Collaboration companies

Avanti Polar Lipids (Alabaster, Alabama).

Avanti is a world-renowned US company, located in Alabama founded by Walter Shaw in 1967. It has a GMP setup that has worked very well with Noveratech for the past decade in developing sterile, endotoxin-free, bioactive VitaSol^TM for incorporation into the prototype packaged product for testing in human trials during FDA phases of approval. A team of 6–8 persons at Avanti will work with Noveratech. We are in the process of requesting an audit of the GMP capacity to manufacture VitaSol^TM in preparation for pre-IND meeting with the FDA.

Hexakit (Edmond, OK).

Hexakit, Inc., is an Oklahoma-based biopharmaceutical company engaged in early-stage research and development of drugs and diagnostic agents for cardiovascular, oncologic, and neurologic diseases. Hexakit integrates social responsibility in its business operations, while maintaining that its primary societal role is to produce innovative medicines, services, and solutions in a profitable, sustainable, and ethical manner. Hexakit follows the principle of justice and well‑being, so that drugs and services created by its efforts are equitably available. The company already has a drug in clinical trial and will work

together with Noveratech toward commercialization.

Comparative Bioscience Inc (CBI, Sunnyvale, CA)

CBI is a preclinical contract research organization with preclinical safety assessment with almost two decades of experience in comprehensive drug development and toxicology services. They have eight individuals with doctoral degrees, two board certified pathologists, a laboratory animal veterinarian and two ophthalmologists. They also have a full time, independent quality assurance unit. All this provides state of the art toxicology, pharmacokinetics, pharmacology, and efficacy studies, particularly in the areas of wound healing, repair and dermal burns. We have been working together for several years and they provide GLP-certified reports designed for FDA-approval.

Investable (Salt Lake City, UT).

Investable has expertise in growing and enabling small businesses that have funded their research and development through SBIR funding. The company aids businesses in preparing to receive private and pharma investments from angel investors and in forming partnerships with big pharma companies with interest in taking products being developed by Noveratech to market. A team of 4–5 persons will be involved with Noveratech.

Scientific advisory board

Bradon Wilhelmi, MD., Chief, Division of Plastic Surgery, University of Louisville, School of Medicine. Dr. Wilhelmi has been working at the University for more than two decades and has performed numerous surgical procedures, including wound care and tissue restoration. He provides every patient and family with the most accurate medical information in a fashion that is understandable, reduces anxiety, and provides a clear path toward treatment and recovery. His practice style incorporates a model of care that uses a collaborative team approach to meet the medical, surgical, and psychosocial needs of our patients and families. Dr. Wilhelmi will play a major role in scientific guidance on the dressing development.

Susan Galandiuk, MD, Susan Galandiuk, MD, is Professor of Surgery & Director, Division of Colorectal Surgery at the University of Louisville School of Medicine. Dr. Galandiuk is Director of the Price Institute of Surgical Research a Center of the University of Louisville, and Editor in Chief, of the Journal Diseases of the Colon and Rectum. As a physician, she strives to provide her patients with the best medical care available today. As a researcher, she improves the quality of life for patients and future generations at risk of developing colorectal cancer by engaging medical students, graduate students and fellow surgeons in the search to find ways to manage it better, cure it faster, and most importantly to prevent it altogether. Dr. Galandiuk will play a major role in the integrity of our project.

Hiram Polk, MD, Professor of Surgery, University of Louisville. Dr. Polk is known for his pioneering research on proper surgical antibiotic use to reduce surgical site infections and on burn care, concepts in treatment of malignant melanoma, surgical oncology, hiatal hernia treatment, and trauma surgery and systems development, and he has made many contributions in the development of contemporary surgical training methods and models. He served as the Ben A. Reid Professor and Chairman of Surgery at the University of Louisville from 1971–2005. Since 1963, he has authored or co-authored over 450 papers and journal articles, 152 textbook chapters, and 11 books. He is still actively involved in various research projects and in teaching residents. Dr. Polk will play a major role in scientific integrity of our project.

Timothy Ford, MD, Is an Associate Professor in the Department of Orthopaedics University of Louisville.  Dr. Ford is a board-certified podiatric surgeon and the Director of the Podiatric Medicine &  Surgery Residency Program as well as the Director of the Reconstructive Foot/Ankle and Limb Salvage Fellowship at University of Louisville. He is the Medical Director of UofL Health’s Wound Care Center and treats multiple diabetic patients daily with various modalities with none being highly effective for DFUs. Dr. Ford will provide scientific advice for our project.

Sri Prakash L. Mokshagundam, MD, Chief of Endocrinology, University of Louisville, School of Medicine. Dr. Mokshagundam is an endocrinologist in Louisville, Kentucky, and is affiliated with multiple hospitals in the area. He has been in practice for more than 20 years. He has many years of experience in treating disorders of the hormone-secreting glands that regulate countless body functions. These ailments include diabetes, thyroid ailments, metabolic and nutritional disorders, pituitary diseases, and menstrual and sexual problems. Because the DFU is not a local disease, its treatment involves a whole-body view and management. He has provided our group with multiple developmental suggestions for dressing development.

Arash Tirgan, MD, MBA. Dr. Tirgan began his career in health care while studying to qualify as a podiatrist, but he then transferred to University of Medicine and Health Science medical school, where he was a student of Microbiology, Immunology, and Biochemistry 8 years ago. In addition to obtaining his MD degree, he also received an MBA and is currently accepted to do his residency in Family Medicine in Southern Ohio, at a driving distance from downtown Louisville. He will be an important resource in providing a unique perspective from both clinical and business side of podiatric disease conditions.

