Speakers and Participants
CEO, Sonitus Medical
Amir founded Sonitus Medical, Inc. in 2006, leveraging 20 years of experience in founding, building, and managing medical device companies. Prior to Sonitus, Amir served for six years as an Officer, Vice President of R&D at Align Technology Inc. (NASDAQ: ALGN), creators of a unique, invisible orthodontic product. Previously, Amir was the first member of the senior management team at Embolic Protection Inc., where he was a consulting VP of Operations. EPI was successfully acquired by Boston Scientific in 2001. In early 1995, Amir co-founded EndoTex Interventional Systems, developers of minimally invasive solutions for treatment of carotid artery disease, which was also acquired by Boston Scientific in 2006. Amir has also held various management and engineering positions at Pfizer, Guidant, and Baxter-Edwards. As a seasoned entrepreneur, Amir has over 60 issued and pending patent applications, including 11 publications in peer review journals. Amir received his M.S. in Engineering Management from the University of Southern California and a B.S. in Biomedical Engineering from UC San Diego.
VP, Quality, Regulatory and Clinical Affairs, Medtronic Surgical Technologies
Francis joined Medtronic in June 1996 as a Quality Manager in the Cardiac Surgery business. Over the past 15 years, Francis has worked in Cardiac Surgery, Diabetes, Corporate Quality/Regulatory/Compliance, Operations (Manufacturing and Supply Chain), and Supplier Quality. Francis has also held developmental opportunity positions in Marketing and Program Management. Francis became a Director of Quality/Regulatory in 2006, a Sr. Engineering Director in 2008, and joined Surgical Technologies in January of 2011 as VP, Quality Operations, and April 2011 as VP, Quality, Regulatory and Clinical. Francis has also completed a number of extended work assignments in Physio Control, Spinal, and Neurological and most recently in Navigation. Francis also served as a member of Medtronic Foundation for 2 years.
General Partner, D3DC
Doug Koo has served as CEO, CFO, and COO of companies in several industries including medical device, mobile software for medical device companies, mobile entertainment, healthcare services, systems integration, and internet commerce. Mr. Koo has also held Managing Director and EIR positions with venture, venture incubator, and advisory firms. Mr. Koo has been involved in equity and debt financing totaling more than $200 million and has been a principal and an advisor in more than 25 M&A transactions. Mr. Koo is a member of the Board of Directors for Bear Data Systems, MVRx, NasoForm and d3dc Corp. He received a B.A. from University of California, San Diego and an M.B.A. from Stanford University.
Mark B. Leahey
President & CEO, MDMA
As the President of the MDMA, Mr. Leahey's responsibilities include advocating on behalf of the entrepreneurial sector of the medical device industry to Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services(CMS), and other federal and state agencies. He has lobbied for a more reasonable user fee for smaller companies, worked to open access to the hospital marketplace by challenging the exclusionary and anti-competitive nature of certain large group purchasing organizations (GPOs), as well as ensure that medical device technologies are reimbursed adequately. Mr. Leahey has been named one of the medical device industry's top lobbyists and sits on the Editorial Advisory Board of Medical Product Outsourcing.
Sr. VP, General Manager ENT, ArthroCare Corporation
Andrew Miclot joined the Company in June 2009. Andrew has more than 25 years of executive management experience within the medical device industry. Most recently, he was President and CEO of Ascension Orthopedics. Prior to this, he held senior level positions at Orthofix, Symmetry Medical, DePuy Orthopaedics and Zimmer, among others. During his thirteen years at Symmetry, Andrew held several positions including Senior Vice President and Investor Relations Officer. Andrew earned a bachelors degree in Speech and Hearing Sciences and a M.A. in Audiology from Indiana University. He also earned a M.B.A. from the Lake Forest Graduate School of Management.
Venture Partner, Prism Ventures
A member of Prism's life sciences investment team, Tony blends his extensive business, investment and company formation experience with a background in clinical medicine. He focuses on medical device investments for the firm. He is currently a director for Avedro, XLumena and Entrigue Surgical. Previously he was a director and lead investor of several venture-backed life sciences companies, including Mako Surgical.
Tony has invested across a number of therapeutic areas, including orthopedics, interventional medicine, radiation oncology, minimally invasive technologies, neurology, robotics and women’s health. He has extensive knowledge in company formation, deal structuring and syndication. A committed board member, Tony works alongside entrepreneurs to build out management teams, establish effective corporate governance and bring operational discipline to R&D and early commercialization efforts.
Tony’s clinical background is surgical. He trained in General Surgery and Otolaryngology/Head and Neck Surgery at the University of Connecticut and Hartford Hospital and held clinical appointments in Hartford area hospitals before transitioning into entrepreneurial activities.
Partner, Gilde Healthcare
Mr. Pardo joined Gilde Healthcare Partners in2011 as a Partner.
