Direct Flow Medical Announces D. Scott LIM, MD, As New Co-Principal Investigator for U.S. Salus Pivotal Trial
Company Also Names Steering Committee for the SALUS Trial

SANTA ROSA, Calif. – October 27, 2015 – Direct Flow Medical®, Inc., an innovative structural heart company, today announced that D. Scott Lim, MD, will be joining the SALUS pivotal trial as national co-principal investigator. Dr. Lim is an associate professor of medicine and pediatrics for the Advanced Cardiac Valve Center at the University of Virginia (UVA) and medical director of the Bon Secours Virginia Advanced Cardiac Valve Center. He will be leading the SALUS Trial with co-principal investigator Isaac George, surgical director of transcatheter therapies for the Columbia Heart Valve Center at Columbia University Medical Center.

Dr. Lim is noted internationally for his expertise in novel percutaneous approaches to heart valve disease, and has been at the forefront of U.S. research into transcatheter aortic valve and mitral valve replacement. Dr. Lim is also the co-director of the Advanced Cardiac Valve Center at UVA. He became the first proctor of the MitraClip procedure in the world. He created and continues to run a humanitarian charity endeavor between UVA and Cedimat hospital in Santo Domingo, Dominican Republic, for the care and education of rheumatic heart disease.

Dr. Lim replaces Murat Tuzcu, MD, of the Cleveland Clinic, who was previously national co-principal investigator representing interventional cardiology for the SALUS Trial. Dr. Tuzcu has accepted a position running the Cleveland Clinic program in Abu Dhabi.

“Direct Flow Medical has developed an ingenious device that improves upon the limitations of current commercial transcatheter valves,” said Dr. Lim. “I am excited to lead the U.S. research into this novel valve along with Dr. Isaac George, and we fully expect for the SALUS study to validate the clinical and real world results showing the virtual elimination of paravalvular leak and excellent survivability with a superior risk profile.”

The SALUS Trial is a prospective, randomized, multi-center, core lab-adjudicated U.S. clinical trial, evaluating the Direct Flow Medical Transcatheter Aortic Valve System. The primary endpoint of the trial is a composite of all-cause mortality and disabling stroke at 12 months. Completion of enrollment in the SALUS Trial is expected by the fourth quarter of 2016.

The company has also named the Steering Committee for the SALUS Trial, which will be responsible for advising the investigators and guiding the trial:

• Isaac George, MD - Columbia University Medical Center, New York, NY - *Co-principal investigator
• D. Scott Lim, MD – University of Virginia/Bon Secours, VA - *Co-principal investigator
• Federico De Marco, MD - Policlinico San Donato, Milan, Italy
• G. Chad Hughes, MD – Duke University Medical Center, Raleigh, NC
• Samir Kapadia, MD - Cleveland Clinic, Cleveland, OH
• Azeem Latib, MD – San Raffaele, Milan, Italy
• Mubashir Muntaz, MD – Pinnacle Health System, Harrisburg, PA
• Christoph Naber, MD - Contilia Heart and Vascular Center, Essen, Germany
• Jeff Popma, MD – Beth Israel Deaconess Medical Center, Boston, MA
• Vivek Rajagopal, MD - Piedmont Heart Institute, Atlanta, GA
• Michael Reardon, MD – Houston Methodist, Houston TX
• Newell Robinson, MD – St. Francis Hospital, New York, NY
• E. Murat Tuzcu, MD - Cleveland Clinic, Cleveland, OH

“Dr. Lim is one of the top interventional cardiologists and TAVR researchers in the country, and we are enthusiastic about welcoming him to the esteemed SALUS team,” said Dan LeMaitre, Direct Flow Medical’s chief executive officer. “As we expand the SALUS Trial into high risk patients and move from a single-arm to randomized controlled study for FDA approval, we will benefit from his expertise, and that of our Steering Committee. I also want to thank Dr. Tuzcu for his strong leadership of the SALUS Trial and look forward to continuing to benefit from his guidance as part of the Steering Committee.”

The Direct Flow Medical system received the CE Mark in January 2013 for the treatment of patients with aortic stenosis who are at extreme surgical risk and is commercially available in Europe.

About Direct Flow Medical, Inc.

Founded in 2004, Direct Flow Medical, Inc. is a privately-held structural heart company. The Direct Flow Medical Transcatheter Aortic Valve System is commercially available in Europe and is being studied in a pivotal trial in the U.S. The Company is headquartered in Santa Rosa, California, with technology and manufacturing facilities in Lake Forest, California. Direct Flow Medical investors include EDF Ventures, New Leaf Venture Partners, Spray Venture Partners, Foundation Medical Partners, SV Life Sciences, VantagePoint Venture Partners, ePlanet Venture Partners and strategic corporate investors. For further information, please visit the Web site at http://www.directflowmedical.com.

The Direct Flow Medical Transcatheter Aortic Valve System has not been approved for sale in the USA, Canada, or Japan.

Direct Flow Medical and the Direct Flow logo are registered trademarks of Direct Flow Medical, Inc.

Michelle McAdam
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