A Medical Device Daily
The development of new medical technologies such as hip and knee replacements, pacemakers and coronary stents get a boost in the UK on Thursday, as a new agreement was reported that makes it easier to get approved trials in patients under way.
Launched jointly by the UK Department of Health and the Association of the British Healthcare Industries (ABHI), the model Clinical Investigation Agreement (mCIA) was welcomed by the medical technology industry as timely and helpful.
The mCIA covers all medical technology trials involving patients in National Health Service (NHS) hospitals that are funded by industry.
According to the Department of Health, "it removes much of the previous bureaucracy, which was a significant barrier to the efficient start-up of such trials in the UK."
Previously it was necessary for site-by-site reviews and local legal agreements to be drawn up before industry-sponsored trials could begin. The announcement of the new accord said the mCIA meets the UK government's requirements for transparency about research involving NHS patients, "and ensures that all medical technology industry-sponsored clinical trials are registered and published."
Experience with use of the new agreement will be reviewed after one year.
The agreement is "closely aligned," the Department of Health said, with the revised model Clinical Trial Agreement (mCTA) for pharmaceutical and biopharmaceutical industry-sponsored research in NHS hospitals that was published in 2006, and the Tripartite clinical trial agreement for pharmaceutical and biopharmaceutical industry-sponsored research in NHS hospitals, managed by contract research organizations (CRO-mCTA) published last year.
Peter Ellingworth, chief executive of ABHI, said the association "welcomes the launch of the model Clinical Investigation Agreement which has been the result of a great deal of work by the Department of Health, the medical devices industry and NHS stakeholders. The new agreement for both regulatory and post-market medical device studies will fulfill the need for a document that has the confidence of all parties in order to streamline the administrative process of getting approval for clinical investigations underway at NHS sites."
He added that the agreement "should ... help with the goal of making the UK a world-class environment in which to conduct clinical research on innovative medical technologies."
Public Health Minister Dawn Primarolo said, "The model Clinical Investigation Agreement is the first time that all UK health departments, the NHS and representatives from industry have agreed [to] standard contract requirements for medical technology industry-funded clinical trials."
She added that the mCIA was developed "to enhance the UK clinical research environment for the benefit of NHS patients."
John Jeans, industry co-chair of the Ministerial Medical Technology Strategy Group, said the group "fully supports the principle of the model Clinical Investigation Agreement for medical device companies carrying out clinical investigations in collaboration with the NHS. This document should serve as another step [toward] enhancing the UK environment for medical device research and development."
The mCIA agreement is the latest is a series of initiatives that have already been introduced to improve the clinical research environment in the UK, including:
• The Medicines and Healthcare products Regulatory Agency's introduction of new services that speed-up the assessment of clinical investigations for regulatory purposes and an industry-focused advice service.
• The National Research Ethics Service's introduction of a speedy and streamlined process using device-flagged committees that have expertise in device studies, as well as guidance on the ethical review of device studies.
• The Integrated Research Application System, which provides an electronic portal for the single submission of data required for the regulatory research permissions and approvals needed to initiate a clinical research study.
EPO grants patent for Noveon
Nomir Medical Technologies (Waltham, Massachusetts), a developer of optical energy technologies for medical applications, said the European Patent Office has granted a patent to Nomir which protects its core Noveon technology.
Noveon is a light-based system that targets the elimination of bacterial and fungal infections through a unique near-infrared photo-inactivation effect, while preserving healthy tissue and promoting recovery.
The new European patent coverage provides for use of two proprietary near-infrared wavelengths that have proven to damage and eradicate bacteria and fungi in human diseased tissue ranging from onychomycosis (toenail fungus) to MRSA infection in the human nose, without thermal injury to surrounding tissues.
The patent, No. 1,663,393, has broad coverage through apparatus claims, including general bacterial infections, specialty optical clips for fingers and toes, handpieces, root-canal tips, dental scalers and otoscopes.
Dr. Eric Bornstein, Nomir's chief scientific officer, said, "We have been developing the Noveon system for five years, and are grateful for the protection that this patent now offers to this unique and proprietary therapy for fighting human infections. This patent covers important systems and is currently integrated into our core medical and dental products and rich research and development pipeline."
President/CEO Richard Burtt said, "This new European patent contains broad claims that cover many of the unique and important characteristics in our Noveon system, and adds to our substantial photobiology portfolio."
Nomir received 510(k) clearance from the FDA in November 2007 to utilize Noveon during contact and non-contact surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry, and otolaryngology.
The system is designed to effect near-infrared photo-inactivation of bacteria and fungi at energies and temperatures that are safe to normal and healthy tissue.
Nomir said it will present detailed data from a recent MRSA human study at the Termis North America annual conference and exhibition in San Diego next month.
The company initiated an FDA pivotal study of the Noveon device for the onychomycosis indication in May.