The European Commission (EC) and the FDA have agreed to new confidentiality arrangement intended to lead to better health protection and easier trade between the European Union and the U.S. Under the new arrangements, agreed to during a meeting in Brussels, the EC and the U.S. government, going forward, will be able to exchange confidential information about the safety of cosmetics and medical devices.
“We agreed to put in place a new framework for transatlantic economic integration,” said EC VP Günter Verheugen, European chairman of the Transatlantic Economic Council (TEC) and commissioner for enterprise and industry policy. “I’m pleased to see that our ongoing cooperation with U.S. regulators is delivering tangible results for our citizens and businesses.” He added: “The EU and U.S. will be able to exchange early information to protect public health, [while] taking away stumbling blocks for trade.” As an example, he said that in the field of cosmetics, the agreement “represents an important step toward our goal of accepting each other’s alternative methods to animal testing.”
Closer economic cooperation is the main aim of the TEC, which was launched in Berlin in late June. The group’s work program covers cooperation initiatives to harmonize standards and improve trade in the areas of regulatory cooperation, Intellectual property rights, secure trade, financial markets, innovation and technology, and investment.
The types of information covered under the new confidentiality arrangements include:
• Advance drafts of legislation and/or regulatory guidance documents.
• Post-marketing data and information that could have an impact on the public health, such as vigilance data or information about impending regulatory actions.
• Information on ongoing and emerging regulatory issues of health and safety in the U.S. or the EU.
LinkMed invests SEK 10M in AnaMar and IMED unit
LinkMed (Stockholm, Sweden) reported utilizing an option to make follow-up investments of SEK 10 million ($1.47 million) in each of two portfolio companies, AnaMar Medical (Göteborg, Sweden) and IMED (Stockholm). LinkMed will utilize its AnaMar Medical option to subscribe to shares for SEK 7.5 million and also invest an additional SEK 2.5 million in share capital. Both investments will be made this month.
AnaMar Medical’s other principal shareholder, Koncentra Holding, has promised to contribute a further SEK 2.5 million in share capital.
LinkMed said that the moves are meant to expand AnaMar’s development “with both additional and further advanced development projects.”
IMED’s principal shareholders, LinkMed and Karolinska Development, through its funds I and II, have decided to contribute SEK 10 million each in a new share issue in August. As a result, LinkMed’s ownership stake in IMED will increase from 39% to 42%.
LinkMed develops new life science companies and has created a portfolio of 11 companies, six in biotechnology, five in medical technology.
HemoBioTech eyes India market for blood substitute
HemoBioTech (Dallas) said last month it has engaged Paragon Biomedical (Irvine, California), a contract research organization, to provide regulatory and clinical services in India related to the company’s human blood substitute, HemoTech. Paragon will submit pre-clinical data regarding HemoTech studies that were part of a European IND and clinical data related to the HemoTech human study in Zaire to the Indian regulatory agency for review. The goal is to receive permission to commence clinical studies of HemoTech in India.
A limited clinical study of HemoTech was performed in 1991 in Zaire. Results of the study were published in Surgery, Gynecology & Obstetrics the following year. In the study, nine sickle cell anemia patients were infused with amounts of HemoTech representing 25% of patients’ total blood volume.
The company said the limited clinical trial resulted in “significant” patient improvement and suggested that HemoTech can work as a physiological oxygen carrier in humans, is non-toxic, is vasodilatory and anti-inflammatory; and induces red blood cell production. Peripheral blood reticulocytes increased from 4% to 49%.
Paragon Biomedical’s India office is located at the Technopark Campus in Trivandrum. The facility is India’s only CMMI Level 4 accredited technology center and one of the two largest IT campuses in India today, Paragon said.
UK expands payments for long-term care
UK Care Services Minister Ivan Lewis said late last month that thousands of people in England are likely to receive more help toward their care costs. The new National Framework for NHS Continuing Healthcare has been developed in close consultation with voluntary groups, professional bodies and patient/user groups and will make funding decisions on who is eligible for NHS continuing care fairer, faster and easier to understand, Lewis said.
At present, people with identical care needs can receive different decisions on whether they are eligible for fully funded continuing care, based purely on where they live. The new system will address these anomalies and will introduce one national system for everyone needing this type of care in England.
Currently, nearly 31,000 people receive NHS continuing care, and about 70% of care home residents already have some or all of their personal care costs paid by the government.
The NHS already provides free registered nursing care for some 123,000 people.
