HepAssure Inc.
HepAssure Inc. is a company whose members consist of a small, private group of healthcare professionals. HepAssure members include: a former FDA General Counsel, a practicing board-certified Gastroenterologist, a practicing Primary Care physician, and a certified Medical Technologist. HepAssure Inc. is dedicated to the clinical validation of nutritional management stretegies and specialized formulas through clinical studies. PathFinder is a dietary supplement containing HepAssure’s patented, clinically-studied formula. HepAssure Inc, has conducted IRB-supervised phase 2 pilot studies with HepAssure members acting as Principal Investigators.
Peter Barton Hutt, is a former FDA General Counsel and leading US attorney of FDA law. Under Mr. Hutt’s guiding hand in the early 1970’s, FDA policy was fundamentally transformed into much of its current modern form. While Mr. Hutt is retired from practicing law at Covington, Burling, he still teaches FDA law at Harvard University, and he is on numerous Boards of Directors, including HepAssure Inc.
During Mr. Hutt’s tenure as Chief Counsel for the Food and Drug Administration, he led the transformation of the agency from outdated law enforcement to modern administrative law. He initially reinterpreted the informal rulemaking authority in the Federal Food, Drug, and Cosmetic Act of 1938 to authorize legally binding substantive regulations in compliance with the Administrative Procedure Act of 1946. Using that newfound authority, he promulgated regulations in almost every area of modern FDA policy.
As a result of all this work he has been called the Father of Modern Food and Drug Law.
Peter Barton Hutt’s full bio is here https://www.cov.com/en/professionals/h/peter-hutt
Dr. Janet Reiser is a practicing Board-Certified Gastroenterologist who practices in Scottsdale Arizona. Dr. Reiser was the principal investigator in HepAssure’s HonorHealth IRB-supervised phase 2 pilot study. Although the study was prematurely discontinued at HepAssure’s request, Dr. Reiser wrote a Case Study about one of the NASH study patients from the study (please the Clinical Studies page). Years ago Dr. Reiser interned with Dr. CS Lieber when he was conducting some of his seminal phosphatidylcholine studies at the Veterans Administration in New York.
Dr. Richard Melde is a practicing Primary Care physician in Wickenburg AZ . Dr. Melde was the prinicipal investigator of HepAssure’s 32-patient phase 2 pilot study (please see the Clinical Studies page). Besides being a physician, Dr. Melde is a graduate of Thunderbird Graduate School of International Management (Glendale, AZ) and has owned and run several succesful healthcare-related businesses in the past.
Michael Hudnall is a Medical Technologist (ASCP, NAACLS), a medical researcher and a nutritional formulator of specific nutritional formulas to address clinical conditions. Mr. Hudnall has a strong science/medical background as well as decades of experience in the Dietary Supplement industry.
