A Medical Device Daily

China Medical Technologies (Beijing), a maker of in vitro diagnostic systems and high-intensity focused ultrasound (HIFU) products, and EDAP TMS (Lyon, France), a developer of HIFU treatment for prostate cancer, reported an agreement under which EDAP will distribute China Medical's HIFU tumor therapy systems in the European Union (EU) and Russia.

The agreement provides EDAP exclusive distribution rights in the EU and Russia initially for four years following receipt of CE-marking for China Medical's FEPBY series of HIFU systems, with renewal periods following the initial term.

China Medical will seek regulatory approval for its HIFU devices, with support from EDAP.

"Based on EDAP's history of success in bringing new and innovative technologies to market in Europe and Russia, we expect the agreement between China Medical and EDAP to not only accelerate the development and understanding of HIFU therapy for the treatment of cancer, but also help facilitate the European regulatory approval process for our HIFU systems," said Xiaodong Wu, CEO and chairman of China Medical. "EDAP already has the strongest HIFU sales network in Europe and we think that pairing our two HIFU companies from the East and the West will help advance our marketing efforts and potentially provide opportunities for future collaboration."

Marc Oczachowski, CEO of EDAP, said, "Together, our companies represent a dominant force in HIFU applications, and we believe our distribution alliance will accelerate worldwide acceptance of this important technology.

He said that EDAP's Ablatherm-HIFU system "has set a new standard in prostate cancer care," while China Medical is the largest provider of extracorporeal HIFU devices in China for the treatment of solid tumors. "Together we will be able to educate the global medical community about the benefits of HIFU more rapidly and make it a major therapeutic tool for the treatment of a broad range of solid-tumor diseases."

China Medical's products use enhanced chemiluminescence and fluorescent in situ hybridization technology to detect and monitor various diseases and disorders, along with products using HIFU for the treatment of both cancerous and benign tumors.

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

Quintiles in South African partnership

Quintiles Transnational (Research Triangle Park, North Carolina) said it has entered a partnership with Thebe HealthCare, one of South Africa's leading black economic empowerment companies.

Thebe has purchased a 30% share of Quintiles' South African commercial division, Innovex, making Quintiles one of the first multi-national healthcare companies in South Africa to enter into a direct equity transaction with a local Black Economic Empowerment partner.

"The agreement will help us continue to grow both our Quintiles and Innovex business lines in South Africa," said Gillian Corken, CEO of Quintiles Africa. "We have formed an alliance with the oldest and largest majority-black-owned pharma company, which has a proven track record of success in South Africa and a healthcare division with a synergistic fit with Quintiles and Innovex."

Yaseen Bhayat, CEO of Thebe, is joining the board of Innovex, now owned 70% by Quintiles and 30% by Thebe.

A group company of Thebe Investment, Thebe Healthcare provides healthcare through its pharmaceutical, medical and consumer products.

Quintiles South Africa has commercialization and research offices in Centurion, Bloemfontein, Durban and Cape Town.

Lifeline in First Warning plans

Lifeline Biotechnologies (Reno, Nevada) said it has entered into final negotiations for the development of a computer software system that it said is the basis for its First Warning System, designed to assist in the early detection of breast cancer.

Lifeline recently reacquired the First Warning System, which it had sold in 2006, the company saying it will focus on completing system development. It said the underlying technology upon which the First Warning System is based "holds the possibility of eliminating over 90% of unnecessary breast biopsies performed each year," providing a potential savings to the healthcare system of up to $2.8 billion annually.

Jim Holmes, CEO of the company, reported negotiations with a "major southeast-Asian-based university" to complete development of the software that provides the capability for the First Warning System. "Lifeline has been working with engineers at the university for several years on an informal basis and a contract for a formal arrangement is expected to be concluded near-term," he said.

Upon completion of the development involving the analysis of from 100 to 150 patient data sets from women previously tested using the First Warning System, additional testing will be undertaken in order to validate the technology, Holmes said. "To date, the development has indicated a potential breakthrough in identifying breast cancer and the false positives and false negatives have been within acceptable levels."

The company also reported that the cut-off date for the previously reported exchange of Series B preferred stock for common stock, to Lifeline's transfer agent, OTC Corporate Stock Transfer (Jericho, New York), was extended to May 18. The exchange is for one share of preferred stock, valued at $1 each, for each 1,600 shares of common stock submitted. The value of the common stock is $.000625 a share.

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