachi eyed as Hi Art distributor

TomoTherapy (Madison, Wisconsin) said it has signed a letter of intent with Hitachi Medical (HMC; Tokyo) to distribute the U.S. firm's Hi Art cancer treatment system in Japan.

TomoTherapy CEO Fred Robertson, MD, said, "HMC should prove to be an ideal partner for TomoTherapy, and for our valued Japanese customers."

Terms of the agreement between TomoTherapy and HMC are being finalized, with the partnership expected to commence by the end of 2008.

Hitachi Medical is a full-line supplier of medical equipment in Japan and a subsidiary of Hitachi Ltd., the global electronics company.

The Hi Art treatment system, is said ti have an advanced radiation therapy system for the treatment of a wide variety of cancers, combining integrated CT imaging with conformal radiation therapy to deliver radiation treatments with speed and precision while reducing radiation exposure to surrounding healthy tissue.

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