bioAffinity Technologies relies on an expert team of advisors who support all aspects of Company development. This experienced group works with bioAffinity executives and researchers to advance CyPath® and ensure a quicker, compliant and most successful result for its cancer diagnostic products to enter a global market.
Greenleaf Health, LLC
Greenleaf Health LLC is a full-service regulatory consulting firm that provides strategic guidance to FDA-regulated companies that are developing innovative solutions to pressing public health challenges. bioAffinity Technologies is among a select group of clients in the healthcare sector seeking to advance breakthrough technologies that make a difference in the medical field. Daniel Schultz, MD, a former Director of the FDA’s Center for Devices and Radiological Health (CDRH), leads Greenleaf’s Medical Devices and Combination Products team. Together, these experts provide bioAffinity Technologies with strategic guidance on regulatory issues including pre-market review, product lifecycle management, manufacturing and compliance, and marketing and promotional practices within a rapidly changing regulatory environment.
Peacock Myers, P.C.
Peacock Myers, P.C. has served as intellectual property counsel to bioAffinity Technologies since the Company’s incorporation. The law firm has helped build bioAffinity’s strong U.S. and international patent portfolio in 20 countries, including the U.S., EU, Canada, Australia, Japan, Mexico, China and Japan. Collaboration with the law firm has led to 40 awarded patents and seven patents pending, with enforceable rights extending to 2030. bioAffinity’s patent counsel, Janeen Vilven-Doggett, Ph.D., brings a scientific background to her practice of law, guiding innovative products to the marketplace by protecting proprietary technologies. Peacock Myers’ broad base of global connections has helped bioAffinity secure patent protection in all major markets.
bioAffinity Technologies works with Emergo, a global medical device consulting group with experience and access to the 24 largest medical device markets in the world, to advance the global commercialization of the Company’s technologies. Emergo provides strategic advice to ensure that CyPath® moves smoothly through global device registration, quality management system compliance, in-country regulatory representation, and reimbursement issues in all markets and countries.
Hyman, Phelps & McNamara, P.C.
Hyman, Phelps & McNamara is the largest dedicated FDA practice law firm in the country. Founded in 1980, the firm was named the top FDA law firm by US News and World Report three years in a row. In its medical devices and diagnostics practice area, Hyman, Phelps & McNamara helps clients understand all aspects of FDA’s regulation of medical device development, approval, clearance, manufacturing, post-market requirements, and marketing. The firm works collaboratively with physicians and consultants to provide targeted medical and scientific expertise to help accomplish the regulatory goals of its clients.
Founded in 2000 by Madeleine Lemieux, Ph.D., Bioinfo specializes in high-throughput data analysis, mining, integration and visualization. Bioinfo provides bioAffinity Technologies with key insights and analysis of data and clinical results to advance the development and commercialization of the Company’s CyPath® test. Dr. Lemieux combines her training in computer science and stem cell biology to provide bioinformatics consulting services to clients. She works closely with the scientists at bioAffinity and The UT Health Science Center to better focus research on the CyPath® assay and support its commercialization.
Dykema Cox Smith
Dykema is a leading national law firm serving business entities worldwide on a wide range of issues. Wilhelm Liebmann is bioAffinity’s external corporate counsel. Mr. Liebmann advises public and private companies on mergers and acquisitions, public offerings, private placements, joint ventures, and general corporate and partnership matters. He also counsels companies on corporate governance, financial reporting and disclosure, and SEC compliance issues. He is the leader of the firm’s Corporate Finance Practice Group in the Business Services Department. He represents clients in a variety of industries and has extensive experience working with government regulators to assist clients in structuring transactions in regulated industries.
JR Associates Reimbursement Consultants
JR Associates provides reimbursement services to medical technology companies. Led by founder and President Judy Rosenbloom and Vice President Jo Ellen Slurzberg, JR Associates applies its extensive knowledge of medical technology reimbursement requirements to provide bioAffinity Technologies with strategic analysis, planning, positioning and support for product reimbursement in the U.S. market. JR Associates’ world-class team of professionals is assessing the reimbursement environment for the CyPath® assay and creating the roadmap for optimal acceptance and insurance reimbursement from early concept testing through product commercialization. The JR Associates team has extensive experience in the diagnostic and medical device fields and brings its years of experience in the complex world of reimbursement to position bioAffinity Technologies to succeed in a rapidly changing market.