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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

Biogen And Sage On Plans To Build A Brain Franchise Together

The companies think they can build out the indications for zuranalone and SAGE-324 faster and more broadly and commercialize the drugs more effectively as partners.

US FDA Allows Dry-Heat Systems For Mask Deep Cleaning

The guidance document allows manufacturers to promote their dry-heat systems for mask bioburden reduction if they meet certain standards.




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