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American BioMed To Recommence Trial For Peripheral Atherectomy Catheter

This article was originally published in The Gray Sheet

Executive Summary

American BioMed plans to submit an investigational device exemption in the next 90 days for use of its OmniCath peripheral atherectomy catheter for treatment of hemodialysis arteriovenous (A-V) fistula restenosis.

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American BioMed

$10 mil. equity financing agreement, provides "sufficient operating capital" to enable expeditious implementation of a strategic plan to "reposition the company as a developer and marketer of minimally invasive surgical devices," the firm says. Additional "funding tranches" are anticipated as the plan is implemented and specific milestones are completed, American BioMed notes. The Woodlands, Texas firm says it is now positioned to "aggressively" pursue acquisitions and product commercialization activities. The NIR Group has been retained as the firm's investment banker and financial advisor for acquisitions and strategic planning

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Partisan Politics Returns To US FDA Congressional Oversight

The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.

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