BB&Ts

Royal Philips Electronics (Amsterdam, the Netherlands) reported an agreement to acquire Alpha X-Ray Technologies (Mumbai, India), a manufacturer of cardiovascular X-ray systems targeting the economy segment of the Indian market. Upon closing of this transaction in 4Q08, Alpha will become part of the Cardiovascular X-ray business within Philips' Healthcare. Financial details were not disclosed.

"The acquisition of Alpha is another great example of how Philips continues to strengthen its industrial and commercial footprint in emerging markets," said Ronald de Jong, CEO of Emerging Markets for Philips Healthcare. "It provides us with significant presence in the high-growth economy segment for Cardiovascular X-ay systems, underlining our commitment to deliver affordable healthcare solutions in emerging markets."

Philips said Alpha's product portfolio complements its existing high-end cardiovascular X-ray range and helps Philips to capture an even larger slice of the global e1.8 billion cardiovascular X-ray market.

"The addition of Alpha represents another significant addition to our emerging markets healthcare product portfolio, and comes on the heels of two key product introductions in India: the SureSigns VM3 patient monitor and the cost-effective Ultrasound HD15 system," said Murali Sivaraman, CEO of Philips Electronics India.

CI reimbursement in Japan for Oxinium

Smith & Nephew's Orthopaedic Reconstruction & Trauma business (S&N; Memphis, Tennessee) and Smith & Nephew Orthopaedics KK Japan reported getting Japanese regulatory C1 Category Reimbursement approval for its Oxinium oxidized zirconium technology.

S&N's Genesis II Oxinium Total Knee System is the first orthopedic product to gain the C1 Category reimbursement in Japan, the world's second-largest orthopedic market after the U.S.

The company said that Japan's C1 classification "rewards innovative products with a higher reimbursement price and is reserved for those products where the advantages are recognized" by the MHLW [Ministry of Health, Labour and Welfare] over other available products."

Smith & Nephew Orthopaedics KK Japan received regulatory approval for the Genesis II Oxinium Total Knee System in Japan on Feb. 18.

Oxinium is a transformed metal alloy with a ceramic bearing surface that S&N said combines low friction and wear resistance technology with the strength of a metal implant.

"It is this ceramic surface that gives Oxinium its advantages over CoCr implants," the company said in a statement. "Because only the surface is changed, the rest of the component is still metal and therefore the implant retains its overall strength."

The Oxinium material presently is used for total hip and total knee joint replacements.

"Getting the Genesis II Knee System with the Oxinium Technology approved in Japan is a great opportunity for Smith & Nephew Orthopaedics KK Japan to offer a new state-of-the-art material to the Japanese patients and the surgeons who perform these procedures," said Joseph DeVivo, president of Smith &Nephew Orthopaedic Reconstruction and Trauma.

Hailing the MHLW for understanding the benefits of Oxinium, he said the company was pleased by the C1 Category reimbursement, "which recognizes the importance in making these types of new products available to the Japanese patient."

S&N specializes in orthopedic reconstruction, orthopedic trauma & clinical therapies, endoscopy and advanced wound management products.

Zila adds to European distributor rolls

Zila (Phoenix) said it has selected Dentaid to be the exclusive distributor of ViziLite Plus with TBlue, Zila's oral cancer screening product, in Spain, France, Germany and Portugal.

Terms of the agreement were not disclosed.

ViziLite Plus with TBlue is now available to 55% of the residents of Western and Eastern European member countries of the European Union. Zila previously reported the selection of distributors for the product in the UK, Ireland, Greece and Cyprus.

ViziLite Plus is Zila's flagship product for the early detection of oral abnormalities that could lead to cancer. The company said it is the first and only adjunctive medical device cleared by the FDA for use in a population at increased risk for oral cancer.

SituGen completes cord blood device trials

SituGen (Tel Aviv, Israel) reported the completion of clinical trials of its device for the collection of umbilical cord blood.

The company said that the trials show that the device increases the number of stem cells collected by an average of 81%, to 1.51 billion total nucleated cells (TNC), compared to the world average of 0.83 billion TNC. This significantly increases the quantity of stem cells that can be transplanted into adults.

TNC is the main indicator for the quality of cord blood collected. The number of nucleated cells is a significant factor in transplantation success and is a major predictor of recovery speed after transplant, the company said.

