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October 07, 2015 7:02 AM ET

Healthcare Equipment and Supplies

Company Overview of Direct Flow Medical, Inc.

Company Overview

Direct Flow Medical, Inc. develops and manufactures transcatheter aortic valve systems for the treatment of aortic stenosis with minimal risk of aortic regurgitation. The company’s proprietary technology is also applicable to mitral and other heart valve anatomical sites. Direct Flow Medical was founded in 2004 and is based in Santa Rosa, California.

451 Aviation Boulevard

Suite 107 A

Santa Rosa, CA 95403

United States

Founded in 2004





Key Executives for Direct Flow Medical, Inc.

Chief Executive Officer and President
Age: 61
Co-Founder, Chief Technology Officer and Director
Chief Financial Officer
Chief Operating Officer
Age: 47
Chief Commercial Officer
Compensation as of Fiscal Year 2015.

Direct Flow Medical, Inc. Key Developments

Direct Flow Medical, Inc. Appoints Mary Edwards as Vice President, Regulatory and Clinical Affairs

Direct Flow Medical, Inc. announced the appointment of Mary Edwards as Vice President, Regulatory and Clinical Affairs. In her role, Ms. Edwards will oversee all global clinical and regulatory efforts, including administration of the company’s U.S. SALUS pivotal trial studying the Direct Flow Medical Transcatheter Aortic Valve System, as well as the DISCOVER post-market European study. She has served as Global Vice President of Regulatory Affairs for Medtronic Vascular, where she was responsible for the filing and approval of five PMAs.

Direct Flow Medical Reports Two Year Data for its Transcatheter Aortic Heart Valve System

Direct Flow Medical, Inc. announced positive two year data from the DISCOVER CE Mark Trial studying its Direct Flow Medical® Transcatheter Aortic Valve System at the EuroPCR conference in Paris, France. Demonstrating excellent patient outcomes with few complications, the two year data were presented by Antonio Colombo, MD, PhD, from the Ospedale San Raffaele in Milan, Italy. The DISCOVER CE Mark Trial demonstrated an 80% survival rate at 24 months, continuing the positive trend showing 90% survival after one year and 99% after 30 days. All patients experienced mild or less post-procedural aortic regurgitation (AR), with 85% having none or trace AR. The mean gradient remained stable at 12.4mmHg at 24 months, compared to 12.6mmHg at 30 days. At the two year mark, 92% of patients had improved by more than one New York Heart Association (NYHA) functional class, improving upon the 83% of patients that had improved by more than one New York Heart Association (NYHA) functional class at 30 days. All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory and were sustained over time. The fully repositionable and retrievable Direct Flow Medical system is indicated to treat patients with severe aortic stenosis who are at extreme surgical risk, while reducing the risk of post-procedural AR, a strong predictor of long-term mortality. The system addresses this clinical concern by sealing the annulus and enabling complete assessment of hemodynamic performance with “in situ” repositioning of the valve after full deployment. The DISCOVER CE Mark Trial is a prospective, multi-center study conducted at nine European sites of 100 patients with severe aortic valve stenosis who required replacement of their native aortic valve but were at extreme risk for open surgical repair. The Direct Flow Medical system also avoids both rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients. It includes a distinctive heart valve with a metal-free frame, delivered transfemorally via the same flexible delivery system for all sizes (23mm, 25mm, 27mm and 29mm). The Direct Flow Medical system received the CE Mark in January 2013. The system is currently available commercially in Europe and enrolling a pivotal IDE trial in the United States.

Direct Flow Medical, Inc. Announces Management Changes

Direct Flow Medical, Inc. has named Daniel Lemaitre as President and Chief Executive Officer (CEO), and David Boyle as Chief Financial Officer (CFO), effective immediately. The moves come as the company enjoys encouraging commercial uptake of its transcatheter aortic heart valve system in Europe, and continues enrollment in SALUS, its pivotal study in the United States. Current CEO Bernard Lyons will be retiring from the company. Lemaitre previously served as President and CEO of CoreValve from 2008 to 2009. David Boyle has served as CFO for five healthcare companies over the course of his 32-year financial career, most recently for Ogenx Therapeutics.

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