MediGuide has started US clinical trials of medical positioning system

mediaguide MediGuide and Philips announced they have started their planned clinical trials of MediGuide’s Medical Positioning System (gMPS™) technology in the NewYork-Presbyterian Hospital/Columbia University Medical Center, using the Philips Integris Allura Flat Detector catheterization lab.

Royal Philips Electronics and MediGuide have been cooperating since 2003 in the field on cardiac navigation. The gMPS™ system and the GMC™ device are CE Mark certified and are limited to investigational use only in the U.S.

The gMPS™ system is intended for intravascular evaluation of coronary anatomy. It enables real time tip positioning and navigation of an gMPS equipped diagnostic or therapeutic invasive device used in coronary or cardiac intervention in the Cath Lab environment, on both live fluoroscopy or recorded background.  The system is indicated for use as an adjunct to coronary angiography.

The gMPS™ enabled GMC™ intravascular device is aimed to be used in conjunction with conventional X-ray angiography systems to enable real-time tip positioning and navigation, quantitative length measurement, 3D lumen reconstruction, qualitative 3D foreshortening indication and landmarking, in patients who are candidates for coronary angiography and/or Percutaneous Coronary Intervention (PCI).

The trial is conducted by Dr. Giora Weisz and Jeffrey W. Moses from Columbia NYP.

Dr. Moses said after the first patient: "The system performed beautifully. It is the first step of moving beyond fluoroscopy in coronary intervention. The potential here is enormous!"

Haifa based MediGuide, had originally spun off from the renown Elbit Systems. It is a provider of technology, solutions and applications for intra body navigation and less invasive procedures with a special focus on cardiology. Based on its proprietary MPS technology, MediGuide brings the ability to navigate MPS Enabled Devices (catheters, wires and other devices equipped with a sub millimeter MPS sensor) in the MPS Ready Cathlab environment, co-developed by MediGuide in collaboration with the leading imaging companies.

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Medgenics Consolidates Corporate and R&D Operations into New Facility in Misgav

Medgenics Medgenics, www.medgenics.com a biopharmaceutical company developing the “biopump” sustained-action protein therapy for the treatment of chronic diseases, has completed its move to a new facility on the Teradion Business Park in Misgav, Israel. The new facility brings together Medgenics’ corporate operations with larger R&D laboratories on one site.

At the same time, the company has increased its staff preparing for the Phase I/II clinical trial for EPODURE, its lead product in development to deliver a sustained therapeutic dose of erythropoietin (EPO) for the long-term treatment of anemia. Subject to regulatory approval, EPODURE is on schedule to begin Phase I/II clinical trials in mid 2008 and preliminary data are anticipated from these trials within 3–5 months of trial commencement.

Dr. Andrew Pearlman, Medgenics’ CEO, said:

“Medgenics is really gearing up for the start of our Phase I/II clinical trial with EPODURE as a potential new therapy for anaemia, which is due to begin mid year. The new additions to the development team for EPODURE are in keeping with our plan and schedule as we advance toward this important trial.”

Medgenics is developing its unique tissue-based Biopump platform technology to provide sustained-action protein therapy for the treatment of a range of chronic diseases. Medgenics currently has two products in development based on this technology:

• EPODURE – producing erythropoietin (EPO) to treat anemia.

• INFRADURE – producing interferon-alpha (IFN-α) to treat hepatitis C.

The company has demonstrated proof of principle of the Biopump treatment procedure in a clinical trial using a short-acting version of EPODURE in anemic patients. A long-acting version of EPODURE, designed to produce and deliver a therapeutic dose of EPO steadily for six months or more, is scheduled to enter Phase I/II trials in mid-2008. The company plans to follow with clinical trials of INFRADURE in 2009.

Medgenics plans to develop and/or out-license a pipeline of future Biopump products targeting the large and rapidly growing global protein therapy market, which is forecast to reach US $87 billion by 2010. Other potential areas include multiple sclerosis, hemophilia, pediatric growth hormone deficiency and diabetes.

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