China Medical Technologies (Beijing, China), 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.

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, valued at $1 each, for each 1,600 shares of common stock submitted. The value of the common stock is $.000625 a share.

AION reports preliminary study results

Nano-diagnostics company AION Diagnostics (Perth), a developer of imaging agents, reported positive preliminary results of a pilot study showing the high intravascular contrast enhancement of modified porous silicon (mpSi) in reduced dose amounts.

In the in vivo study, a bolus injection of mpSi in saline suspension was administered intravenously. Ultrasonographic imaging of the vasculature and heart indicated that the mpSi showed high echogenicity and produced strong contrast enhancement with no change in vital signs or evidence of acute cardiovascular or respiratory adverse effects. Silicic acid is a natural byproduct of silicon and mpSi metabolism.

The trialed intravascular contrast agent is based on the same formulation as AION’s Marking Agent, a medical device to be registered under the CE mark and the FDA 510(K) route.

The interim results provide “an excellent advancement to consolidate AION’s position in the ultrasound imaging sector,” the company said, calling ultrasound “a powerful imaging technique that can be used in a wide variety of settings, including surgical, outpatient, emergency room and community healthcare environments.”

“Ultrasound avoids the need for expensive and radiation-emitting modalities, and provides clinicians with a practical solution for early detection of cardiovascular disease and cancer,” said Dr. Anna Kluczewska, president/CEO of AION.

mpSi also is visible under other key imaging modalities, including MRI, CT, X-ray and optical imaging.

The European contrast media market, inclusive of all imaging modalities, generated revenues of 11.02 billion in 2006 with an expected CAGR of 7.2% for 2006-2013.

AION said current ultrasound contrast agents have a short imaging life due to their inherent fragility and rapid removal from the bloodstream. The physical stability of mpSi particles overcomes this issue, it said, offering advantages with increased length of time available to clinicians in performing examinations.

“The stability of mpSi particles also will allow clinicians to use higher resolution imaging than is possible with conventional contrast media because of their fragility, which translates to better contrast and improved visualization of anatomical detail,” the company said.

It noted that the high visibility of mpSi at low dose is of “vital importance in molecular imaging applications due to the necessity to image minute clusters of diseased cells.”

No Comments