Investors
Investing in the Future of Hearing Therapies
At Gateway Biotechnology, it is our mission to develop drug therapies that will become the standard of care for the estimated 20% of the global population who suffer from tinnitus. That is a staggering 1.57 billion people.
There are currently NO FDA-approved drugs on the market for tinnitus, and available treatments only attempt to help individuals cope with or mask the unwanted sound. Drug treatments address the symptoms commonly associated with tinnitus, such as depression and anxiety.
GW-TT2, the company’s lead drug candidate, is well-positioned to become the first FDA-approved drug therapy to address recent onset tinnitus, affecting 2 million people in the US alone.
To date, Gateway Biotechnology’s research has been funded almost entirely by over a dozen US federal grants and contracts from the National Institutes of Health and the Defense Health Agency. As we rapidly advance to clinical trials, the company is now seeking investor funds to fast-track GW-TT2 development. To learn more about the company, its people, and its pipeline, please click the button below.
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NIHL
The market size for noise-induced hearing loss (NIHL) is not typically reported as a standalone market value, but its economic impact is captured within the much larger global hearing loss disease treatment market and is a significant driver for that market. The overall market for treating hearing loss, which includes devices and drugs for conditions like NIHL and age-related hearing loss, is substantial and growing:2024 Market Size (Estimated): The global market for hearing loss disease treatment was estimated to be around $11.54 billion to $14.43 billion (USD).
Projected Market Size (By 2030-2034): It is projected to grow to figures ranging from $17.51 billion to over $24 billion by 2030 to 2034, with a Compound Annual Growth Rate (CAGR) around 5.2% to 7.3%.
Tinnitus
The global market size for tinnitus management and treatment is a multi-billion-dollar industry. Currently, it is primarily driven by the sales of therapeutic devices since there are no FDA-approved drugs. An independent analysis by Foresight Science and Technology estimated the global tinnitus market at between $16 and $24 billion using both top-down and bottom-up analyses. Gauging the precise market size for recent-onset tinnitus (also known as acute tinnitus) is challenging, as dedicated market research reports for this specific segmentation are unavailable.SSNHL
The market size for SSNHL is tracked by market research firms, often under the name "Acute Sensorineural Hearing Loss Treatment Market." This market is expected to see significant growth due to the medical emergency nature of the condition and the rise in the aging population. Current estimates for a novel SSNHL drug treatment is $1.2 billion globally.Ménière's Disease
The global market size for Meniere's Disease Treatment is experiencing steady growth, driven by the increasing prevalence of inner ear disorders, the aging population, and advancements in treatment modalities. Global market size for Meniere's Disease treatment is approximately $300-$400 million/year. -
Reimbursement for drugs to treat hearing loss or tinnitus is complex, primarily because there are no drugs specifically approved by the U.S. Food and Drug Administration (FDA) to treat chronic sensorineural hearing loss or tinnitus. For hearing loss, original Medicare and many private insurance plans notoriously do not cover hearing aids, often classifying them as "elective" or non-essential devices. Consequently, there are few drugs that would be prescribed solely for this condition that would receive broad coverage. For tinnitus, if drugs are prescribed to treat a diagnosed mental health condition (e.g., anxiety or depression) that is related to or exacerbated by the tinnitus, they are typically covered by Medicare Part D (Prescription Drug Plan) and most private insurance plans under their mental health/prescription drug benefits.
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Hearing Loss
While no specific, definitive peak sales figures are consistently reported for individual, unapproved hearing loss drugs, a successful first-in-class drug to treat the most common form—Sensorineural Hearing Loss—could have peak sales in the multi-billion-dollar range. New drugs for major chronic conditions with large patient populations (like Alzheimer's, or certain autoimmune diseases) often achieve peak sales of $3 billion to over $10 billion annually. Hearing loss is one of the world's most common chronic conditions, affecting over four hundred million people globally. Unaddressed hearing loss costs the global economy an estimated $1 trillion annually. A successful, widely adopted pharmaceutical treatment could disrupt the device market and easily reach the high end of these projections.Tinnitus
The true peak sales figure will depend entirely on a drug's efficacy and its label, but the potential is enormous. The current tinnitus treatment market is dominated by devices (hearing aids, sound maskers) and therapy (CBT), not drugs. Tinnitus is extremely common. In the U.S. alone, an estimated 1 in 10 adults experiences subjective tinnitus, creating a massive potential market for an effective treatment. If a new, first-in-class drug were to be approved that demonstrated clinically meaningful and lasting reduction or elimination of chronic tinnitus, it would be a multi-billion-dollar blockbuster. A drug that provides a significant and reliable reduction in the loudness and annoyance of chronic tinnitus for a significant percentage of patients could easily achieve $1 billion to $3 billion+ in annual peak sales. Tinnitus has an extremely high unmet medical need, and patients are desperate for relief. A breakthrough drug (e.g., gene therapy or regenerative medicine) that cures a specific subset of tinnitus or provides permanent, significant relief for chronic tinnitus would command a premium price and could potentially reach $5 billion or more in annual peak sales, like other major neurological or chronic condition treatments.