Dr. Steve Levine is the founder of dB Diagnostics, inventor of Hearing Healthcare Pro™ Product Suite, and majority shareholder. He is a clinical practicing otolaryngologist with 35 years’ experience and Assistant Clinical Professor at Yale University School of Medicine. He has been listed by Castle Connolly as a Top Doctor for 15 consecutive years, and has been named such in New York Magazine, US News and World Report, and others. Levine has served on the Board of Governors of the American Academy of Otolaryngology-Head & Neck Surgery including its Executive Committee at an elected post, and has been granted both an Honor Award and Distinguished Service Award from the Academy. He has been a past president of the Connecticut Ear, Nose & Throat Society and is a Council Member of the Connecticut State Medical Society. Levine organized and created HearOPG, a consortium of independent hearing aid retail businesses connected to otolaryngology practices mostly in Connecticut. He is a founder of ATSS, a software development company formed in 1993 that created a black box interface for revenue cycle management systems and electronic medical records to generate accurate evaluation/management service CPT billing codes. He was a Director of the Connecticut Bank of Commerce, a public bank that focused business on asset based lending and accounts receivable financing. Levine is a co-founder of the Society of Physician Entrepreneurs (www.sopenet.org) and Chapter Leader of the New York TriState Chapter of that Society. He has a BS from the Sophie Davis School of Biomedical Education at the City College of New York and MD from the University of Rochester. Levine did residency training at University of Pennsylvania.
Bob Rudolph manages all technologies at dB Diagnostics and has 35 years’ experience as a software developer, data warehouse expert, and project manager. He directed software development at ATSS starting at its very beginning and is co-owner of ATSS with Dr. Levine. His background includes working in both the public and private sectors in the IT industry including technology, infrastructure and strategic business applications. His experience includes extensive Fortune 100 IT experience which spans healthcare, insurance, Medicare/Medicaid, pharmaceutical, defense, manufacturing, banking, retail, and utilities sectors. Companies with which he has direct IT experience includes GE, GM, UnitedHealth Group, Citigroup, Wells Fargo, Anthem, Aetna, Pfizer, Cigna, Travelers, Home Depot, and Hartford Financial. Bob also has start-up experience in the healthcare industry from inception to support. He has a BS from Central Connecticut State University.
David Rothkopf has more than 25 years of professional strategic experience in the development, quality and regulatory control of medical devices. He is currently the President and Founding Principal at MEDIcept; established in 1996 to offer engineering, quality, and regulatory consulting assistance to the medical device and blood plasma industry. Over his career, Mr. Rothkopf has assisted over 400 companies with the aid they require to navigate the national and international regulatory paths. In the last fifteen years, he has performed well over 400: ISO 13485 and FDA-style audits. Mr. Rothkopf has submitted over sixty-five 510ks and PMAs and with other MEDIcept personnel have developed over 125 submissions. He has trained many medical companies and the FDA on the intricacies of Design Control, CAPA, Production Control, Software Validation, Risk Management and hazard mitigation throughout a product life cycle. David has also taught classes at the RAPS, ASQ, and SQA annual meetings. He has leveraged his extensive QA, regulatory, and clinical knowledge with his personal relationships with regulated bodies for his clients’ advantage by finding the most cost effective and efficient method to federal compliance. Mr. Rothkopf holds both a Bachelor and Master of Mechanical Engineering degree from Worcester Polytechnic Institute and an MBA from Boston University. He currently serves on the Boards of Directors of three medical device companies and serves on three non-profit Advisory Boards.
Richard “RJ” Nakkula is a currently finishing his MS in Biomedical Engineering-Medical Product Development at the University of Michigan where he recently completed a BS in Mechanical Engineering with a minor in Multidisciplinary Design. His previous work experience includes working at 3M in front-end innovation and product design. RJ also has performed a combined 5 years of biochemical and orthopedic research while on Michigan’s campus. His current role with dB Diagnostic Systems, Inc. includes conducting R&D and testing.
Michele Johnson’s 30 years’ experience includes Internal Auditor for North Carolina National Bank (Charlotte, NC), Corporate Finance for Chrysler Corporation (Detroit, MI), and General Manager of Bruce Campbell Dodge (Detroit, MI). Based in Connecticut, she has owned her own bookkeeping and financial analysis company since 2005 and just published the book, “Building a Stellar Business: A Structured Guide to Financial Success”, in February, 2016. Michele has a B.S. in Accounting from UNC-Greensboro and an MBA from Indiana University.
