Our Team. Your strategic partner for the entire medical product lifecycle. Quality Expertise Efficiency Teamwork

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1 Our Team Your strategic partner for the entire medical product lifecycle At Boston Biomedical Associates, our experienced and dedicated employees define how we work and give us a competitive advantage with their extensive tenure in the medical device/drug industry. Our commitment to quality has made us a key contributor to biomedical companies. Our employees collective knowledge and experiences are our most important assets. Our company philosophy is the foundation for why BBA employees place a high value on relationships with our clients, our investigators, clinical sites, and strategic partners to establish long-term collaborations. Our management team members are recognized experts in many therapeutic areas, and in the areas of study design, data management, quality systems, statistics, and regulatory. Our collaborative and experienced teams provide unparalleled support to your company during every step of a product development process. Boston Biomedical Associates works to ensure maximum efficiency with your business needs in mind when designing and managing your project. We recruit exceptional, experienced people who seek to continuously advance themselves, thus providing high quality services utilizing industry best practices. Our company culture centers on sharing expertise, developing our team s talents, empowering each other to share their expertise and taking an intelligent, aggressive approach to trial strategy and trial execution to contribute to our partner s long-term business success. The philosophy of quality, expertise, efficiency, and teamwork is central to everyone within our organization. Quality Expertise Efficiency Teamwork

2 Your strategic partner for the entire medical product lifecycle n Michelle A. Michela, MS Consulting Services Ms. Michela is the Group Leader of Consulting Services at BBA. Ms. Michela has more than 20 years of experience in medical devices, data management and analysis, and regulatory submissions in a variety of settings. As a founding member of BBA Ms. Michela has been instrumental in identifying the complex needs of clients and applying her experiences in clinical research, data analysis and management, and biostatistical consulting services to deliver high quality solutions. During her years at BBA, Ms Michela has assembled a strong internal team of PhD and MS level biostatisticians and programmers as well as strong working relationships with external consulting Statisticians to support specialized needs including Bayesian adaptive designs and Data Monitoring Committee support. Ms. Michela has a particular focus in clinical trial design and development and biostatistical analytical methods, including Bayesian and adaptive study designs, critical to evaluation of clinical data to support safety and efficacy of new medical devices across numerous therapeutic specialties. Additional areas of expertise include preparing regulatory submissions; managing Data Monitoring Committees and Clinical Events Committees, designing clinical trials and developing protocols, conducting literature review, designing case report forms, implementing web-based data management, and conducting software validation and statistical analyses for clinical summary reports. Prior to joining BBA Ms. Michela worked at Boston Scientific Corporation and Survival Technologies. Ms. Michela holds a BS in Biochemical Engineering from the University of Rochester and a MS in Physiology from Georgetown University. n Mark Gosnell Consulting Services Mr. Gosnell is a Principal Consultant at BBA. At BBA he provides preclinical, clinical and regulatory consulting services to our clients in the medical device industry. Mr. Gosnell uses his 24 years of experience in cardiovascular disease and devices to provide client consultation in the areas of interventional cardiovascular/ neurovascular devices, mechanical circulatory support, electrophysiology, orthopedic implants, and obesity/gastrointestinal devices in clinical trials within and outside the US. Prior to joining BBA, he was VP of clinical affairs at OmniSonics Medical Technologies Inc., a Clinical Programs Manager and Senior Clinical Research Scientist at Boston Scientific Corporation. During his time at Boston Scientific, he was responsible for worldwide activities in the development of coronary, peripheral and drug-eluting stent technology. He worked to develop regulatory strategies to support new product approvals in the area of drug-device combination products. He has served on an AdvaMed task force for cardiovascular devices. Mr. Gosnell has co-authored eight papers and abstracts in the area of medical devices and holds a US patent with his colleagues for an ultrasonic probe used with a pharmacologic agent. He is a member of the American Association for the Advancement of Science, and the Society for Clinical Trials. Mr. Gosnell holds a BS in Zoology from the University of Wisconsin, Eau Claire. n Diana L. Cunningham, MS Biometrics Ms. Cunningham is the Executive Director of Biometrics at BBA. Ms. Cunningham utilizes her 25 years of research and data management experience to provide oversight of client projects, Clinical Data Managers and Data Entry staff. Prior to Joining BBA in 2005, Ms. Cunningham was a Senior Line Manager and Project Manager at PAREXEL International Corp. and a Senior Data Management Consultant at Muro Pharmaceuticals through Aerotek Consulting. She has 20 years of experience in the development and execution of data management and has established efficient electronic data capture systems in clinical trials for both medical devices and pharmaceuticals. Ms. Cunningham holds a BS degree in Biology with minors in Chemistry and Health from Bridgewater State College and a MS in Secondary Education from Curry College.