The company said it expects FDA approval for the device by the end of the year, with European approval soon to follow.

SituGen's says that the device is disposable and needle-free, relieving the bottleneck effect created by applying a needle to collect the blood from the cord's vein. The device is in full accordance with all the requirements set for all umbilical cord blood collection devices. It is also suitable for operating rooms and caesarean sections.

Following completion of clinical trials, SituGen is preparing to market the device to cord blood banks worldwide. In addition, it will continue R&D in the stem cell and cord blood fields, focusing on blood coagulation aspects in the umbilical cord and the placenta, in pregnancy and birth.

CoveValve completes ReValving system cases

CoreValve (Irvine, California) reported that five clinical evaluation sites — two in New Zealand and three in Australia — have completed their first series of proctored cases using the company's ReValving system for percutaneous aortic valve replacement, featuring a porcine pericardium valve mounted in a self-expanding frame.

During a 12-day period, 24 patients at hospitals in Auckland, Brisbane, Melbourne, Sydney and Hamilton underwent successful percutaneous aortic valve replacement with the system. These hospitals are participating in a clinical evaluation registry as required for market clearance in Australia and New Zealand.

CoreValve says that, to date, more than 1,500 patients at 75 sites worldwide have received a ReValving bioprosthesis since the CE mark was issued for the system.

GE unit funds sale/leaseback financing

GE Healthcare Financial Services (Chicago) said it has provided a $10 million sale and leaseback financing to Catholic Medical Center (CMC; Seoul South Korea), one of the largest hospital chains in South Korea.

The company said it would use the financing to lease back various equipment, including electronics, medical equipment and furniture for its new hospital and cancer center.

CMC's eight hospitals are in Seoul, Kyunggi and other provinces, with a bed count of 4,878. It is building a new cancer center in Seoul, which will increase the bed number to 5,678 by 2009.

Pacsgear opens European office in Munich

Pacsgear (Pleasanton, California), a provider of document and multimedia connectivity solutions for hospitals and healthcare facilities, reported the establishment of its European office in Munich, Germany. Pacsgear's European office will provide sales and logistics functions in support of the company's products, which connect medical image management and electronic health record systems.

Pacsgear provides document and multimedia connectivity solutions for medical image management and electronic health record systems. Its products have CE marking and are available in six European languages.

Israel's Hadasit tests double lumen catheter

Hadasit (Ein Kerem, Israel) reported pre-clinical testing of a prototype of the Double Lumen PCI Guiding Catheter for use in the treatment of coronary artery disease.

As the name implies, the Double Lumen has two lumens rather than one. The second lumen allows for a continuous medication infusion to the coronary artery during percutaneous coronary intervention (PCI), the part of the procedure when the narrowed coronary artery is dilated.

Hadasit is the technology transfer company of Hadassah Medical Organization in Jerusalem, Israel, and promotes and commercializes HMO's continuously generated intellectual property and R&D capabilities.

SinuCleanse on market in Canada

The SinuCleanse nasal washing system, which helps promote sino-nasal health in those who suffer from allergies and sinus issues, now is available throughout Canada,

The system was created and introduced in the U.S. in 1997 by Dr. Diane Heatley, an ear, nose and throat physician at the University of Wisconsin (Madison), in an effort to relieve her patients' uncomfortable symptoms.

"Regular nasal washing can be as effective as medication, but without the harmful side effects," Heatley said. "Additionally, most medications treat the symptoms, rather than the root cause. Nasal washing clears the sinus cavity of germs and irritants and gets users back to breathing easy."

The SinuCleanse nasal washing system is available in three varieties, including the traditional neti pot, the SinuCleanse Squeeze and the new Kids Mist, designed specifically for children and infants.

CADstream sales agreement for EU

Confirma (Bellevue, Washington), developer of the CADstream operating system for MRI, and Medrad (Warrendale, Pennsylvania), a provider of medical devices and services for diagnostic imaging, reported a partnership focused on advancing patient care in the European Union.

The companies have signed an agreement that enables Medrad to sell CADstream in Germany, Italy and the UK. Under the agreement, Confirma will install, train and support all CADstream customers.