Lisa Moyles has over 21 years’ experience as an Intellectual Property (IP) attorney, after spending 6 years as an engineer, working with a wide variety of technologies including medical devices, nonwoven technologies for use in the automotive industry, filtration and personal hygiene, gas and wind turbines, oil and gas perforation technologies, engineering polymers and molded components, explosion clad welding, flooring coatings, combustion and heat transfer equipment, outdoor lifestyle products, specialty packaging, lighting/systems, electronics and business methods, as well as worked with a variety of small business and individuals such as authors, artists and musicians to protect their IP rights. She served in-house as IP Counsel for Fortune 50 companies (GE, DuPont, Kimberly-Clark and Tyco Healthcare), large law firms, and as acting Chief IP Counsel for small to mid-sized companies, and co-founded Moyles and Tremblay Law, LLC (www.mtlaw.us) in April 2011. She has extensive experience in preparing and prosecuting patent and trademark applications, preparing and negotiating IP-related agreements, developing and maintaining an IP budget, drafting freedom-to-operate and validity opinions, and providing training on various legal issues, including IP and trade secrets. She received her JD from the University of Louisville in 1995, after attending law school at night and working full-time as an engineer for DuPont. Her undergraduate degree is a B.S. in Mechanical Engineering, received from North Carolina State University in 1989. She is admitted to practice in Connecticut, Georgia and North Carolina, and is registered to practice before the U.S. Patent and Trademark Office.
Scientific Advisory Board
Dr. Seilesh Babu is certified by the American Board of Otolaryngology with subspecialty certification in Neurotology. He practices at the Michigan Ear Institute in Farmington Hills, MI. He is Clinical Associate Professor at Wayne State University, Michigan State University, and William Beaumont Oakland University School of Medicine. He is Program Director of the St John Osteopathic Otolaryngology Program and a Past President of the Michigan Otolaryngology Society.
Dr. Sujana Chandrasekhar is certified by the American Board of Otolaryngology with subspecialty certification in Neurotology. She practices at New York Otology in New York, NY. She is Clinical Professor at Hofstra-Northwell School of Medicine, Clinical Associate Professor at Mount Sinai School of Medicine. She is Director of Neurotology at the J J Peters Veterans Affairs Medical Center and Director of the Comprehensive Balance Center at the New York Head and Neck Institute. She is the Immediate Past President of the American Academy of Otolaryngology-Head & Neck Surgery and Past Chair of its Board of Governors.
Dr. Hayes Wanamaker is certified by the American Board of Otolaryngology with subspecialty certification in Neurotology. He practices at Ear Consultants of Central New York in Syracuse, NY. He is Research Assistant Professor in Bioengineering and Neurosciences at the Institute for Sensory Research, Syracuse University, Clinical Assistant Professor at SUNY Health Science Center at Syracuse, and Chief of the Department of Otolaryngology, Crouse Hospital. He is the current Chair of the Socioeconomic and Grassroots Committee of the American Academy of Otolaryngology-Head & Neck Surgery Board of Governors and a Director of the New York State Society of Otolaryngology.
Board of Advisors
Rick Epstein currently serves as CEO of OMNIlife science, Inc., a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market. Rick’s extensive healthcare industry experience spans over 30 years and includes senior executive roles at Sonoma Orthopedic Products (President and CEO), Ellman International (President and CEO) Cardinal Health (VPGM at V. Mueller), Intuitive Surgical and Baxter Healthcare. He has held General Management and executive positions in technology development, business development, sales and marketing. Over the course of his career, Rick has been responsible for commercializing new products with annual revenues in excess of $1.7 billion and has run companies from early stage to revenues in excess of $150 million. Rick’s Board of Diretors experience includes Sonoma Orthopedic Products, Ellman International and Nextran. Rick earned an MBA from the University of Chicago, an MS in Mechanical Engineering from Stanford University, and a BS in General Engineering from the University of Illinois.
Jordan Kanfer is a Portfolio Manager focusing on the Healthcare strategy with the Equity Special Situations Group. Prior to joining Arrowgrass in July 2014, Jordan spent more than 15 years of experience on the buyside, working a variety of Portfolio Manager and analyst roles focusing on the Healthcare Sector. Jordan joined Arrowgrass from Zweig Dimenna where he was a Principal with coverage of all Healthcare related sub-sectors. Jordan spent the bulk of his buyside career at TPG- Axon, for two years, and Jana Partners, for four years, covering Healthcare worldwide. Prior to joining Jana Partners, Jordan worked at Goldman Sachs, for three years, as an equity research analyst covering the Healthcare Information & Technology and Healthcare Facilities sectors. Before joining Goldman Sachs, Jordan held a variety of positions in the Healthcare industry ranging from Consulting to the Associate Director of Nuclear Medicine for Montefiore Medical Center. Jordan received his MPH from the University of Massachusetts, Amherst, and BA in History from Yeshiva University.
