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May 25, 2015 12:04 PM 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

FDA Grants Premarket Approval for Silk Road Medical's ENROUTE® Transcarotid Stent System

Silk Road Medical Inc. announced the company has received Premarket Approval (PMA) from the United States Food & Drug Administration (FDA) for the ENROUTE Transcarotid Stent System. The ENROUTE Transcarotid Stent is the first carotid stent that is introduced and implanted into the carotid artery through a direct common carotid access point to enable a safe and more direct approach to carotid artery stenting. The ENROUTE Transcarotid Stent is indicated for use in High Surgical Risk patients and is intended to be used in conjunction with Silk Road Medical's ENROUTE Transcarotid Neuroprotection System (NPS), which recently received 510(k) clearance by the FDA. Together the ENROUTE Transcarotid NPS and Stent System enables a novel hybrid procedure called TransCarotid Artery Revascularization (TCAR), which combines surgical principles of neuroprotection with a less invasive stenting procedure. 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 delivering and implanting the ENROUTE Transcarotid Stent.

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.

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