Previously, he was a Partner at Spray VenturePartners where he led investments into Interlace Medical (sold to Hologic), Solace Therapeutics and TearScience and Cascade Ophthalmics. He served on the board of Solace, TearScienceand Cascade, and was actively involved in Interlace and Conventus Orthopedics.
Mr. Pardo also served as President & CEO of Facet Solutions, a spinal implant company focused on treating lumbar spinalstenosis until the company was sold to Globus Medical in 2011.
Mr. Pardo has also worked at Cardinal Partners as an Associate leading their investing activity in the medical device sector.
Mr. Pardo began his career in medical devices as a product manager with Synthes USA.
Geoff has a B.A. from Brown University and an M.B.A. from the Wharton School of Business.
Managing Director, H.I.G. BioVentures
As a Managing Director atH.I.G. BioVentures, Bruce Robertson focuses on investment opportunities in thelife sciences sector, including biopharmaceuticals and medical devices. Brucecurrently serves on the boards of Apollo Endosurgery, CardioFocus, and ClarusTherapeutics. Bruce has been active in the life sciences sector for more than20 years. Prior to joining H.I.G., Bruce served most recently as ManagingDirector at Toucan Capital, investing in leading drug and device companiesthroughout the U.S. Prior to Toucan, Bruce was a General Partner at GIV VenturePartners, a venture capital firm focused on early stage investments in the US,India, and China.
Partner, Alston & Bird LLP
Marc J. Scheineson is a Partner in the Washington, DC office of Alston &Bird. He heads the firm’s food and drug law practice. He has practiced food and drug law, health care law, and administrative law for over 20 years in national law firms and at the Food and Drug Administration (FDA). His practice focuses on determining the“regulatory course of least resistance” to market medical products, and assisting clients with legal and regulatory issues, drug and medical device applications, marketing, compliance, and enforcement matters. Mr. Scheineson provides legal, regulatory,and legislative counsel to a variety of marketers, research institutions,professional associations, and manufacturers of pharmaceutical and biological drug products, medical devices, cosmetics, dietary supplements, and traditional foods.
VP, Healthcare Economics & Reimbursement , Johnson & Johnson, Acclarent
A seasoned veteran, Charles (“Chuck”) Schneider serves as Vice President of Healthcare Economics & Reimbursement for Johnson’s & Johnson’s ENT franchise Acclarent. With more than twenty-three years of diverse healthcare experience, he has been recognized as a leader within the Reimbursement field through his work as an industry executive and consultant. Working within Acclarent, Chuck serves as a member of the Executive Board providing strategic direction for the Company’s business development and execution. He also serves as the Company’s reimbursement leader, developing and executing comprehensive plans, providing technology development guidance as well as evaluating applications for licensure or acquisition. Chuck directs core reimbursement and health economic outcomes research, serves as a technical expert for the company, while representing Acclarent with major insurance carriers, technology assessment organizations, societies and other stakeholders. Within Johnson & Johnson, Chuck serves on the Company’s domestic and global reimbursement councils, supporting the strategic direction of the enterprise.
Co-founder and CEO, SinuSys
Thomas Schreck co-founded and currently serves as CEO of SinuSys, a sinus health company. Mr. Schreck also serves as Chairman of AcelRx Pharmaceuticals, an emerging specialty pharmaceutical company he co-founded in 2005. As CEO, he raised over $60 million to develop three Phase 3 ready assets which positioned the company for an IPO. Prior to founding AcelRx, Mr. Schreck served as founding President, and then Chief Financial Officer and Director of DURECT Corporation, where he raised approximately $200 million to launch and build DURECT into a NASDAQ listed company with a strong financial position and a robust, diversified pipeline.
Abtin Tabaee, MD
Director of Rhinology and Endoscopic Sinus Surgery, Beth Israel Medical Center
Abtin Tabaee, MD is an emerging academic leader in Rhinology with a specialized focus in the treatment of nasal, paranasal sinus and skull base disorders. He has presented nationally and internationally on the techniques and outcomes of surgical approaches for these disorders and has authored numerous peer-reviewed scientific articles and book chapters. He is currently the Director of Rhinology and Endoscopic Sinus Surgery and Attending Physician in the Department of Otolaryngology at Beth Israel Medical Center in New York. He is an Assistant Professor of Otolaryngology at Albert Einstein College of Medicine. Dr. Tabaee graduated magna cum laude from Duke University and received his medical degree with honors from Cornell University Medical College. He completed residency in Otolaryngology – Head and Neck Surgery at New York Presbyterian Hospital, the combined Columbia University-Cornell University-Memorial Sloan Kettering Cancer Center training program. He subsequently completed a fellowship in Rhinology and Endoscopic Sinus and Skull Base Surgery at Weill Medical College of Cornell University. He is board certified by the American Board of Otolaryngology, is a member of the American Rhinologic Society and a Fellow of the American College of Surgeons.