Dan Kreisler is a specialty pharmaceutical industry veteran with over 30 years of experience. He is currently President of Xaleron Pharmaceuticals, Inc., a specialty pharmaceutical start-up focused on in-licensing late stage development compounds. Prior to Xaleron, Dan was a co-founder of Acton Pharmaceuticals and served as its President, Chief Operating Officer and was a member of the Acton Board of Directors. Acton was a specialty pharmaceutical company with a focus on respiratory products. The company was founded in 2008 and was funded by Sequoia Capital. Acton licensed in two products, Aerospan, an inhaled steroid, from Forest Laboratories in 2009 and Nasacort HFA, a nasal steroid, from Sanofi U.S in 2011. Acton completed the development of Aerospan and received FDA approval in 2012 clearing the product for commercialization in the U.S. In 2013, Dan helped lead the successful exit from Acton when the company was sold to Meda Pharmaceuticals, Inc. of Sweden (purchased by Mylan in 2016) in October 2013. Previously, Dan was a co-founder of JDS Pharmaceuticals, LLC, a ventured backed specialty pharmaceutical company formed in 2004 where he held the position of Vice President, Business Development. In 2007, JDS was acquired by Noven Pharmaceuticals, Inc. for $125 million. Dan remained with Noven as Vice President, Business Development until co-founding Acton. In addition to co-founding Acton and JDS, Dan was a co-founder of Krele Pharmaceuticals, which currently operates as Tonix Pharmaceuticals, Inc. Earlier in his career, Dan spent over 16 years at Forest Laboratories where he held positions in marketing management and business development and helped transition the company from a generic manufacturer to a specialty pharmaceutical company. Dan holds a B.S. degree in Pharmacy from the University of Rhode Island.
Rich Marin is a 43-year finance, real estate, and venture capital industry executive who is currently the CEO of Low Emissions Resources Corporation, a start-up scientific research & development company working in the areas of hydrogen and ammonia production. He also is involved in managing private equity investments, consulting on major commercial real estate and attractions projects, and an expert in the retirement field. Within his career, he has been a senior executive at Bankers Trust Company, Deutsche Bank and Bear Stearns. His initial career spanned corporate finance, sales and trading, structured products, emerging markets, processing and several other disciplines. Later in his career he focused on building and running large asset management businesses in both the traditional and alternative spaces and in the institutional and high net worth markets. He has been a successful financial entrepreneur, involved in founding several venture capital firms (Beehive Ventures and Green Visor Capital) and a hedge fund (Ironwood Global). He has a BA in economics and government and an MBA in finance from Cornell, and is a retired Clinical Professor from the Cornell's Johnson Graduate School of Management where he taught on topics such as asset management, alternative assets, retirement and pensions and project financing.
Doris Nagel has nearly 30 years of hands-on experience working with medical device companies. She began her career as an associate at the law firm of Sidley Austin, followed by positions at Baxter Healthcare, Allegiance Healthcare, and Cardinal Health. Since setting up her own legal services and consulting company in early 2007, she has helped mostly smaller and mid-sized device companies, including Ohio Medical, Devicor Medical, Fenwal, iRhythm, Briggs Medical, and Natus. She has worked with a number of startups, as well helped manage new start-up subsidiaries in at least 44 countries. She also has a wealth of transactional experience, having worked closely with international tax advisors, finance teams, and bankers on numerous cross-border acquisitions, divestitures, joint ventures, and global restructurings. As a practicing lawyer, she also assists companies with a wide variety of agreements, regulatory compliance and risk management issues. She is a member of the board of directors of the International Trade Association of Chicago, as well as an instructor at the Proformative Academy for mid-market tax, finance, and treasury executives. She is the author of a frequent blog on international expansion issues, and is also the former co-owner of startup companies MedEvolution and DocStudio, as well as a former adjunct professor of law at DePaul University.
Whit Stearns has over 40 years’ experience in accounting and finance. The first decade of his career was at KPMG as Audit Partner, Audit Manager and Staff Accountant. The next decade was at Schein Pharmaceutical where he became CFO and guided the company to acquisition. Since 2000, he has served as CFO to a host of pharmaceutical companies in both start-up and mature phases, namely Phytoceutica (early stage venture financed), Savient Pharmaceuticals (NASDAQ listed), JDS Pharmaceuticals (sold to Noven Pharmaceuticals), URL Pharma (generic manufacturer sold to Sun Pharmaceuticals), and Sun Pharmaceuticals (India-based multinational). He has a BS in accounting from Lehigh University.
Kevin Quilty has been a driving force behind the success of multiple clinically unique medical device and healthcare service companies. He has over 30 years of experience leading early stage venture backed and large companies, building sales, marketing and operational teams that successfully generate exceptional results. Most recently, Quilty was Senior VP Global Advanced Wound Care Marketing and Distribution at Derma Sciences Inc. a leader of innovative regenerative tissue products. Previous roles included the commercialization of a novel hand hygiene monitoring device to reduce hospital acquired infections (Executive VP Sales at HyGreen), Senior Vice President of Sales & Marketing for Endocare, Inc. where he developed the global strategy that successfully launched cryoablation technology for the treatment multiple types of cancer. He built a global sales and marketing team of 50 individuals that generated revenue of $32 million and the successful sale of the company. During twelve years at Tokos Medical Corporation, he held multiple sales management and operational roles as the company grew from early stage to revenue growth of 130 Million. Tokos was the first company to launch a unique telemedicine offering combining product and service for high risk obstetrical patients. Quilty’s solid foundation in medical sales and general management was built during these eight years at Baxter Healthcare in acute care hospital product sales and home healthcare products and services.