German university, Philips develop CAD diagnosis for dementia
University Medical Center Hamburg-Eppendorf (UKE; Hamburg, Germany) and Royal Philips Electronics (Amsterdam, the Netherlands) said they have collaborated on the development of a computer-aided diagnosis (CAD) technique for neurodegenerative diseases to support clinicians in diagnosing the onset and type of disease as early as possible. The new diagnostic technique, which the companies said already has proven its accuracy using historical image data and known patient outcomes, is about to undergo clinical evaluation at UKE.
The CAD system is a software package that automatically interprets positron emission tomography (PET) brain scans of patients suspected of having a neurodegenerative disease that leads to dementia, and combines them with MRI scans for accurate differential diagnosis.
The companies said that the development of the system will mean a better quality of life for patients by enabling earlier prescription of drugs that delay progression of the disease, and thereby delay the worst effects of dementia. Another goal is to provide pharmaceutical companies and clinicians with a tool for the development and testing of new, potentially curative drugs for neurodegenerative diseases such as Alzheimer’s.
The software tool developed by Philips Research and UKE overlays anatomical images of the brain obtained from MRI scans with PET scans that display brain activity — specifically the uptake of glucose that fuels brain activity.
By using advanced image processing and computer learning techniques in combination with a database of reference brain-scans, the system then analyses the images automatically and displays anomalous brain patterns in a concise way. Based on these patterns, it then suggests a diagnosis.
The clinical evaluation that is about to start will run the CAD system alongside the university’s existing dementia-diagnosis procedures, with the aim of fine-tuning the system’s ability to detect and differentiate the three most common types of neurodegenerative disease: Alzheimer’s disease, Lewy-body dementia and frontotemporal dementia.
Distribution pact for Rapid BSE Assay in China
Genesis Bioventures (Los Angeles) reported that BioBDC, the company’s exclusive agent for sales and distribution of Prion Developmental Laboratories’ (PDL; Buffalo Grove, Illinois) Rapid BSE assay for “mad cow” disease testing for the Pacific Rim, has received a letter of intent from Wantai Biological Pharmacy Enterprise Co. (Beijing, China) to sell and distribute the Rapid BSE test kits throughout that country.
Genesis, which holds the exclusive worldwide sales, marketing and distribution license for PDL’s rapid assays, said the BSE assay is “an inexpensive, fast, and easy-to-perform alternative to current laboratory methods.”
BioBDC is a diagnostic marketing company holding an exclusive sales and distribution contract for the lateral flow test — which will become the benchmark platform for testing for Prion related animal diseases — in the Pacific Rim.
Genesis said it intends to establish international distribution by exclusive licenses with key partners in six major territories: Pacific Rim, U.S., Canada, Europe, South America and Rest of World.
Medusa software implemented for ambulance program in Nova Scotia
Medusa Medical Technologies (Halifax, Nova Scotia) reported that its flagship electronic patient care reporting software, the Siren ePCR Suite, is being implemented in a pilot program for ground ambulances operated by Emergency Health Services Nova Scotia (EHS). Upon completion of the pilot, the Siren ePCR Suite will be in all 150 of EHS’ ground ambulances, as well as in both LifeFlight air ambulances operated by the service, and more than 800 paramedics will have been trained by EHS to use the system.
The Siren ePCR Suite is an electronic patient care reporting system that Medusa said “improves the speed and accuracy with which paramedics can record patient information while in an ambulance en route to hospital. Ultimately, Siren allows paramedics to spend less time documenting patients’ ailments, and more time treating them.”
Medusa said its contract with EHS “positions Nova Scotia as Canada’s first province to offer all of its residents the benefits of a complete electronic patient care solution in a pre-hospital/out of hospital emergency services environment.”
It said the initiative also will create advances in pre-hospital emergency medicine for EHS. The Siren ePCR Suite includes data analysis tools that will allow EHS to generate reports to measure the performance of the system.
BreastCheck Ireland selects Bioptics, DAAX for radiography
Bioptics (Tucson, Arizona) said it has been awarded a contract by BreastCheck Ireland, that country’s national breast screening program, along with its local distributor, DAAX. Bioptics and DAAX have been selected exclusively to provide digital specimen radiography equipment to BreastCheck clinics throughout Ireland.
Bioptics’ piXarray line of FDA-cleared Digital Specimen Radiography products are marketed worldwide and provide digital specimen imaging of both surgical and core biopsies. The company said its system “dramatically improves efficiency by providing full PACS networking, allowing surgeons, radiologists and pathologists the opportunity to digitally analyze suspected breast tissue on a real-time basis while the patient is on the operating table.”
