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February 06, 2016 3:11 AM ET

Healthcare Equipment and Supplies

Company Overview of Silk Road Medical, Inc.

Company Overview

Silk Road Medical, Inc. develops and manufactures less-invasive medical devices to improve treatment of carotid artery diseases through proprietary transcarotid therapies. 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, President and Director
Senior Vice President of Operations
Chief Medical Officer
Executive Vice President of Clinical, & Regulatory Affairs, and Quality Assurance
Age: 48
Compensation as of Fiscal Year 2015.

Silk Road Medical, Inc. Key Developments

Silk Road Medical Announces First U.S. Commercial Case with the ENROUTE Transcarotid Stent System

Silk Road Medical Inc. announced the first U.S. commercial case using the ENROUTE Transcarotid Stent System was successfully performed at Kaiser Permanente Moanalua Medical Center in Honolulu, HI, by Vascular Surgeon Peter A. Schneider, M.D. The ENROUTE Transcarotid Stent is the first and only carotid stent designed specifically for a new procedure called TransCarotid Artery Revascularization, or TCAR. TCAR combines surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. The ENROUTE Transcarotid Stent is indicated for use in High Surgical Risk patients and is intended to be used in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS) during the TCAR procedure. The ENROUTE Transcarotid NPS is a first in class device 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. The ENROUTE Transcarotid Stent was granted Premarket Approval (PMA) from the United States Food & Drug Administration (FDA) in May of 2015 based in part on data collected from a subset (52) of 141 High Surgical Risk patients in the ROADSTER study who were treated with the Cordis PRECISE PRO RX® Stent System and the ENROUTE Transcarotid NPS. The ENROUTE Transcarotid Stent was developed pursuant to a license with Cordis Corporation and leverages the micromesh design and long term durability of the Cordis Precise® Carotid Stent that was clinically proven in tens of thousands of patients across multiple clinical trials including SAPPHIRE, CASES-PMS and SAPPHIRE Worldwide.

Silk Road Medical Appoints Andrew Davis as Executive Vice President of Global Sales

Silk Road Medical Inc. announced the appointment of Andrew (Andy) Davis to the position of Executive Vice President of Global Sales. In this new role, Andy will assemble a sales organization and lead the company's commercialization efforts for the TransCarotid Artery Revascularization (TCAR) procedure with the ENROUTE® Transcarotid Neuroprotection System (NPS) and the ENROUTE® Transcarotid Stent System. Prior to joining Silk Road Medical, Andy was the Vice President of Sales and Marketing at Acelity's Advanced Wound Therapy Group and previously held Vice President of Sales positions for Medtronic's CoreValve, Endovascular, Peripheral and Spinal/Biologics divisions.

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.

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