3 n Ken Dhimitri Clinical Operations Mr. Dhimitri is Executive Director of Clinical Operations at BBA. He offers more than fifteen years of clinical leadership including the operational and financial oversight of drug, biologic and device trials. He has developed the global operational strategy for multiple clinical programs and has a successful track record building and mobilizing cross-functional teams to deliver on clinical and organizational objectives. Prior to joining BBA, Mr. Dhimitri was Senior Portfolio Director and Director of Project Management at PAREXEL International where he provided operational and financial oversight for a portfolio of more than 50 clinical trials with P&L responsibility in excess of $300M. Previously he led a multi-disciplinary research program at Lahey Hospital & Medical Center. As a consultant, he provided data analytics to researchers in the healthcare arena. His background also includes five years of direct patient care as a licensed Physical Therapist. Mr. Dhimitri holds a BS in Physiology and an MS in Physical Therapy from the University of Massachusetts, Lowell. n Maria Francescon, MPH Safety Ms. Francescon is the Director of Safety at BBA where she oversees Clinical Events Committee (CEC) and Data Monitoring Committee (DMC) services. Ms. Francescon and her experienced team provide expertise to our clients related to the establishment of these oversight committees to ensure the integrity and validity of trial data for endpoint analysis reporting and to ensure patient safety which are critical functions of clinical trial conduct. Prior to joining BBA, she served as Senior Program Director of CEC and DMC services at Harvard Clinical Research Institute, an academic CRO, working with leading medical device and pharmaceutical clients for 10 years in various therapeutic areas, including interventional cardiology, neurology, endovascular, and peripheral vascular. She executed and led CEC and DMC services for 80 projects during her tenure at HCRI, including MD recruitment, charter development, and serving as the client liaison to maintain independence between the client and committees while working with clients to educate them on the importance and functionality of these committees in order to ensure data integrity. She grew the business in this area significantly and worked closely with internal colleagues and clients to ensure the delivery of quality and client service. Earlier in her career, she was employed with several health care consulting firms for 10 years where she worked and developed significant experience within project management and client services. Ms. Francescon earned her MPH from Boston University. n Marybeth Gamber Consulting Services Ms. Gamber is a Principal Consultant in Consulting Services at BBA. Ms. Gamber utilizes her extensive regulatory and quality systems experience to help develop preclinical, clinical, and strategic regulatory programs for our clients. Ms. Gamber joined the company in 2009 after working for over 11 years in Regulatory Affairs for Boston Scientific Corporation, Acumen Medical, Concentric Medical and Bacchus Vascular Inc. where she formulated and executed aggressive regulatory strategies for medical devices, as well as created and maintained quality systems meeting ISO and FDA QSR requirements. While serving in those roles, Ms. Gamber established herself as an experienced and strategic Director of Regulatory Affairs. She has experience with regulatory submissions for a wide range of therapeutic areas to support product approvals in the United States and internationally in the European Union and Canada. She has experience in the medical device product development process as well as post market surveillance activities. In addition, Ms. Gamber has clinical experience including development of study protocols and other study related documents. She has executed site study start up activities, monitored clinical sites and continues to perform BIMO audits at clinical sites in preparation for FDA audits. Ms. Gamber s therapeutic experiences include cardiovascular, peripheral vascular, neurovascular, gastroenterology and orthopedics. Ms. Gamber developed and implemented the plan and process for BBA to obtain ISO 13485:2003 certification. Ms. Gamber holds a Bachelor of Arts from Juniata College in English and is a member of the Regulatory Affairs Professional Society.

