Management

Michael Kleine, President & CEO
Mr. Kleine has more than 25 years experience in the medical device industry. He joined EndoGastric Solutions from Biosensors International Group, Ltd., a publicly traded company in the interventional cardiology and critical care markets where he served as President and CEO. Prior to Biosensors, Mr. Kleine was President and CEO of MicroVention, a start-up focused on the minimally invasive treatment of cerebral brain aneurysms, which was acquired by Terumo. Additional executive experience includes President and CEO roles with Thermo Cardiosystems Inc. and Sorin Biomedical Inc.

He holds a BA in Biology and Math from Missouri Valley College and a MA in Marketing from Webster University.

Ken Ludlum, Chief Financial Officer
Mr. Ludlum is an experienced executive in the medical device industry. Prior to joining EndoGastric Solutions, he was Chief Financial Officer of life science, medical device, medical equipment and biotechnology companies. He has also been a consultant, investor, board member and advisor to medical and health care companies. 

From 1995-2000 he was Chief Financial Officer at Perclose (NASD:PERC), an interventional cardiology products company. During his five years at Perclose, sales grew from $2 million to $100 million a year, when Abbott Laboratories purchased Perclose. Prior to that, he was in investment banking for 10 years, primarily at Montgomery Securities, working with emerging growth health care companies.

He holds a BS degree from Lehigh University and a MBA from Columbia Business School.

Richard Romley, Senior Vice President, Research & Development
Mr. Romley drives the design process and manages the functional relationships across the organization. Mr. Romley brings a wealth of experience in medical product design, material sciences and the introduction of new products to the organization.

Prior to joining EGS, Mr. Romley was Director of Research and Development and Chairman of the Patent Review Board for Boston Scientific Corporation’s imaging franchise. Prior to Boston Scientific, Mr. Romley held a number of leadership positions including Vice President of Technology & Operations at BioInterventional Corporation and project management positions at Prolifix, Heartport, and Baxter Healthcare Corporation.

Mr. Romley holds several patents and a BS in Mechanical Engineering from San Diego State University.

Randall Sullivan, Senior Vice President, Operations
Mr. Sullivan has nearly 30 years of experience in high tech and medical device operations. Prior to joining EGS, Mr. Sullivan was the Chief Operations Officer of BARRX Medical, where he led the organization through the significant growth and scaling of operations, resulting in more than double the production output within two years. Additionally, he led the R&D department in launching and gaining FDA clearance for several new products.

His previous experience also includes leading the manufacturing and supply chain operations for Sanarus Medical, Microvention, and Cardiac Pathways. His long career also includes leadership roles in larger medical device companies such as Boston Scientific and Mallinckrodt/Covidien.

Mr. Sullivan has a Bachelors Degree in Electrical Engineering from California State University, Fullerton.  

David Schummers, Vice President, Marketing
Mr. Schummers joined EndoGastric Solutions from Medtronic’s Spinal and Biologics business, where he served as Marketing Director with responsibility for the company’s dynamic stabilization franchise.

Mr. Schummers joined Medtronic through the 2007 acquisition of Kyphon Inc. While at Kyphon, Mr. Schummers served in key leadership roles in marketing, R&D, operations and finance. Prior to joining Kyphon, Mr. Schummers headed the life science practice of the investor relations consulting firm the Blueshirt Group, worked in equity research at Piper Jaffray and contributed as a business writer to the medical device trade journal The Gray Sheet.

Mr. Schummers holds a BA in Economics from Oberlin College.

Greg Bowles, Vice President, Sales
Mr. Bowles leads the commercial sales efforts at EndoGastric Solutions. Prior to joining EGS, Mr. Bowles held sales and management roles with Intuitive Surgical and Johnson & Johnson and also served in the U.S. Navy for 15 years as a cryptologist.

Mr. Bowles holds a BA in Business Administration from Northwood University in Midland, Michigan.

Michael Daniel, Vice President, Regulatory Affairs
Mr. Daniel leads EndoGastric Solutions regulatory, clinical affairs and quality assurance groups. He has over 30 years of regulatory, clinical and quality experience.

Prior to joining EndoGastric Solutions, Mr. Daniel was President of a medical device consulting firm where helped venture capital funded companies bring products to market through the effective management of clinical studies and regulatory processes. He has familiarity with a broad range of medical devices, including: implantable heart assist devices (Novacor), in vitro diagnostics (SKD), endometrial resection/ablation devices (FemRx), coronary and peripheral catheters (LuMend, FHT, Kerberos), coronary anastomotic and general surgical implantable clips (Coalescent), implantable bronchial valves (Emphasis) and endoscopic/percutaneous robotics (Intuitive Surgical, Hansen Medical, NeoGuide).

Mr. Daniel holds a BS in microbiology from Michigan State University, a MS in biology from the Illinois Institute of Technology, and a MBA from University of California, Berkeley.