Chief Executive Officer
Mr. Goldberger has more than 25 years of experience in the medical technology and device industry. Prior to joining Bacterin, Dan was the CEO of Sound Surgical Technologies from April 2007 through its merger with Solta Medical (Nasdaq SLTM) in February 2013. During his career, he has held several executive leadership positions within the medical device industry, as the CEO and Director of Xcorporeal Inc. and President of Medical Group of OSI Systems. He holds a BS in Mechanical Engineering from the Massachusetts Institute of Technology and an MS in Mechanical Engineering from Stanford University. Dan is a named inventor on more than 60 U.S. patents.
Carl O’Connell has over 30 years of experience working in leadership positions in healthcare and the medical device arena. Carl most recently worked as Global Vice President of Marketing for Wright Medical as the leader for Foot and Ankle, the fastest growing segment in Orthopedics. Carl also served as President for the US healthcare division of the Japanese conglomerate, ITOCHU Corporation, and previously as Global Vice President for Stryker Spine, and President for Carl Zeiss Surgical Inc. His responsibilities have spanned from global marketing, sales, manufacturing, leadership development, regulatory affairs, corporate quality systems and research, product and business development functions.
John P. Gandolfo
Chief Financial Officer
Mr. Gandolfo has 26 years of experience as chief financial officer of rapidly growing private and publicly held companies with a primary focus in the life sciences, healthcare and medical device areas. Mr. Gandolfo has had direct responsibility over capital raising including 4 public offerings, financial management, mergers and acquisition transactions, and SEC reporting throughout his professional career.
Chief Operating Officer
Mr. Schmitz brings over 20 years of experience in financial and operational leadership roles in diverse industries including medical device, manufacturing and technology, as well as a background in public accounting at PricewaterhouseCoopers. Prior to being named Chief Operating Officer at Xtant Medical, Mr. Schmitz was the Chief Financial Officer and VP Operations at X-spine Systems. He received his BS in accounting, cum laude, from Miami University of Ohio. Mr. Schmitz is a certified public accountant and certified management accountant.
Vice President Regulatory Affairs/Quality Assurance
Mr. Smith brings over 25 years of experience in the medical device and tissue banking industries. His most recent position was Vice President of Regulatory Affairs and Quality Assurance for Sound Surgical Technologies LLC/Solta Medical. Prior to this position, Mr. Smith worked for AlloSource and Valleylab (Covidien). He has extensive knowledge pertaining to ISO 13485, FDA, and AATB regulatory requirements, guidelines, and standards. As Vice President of Regulatory and Quality Assurance he oversees the Regulatory and Quality Departments at Bacterin and X-spine.
Debbie Kirschman Klopsch
General Counsel and Compliance Officer
Ms. Kirschman Klopsch expanded her previous role as General Counsel for X-spine, and is now working as General Counsel for X-spine, Bacterin and Xtant Medical. She has over twenty three years’ experience in the legal field, including eight years as General Counsel for X-spine. She specializes in commercial transactions and litigation, IP licensing and trademarking, product liability, and medical device compliance, including risk management and corporate compliance issues relating to health care fraud and abuse, anti-kickback, Stark Law, False Claims Act, Physician Payment Sunshine Act, the AdvaMed Code of Ethics, investigations and related matters. She received her Bachelor’s Degree in Psychology (with honors) from the University of Colorado at Boulder, and received her J.D. from the University of Denver Sturm College of Law in Denver, Colorado. She is licensed to practice law in Colorado and Ohio, and is currently based at X-spine headquarters in Miamisburg, Ohio.
Chief Scientific Officer
Dr. Juda joined Bacterin International in 2005 and played an integral role in the growth of Bacterin’s biomaterials business from pre-revenue to almost $40 million in annual revenue at the time of the merger with X-Spine Systems. During his time with the company, Dr. Juda has been responsible for guiding the development, commercialization, and clinical marketing of all of Bacterin’s allograft product lines including the OsteoSponge, OsteoSelect, hMatrix, and 3Demin product families. Dr. Juda directed clinical research efforts for the Bacterin subsidiary from 2012-2015 resulting in a dossier of peer-reviewed publications that highlight the clinical success of these products. Currently, he directs Research and Development efforts for Xtant Medical and serves as a primary source of technical expertise for the company’s Sales and Marketing initiatives. Dr. Juda’s current research interests include novel surface modification of orthopedic hardware and the development of enhanced biomaterials for tissue repair and replacement. He received a BS in Biochemistry from Virginia Polytechnic Institute and State University and a PhD in Biochemistry from Montana State University.
Vice President Business Development and Contract Administration
Ms. Mason serves as the Vice President of Business Development and Contract Administration for Xtant Medical. She is responsible for targeting and securing new business, executing strategic relationships, overseeing management processes of contracts, and working closely with sales, marketing, and research and development on various initiatives. She previously served as the Vice President of Marketing and National Accounts for Bacterin and has been with the organization for over 10 years. Prior to joining Bacterin, Ms. Mason worked as a Promotions Director and Service Manager for a small network of restaurants and offers over 17 years of marketing, hospitality and customer service experience. She graduated with honors and received degrees in Marketing and Entrepreneurship from Montana State University-Bozeman.
Vice President of Clinical Affairs
Ms. Chase brings over 20 years’ experience in clinical and professional development in the medical and device industry. Responsible for the management of clinical strategies and leading the clinical elements of pre and post market product development, her philosophy relies on strong physician relationships to ensure that our products and procedures are effectively, safely and ethically utilized to benefit patients. She previously served as Vice President of Clinical Affairs and Professional Development for Bacterin prior to becoming Vice President of Clinical Affairs for Xtant Medical. Serena has held various positions in the clinical industry to include Vice President of the Clinical Affairs for Sound Surgical Technologies until it was acquired whereby she transitioned to Solta Medical directing their Global Luminary and Clinical Education Programs. Prior to 2004, Ms. Chase worked at PacifiCare Health Systems co-developing Disease State Management programs. Serena holds a Bachelor’s degree in Biological Sciences and a Master’s degree in Business Administration.
Vice President of Marketing and Customer Care
Mr. Valois has spent over 17 years in the medical device industry with roles in Marketing, Sales, R&D, and Operations. Prior to joining Xtant Medical, Inc. in the summer of 2015, he held leadership positions at Medtronic, Tornier (Wright), Zimmer (Zimmer Biomet), and St. Jude Medical. He holds a Bachelor of Science degree from the University of Wisconsin – Stout and an MBA from the University of St. Thomas.