A Medical Device Daily
Angiotech Pharmaceuticals (Vancouver, British Columbia) reported receiving the CE mark for the HemoStream Chronic Dialysis Catheter, allowing it to begin marketing the device in Europe.
The CE-mark approval follows by a year Angiotech's receipt of FDA approval for the catheter.
Angiotech entered into an agreement with Rex Medical (Conshohoken, Pennsylvania) in April 2007 granting it an exclusive license to market and distribute HemoStream worldwide.
"With Rex Medical as our worldwide licensing partner, we look forward to expanding HemoStream's availability in Europe as well as in the U.S.," said Dr. William Hunter, president/CEO of Angiotech.
Dealing with the dialysis requirements of patients suffering from end-stage renal disease (ESRD) is a rapidly growing global healthcare challenge, Angiotech said. "Chronic dialysis catheters, such as HemoStream, are used as long-term vascular access for hemodialysis," it said. "HemoStream may also be used as a temporary access while more permanent options mature or become ready for use, such as surgically created AV fistulas."
Rex Medical is a private company specializing in developing minimally invasive medical devices targeting the cardiovascular, venous access, endosurgery and oncology markets.
Angiotech markets treatment solutions for diseases or complications associated with implants, surgical interventions and acute injury.
Curative licenses Inion technologies
Inion (Tampere, Finland) has signed an outlicensing agreement with Curative Biosciences (Waltham, Massachusetts), covering certain of its bioactive technologies for the promotion of bone regrowth and repair when treating patients undergoing orthopedic surgical procedures.
Under the terms of the licensing agreement, Curative will pay Inion a small up-front fee, plus development and sales milestones of up to $2,025,000 and royalties on revenues generated from any products developed using the technology.
The licensed technology is based on the use of N,N-dimethylacetamide (DMA) and its pharmaceutically acceptable salts and prodrugs, either alone or incorporated in resorbable polymer structures such as plates, membranes and screws for implantation in patients.
Patent applications covering this technology in the UK and internationally have been filed and are pending.
Inion CEO Chris Lee said, "DMA was discovered to have bioactive properties in promoting bone repair and regrowth through research work undertaken at our Cambridge facility prior to its closing last year. Inion, however, is no longer pursuing early stage development work in this area, as it focuses on the commercialization of its existing product portfolio for spinal surgery and orthopedic trauma."
He added, "By outlicensing non-core intellectual property and technologies, such as DMA, we seek to realize the value resulting from our research through companies more focused in these areas."
Inion is focused on the development and commercialization of biodegradable and bioactive surgical implants in selected orthopedic market segments, including biodegradable plates, screws, pins and membranes, which are used to enhance the healing of bone or soft-tissue injuries, such as those caused by trauma or by reconstructive surgery.
The company's implants are made from its Optima family of biomaterials, with properties tailored for specific surgical applications in terms of strength, flexibility and rate of degradation. Inion also is focused on developing new bioactive and biodegradable biomaterials that promote bone healing and accelerate patient rehabilitation.
In adition to its Tampere headquarters and production facilities, Inion has offices in the UK and U.S.
Lab21 offering new tests from deCODE
Lab21 (Cambridge, UK) said it has entered into a partnership with deCODE genetics (Reykjavik, Iceland) to offer deCODE's tests for predisposition to a growing number of common diseases.
The license allows Lab21 to offer its clients in the UK and Ireland access to new tests for Type 2 diabetes, myocardial infarction, atrial fibrillation, prostate cancer and glaucoma.
This new agreement means Lab21 now has licenses with three major genetic test providers — deCODE, Myriad Genetics and PGxHealth, and is the only service provider in Europe to offer such an extensive range.
In addition, the license will allow Lab21 to offer a pipeline of new tests as they are developed by deCODE, including one for increased risk of oestrogen-positive breast cancer. All deCODE tests have been validated in thousands of patients and controls from multiple populations; have full regulatory approval; and will be handled through Lab21's clinical service laboratory in Cambridge.
Lab21's line of genetic tests now includes tests for breast, ovarian, skin and colorectal cancer, a comprehensive portfolio of tests for cardiovascular disease and now, with deCODE's tests for Type 2 diabetes, prostate cancer and exfoliating glaucoma, the first ones in new disease areas.
Dr. Berwyn Clarke, chief science and development officer at Lab21, said, "Genetic testing is becoming an increasingly important part of medicine. In many patients, awareness of clinical predisposition can provide critical early warnings of the possible development of disease and vital pre-emptive and precautionary measures such as dietary factors, detailed screening or pharmaceutical intervention can be implemented. This is critical as we work to shift the focus of healthcare from intervention to prevention."
CEO Graham Mullis added, "This deal ... ensures [that] we are able to provide our customers with the widest range of high-quality genetic tests in Europe."