A Medical Device Daily

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 company said its international expansion has begun with the introduction of its products in Spain and the UK. The product portfolio cleared for sale encompasses a full array of 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.

"ISO certification and CE clearance for our products are important milestones in our international efforts and will be key to fueling our continued growth," said President/CEO Eric Major. "We are committed to expanding the availability of our innovative technology to countries around the world and supporting surgeons treating the most difficult spinal deformities. Our mission is to be the worldwide leader in providing solutions to complex spinal pathologies."

K2M is focused on developing simplified solutions for the treatment of complex spinal pathologies and procedures. John Kostuik, MD, chairman, co-founder, chairman and chief medical officer, is a former chief of spine surgery at the Johns Hopkins University School of Medicine (Baltimore).

Kostiuk is a primary driver behind K2M's commitment to redefining the market. The company says it has an "unprecedented" board of scientific advisors, consisting of widely-known spine surgeons.

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.

"Our partnership with Medrad will make CADstream available to more physicians and patients, ultimately helping improve patient care in the EU," said Confirma President/CEO Wayne Wager. "With their customer relationships, dedication to the radiology market and reputation as a leader in medical imaging devices, Medrad will be a strong partner."

Joe Havrilla, senior vice president for Medrad's MR business unit, said, "We are delighted to be able to offer CADstream to our customers who are starting or growing their breast or prostate MRI programs. CADstream is an excellent complement to our MRI products and will allow us to offer application-based breast and prostate MRI solutions."

Under this agreement, Medrad will be selling 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 agreement 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.

The company said, "This program will be managed by Dr. Kevin Curran, who states that the main focus of the program is to show how technology can assist in monitoring patients from their home in modern life, with the main emphasis being to reduce costs for healthcare systems worldwide and improve the care delivered to patients."

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.