Brazos Biomedical (Brazos) is a privately-held Texas-based limited liability corporation led by Kurt Berens and David Foster, PhD, JD. Mr. Berens and Dr. Foster have more that 45 combined years in developing medical products from devices to therapeutics with particular expertise in development, regulatory and intellectual property strategies. Brazos recently acquired the rights to a suite of intellectual property (IP) including two US patents, PCT and two national phase (AU, CA) applications. The Company also has acquired a prototype device based on the IP that will be used to design, construct and mass produce a market image Class II medical device. In June 2018 American Diversified Holdings Corporation (ADHC) acquired the assets associated with this product. Brazos remains a majority-owned subsidiary of ADHC and Brazos will continue to manage product development.
Nearly 50% of adults experience at least one headache annually and up to 4.0% of the global adult population experience recurrent headaches (15 or more days/month). In the Global Burden of Disease Study (2016), migraine headaches alone resulted in 1.3 percent of years lost due to disability (YLD). In the European Union, it has been estimated that the total annual cost associated with headaches is €112 billion. In the United States, the estimated total annual economic burden associated with headaches is reported to be $31 billion.
Over 43 million Americans regularly experience some form of headache pain, including tension-type, migraine (acute and chronic forms) and cluster-type. The most common headaches are tension-type headaches, characterized by diffuse, intense pain on both sides of the head. About 78% of adults experience tension-type headaches at some point in their lives. Chronic daily headaches manifest characteristics of both tension- type and migraine headaches, and occur at least 180 days per year (15 days per month).
Nearly 37 million Americans experience migraine headaches which manifest with throbbing (usually restricted to one side) head pain often concomitant with nausea and photosensitivity. Up to 12 million Americans suffer from chronic migraine headaches. Migraine headache has an estimated global market size of US$3.3 Billion with 70% of sales coming from the US market. The major class of pharmaceuticals sold for treating migraine headaches is the triptans, led by Pfizer’s Relpax® (eletriptan). The market for migraine therapies is expected to increase from $3.3 Billion in 2018 to $8.5 Billion by 2026.
Clearly there remains a substantial, unmet medical need for a simple, effective treatment for headache pain, and this unmet need represents a substantial market opportunity. The management team at BRAZOS believes that AuracisTM will prove to be a disruptive force in this underserved market.
It has been reported that approximately half of people that experience headaches self- treat without consulting a medical professional. Typical self-treatment strategies for headaches involve use of aspirin (acetylsalicylic acid) Tylenol (acetaminophen) or non- steroidal anti-inflammatory medications (ibuprofen, naproxen or indomethacin). Current
pharmacologic intervention for all types of headache includes a wide variety of over-the- counter and prescription medications. Triptans, serotonin (5-HT) antagonists, are the most widely used medications for abortive treatment of migraine headache, and represent almost 80% of antimigraine analgesics prescribed. Non-steroidal anti- inflammatory medications (NSAIDs) have considerable, dose-limiting gastrointestinal side effects, which limit their use in migraine treatment. In cases of severe migraine pain, some patients are administered narcotic analgesics, with a significant addiction risk potential due to the requirement for long term use.
In some case, preventive medications for migraine headache may be given. Prophylactic therapy is sometimes initiated in patients that manifest frequent migraine attacks, or in cases where treatment repeatedly fails or is contraindicated by pre-treatment with beta blockers or anticonvulsants often prescribed for treatment of chronic pain. Amitriptyline, other tricyclic antidepressants, and calcium channel blockers are also used in attempts to prevent migraine.
Due to the frequency of treatment failures and in part due to lack of patient education and misinformation, many alternative therapies are attempted to relieve headache pain. Some of these approaches include the use of herbal and/or homeopathic remedies that are not evidenced based. There are even cooling methods, e.g., the Headache Hat, which provides little or no benefit to the patient.
Non-pharmacologic medical devices are becoming more common within the headache treatment arena. The most successful of these treatments involves surgical implantation of electrodes (subcutaneously in the scalp) to provide a holocephalic, peripheral neurostimulation of the superficial branches of the trigeminal and cervical plexus. Despite the dramatically positive results from this therapy, the high cost ($50,000 per procedure) and invasiveness limit its use. Motivated by the striking efficacy of this method and the need to identify a cost-effective way to deliver this treatment modality, a physician specializing in pain management invented the technology enabling the Company’s lead product AuracisTM. AuracisTM is an external, wearable, headache treatment device that provides neurostimulation of specific regions of the head to prevent the evolution and severity of chronic headaches.
BRAZOS REGULATORY STRATEGY
The existence of predicate devices suggests that BRAZOS will follow a proven regulatory approval pathway for AuracisTM through filing for market clearance using the 510(k) pathway.
Brazos is currently soliciting and evaluating proposals for product development services from some of the most experienced ISO 13485 certified medical design firms in the US. A comprehensive package of full development lifecycle services conducted under FDA- compliant conditions will rapidly advance the AuracisTM prototype to a market image product. A few examples of services include human factors analysis, power
management, system architecture, biocompatibility and verification & validation. Four phases of development are anticipated and the timeline to complete this work is 18-24 months. The Company expects the costs for these contracted services ($1.0-2.0MM) to be recouped rapidly with AuracisTM product sales.
David Foster, Ph.D., J.D.
Dr. Foster has over 20 years of experience in the development and commercialization of healthcare products, including more than 18 years legal experience working as patent counsel in international law firms as well as in-house at Medarex, a biopharmaceutical company acquired by Bristol-Myers Squibb. In addition, David has co-founded multiple biotechnology companies. David currently serves as partner of Roberts Foster LLP, a law firm focusing on emerging technology companies, and on the Board of BioNorthTx, a regional life science trade association he co-founded. Dr. Foster received his BS in Biology from the University of North Texas, his Ph.D. in Cell Regulation from the University of Texas Southwestern Medical Center at Dallas and his JD from Golden Gate University School of Law in San Francisco, CA. Dr. Foster is a member of the patent bar as well as California and Texas state bars.
Kurt L. Berens
Mr. Berens has over twenty-five years of experience in the development and commercialization of biopharmaceutical and medical device products. Mr. Berens has been part of development teams that received registration and marketing approval for two ethical drug products [Argatroban® (US ), Thelin® (EMEA)] and one medical device [Galileo® System centering catheter and intracoronary brachytherapy system]. Mr. Berens has developed novel drug dosage forms and delivery technology for NASA Pharmacotherapeutics Group and served as the Manager for Cellular and Biomedical Section in the Bioastronautics Group at Johnson Space Center in Houston, TX. Mr. Berens served as Senior Project Manager at Texas Biotechnology Corporation and as Vice President, Product Development, at CytoGenix, Inc., (both located in Houston, TX) and is currently Vice President of Tuevol Therapeutics, Inc. Mr. Berens received his BA from the University of Minnesota with post-graduate training in Pharmaceutics at the University of Houston.