Revolutionizing
Say Hello to the Future!
The First Intranasal Dry Powder GLP-1 Treatment Platform
Self Propelled Single-use Patented Device
CLINICAL & PATIENT ADVANTAGES
- Ease of use for compliance & adherence for pediatrics to the elderly
- Discrete & portable
- Active delivery (non-patient inhalation dependent = consistent dosing)
- Lower dose = less API = decreased cost to manufacturer
- Nasal retention for improved absorption & bioavailability
- Preservative & solvent-free leading to pain free delivery and no long-term nasal damage
- Application for a wide range of therapeutic areas past GLP-1 agonist
TECHNOLOGY ADVANTAGES
- Engineered optimal particle size & slow, narrow plume for targeted delivery of 5mg to 40 mg of powder
- Only device with medical grade propellant in gaseous phase
- Optimized nozzle design for targeted dose
- Two granted patents in key markets
- Low cost of goods
- Design for manufacture
- Inherent benefits of a powder formulation
- Chemical & physical stability
- Longer residence time
- Reduced oesophageal run-off
- More consistent absorption profile
- Controlled particle morphology
- Increased formulation options
Intranasal--Powders Versus Liquids
Summary of PK (pharmacokinetics) of a current marketed migraine medication delivered by intranasal liquid, oral tablet & intranasal powder (TRZ)
Plasma concentration ng/ml = how much is in the bloodstream
Enhanced absorption of powder formulation (TRZ) was confirmed. The concentration of migraine powder formulation (TRZ) in blood increased swiftly after administration, reaching maximum concentration (Cmax) within 20 minutes after administration. On the other hand, the marketed migraine tablet and nasal spray showed Cmax at 120 minutes after administration.
PK (pharmacokinetics) for both oral tablet and nasal liquid are comparable indicating that the liquid nasal spray PK is driven predominantly by GI absorption.
Nasal - Product Development In-vitro Testing
Plume geometry, using laser light sheet and advanced imaging, have guided our nasal device technology development.
The plume can be seen evolving steadily over a short duration of time, while exhibiting a tight cloud of aerosolised particles. The plume angle can be varied on a case by case basis.
TEAM
Lawrence H. Fox
Co-Founder and Chief of Operations Officer
Mr. Fox owns and operates Fox Automotive Inc., which began in 1999. Fox Automotive is an importer and wholesale distributor of automotive supplies and lubricants. Mr. Fox has vast experience in sales, purchasing and logistics as well as inventory management. Mr. Fox is an officer, Director, and Founder of Measurement Vault Corporation. Measurement Vault Corp. is a company that provides accurate 3D modeling of body measurements. Mr. Fox is also one of the inventors of a patent. The patent was issued by the USPTO under patent number 11, 776, 116. Mr. Fox also works with various businesses helping many companies facilitate complex financial transactions. These transactions include taking private companies public through mergers and acquisitions as well as SBA funding. Mr. Fox graduated from Temple University in 1989.
Jude Uzonwanne
Strategic Adviser
Jude has worked as a transaction and strategy adviser for over 20 years across life sciences and industrial markets.
Jude’s work involved advising clients on growth strategy choices in the context of rapidly evolving ecosystems. From a transaction perspective, Jude has advised clients on identifying investment targets, building financial models and forecasts, negotiating licensing and co-development agreements, and conducting commercial due diligence in support of M&A and joint venture activity. Jude has deep working experience across multiple continents with a variety of sovereign, regional government, philanthropic, and corporate clients.
Jude has served in several senior roles in consulting, industry, government, and philanthropy, including with ZS Associates, IQVIA, Inc., EY-Parthenon, Bain & Company, the Bill & Melinda Gates Foundation, AgencyRx/DDB, Overseas Shipholding Group, and Monitor Group (now Monitor Deloitte). Jude also served as an adviser and founding Managing Director for Nirsal Plc, a wholly-owned subsidiary of the Central Bank of Nigeria. Jude presently serves on the Board of Directors of a privately held African specialty food and snacks manufacturer, Bonita Foods. Jude graduated from Swarthmore College with a double Honors B.A. in Economics and Political Science.
Robert Clayborough BSc, PhD, MBA, CPhys, MInstP, CChem, MRSC
Chief Scientific Officer
Dr Clayborough is an internationally experienced CEO, Head of Development, VP of R&D, Project Director, and Consultant with a track record of success in both large Pharma corporates and specialist Pharma/Biotech businesses, leading development programs, developing business, raising finance and delivering innovative business and technical solutions that have directly contributed to the sustainable, profitable growth of the organizations for which he has worked. Innovative leader in pre-clinical, clinical and CMC drug product development and commercialization for both originator and generic programs within the respiratory, transdermal and parenteral pharmaceutical sectors. He has guided more than 15 development programs through to high quality global regulatory filings, and has worked on more than 100 different molecules for both local and systemic administration.
Frank Puglisi PharmD.
Co-Founder, Chief Clinical Officer
Dr. Puglisi has been a Clinical Pharmacist for the last 21 years (Hospice Pharmacia and now with VITAS Healthcare) specializing in chronic medication management of palliative care and hospice patients. Dr. Puglisi consistently challenges current pharmacotherapy guidelines (innovative) to optimize clinical pharmacology and patient compliance of medication with the goal of best case clinical outcome. Dr. Puglisi’s innovational thinking has led to USPTO issued patent 11,808,708, METHOD FOR MAINTAINING THE HEALTH OF A DIABETIC PATIENT BY PREVENTING THE OCCURRENCE OF DIABETIC KETOACIDOSIS. Dr. Puglisi was elected into the RHO CHI Honor Society School of Pharmacy Dean’s list and received his Doctor of Pharmacy Degree in 2002 from Temple University School of Pharmacy.
Johnathan Helfgott
Vice President of Regulatory Affairs
Jonathan Helfgott is a healthcare executive specializing in U.S. Food and Drug Administration regulatory strategy, clinical development, and market access. In this role, he provides expertise to companies across all phases of medical product commercialization, overseeing global regulatory submissions, clinical trial design and execution, health authority communications, and market entry strategies. He is also the Founder of FDA Partners, a boutique advisory firm focused on global regulatory and clinical strategy.
Jonathan Helfgott is currently a program coordinator and senior lecturer for the MS in Regulatory Science program at Johns Hopkins.
Previously, Helfgott served at the FDA from 2006 to 2015, most recently as Associate Director for Risk Science in the Office of Scientific Investigations at the Center for Drug Evaluation & Research. He also held roles as a Compliance Officer and Pre-Market Reviewer at the Center for Devices & Radiological Health, where he specialized in Digital Health Technologies and Software as/in a Medical Device.
Helfgott is the elected President of the Association of Graduate Regulatory Educators and has lectured extensively at academic institutions and professional organizations. His work has been featured in The Washington Post article, Regulatory Science Degrees Help Researchers Think Outside the Lab. He is a co-editor of the Food and Drug Law Institute’s Biomedical Software Regulation, a contributing member of the Clinical Trials Transformation Initiative – Digital Health Technologies, and has published extensively in Applied Clinical Trials and Medical Device and Diagnostic Industry.
Earlier in his career, Helfgott was a research fellow at the National Institutes of Health, where he supported genomic research and clinical study design at the National Institute on Aging under the Intramural Research Training Award program.
He holds an MS in Bioscience Regulatory Affairs from Johns Hopkins University and a BS in Cell/Molecular Biology & Genetics from the University of Maryland.