“BreastCheck Ireland’s initiative is one of the most impressive in the world, and we are excited to be a part of their pioneering efforts,” said Emre Toker, founder of Bioptics.
Cinpathogen, Fudan U. in joint research venture
Bioresearch firm Cinpathogen (Boulder, Colorado) said it has partnered with the Institute of Biomedical Sciences at Fudan University (Shanghai, China) to form the Fudan Cinpathogen Center for Clinical and Molecular Research.
Cinpathogen said the collaboration “brings together clinical operations, modern diagnostic laboratories and access to one of the largest tissue banks dedicated to diseases of the blood and immune systems in order to support diagnosis and conduct protocol-driven research on the etiology, pathogenesis and treatment of disease.”
Signalife wins okay for Mexican sales
Signalife (Greenville, South Carolina) said it has received a Certificate to Foreign Government, which allows the importation of the Signalife Fidelity 100 ECG Monitor System into Mexico. The certification states that the Fidelity 100 may be marketed in, and legally exported from the U.S. to Mexico.
Signalife develops signal-monitoring devices for detecting diseases. It primarily offers patient modules that are used as part of a heart monitor system to acquire, amplify, and process physiological signals associated with a patient’s cardiovascular system.
Ivivi wins CE mark for electrotherapy devices
Ivivi Technologies (Northvale, New Jersey) reported receiving the CE mark for certain of its electrotherapy devices for use in the promotion of wound healing, reduction of pain and post-operative edema. André DiMino, co-CEO of Ivivi, said that the approval “supports our strategy of establishing channel partnerships with global medical device and healthcare companies.”
Ivivi’s electrotherapy devices consist of a signal generator and applicator programmed to provide therapy at optimal intervals throughout the course of therapy. The company said a recent study conducted at Akademikliniken Hospital (Stockholm, Sweden) by Dr. Per Heden “reinforced clinical data that shows the ability of Ivivi’s technology to enhance post-surgical pain management.”
• NMT Medical (Boston) received CE-marking approval for its BioSTAR bioabsorbable septal repair implant technology and Rapid Transport delivery system.
BioSTAR is designed to provide biological closure of atrial level defects using the patient’s natural healing response. NMT said data has shown that 90% to 95% of the implant is absorbed over time and replaced with healthy native tissue. It said the data from the prospective multi-center BioSTAR Evaluation Study (BEST) trial, published in the October 2006 edition of Circulation, demonstrated that BioSTAR provides a more rapid and complete closure of atrial septal defects, with a 92% closure rate at 30 days and 96% at six months.
John Aher, president/CEO of NMT, said that BioSTAR also recently received Canadian regulatory approval “and we anticipate initiating a market launch for BioSTAR in both Europe and Canada early in the third quarter.” BioSTAR also has been approved for use in MIST II, the company’s pivotal patent foramen ovale (PFO)/migraine trial in the U.S.
Equipped with the Rapid Transport delivery system, the average procedure time to close a septal defect with BioSTAR is about 40 minutes.
BioSTAR incorporates a purified acellular collagen matrix delivered on the company’s STARFlex alloy framework. The collagen used in BioSTAR also is a platform for timed release of biological response modifiers such as genes, cells, proteins and drugs.
• Urologix (Minneapolis) received CE-marking for its CoolMax Microwave Catheter. The company said the new catheter “is expected to allow doctors to more comfortably treat men who suffer from the symptoms of benign prostatic hyperplasia, a condition that affects some 23 million men.” Urologix said it next plans to enter into discussions with the FDA to seek U.S. approval for the device.
The CoolMax microwave catheter features the Urologix gamma matched dipole antenna design and features the addition of an enlarged cooling balloon. The company said this next-generation catheter is part of its program to blend patient comfort with durability.
• Allium Group (Caesarea, Israel), a maker of stents for the urinary, gastrointestinal, pulmonary and peripheral vascular tracts, received two CE marks for its biliary and ureteral stents. The stents are designed to treat malignant as well as benign obstructions and are engineered to prevent foreshortening during deployment, allowing what Allium described as “excellent accuracy in their placement and to prevent tissue in-growth.”
The company said its thin-walled, large-caliber, self-expanding, fully covered metal stents “are unique because they can be left in the body for long periods without being changed and easily removed even after long implant periods.” Alliums said that several of its projects have received funding from the R&D investment program of Israel’s Ministry and Trade Industry’s Office of the Chief Scientist and Bi-National Cooperation Funds.