A Medical Device Daily

Itamar (Caesarea, Israel) signed an agreement with Roche (Basel, Switzerland) for use of Itamar's EndoPAT device in a clinical phase II study for patients with peripheral arterial disease (PAD) at 80 worldwide medical centers. The assessment of endothelial function by EndoPAT will provide one endpoint of the study that will test the effectiveness of a newly developed drug.

The agreement is valued at about $2.7 million to be paid in installments through the study period that is scheduled to last until December 2012.

"We are very excited to work with Roche in this study that reinforces our strategic direction whereby EndoPAT plays a major role within the pharmaceutical industry of personalized medicine and companion diagnostics," said Dov Rubin, Itamar-Medical's president/CEO.

"EndoPAT offers the only non-invasive technology that is FDA-indicated for detecting endothelial dysfunction which is easily applied and totally operator independent," said Koby Sheffy, Itamar-Medical's CTO and senior VP. "With more than 80 papers to date in peer-reviewed journals and over 100 abstracts at major scientific meetings, we feel EndoPAT is well positioned as a clinically valid procedure."

In other agreements and contracts news,:

• SpineMark CRO Management, a wholly-owned subsidiary of SpineMark (San Diego), recently signed an agreement with Ranier Technology (Cambridge, UK) to provide contract research support services for the Ranier CAdisc-L clinical trial, a third-generation lumbar total disc replacement device for treatment of degenerative disc disease in the lumbar spine. SpineMark CRO Management provides site recruitment including utilization of principal investigators from its network of sites, reimbursement strategy development, payer education, trial management, site training, patient recruitment, data management, monitoring, regulatory advice and general oversight to allow Ranier to effectively complete their FDA requirements for approval of new spinal devices.

• CardioGenics Holdings (Mississauga, Ontario), a developer of technology and products targeting the point-of-care (POC) segment of the IVD market reported that the company has entered into a lock-up agreement with its CEO, Yahia Gawad, pursuant to which Gawad has agreed to lock-up 150 million shares of the company's common stock held indirectly by Gawad through exchangeable shares in the company's wholly-owned subsidiary, CardioGenics ExchangeCo.