Novoteris is a privately held limited liabilities corporation (Nevada) that is managed by a group of international industry veterans and clinicians involved in developing and producing innovative, cutting-edge medical products.
Novoteris was formed in 2013 for the sole purpose of bringing a novel inhaled antimicrobial drug product to the market for the treatment of Cystic Fibrosis. The science and intellectual property that formed the basis of Novoteris was acquired primarily from 12th Man Technologies, Inc. (Garden Grove, CA) and Nitric Solutions Inc. (Vancouver, BC) and includes drug delivery technology, the science base for the drug product and clinical trial data.
The lead entity being pursued by Novoteris is its Thiolanox® nitric oxide gas formulation.
Alex Stenzler, Founder and President
Alex Stenzler was the former Vice President of Advanced Technologies for CareFusion 207, Inc, (VIASYS, Cardinal Health) where he worked from 1991 until 2011 at which time he formed 12th Man Technologies, Inc., an R&D organization based in Garden Grove, CA (www.12thmantec.com). Mr. Stenzler brings more than thirty years of clinical and commercial experience in pulmonary medicine to his position. Prior to joining CareFusion, he was President of a respiratory research and development firm in New York and had directed Pulmonary Physiology Laboratories and Respiratory Care Departments in New York and Florida. Mr. Stenzler has been the principal investigator for two NIH and one DARPA study and has served on the steering committees for randomized controlled trials in High Frequency Ventilation, Inhaled Nitric Oxide and Liquid Ventilation. Mr. Stenzler has also held several academic appointments, including Assistant Professor at the State University of New York at Stonybrook and twelve years at the Graduate School of Adelphi University. He has published numerous papers and abstracts and has been an invited speaker at many national and international congresses. He also holds more than two dozen US patents for various technologies.
Chris Miller, PhD, BA, RT, Founder and Scientific Advisor
Dr. Chris Miller, is a part time, Assistant Professor in the Faculty of Medicine, Respiratory Division with an affiliation in Infectious Diseases at the University of British Columbia, Canada. Dr. Miller has established himself as a pioneer in gaseous nitric oxide technology and therapeutic research. He was the founder of Pulmonox Research and Development Corporation (1993) based on nitric oxide gas as a platform technology. For nearly a decade he was the CEO of Pulmonox Medical Inc. and was responsible for the design of two of the first three FDA approved NO gas delivery devices for humans. He is listed as the inventor of at least eight issued U.S. patents and many more pending patents.
Dr. Miller has a doctorate in experimental medicine and degrees in Health Management and Respiratory Therapy. His Doctoral research evaluated the use of gaseous nitric oxide as antibacterial agent for respiratory tract infections and surface wound infections. In 2007, Miller characterized one of the bactericidal mechanisms of action of NO and identified the effective dose against a wide range of microbes including bacteria, fungi, parasites and viruses (Antimicrobial Agents And Chemotherapy, 2007). He then designed and completed the first in human clinical trial demonstrating that the inhaled NO was safe in healthy adults as a potential inhaled antimicrobial strategy (Journal of Cystic Fibrosis, 2012). As a culmination of Miller’s research, in collaboration with Drs. Doering & Riethmueller (Tubingen University, Germany), they completed the first human trial to study the safety and effect of inhaled NO in eight patients with cystic fibrosis which he presented these breakthrough findings at the 2013 European Cystic Fibrosis Meeting in Lisbon and at the North American Cystic Fibrosis Conference in Atlanta in 2014.
The use of antibiotic and antiviral therapies increases the development of resistance. As a result, public concern has stimulated the search for novel non-specific and non-antibiotic based antimicrobial agents. Dr. Miller’s laboratory (www.iirc.ca/nitric-oxide) has been intensively studying nitric oxide (NO), a naturally occurring nanomolecule in the body, as a first-in-class nitrosylite drug with the potential to be an antimicrobial agent or act as an adjuvant to antibiotics. Dr. Miller with his laboratory team has authored over 40 papers in peer review publications.
Steve Han, Founder and Vice President Engineering
Steve Han brings more than 19 years of product development in medical and consumer products, including respiratory critical care and disposal products, infusion pumps and disposals, handheld insulin delivery systems, sterilization equipment, and 3D rapid prototype printers. He has worked with many medical companies such as CareFusion (formally Cardinal Health), Johnson and Johnson, Abbott Laboratories, and Philips (formally Respironics). Steve has significant experience in the application of FDA, CGMP, GQR, and ISO regulations. He has extensive experience with both R&D, product development, manufacturing, designing equipment and assemblies, as well as injection molding for plastic and silicone. Currently he has 4 released patents and 9 patents pending in medical and consumer products. His area of expertise includes electro-mechanical design, pneumatic and hydraulic systems, and overall mechanical designs with strong background in FEA and CFD analysis. He graduated with Provost Honors at University of California, San Diego with BS in Mechanical Engineering.
Barry Sugarman, Chief Regulatory Officer
Barry Sugarman is a Senior Pharmaceutical Executive with over 32 years of public and private company experience in all aspects of business including domestic and international management, strategic planning, manufacturing, product development, quality control, quality assurance, Good Manufacturing Practices (GMP’s), Good Clinical Practices (GCP’s), Good Laboratory Practices (GLP’s), regulatory affairs operations, engineering, new business development, marketing, and distribution. Experience includes mergers, startups, reorganization, process improvements, and sales management. Licenses: California Board of Pharmacy, Supervisor of Pharmaceutical Manufacturing or Wholesale Operations.
