President & CEO
Maria Sainz was appointed President and CEO of Aegea Medical in May 2018. She has over 25 years experience in commercial and leadership positions in the medtech industry. Ms. Sainz has served as the President and CEO of Cardiokinetix, a medical device company pioneering a catheter-based treatment for heart failure and prior to that, she was the President and CEO of Concentric Medical, Inc., a developer of minimally invasive products for the treatment of acute ischemic stroke acquired in 2011 by Stryker Corporation. Maria begun her medtech career at Guidant corporation where she held positions of increasing responsibility in Europe and the US. At the time of the acquisition of Guidant by Boston Scientific she served as President of the Cardiac Surgery division of Guidant Corporation. Maria has been intimately involved in several major medtech product launches such as coronary stents or Cardiac resynchronization therapy devices. Ms. Sainz also serves as a director of several public and private medical company boards. She received an M.A. in Languages from the University Complutense in Madrid, Spain and a Masters in International Management from the American Graduate School of International Management.
Chief Technology Officer
Don brings more than 20 years of device development and leadership experience. In addition to a track record of building and directing highly effective teams, Don has held key roles taking products from inception, through device development, clinical trials, and then successfully into commercialization. Don has extensive experience directly helping transform women’s healthcare with key innovation and leadership roles at all stages for Conceptus (acquired by Bayer AG). More recent activity includes serving as VP of R&D leading both heart valve replacement prosthetics and minimally invasive implantation programs at Arbor Surgical Technologies (acquired by Medtronic). Don is a named inventor on 48 issued US patents. Don has a B.S. in Biomedical Engineering from University of California, San Diego.
Executive Vice President, Research & Development
Hiram is responsible for design and development. He has over 30 years of broad operations and management experience in the medical device industry. Previously, Hiram was a consultant for start-up medical device companies responsible for development of a variety of disposable and implantable devices from concept through clinical evaluations, manufacturing scale-up and commercialization. He was Chief Operating Officer at Tautona Group, LLC, a private equity fund and incubator focused on wound healing, reconstructive and aesthetic surgery. Hiram was Executive Vice President at Spinal Kinetics, Inc. a venture-backed company developing and commercializing implants for the spine where he led product development, manufacturing, quality assurance, regulatory, and clinical affairs. He was Entrepreneur-in-Residence at US Venture Partners where he developed novel product concepts and conducted investment diligence. Hiram was Vice President, Research and Development and Operations, at MicroHeart, a startup that developed devices and pharmaceuticals to treat cardiovascular disease, acquired by Boston Scientific. He was Vice President Peripheral Vascular and Vice President, Research and Development at Target Therapeutics, a publicly traded company that developed intravascular devices to treat stroke and diseases in remote areas of the body, acquired by Boston Scientific and later acquired by Stryker.
Hiram received a B.S. in Chemical Engineering from the University of California, San Diego and a Certificate in Biomedical Engineering from the University of California, Irvine. Hiram is named inventor in over 50 issued US patents.
Acting Vice President, Regulatory Affairs
Alexis is a regulatory affairs professional with over 25 years experience in the start-up medical device company environment. She has a proven ability to drive the regulatory process, both as a direct employee and as a consultant. Her experience includes cardiovascular and gynecological device regulatory approvals, helping to grow companies from early start-up to viable companies. She developed and implemented regulatory and clinical strategies for multiple successful device approvals, three of which were novel first-of-a-kind devices. Past clients include Evalve, Inc. (acquired by Abbott Vascular), Asthmatx (acquired by Boston Scientific), Cierra, Inc and numerous other start-up device companies. Prior to working as a consultant, Alexis worked at the Foundry, LLC as Vice President of Clinical Research and Regulatory Affairs. Before that, she held positions including Vice President, Clinical Research and Regulatory Affairs at EMBOL-X, Inc. (acquired by Edwards Lifesciences), Director of Clinical Research and Regulatory Affairs at Conceptus, Inc. (public and later acquired by Bayer AG) where she was a Charter Member of the company, and various Clinical Research and Regulatory Affairs positions with increasing responsibility at Target Therapeutics, Inc. (a public company, acquired by Boston Scientific and later by Stryker). Alexis holds a Bachelors degree in Organizational Psychology from the University of California, Santa Barbara.
