Our team brings decades of experience building successful therapeutics enterprises from inception to large and successful publicly traded biotechnology companies. Select key team members have been involved in development of Nitric Oxide delivery systems, some of which are currently market leader in sales.
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.
Mr. Aviv brings over 10 years of accounting and financial management practice in publicly traded companies. He was previously the CFO at Babylon Ltd., a publicly-traded Israeli company listed on the Tel Aviv Stock Exchange and operating in the fields of internet, risk capital investments and software. In his role he was actively involved in mergers, acquisitions, and investments. From 2010 to 2013, Mr. Aviv was Babylon’s Corporate Controller. From 2005 to 2010, he was a manager at the Ernst & Young Accounting Firm of Kost Forer, Gabbay & Kasierer, in Tel Aviv, working predominantly with the high-tech team. Mr. Aviv is a Certified Public Accountant, and holds a Bachelor of Arts degree in Business and Accounting, and an MBT in Business and Taxation from The College of Management, Israel
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.
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.