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March 31, 2015 8:04 AM ET

Biotechnology

Company Overview of Silk Road Medical Inc.

Company Overview

Silk Road Medical Inc. provides research and development services for neurovascular diseases. The company was founded in 2007 and is based in Sunnyvale, California.

735 North Pastoria Avenue

Sunnyvale, CA 94085

United States

Founded in 2007

Phone:

408-720-9002

Fax:

408-720-9013

Key Executives for Silk Road Medical Inc.

Chief Executive Officer and President
Chief Medical Officer
Chief Technology Officer
Executive Vice President of Corporate Development & Commercialization
Compensation as of Fiscal Year 2014.

Silk Road Medical Inc. Key Developments

Silk Road Medical Announces FDA 510(k) Clearance of ENROUTE® Transcarotid Neuroprotection System

Silk Road Medical Inc. announced the company has received Food & Drug Administration (FDA) 510(k) clearance for its ENROUTE Transcarotid Neuroprotection System (NPS). The ENROUTE Transcarotid NPS is a first in class system used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while performing carotid angioplasty and stenting (CAS). The FDA cleared the ENROUTE Transcarotid NPS based in part on the results of the ROADSTER trial, which achieved a 30 day stroke rate of 1.4% in the pivotal cohort, the lowest to date for any prospective trial of CAS. There were no major strokes and there were no strokes in important high risk subgroups, including the elderly (age ¥75), women, and symptomatic patients. Silk Road Medical has also submitted a Premarket Approval (PMA) application for the ENROUTE Transcarotid Stent System (Stent), which is an optimized stent delivery system designed for use with the ENROUTE Transcarotid NPS.

Silk Road Medical, Inc. Appoints Michael P. Wallace to the Position of Chief Technology Officer

Silk Road Medical Inc. announced the appointment of Michael P. Wallace to the position of Chief Technology Officer. In this new role, Michael will lead the company's Research and Development efforts across its family of transcarotid access and treatment devices. Prior to joining Silk Road Medical, Michael was the Vice President of Research and Development at Boston Scientific's Electrophysiology Division and previously held senior technical leadership roles at Baxano Surgical Inc., BARRx Medical, and Boston Scientific Neurovascular /Target Therapeutics.

Silk Road Medical Inc. Completes Enrollment in the ROADSTER Clinical Trial for Carotid Artery Disease

Silk Road Medical Inc. announced the completion of enrollment in its pivotal ROADSTER study. The trial to study the treatment of carotid artery stenosis by placing a stent via direct access to the common carotid artery in the neck in an entirely new minimally invasive procedure. The device under study is the Company's ENROUTE Transcarotid Neuroprotection System which incorporates proven surgical principles to protect the brain from a stroke during carotid angioplasty and stenting, and features a mechanism to divert dangerous debris away from the brain by temporarily reversing blood flow. Data from the trial will be used to support 510(k) clearance of the ENROUTE Transcarotid NPS as well as PMA approval of the ENROUTE Transcarotid Stent System. The carotid arteries, located on either side of the neck, are the main conduits for blood flow to the brain. Plaque formation in these arteries can put patients at risk for stroke.

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