4 Quality Expertise Efficiency Teamwork n Paulette Niemyski, RN, BSN Consulting Services Ms. Niemyski is a Principal Consultant in Consulting Services at BBA. Ms. Niemyski utilizes her more than 25 years of experience in clinical affairs helping clients develop and execute clinical investigations. She is a senior clinical affairs expert with clinical research knowledge and skills gained from serving in such positions as the Senior Director of Clinical Affairs at Minerva Surgical, the Director of Clinical Affairs at NeoTract, Nellix Inc., and the Director of Clinical Research at Medtronic Vascular. She formerly spent five years at the Harvard Clinical Research Institute (CRO) where she was the Director of Trial Design and Development. Ms. Niemyski has led or been a member of teams that created and executed reliable research programs, yielding accurate, safe, and effective data toward US and non-us approval of new clinical products. She has been a collaborator with over 100 medical companies in the development of clinical trials for investigational medical devices and pharmaceutical products and has a proven record of mobilizing teams to deliver timely solutions using creative approaches. Ms. Niemyski has a BS in Nursing from the Indiana University School of Nursing and practiced nursing for many years in both Surgical and Cardiac Intensive Care Units. Ms. Niemyski has also authored various publications in cardiology journals. n Puja Shakour, MD Medical Affairs Dr. Puja Shakour joined BBA s department of Medical Affairs as the Director of Medical Writing in January of 2013 bringing with her 14 years of experience in the medical device and pharmaceutical industry with vast US and international exposure to regulations, guidance and standards. Her expertise includes: providing medical/clinical expertise in clinical trial designs, literature review/ summary/ manuscripts development, document reviewing/writing, clinical experience reports, clinical sections (PMA,510(k), and DDs), contributing to medical relevance risk assessments and overseeing safety and quality analysis processes. Her body of work includes securing European Union approval for several products with no clinical trial justification and in the US, PMA and 510(k) approvals in addition to clinical and post-market safety surveillance. Dr. Shakour comes to BBA from Boston Scientific after making stops at Abbott Vascular and Scios Inc. Dr. Shakour is a graduate of King Edward Medical College in Lahore, Pakistan. n Mack D. Rubley, PhD, ATC Business Development Dr. Rubley is the Director of Business Development for BBA. He has 10 years of experience working as a clinician in sports medicine as a Certified Athletic Trainer in collegiate sports. In addition he was an Associate Professor of Athletic Training in the School of Allied Health Sciences at UNLV for 10 years and the director of the Athletic Training Education Program form During that time he was a member of the UNLV Biomedical IRB and Director of the Athletic Training Research Laboratory. He has published over 20 papers and 50 abstracts in the Journal of Athletic Training, Journal of Strength and Conditioning Research, Journal of Sports Rehabilitation and the International Journal of Sports Medicine. He has presented at over 50 medical meetings internationally, nationally and locally on topics related to injury prevention, diagnosis, treatment and rehabilitation. He is currently a member of the National Athletic Trainers Association, and the American College of Sports Medicine. As an established clinical scientist, Dr. Rubley understands the needs of executing appropriate clinical studies that are appropriately designed to suit your research question. He manages the business development area and ensures that your project is targeted with the optimal BBA team members assigned. Dr. Rubley holds a BS and MS in Kinesiology from the University of Colorado and Pennsylvania State University respectively, and a PhD in Exercise Science and Wellness from Brigham Young University.

5 Senior Management Team n Lauren S. Baker, PhD, PE President Dr. Baker is the President and Owner of Boston Biomedical Associates (BBA). She established BBA in 2000 after an extensive career of nearly 10 years running the corporate clinical research group for Boston Scientific. Prior to BSC, she was employed as a Research Assistant Professor at the University of Massachusetts Medical School where she worked in the Cardiac and Vascular Surgery Departments. She has served as a Professor in Mechanical Engineering at Worcester Polytechnic Institute and has established herself as a leader in clinical research in a variety of medical areas including cardiovascular, neurovascular, orthopedics, GI and GU. Dr. Baker is a licensed professional engineer and holds a BS in Chemical Engineering and a Masters and PhD in Mechanical Engineering with an emphasis in Biomedical Engineering. She has received her degrees from Worcester Polytechnic Institute and her research was performed in the Vascular Surgery Department at UMASS Medical School. n Bonnie Weiner, MD, MSEC, MBA Medical Director Dr. Weiner is the Medical Director at BBA, a Professor of Medicine at University of Massachusetts Medical School, Director of the Cardiology Fellowship Program Division of Cardiology, Saint Vincent Hospital and President of Imaging Core Lab Services, LLC. Dr. Weiner has served as principal investigator/sub-investigator for studies in the specialty of cardiovascular medicine in numerous studies. She has published over 100 peer-reviewed manuscripts, over 100 abstracts accepted, presented at over 50 medical symposiums, and serves as a manuscript reviewer for many journals including the New England Journal of Medicine. Dr. Weiner oversees all medical aspects of the projects managed by BBA. Dr. Weiner holds a BA with Honors in Chemistry from Mills College and an MD from the University of Oregon Medical School, an MSEC and MBA from the University of Maryland. n Jake Martz, MBA Chief Financial Officer Mr. Martz is the Chief Financial Officer (CFO) at BBA. Before BBA, Jake was employed at Accounting Management Solutions providing interim CFO and Consulting Services to a variety of clients in both the Boston and New York regions. Prior to AMS Jake spent 13 years working for Boston Scientific in a variety of project management and senior finance roles including extensive international experience in Asia, Europe and South America. Jake has more than 30 years of diverse accounting and financial management experience with small, medium and large companies. Mr. Martz earned his Bachelor s degree from Northern Kentucky University, and his Masters degree from Northeastern University in Boston.

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