Vice President, Clinical Affairs
Connie brings over 20 years of clinical research experience in the medical device industry with the implementation of pre-clinical, phase I, II, III, and IV clinical trials in the U.S., Europe, Australia, Canada and Mexico to support PMA, 510(k), CE Marking filings and peer review publications. Prior to joining AEGEA, Connie was the Sr. Director of Clinical Affairs at Ventus Medical, a venture-backed company developing a novel therapeutic device for sleep apnea. Connie led the rapid execution of a 19 center, 250 patient, randomized, double blind, sham-controlled trial in the United Status to provide Level 1 evidence for payers and support physician product adoption. She also served as the Director of Clinical Affairs for Kyphon, a publicly held orthopedic spine company specializing in the treatment of spinal compression fractures with balloon kyphoplasty. Kyphon was acquired by Medtronic in 2007. While at Kyphon, Connie developed a 20+ staff member team running 9 clinical trials involving over 1,800 subjects. Before joining Kyphon, Connie served in roles of increasing responsibility at Conceptus, a publicly held women’s health care company (acquired by Bayer AG). Connie was the Director of Clinical Research for the Essure® pivotal trial. She drove the acceleration of study enrollment for this 500+ subject, multi-center, global trial enabling an earlier than anticipated PMA submission. Connie holds a B.A. in Business Administration from the University of Washington School of Business.
Vice President, Operations & Quality Assurance
Thomas brings to AEGEA a strong combination of management skills in Operations and Quality Assurance gained through 25 years in the medical device industry. Before joining AEGEA he was Vice President of Operations & Quality at ForSight VISION4, a startup company developing an ocular implant to facilitate sustained drug therapy; the company was acquired by Genentech. Prior to ForSight, Thomas served as Vice President of Operations and Quality at Arstasis. He implemented and managed the Operations and Quality functions, growing the femoral access technology from pre-clinical to FDA 510k and CE approval through market launch. At Cierra, Thomas implemented and managed the QA function as Director of Quality Assurance leading to ISO 13485 certification and achievement of the CE Mark for the Patent Foramen Ovale closure device. Thomas worked for Perclose developing arterial closure devices, contributing to the company’s growth from a small, pre-clinical startup to a successful publicly traded company, followed by acquisition into Abbott Laboratories. He contributed in several areas, developing a solid foundation in Quality Assurance, Manufacturing Engineering, and Research and Development. He headed cross-functional product development and manufacturing transfer teams for new products, including integration of an acquired technology, through market launch. Thomas started his medical device career with Stryker Corporation’s Endoscopy division in Quality Assurance. Thomas holds a B.S. in Manufacturing Engineering from Oregon State University.
Micah Harris, M.D.
Micah Harris, M.D., F.A.C.O.G. has been conducting clinical research trials through OB/GYN Consultants, Ltd., for more than a decade. In 1998, he and the late Dr. Jay Cooper, opened the first clinical research facility in Arizona designed for the evaluation of new medications and medical/surgical devices for the advancement of women’s healthcare.
Dr. Harris is a board certified Obstetrician/Gynecologist and he holds a medical degree from University of South Florida College of Medicine. He completed his postgraduate training at the University of South Florida in Tampa, Florida.
Dr. Harris’ research has been published in both the Journal of Reproductive Medicine and Obstetrics and Gynecology, and he has served as investigator for over 100 clinical trials including all of the commercially available endometrial ablation devices approved by the FDA.
Acting Chief Financial Officer
John started BeckCFO in 2007 and brings over 30 years of experience in financial management, strategic planning and execution for technology firms. John has worked with early stage companies in life sciences (medical device and pharmaceutical), fabless semiconductor, software and software as a service, hardware systems, and services. John has held full-time CFO positions with both public and private companies, and, in addition to finance, has broad experience managing cross-functional areas such as IP management, legal, treasury, risk management, HR, IT and facilities. John’s background also includes managing the accounting, finance and reporting requirements of European and Asian offices.
Before starting BeckCFO, John previously served as CFO for several companies including: Silicon Bandwidth, Inc., nDSP Corporation (acquired by PixelWorks), Sigma Designs, Inc., Augeo Software, Meta-Software, Inc. (acquired by Synopsys), Sellectek Incorporated, RayLAN Corporation, Optimem and Spectra Logic subsidiaries of Cipher Data Products, and Minton Company. Prior to his tenure at technology firms, John held senior audit positions at Ernst & Young and KPMG Peat Marwick certified public accounting firms.
John earned a B.S. degree in Commerce with an Accounting emphasis, cum laude, from Santa Clara University. He is also a licensed C.P.A. (inactive), with the State of California.