CADstream is a dedicated CAD operating system designed for radiology networks and workflow-specific MRI applications. The system automates the analysis, reporting, and interventional planning of studies and promotes standardization of MRI studies with the incorporation of recognized standards. Workflow-specific applications include breast and prostate.

Medrad will sell Confirma's next-generation CADstream, version 5.0, for breast and prostate in the EU. This version of CADstream is currently under clinical investigation in the U.S.

Medrad is a unit of Bayer (Leverkusen, Germany).

Licensing pact on anti-bacterial tech

HemCon Medical Technologies (Portland, Oregon) reported signing an exclusive licensing agreement with Institute of Technology Sligo in Ireland to develop new antibacterial technology.

HemCon's agreement licenses global rights to research, develop, manufacture and market a controlled-release hydrogen peroxide technology that provides broad spectrum antibacterial and antiseptic properties. The technology releases hydrogen peroxide through a process allowing control of the dose and of the period of delivery of the produced hydrogen peroxide.

The company said the technology allows entry into major new market opportunities, giving it the ability to sell directly or sub-license technologies to global device and pharmaceutical partners.

HemCon said the technology has shown "good potential" in early studies for the treatment of fungal nail infection, the treatment of which is a global market approaching $4 billion.

Telemed program set in Northern Ireland

XTend Medical (Sun Valley, California), a developer of telemedicine solutions, said it has begun a remote patient monitoring program through the University of Ulster in Northern Ireland, to monitor patients and remotely manage their diabetes and blood pressure.

XTend said the program "is designed to assist doctors in helping patients to control diabetes through up-to-the-minute online reports of their insulin levels."

Regulatory approvals

A sampling of regulatory approvals in Europe reported in the past month:

• Hoana Medical (Honolulu, Hawaii) said it has completed the regulatory audits for ISO 13485 and the Medical Device Directive (for most European Union countries), which allows the use of the CE mark for its LifeBed Patient Vigilance System.

The LifeBed technology is designed to invisibly track a patient's basic vital signs without any connection to the patient whatsoever. If the patient begins to deteriorate, the LifeBed immediately notifies the nursing staff.

• K2M (Leesburg, Virginia), a spinal device company developing solutions for the treatment of complex spinal pathologies and procedures, reported that it has entered the international spine market via recent ISO 13485 certification and CE-mark clearance for its spinal devices.

The portfolio cleared for sale encompasses products developed to treat complex spinal conditions, including stabilization systems, minimally invasive systems, motion preservation systems and other advancements in spine solutions.

Its product trade-names include the Range Spinal System, Mesa Spinal System, Denali Spinal System, Pyrenees Cervical Plate System and Aleutian Spacer Systems.

• Live Tissue Connect Technologies (LTC; Santa Barbara, California) reported CE-mark certification for its Bipolar Forceps by its notified body, BSI Product Services. Receipt of the CE mark allows LTC to market the forceps with the previously CE-marked VAD.400 generator within the 30 countries of the European Economic Area and Switzerland. The LTC Bipolar Forceps consist of two configurations of disposable instruments that are used exclusively with the LTC VAD.400 generator. Its intended use is for the application of electrosurgery in general surgery and gynecological procedures for the sealing of arteries, veins and ducts.

The company said the Bipolar Forceps system is an alternative to mechanical clamping via clips or staples, and suturing, and can be used on veins and arteries up to 7 mm diameter, on ducts up to 2 mm diameter and on tissue bundles as large as will fit between the jaws of the instrument.

• StemCor Systems (Menlo Park, California), a company developing regenerative medicine systems, reported receiving the CE mark for its MarrowMiner system, a minimally invasive device used to harvest adult stem cells from the ilium (pelvis). The company calls the system a "next-generation technology" for use in bone marrow transplants, for accelerating bone healing in spinal fusions and other orthopedic procedures, and an expanding array of clinical applications utilizing bone marrow-derived cells.

• Vitrolife (Kungsbacka, Sweden) said it has received the CE mark for its new Swemed Sense needle for the collection of human oocytes. The company said the needle, which is in commercial launch, has received "very positive response."

The Swemed Sense needle is designed with a thinner front part and tip so as to minimize tissue damage, bleeding and pain, while the rear part of the needle has a larger diameter that makes the needle more stable during the collection process.