Gerd Doering, Founder (1948-2013)
Gerd Doering, Professor of Medical Microbiology and Hygiene at the University of Tubingen (Germany), studied chemistry at the University of Tubingen obtained a PhD for his work on transition metal complexes in 1978. His post-doctoral ‘habilitation’ thesis published in 1986 dealt with pathogenic mechanisms of P. aeruginosa, their regulation and consequences for inflammation. Gerd was intrigued by observations indicating that P. aeruginosa must be well adapted to hypoxic conditions and in particular in the CF lung. He eventually managed to assemble compelling evidence for the fact that the mucus layer in the CF lung becomes depleted of measurable oxygen and nevertheless supports persistent growth of P. aeruginosa (Worlitzsch et al. J Clin Invest 109: 317–325, 2002). This important work has been cited more than 500 times and has led to further important discoveries. Gerd was involved in the first clinical trial on aerosolized tobramycin to eradicate P. aeruginosa from CF patients’ lungs during the early phase of infection. Virtually as a one-man show, he conducted phase II and phase III studies on the efficacy of a P. aeruginosa flagella vaccine and lately he strongly pursued the concept of using nitric oxide (NO) inhalation therapy in CF patients, to help disperse P. aeruginosa biofilms in the lung.
Gerd Doering was the President of the European Cystic Fibrosis Society from 1998 to 2006, and thereafter until his death on 2 July 2013, after a malignant melanoma had spread to his lung with uncanny speed, the Editor-in-Chief of the Journal of Cystic Fibrosis. During these fifteen years, Gerd organized European Consensus Conferences that resulted in guidelines for the early intervention and prevention of lung disease, clinical trials, and the management of nutrition and infections. The first consensus paper was published in 2000 on the antibiotic therapy against P. aeruginosa in CF.
Gerd Doering was a very creative and inspiring scientist amply reflected by his list of over 200 scientific publications. He was a founding member of Novoteris which was an extension of his interest and efforts to affect the lives of patients with cystic fibrosis. His untimely death left the other members of Novoteris with a real sense of loss but with a greater motivation to see Gerd’s efforts reach it goals.
Founded in 2011, 12th Man Technologies, Inc. is the new home for the former Advanced Technologies Respiratory Team of CareFusion (previously VIASYS Healthcare and Cardinal Health), formed as an independent technology development corporation when that department was closed at CareFusion.
Focusing on the development of innovative medical technology for pulmonary and critical care medicine as well as infectious diseases, this group developed products ranging from small plastic devices to large drug/device development programs. Its unique system of rapid technology development resulted in paradigm shifting designs and significant market success. The regulatory roadmap that 12th Man’s programs has run through included FDA Class I through FDA Class III PMA devices requiring clinical trials, and FDA PMA panel presentations by its members for approval. These experiences included development of devices such as High Frequency Oscillatory Ventilators, SiPAP, and the development of drugs such as Inhaled Nitric Oxide and liquid perfluorocarbon ventilation.
12th Man’s more than 30 years of experience developing medical devices and drug/device technology, plus several decades of clinical experience, give it the unique combination of clinical, engineering and regulatory experience to lay the foundation for its ability to conceive and develop paradigm shifting medical products for its customers. 12th Man is responsible for the development and manufacturing of the high dose inhaled nitric oxide delivery systems that will be used in the Novoteris clinical trials.
Nitric Solutions, Inc.
Nitric Solutions Inc. (NSI) is a privately held research and development corporation, based in Vancouver, Canada, dedicated to developing new therapies and technologies to utilize the beneficial effects of nitric oxide in human and veterinary medicine. NSI was founded in 1993, then known as Pulmonox Research & Development Inc. and became an industry leader by designing and manufacturing bedside nitric oxide gas analysis and delivery equipment.
NSI has built a team with basic and clinical research expertise in the field of nitric oxide chemistry, analytics, cellular biology, immunology and microbiology. The team has developed innovative ways to produce, measure and deliver nitric oxide for the prevention and treatment of infectious diseases. Through collaboration with both academic centers and industry, a broad and far reaching nitric oxide research network has been established. NSI has participated directly in nitric oxide related research throughout North America, Europe, Africa, Central America and Asia. These efforts have resulted in advancement of breakthrough research to answer the challenge of antimicrobial drug resistance for unmet treatment needs and vulnerable populations such as those associated with cystic fibrosis, tuberculosis, influenza, viral bronchiolitis and food chain sustainability.
Diligent in-licensing of patents from entities such as Cardinal Health, filing of new patents and key partnering has established a strong foundation to support commercialization of nitric oxide for multiple disease indications. Market differentiation and protection for a variety of nitric oxide indications to treat diseases is achieved through novel and innovative drug targeting, packaging and delivery methodologies. This strategy provides de-risking of investment resources and accelerates directed drug development efforts for multiple indications in parallel. This approach has already resulted in the successful creation of a number of single asset entities, Novoteris LLC. being one of these.