Reinhard J. Warnking
Mr. Warnking is a seasoned entrepreneur, inventor, and an acknowledged expert in the field of ultrasonic imaging and therapy. Mr. Warnking has successfully led five ultrasound companies, most notably EndoSonics Corporation and was responsible for the sale of that company to Jomed in 2000. Prior to EndoSonics, Mr. Warnking was President and CEO of Acoustic Imaging Technology Corporation, a manufacturer of ultrasound imaging systems, a division of Dornier Medizintechnik GmbH.
He founded and developed Warnking Medizintechnik, a German ultrasound company that was acquired by Dornier in 1990. Most recently, Mr. Warnking was President and CEO of ProRhythm, a therapeutic ultrasound company that developed HIFU technology for various cardiac applications. At ProRhythm, he initiated and subsequently sold an ultrasound program for the percutaneous treatment of mitral valve insufficiency.
Mr. Warnking has numerous publications, holds over 10 patents in the field of ultrasound-based medical devices and is responsible for the design and development of the first commercially successful fetal ultrasound duplex scanner.
David A. Smith
President & CEO
Mr. Smith has over 25 years of cardiac device experience with both large multi-national corporations (Baxter, Johnson & Johnson) and multiple start-up companies (Cardima, CryoCath, ProRhythm, Sound Interventions). Mr. Smith’s experience includes 20 years of international sales and marketing expertise fostered as an expatriate in Europe with Baxter Healthcare. In addition to his years in Germany, he has served as an Officer of several emerging companies, and built global sales and marketing organizations. He has considerable experience in bringing innovative cardiac devices to market.
Mr. Smith has additional experience in key functional areas including regulatory and clinical affairs. He has built and maintained relationships with cardiovascular thought leaders on several continents.
Yegor Sinelnikov, Ph.D.
Dr. Sinelnikov is a research development scientist in a field of medical application of ultrasound. He brings extensive experience in medical acoustics, focused ultrasound therapy, imaging, transducer development, acoustic holography, interferometry, and acoustic swimmer deterrent.
He is a member of Acoustical Society of America, published over 15 papers, co-inventor on 6 patent applications, and is a reviewer on several scientific magazines. Dr. Sinelnikov also brings over 12 years of medical device development management experience from concept to clinical studies and product launch at ProRhythm Inc.
Mr. Zou brings more than 15 years of Sr. Engineering experience in emerging organizations including ProRhythm and Biosense. He is an expert in the design and development of complex medical systems including MRI, ultrasound and robotics. He has extensive experience in the development of various medical applications, especially in the field of therapeutic ultrasound.
Mr. Zou is specialized in the development of medical software architecture, design and implementation. His strong background includes software verification, validation and life cycle management, as well as software risk management and regulatory compliance. Mr. Zou has also brought in rich experience in bringing prototype devices into successful pre-clinical and clinical studies.
In-house Patent Counsel
Sharon Barkume has been practicing in the patent field for over fifteen years as in-house patent attorney, associate, and patent agent (Sound Interventions, Canrock Ventures, Barkume & Associates, and Greenberg Traurig LLP) with extensive previous experience as an electrical engineer (AIL Systems). Sharon specializes in representing start-up companies with a focus on protecting confidential information and trade secrets; conducting intellectual property audits, brainstorming sessions, and prior art searches; preparing and filing patent applications, amendments, and trademark applications; providing competitive IP intelligence and infringement analysis; overseeing outside patent counsel and patent litigation counsel; and reviewing employment, confidentiality, development, and licensing agreements. Sharon is currently studying for a Masters Degree in Business Administration at the State University of New York at Stony Brook with a focus on innovation and entrepreneurship. Sharon graduated cum laude from the Touro College Jacob D. Fuchsberg Law Center and was a member of Law Review. Sharon graduated with a Bachelor of Science in Electrical Engineering from the University of Maryland. Sharon’s publications include “Strict Interpretation of 35 USC § 112: Requires Universities to Examine Their Patenting Methods”; 28 Touro Law Review 183, 2012 and “Bilski’s Effect on Patent Law: Patent Processes Under 35 USC § 101”; 27 Touro Law Review 379, 2011.
Clinical Affairs (Consultant)
Donna Mendelson brings over 20 years of experience in the design and management of clinical trials and regulatory compliance for cardiovascular and electrophysiology medical devices. Formerly Director of Clinical Research for ProRhythm, Inc., Ms. Mendelson has been actively engaged as an independent consultant and project manager for Health Policy Associates, Inc. Previously, Ms. Mendelson has held Clinical Affairs responsibilities for Kika Medica, TissueLink Medical (now, Salient Surgical Technologies), MedSystems, Oscor Medical Corporation, and Cardiac Control Systems, Inc.
Regulatory Affairs (Consultant)
John Talarico, Regulatory and Clinical Affairs Consultant, has spearheaded many Company’s regulatory, clinical and quality commitment. His expertise is in regulatory cGXP & ISO compliance, PMAs, 510(k)s, INDs, 505(b)2, and IDE as well as FDA, CE and other non-EU countries. John has over 25 years of medical device experience in Quality, Clinical and Regulatory Affairs. He held executive positions previously at Johnson & Johnson, Honeywell Medical, Bell Labs, ProRhythm, and Optovue, Inc.