Don William Gurskis is a seasoned medical device executive and innovator with over 25 years of experience driving breakthrough technologies from concept to commercialization. A proven leader in the medtech industry, Don has held multiple executive roles, including Founder, CEO, and Chief Technology Officer across several successful startups and high-growth ventures, contributing to multiple acquisitions by leading medical technology companies which include Medtronic, Bayer, and Cooper Surgical.

Currently serving as Founder and CTO of Arctx Medical, Don previously led AEGEA Medical as President, CEO, and CTO, where he raised over $100M in venture capital, led pivotal global clinical trials, and guided the company to successful FDA PMA approval for its Mara™ Water Vapor Ablation System. Under his leadership, AEGEA was acquired by Cooper Surgical, with its technology now positioned as a market-leading solution in women’s health.

Don’s core strengths lie in medical device design, fundraising, regulatory strategy, clinical trial execution, intellectual property development, and building cross-functional teams. His passion lies in working directly with clinicians to solve complex procedural challenges and develop technologies that improve patient outcomes. He is named on 54 U.S. and international patents.

Don holds a B.S. in Biomedical Engineering from the University of California, San Diego.

Connie Rey is a senior clinical research executive with over 30 years of experience leading global medical device trials across women’s health, neurovascular, orthopedic spine, sleep apnea, and emerging therapeutic technologies. She has successfully directed pre-clinical through pivotal studies in the U.S., Europe, Australia, Canada, Latin America, and New Zealand, supporting multiple FDA PMA and 510(k) approvals, CE Marking, and peer-reviewed publications. Connie has held executive leadership roles at innovative medtech companies, overseeing multi-center trials involving thousands of participants, accelerating enrollment for pivotal studies, and building high-performing clinical operations teams. She is recognized for her strategic vision, operational excellence, and ability to deliver complex trials on time and within budget, advancing groundbreaking technologies from concept to market.

Cindy Domecus, R.A.C. has worked in the medical device industry for over 35 years, serving in Regulatory Affairs and Clinical Research executive management positions since 1994.  Cindy was selected by FDA to serve as the Industry Representative to the OB/GYN Devices panel and served as the temporary Industry Representative to other FDA panels during her 6-year term.  She was also elected to the Board of Directors for the Orthopedic Surgical Manufacturers Association.  She currently consults to medical device firms at various stages of product development in a wide variety of technology and diagnostic and therapeutic areas.  She has led successful PMA, De Novo, 510(k), Breakthrough Device Designation, IDE, Pre-Submission and regulatory compliance efforts.  She has a B.A. from University of the Pacific in Psychology and has attended executive education programs at Harvard School of Business and Kellogg School of Management.  She is a regular guest speaker and coach at Stanford’s Biodesign Program.  She has obtained Regulatory Affairs Certification from the Regulatory Affairs Professionals Society (RAPS) for both the US and the EU.

Professor of Medicine
Executive Director, Digestive Health Institute
Keck School of Medicine of USC

Associate Professor of Medicine (Gastroenterology & Hepatology)
Northwestern University Feinberg School of Medicine
Medical Director, National Pancreas Foundation, Illinois Chapter

Associate Professor, Division of Gastroenterology
Director or Advanced Endoscopy and Medical Pancreatology
University of Minnesota Schol of Medicine

Director, Orlando Health Pancreas Program
Formerly Professor of Medicine and Director of the Division of Gastroenterology and Hepatology at the University of Alabama, Birmingham