Business Advisory Board

Vibhudutta Awasthi PhD., Founder and CEO, Hexakit, Edmond, OK. Dr. Awasthi has special expertise in liposome manufacturing in aseptic manner, with over 25 years of relevant experience. His company, Hexakit, Inc., is involved in a clinical project with University of Texas for manufacturing a liposome product for radiotherapy of glioblastoma tumor. He also has pharmaceutical industry experience and knows the regulatory process and DMF records leading up to IND application. He will provide guidance in both scientific and financial aspects toward clinical trial and commercialization.

Arash Tirgan, MD, MBA. Dr. Tirgan began his career in health care while studying to qualify as a podiatrist, but he then transferred to University of Medicine and Health Science medical school, where he was a student of Microbiology, Immunology, and Biochemistry 8 years ago. In addition to obtaining his MD degree, he also received an MBA and is currently accepted to do his residency in Family Medicine in Southern Ohio, at a driving distance from downtown Louisville. He will be an important resource in providing a unique perspective from both clinical and business side of podiatric disease conditions.

Maria Labreaux, PhD., Executive Director, Kentucky Science and Engineering Foundation (KSEF), Kentucky. Dr. Labreaux joined KSEF in February 2007 as program manager. She currently serves as the Executive Director for the foundation and is a member of Kentucky Science and Technology Corporation (KSTC)’s senior team leads. She has served as Executive-In-Residence for SBIR/STTR graduate companies seeking private capital and venture financing. Over the years, she has worked with more than 100 research entrepreneurs in universities and small businesses throughout Kentucky, supporting technology development and commercialization beyond the walls of the university. Through KSEF, she designed an array of SBIR/STTR advocacy and support mechanisms that transformed the state’s perception of the program. She has provided continuous help to Noveratech toward commercialization and financial stability with her expertise and she will do the same for this project.

Mahendra Jain, PhD. Dr. Jain is an accomplished executive with technical background and extensive experience in creating and leading new R&D and commercialization activities, in intellectual property development, and in nurturing start-ups through several federal and state programs including the SBIR/STTR Program. As Director of Applied Biocatalysis at MBI International in Lansing, Michigan, he directed advanced research and development of technologies in several areas using various microorganisms including aerobes, anaerobes, extremophiles and archaebacteria, and developed intellectual property. Some of the technologies developed by him were transferred to industries for commercialization. Dr. Jain has worked in the U.S., Europe, and Asia to support innovation and entrepreneurship. As the Founding Executive Director of Kentucky Science and Engineering Foundation (KSEF) since 2001 and as Senior Vice President of Kentucky Science and Technology Corporation (KSTC), Dr. Jain has made major contributions to the support, success, growth and sustainability of Kentucky’s entrepreneurial community.  KSEF and the Kentucky Commercialization Fund that he administered at KSTC facilitated innovations and provided opportunities to translate these innovations into potential technologies for commercialization with opportunity to create new start-ups. Under Dr. Jain’s leadership, Kentucky rose to a position of national prominence in SBIR/STTR support programs (e.g., Phase Zero and Phase Double Zero grant programs, Kentucky Matching Funds Program, proposal development workshops, annual SBIR/STTR conferences, and SBIR Connect) that he created and administered with funding from the Commonwealth of Kentucky Cabinet for Economic Development. He has been a consultant to national and international small and large businesses and organizations for projects under the United Nations Development Program, Food and Agriculture Organization and the Organization of American States.  This has helped him in forging partnerships between academic, industrial and other organizations for building and expanding efforts towards commercialization. Signifying best in SBIR at the national level, Dr. Jain was awarded the prestigious Tibbetts award in 2006 and recognized as SBIR Person of the Year 2014. Further, he was honored with a Small Business Advocacy Lifetime Achievement Award in 2017 from the Small Business Technology Council of the National Small Business Association. At the local level, he was recipient of the 2017 Harvey Award from SPARK, a Bluegrass Business Development Partnership (BBDP) initiative.  Since early 2017, however, he chose to remain an independent professional advising small businesses about business plans, moving technologies from bench to commercialization-ready stage, identification of intellectual property, product validation, technology-transfer/commercialization, innovation and entrepreneurship, and GRASS certification. He will continue to provide directions to Noveratech, in moving its technology toward commercialization and getting it investment ready.

Joseph Wyse, PhD. President, Wyse Innovations, LLC, Lexington, KY. Dr. Wyse offers an outstanding blend of executive experience across the life sciences and pharma industries with success overhauling and building pharmaceutical manufacturing operations, driving products through to FDA approval, leading due diligence process on multimillion-dollar deals, and building teams, processes, and operations from the ground up. He has the ability to step into any operation and define needed action plans and roadmaps for progress and innovation. He has experience deconstructing problems, conceptualizing solutions, and providing synergistic answers to complex business demands and client needs. Skillfully blends intellectual curiosity and business acumen to deliver increased business and product gains while facilitating a vision for the future. He has secured engagements with clients that included Humed Technologies, Bluegrass Advanced Materials, Naprogenix, Alcomed, Aruna Biosciences, GLP Neuroscience Center, Twin Star TDS, and Bexion Pharmaceuticals, with over $2.5M in revenue gained. He will guide Noveratech towards obtaining FDA approval and collaborations with larger pharma companies as well as private funding. 

Kelby Price, BS. Executive Director of Venture Finance at KSTC, and manages investments for the Kentucky Enterprise Fund. He is active in supporting Kentucky’s tech economy, startups, capital formation, and corporate connections to innovation. Before joining KSTC he served as a consultant with Chrysalis Ventures in Louisville, KY, and a partner and cofounder in multiple technology companies. He will provide expertise and guidance towards business development and capital financing for Noveratech.