Lexington Biosciences moves forward with its affordable heart diagnostic device


Lexington Biosciences HeartSentry

[Image courtesy of Lexington Biosciences]

Lexington Biosciences (Vancouver, British Columbia) said today that it has brought on reimbursement experts as it seeks FDA clearance for its HeartSentry device.

The strategic business relationship with a San Francisco arm of Chicago-based Navigant Consulting, is meant to help Lexington(CSE: LNB) (OTCQB: LXGTF) better work with relevant authorities to develop a coverage policy to support the commercial rollout of HeartSentry, an endothelial function measurement product that holds the promise of better pinpointing of people at risk of heart attacks.  The San Francisco arm was previously Quorum Consulting, which Navigant recently acquired.

Lexington Bioscience is moving ahead quickly to start its HeartSentry pilot clinical research to support FDA clearance, according toLexington’s President Eric Willis.

“As we plan for market entry, we know that a key element to commercial success will come from fielding a product that meets the threshold for medical insurance coverage,” Willis said in a news release.

“Regulatory approval rarely guarantees payment coverage for new devices, so we are undertaking what we believe is the prudent strategy of beginning that process today,” Willis said.

HeartSentry is a non-invasive diagnostic device to measure and monitor cardiovascular health. In operation, it is much like a standard blood pressure monitoring cuff. It’s meant to assess the function of a person’s vascular endothelium and is meant to be a more affordable option in comparison to external ultrasound, which requires a highly trained technician.

Lexington Bioscience officials claim that the affordability of the HeartSentry device could make vascular endothelium diagnostics far more common – helping to better catch which people are at risk of plaque buildup that can lead to heart attacks.

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