CEO and Chairman of the Board
President and Chief Operating Officer
Giora Davidai, MD
Chief Medical Officer
Steven Lisi has served on our Board since January 2017 and on the Board of AIT Ltd., our wholly-owned subsidiary, since June 2016. Mr. Lisi was previously Senior Vice President of Business and Corporate Development at Avadel Pharmaceuticals (AVDL) where he was instrumental in restructuring the company, raising $121m and transforming it from $100m enterprise value to $1b in three years. Prior to his position at Avadel, Mr. Lisi spent 18 years investing in the global healthcare industry at Mehta and Isaly (now Orbimed), SAC Capital, Millennium Management, Panacea Asset Management and as a Partner at Deerfield Management. Mr. Lisi serves as Chairman of the Board of Mico Innovations, a next generation coronary and neurovascular stent company. He received his Master in International Business from Pepperdine University.
Amir Avniel is the COO and co-founder of AIT. He has over 20 years of experience leading biotechnology companies. Prior to AIT, he co-founded Rosetta Green, which was eventually acquired by Monsanto. Prior to Rosetta Green, he served as the president and the Chief Executive Officer of Rosetta Genomics, a NASDAQ company. He studied computer science at the Academic College of Tel Aviv – Jaffa Israel and earned a Bachelor’s degree in Social Sciences and Humanities – from Open University in Israel. Prior to his academic studies, he served as an officer in the Israel Defense Force, where he was awarded four commendations for excellence.
Giora Davidai, MD, joins AIT from Boehringer Ingelheim (BI), where he oversaw clinical development, most recently as Executive Director and Department Head of Established Products in Clinical Development and Medical Affairs. Dr. Davidai also served as the head of Cardiovascular, Metabolic, CNS, and Respiratory, Clinical and Medical Affairs. Prior to BI, Dr. Davidai held various management roles at Glaxo Wellcome (GW), establishing the Global Bone Research team within GW R&D, in addition to leading clinical development as Global Medical head for Migraine, Headache, Epilepsy, and Smoking Cessation. Dr. Davidai is a Board-Certified physician in Pediatrics and Pediatric Nephrology and received his medical degrees from Tel Aviv Sackler School of Medicine, Haifa Medical Center and Duke University School of Medicine.
Director of Regulatory Affairs
Frederick Montgomery, PhD
Vice President of Medical Systems
Vice President of Engineering
Rhona Shanker is the Director of Regulatory Affairs at AIT. She is a regulatory affairs expert and a former FDA/CDRH/ODE expert regulatory reviewer with an extensive experience in the medical device industry, more than 35 years, where she reviewed over 3,500 applications. Rhona’s professional experience is focused on developing strategies for complying with FDA pre- and post-market regulatory requirements, including: developing regulatory strategies for pre-market submissions, planning IDE, 510(k), PMA, HUD, HDE, and CE projects; preparing 510(k), IDE, PMA, Design Dossiers, and Clinical Evaluation Reports for submission and more. Previously, Rhona held a position of the Expert Regulatory Review Scientist for heart assist devices at the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), in the Office of Device Evaluation (ODE), Division of Cardiovascular and Respiratory Devices, (DCRD/DCD). Prior to that, she also worked in the positions of Senior Reviewer and Consumer Safety Officer at the FDA. Rhona has been an invited speaker at multiple medical and regulatory affairs affiliated conferences, expositions and webinars. She graduated from Emory University with a degree in Biology and has co-authored several professional publications.
Fred Montgomery has spent the last 24 years developing and patenting NO delivery system technology leading to the commercialization of nitric oxide therapy. This includes the NO delivery systems used in 2 of the 3 pivotal studies that led to the FDA drug approval of NO in 1999. He also lead the development of the INOvent delivery system for Datex-Ohmeda, which was first FDA 510(k) cleared nitric oxide delivery system that lead to the commercial marketing of INO Therapy in the year 2000. In 2003, he joined INO Therapeutics (sold to Mallinckrodt in 2015 for $2.3B ) as their VP of Medical Devices where he established their Medical Device Group and developed the INOmax DS and DSIR products, the dominant NO delivery systems in the United States to this day. He left INO Therapeutics in 2011 and co-founded NitricGen Inc., where he was one of the inventors of the NO generator technology used in the NOgen product. He received his Doctor of Philosophy degree from the University of Salford, England and his Masters of Business Administration from the University of Bradford, England.
Duncan Bathe has been pivotal in the development of NO delivery system technology that has lead to the commercialization of nitric oxide therapy and is the named inventor in over 30 patents associated with nitric oxide delivery. He was the lead engineer in the development of the INOvent delivery system for Datex-Ohmeda, which was the first FDA 510(k) cleared nitric oxide delivery system that lead to the commercial marketing of INO Therapy in the year 2000. In 2003, he joined INO Therapeutics as their Engineering Manager where he developed the INOmax DS and DSIR products. He also developed the INOpulse delivery system for home and ambulatory NO delivery. He left INO Therapeutics in 2011 and co-founded NitricGen Inc., where he was one of the inventors of the NO generator technology used in the NOgen product. He received a Masters of Science in Engineering Mechanics from Cranfield Instute of Technology, England.
Douglas Beck, CPA
Chief Financial Officer
Professor Asher Tal, MD
Senior Vice President of Clinical Research
Senior VP Device & Business Development
Douglas Beck, CPA joined AIT as its Chief Financial Officer in November 2018. Mr. Beck has been a Chief Financial Officer for five public companies, three of which were biotechnology companies. Mr. Beck has assisted companies’ raising equity and debt in excess of $100 million. He spent over four years at Lev Pharmaceutical, Inc. until the completion of a $618 million sale of the company. Mr. Beck serves on the New York State Society of CPAs Chief Financial Officer and SEC committee.
Asher Tal, MD, Professor of Pediatrics and Founder of the Pediatric Pulmonary Unit at Soroka Medical Center, Ben-Gurion University of the Negev, Beer-Sheva, Israel, joins AIT as Senior Vice President of Clinical Research. During his 25 years as head of the Department of Pediatrics at Soroka, Professor Tal authored or co-authored over 100 publications. His research interests include childhood asthma, bronchiolitis and wheezing in infancy, sleep-disordered breathing, pediatric and adult obstructive sleep apnea syndrome and insomnia. During his esteemed career, Dr. Tal was responsible for developing the Tal score for assessing the severity of bronchiolitis in infants, which is now the accepted clinical measure of severity of respiratory infections in clinical and research settings.
For the past 18 years, Ali Ardakani has been pivotal in start-up and development of several biotech companies, drugs and medical devices, for which he has raised millions of dollars in private and grant financing. Most recently, he co-founded virtual biotech Niiki Pharma Inc in NYC, where he acquired two first-in-class oncology drugs from Europe and took them through US IND, UK CTA and Phase 1 and 2 clinical trials within 3 years. Prior to Niiki Pharma, he was the director of corporate development at iCell Therapeutics, a drug delivery platform company. Prior to iCell he led operations of PulmoNOx Medical Inc, a medical device company responsible for 510(k) approval of two novel medical devices. At the same time, he was VP of Operations of EquATec, a virtual med-tech veterinary company developing novel therapies for the equine, where he led global operations and trials in Canada, US and Hong Kong. He also managed the global alliance of EquATec with a large pharma partner.