• Aethlon Medical (San Diego) has entered into a non-exclusive agreement with Bioserv (formerly known as NextPharma Technologies; San Diego) to establish manufacturing of the Aethlon Hemopurifier under good manufacturing practice requirements set forth in quality system regulations for medical device commercialization. The Hemopurifier is a first-in-class medical device that assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins from the entire circulatory system.

• AMDL (Tustin, California) reported that it has entered into a collaborative agreement with the Mayo Clinic (Rochester, Minnesota) to conduct a clinical study for the validation of AMDL's FDA-approved DR-70 (FDP) cancer test. Through this validation study, AMDL and Mayo Clinic will perform clinical diagnostic testing to compare AMDL's DR-70 (FDP) cancer test with a new test. The primary goal of the study is to determine whether DR-70 (FDP) serves as a higher-performing test to its existing predicate test and can lead to improved accuracy in the detection of early-stage cancers. For FDA approval on the new test, AMDL intends to perform an additional study to demonstrate the safety and effectiveness in monitoring colorectal cancer.

Biomedical diagnostics instrument maker Beckman Coulter (BC; Fullerton, California) said it will buy the lab-based diagnostics business of Olympus (Tokyo) for 77.45 billion yen, or about $800 million. BC said the deal will provide it with new chemistry products, give it more tests for sale to hospital laboratories, and bring new customers to its immune system tests. The diagnostics business is part of the Olympus life science unit. BC said it expects the buyout to close in 3Q09, following regulatory approvals and other clearances.

• BG Medicine (Waltham, Massachusetts) reported signing a Cooperative Research and Development Agreement (CRADA) with the National Heart, Lung, and Blood Institute (NHLBI) and Boston University (BU). Under the agreement, the three parties will jointly conduct a series of biomarker discovery studies for heart disease and early detection of metabolic syndrome a combination of certain risk factors, including abdominal obesity, hypertension and insulin resistance, which are believed to increase the risk of developing cardiovascular disease and diabetes.

• Hansen Medical (Mountain View, California) reported an equity investment in Advanced Cardiac Therapeutics (ACT; Laguna Beach, California), and the securing of exclusive rights to certain ACT intellectual property for certain robotic applications. Details of the transaction were not disclosed. ACT, a privately held company, is developing a technology designed to accurately measure the temperature in a lesion during cardiac ablation procedures.

• Nanogen (San Diego), developer of molecular and rapid diagnostic products, said it has signed an end-user license agreement (EULA) with Quest Diagnostics (Madison, New Jersey) for use of the company's MGB Probe technology in human in vitro diagnostic testing. According to the agreement, Quest will have rights to use and sell products and services incorporating the MGB Probe technology.

• PhotoMedex (Montgomeryville, Pennsylvania), a developer of excimer lasers and products for other dermatological applications, said it has acquired Photo Therapeutics (Cheshire, UK). The initial purchase price of $13 million was paid at closing, and up to an additional $7 million of consideration will be paid if certain gross profit milestones are met by June 30, the company noted.

• PolyOne (Cleveland) and Zyvex Performance Materials (Columbus, Ohio) reported a joint development agreement to provide carbon nanotube-filled polymer materials for structural and electrically conductive applications. PolyOne will compound the functionalized nanotubes with a variety of high-performance engineering thermoplastics, and will market and sell the compounds through its global commercial teams. Zyvex Performance Materials will provide the chemistry and carbon-nanotube functionalization necessary to be compatible with select high-end thermoplastics. PolyOne will supply the compounding technology, product development and process optimization to take full advantage of the nanotubes and chemistry.

• Small Bone Innovations (SBi; New York), a provider of products for the small bone & joint (SB&J) segments of the orthopedics industry, reported that it has entered into an amended licensing agreement with Artimplant (V stra Fr lunda, Sweden) to develop resurfacing and interposition applications in the fingers, hand and wrist domain based on the Artelon technology. SBi said it also recently signed an exclusive license agreement with CF&M, a French business, to market, distribute and sell the Humelock Trauma Shoulder implant worldwide.

• Spectral Diagnostics (Toronto) reported that it has signed a license agreement with Toray Industries (Tokyo) granting Spectral the exclusive development and commercial rights in the U.S. for Toraymyxin, a therapeutic device for the treatment of sepsis that removes endotoxin from the bloodstream. Under terms of the agreement, Spectral will seek FDA approval for Toraymyxin and intends to commercialize the product together with its Endotoxin Activity Assay (EAA), the only FDA-cleared diagnostic for the measurement of endotoxin.

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