A Medical Device Daily Staff Report
Reverse Medical (Irvine, California) reported that it has received the CE mark for its RePort guide catheter system, intended to provide intracranial access during interventional neurovascular procedures.
The RePort system is designed to provide the neurovascular specialist with a new tool that can navigate deeply into the cerebral vascular anatomy, enabling them to treat more patients than with currently available technologies.
Commenting on this regulatory approval, Reverse Medical's President/CEO Jeffrey Valko said, "The timing for the RePort guide catheter system regulatory approval is perfect as access to the deep neurovascular anatomy is a current focus of neuro interventionalists' interest. The various RePort guide catheter system models will enable physicians to treat a broader group of patients, helping to increase patient throughput and to enhance the economic viability of neuro labs and stroke centers worldwide." The company plans to commence commercialization during 2010.
Reverse scientific and clinical advisor Satoshi Tateshima, MD, UCLA Interventional Neuroradiology, Ronald Reagan UCLA Medical Center (Los Angeles) said, "The system is designed to be used across a broad range of neuro interventional procedures. [It] has been designed to enable placement beyond the skull base more easily and safely than other currently available devices.
RepRegen gets CE mark for stronbone
RepRegen (London), previously known as BioCeramic Therapeutics, reported that it has received the CE mark for Stronbone bioactive glass with Strontium, the first product that will be commercialized from RepRegen's repair-and-regeneration platform of 'smart' biomaterials for hard tissue, such as bone.
"This European regulatory approval enables us to fast-forward the discussions we are having with several potential strategic partners about our hard tissue platform, in general, and our StronBone product, in particular," said Ian Brown, RepRegen's CEO.
RepRegen is a device company that uses patent-pending repair and regeneration technology platforms designed to mend and regrow hard tissue such as bone and soft tissue such as cartilage. Other products on the hard tissue repair and regeneration runway are targeted for orthopedic (trauma, spine) and craniomaxillofacial applications.
Synexus expands its Polish operations
Synexus (Manchester, UK), a company dedicated to the recruitment and running of clinical trials is expanding its operations in Gdynia, Poland when it moves to new premises later this year. It has also recently increased the capacity of its original centre in Wroclaw, Poland by several hundred square meters.
The new dedicated research center in Gdynia will have the capacity for four full-time investigators, with an increase from one hundred to three hundred square meters of space and will include a wide range of diagnostic instruments to cover Synexus' expanding therapy area coverage.
Synexus has been operating in Poland since 2006 from its site in Wroclaw and expanded its operations there in August 2009 when it acquired three new dedicated research centers in Warsaw, Gdynia and Katowice, following its takeover of CLCC.