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RayBalance, Inc.

RayBalance is developing a non-invasive, photonic energy treatment to prevent and mitigate chemotherapy and noise-induced hearing loss, supported by robust preclinical data, a protected IP portfolio, and a defined FDA 510(k) De Novo clearance pathway.

San Diego, CA, USA

One Liner

One Liner
RayBalance is developing a non-invasive, photonic energy treatment to prevent and mitigate chemotherapy and noise-induced hearing loss, supported by robust preclinical data, a protected IP portfolio, and a defined FDA 510(k) De Novo clearance pathway.

What Problem We are Solving

Problem
Hearing loss is a global health crisis, affecting approximately 477 million people worldwide and ranking as the fourth leading cause of disability. In the U.S., 48 million people suffer primarily from sensorineural hearing loss, a condition caused by damage to inner ear sensory cells, often resulting from exposure to ototoxic drugs such as chemotherapy agents, elevated noise levels, or aging. Despite its widespread impact, comparable to Type 2 diabetes, there are no FDA-approved treatments that prevent or mitigate adult hearing loss. Current interventions, such as hearing aids, only amplify sound and require functional inner ear cells, failing to address the root cause of hearing damage. 

RayBalance is addressing this critical gap with a novel, non-invasive treatment designed to prevent and mitigate hearing loss in two high-impact areas:

  •  Ototoxic Chemotherapy Hearing Loss: Cisplatin, a widely used chemotherapy drug, results in hearing loss in over 50% of patients, often exceeding 20dB in severity (equivalent to the difference between a whisper at 20dB and normal conversation around 60dB). This can severely impact communication, social interaction, and treatment adherence. RayBalance’s photonic energy treatment targets cellular repair mechanisms to prevent and mitigate cisplatin-induced hearing damage, addressing a significant unmet need in oncology care​ 

  • Occupational Noise-Induced Hearing Loss (NIHL): Approximately 22 million U.S. workers across construction, manufacturing, defense, and public safety sectors face damaging noise exposure, making NIHL the most common occupational injury. Current personal protective equipment (PPE) often falls short in preventing long-term hearing damage. RayBalance’s treatment provides a proactive, non-invasive solution designed to protect workers from NIHL by preventing cellular damage before it occurs, seamlessly integrating into existing safety programs​.

RayBalance’s differentiated approach targets both prevention and treatment, positioning us to fill a significant market void. With a protected intellectual property portfolio, compelling preclinical data, and a clearly defined FDA 510(k) De Novo submission pathway, we are poised to transform the standard of care. Our therapy is uniquely positioned to benefit patients, healthcare systems, and employers by reducing the long-term health and economic burdens associated with hearing loss​.

About Us

About Us
Company Focus:
RayBalance is a clinical-stage healthcare venture advancing from preclinical to clinical studies with a novel, non-invasive photonic energy treatment designed to prevent and mitigate sensorineural hearing loss. Our primary focus is on two critical applications: ototoxic chemotherapy-induced hearing loss and occupational noise exposure-related hearing loss.

Solution:
RayBalance employs a proprietary photonic energy treatment, a non-invasive therapeutic approach already FDA-cleared for other medical applications. Our system includes an earpod-like treatment device, a smartphone app, and a HIPAA-compliant cloud platform for remote treatment monitoring. The therapy stimulates cellular repair and protection processes in the inner ear sensory and supporting cells. The system is designed for ease of use and remote monitoring, making it scalable for both clinical and occupational settings.

Target Market Applications:
Our initial focus is on hearing loss resulting from cisplatin chemotherapy, which affects over 50% of the 925,000 U.S. cancer patients treated annually. These patients frequently experience significant hearing loss (>20dB, with normal conversation around 60dB for context), which can severely impact communication, treatment adherence, and quality of life​.

The second target market is occupational noise exposure, where 22 million U.S. workers across industries like construction, manufacturing, and military face elevated noise levels daily. Noise-induced hearing loss (NIHL) is the most common occupational injury, often exceeding 20dB of impairment. Despite existing PPE, NIHL prevention strategies remain ineffective in many cases. RayBalance offers a proactive treatment that can integrate into existing safety programs, aiming to prevent long-term damage.

Development and Clinical Validation Status:
Our photonic energy treatment has demonstrated approximately a 20dB improvement in preclinical studies involving animal models of both acoustic trauma and cisplatin-induced ototoxicity. RayBalance is advancing into clinical trials, with a pilot study for chemotherapy-induced hearing loss scheduled for Q2 2025 and a pivotal trial completion targeted for Q3 2025. A pilot study for noise-induced hearing loss is scheduled for Q4 2025, with a pivotal trial targeted for completion in Q1 2026​.
 
Regulatory Submission Plans/Status:
A Q-Submission meeting is planned for Q2 2025 to ensure alignment with the FDA on trial design and data requirements. RayBalance plans to pursue a De Novo submission for cisplatin chemotherapy-induced hearing loss, with the first submission projected for Q2 2026 following the completion of the pivotal trial. For noise-induced hearing loss, RayBalance intends to submit a 510(k) application using the cleared chemotherapy treatment as the predicate device, following the completion of its pivotal trial in Q1 2026.​

Risks:
We acknowledge the inherent risks in developing medical technologies, including regulatory hurdles, clinical validation, and competitive market challenges. Our strategy mitigates these risks through a phased clinical development plan, ongoing FDA engagement, strong preclinical data, and a differentiated, IP-protected approach that directly addresses an unmet need​.

Team and Advisors:
Our leadership team has extensive experience in biophotonics, medical device development, clinical trial design, and regulatory strategy, with a collective track record of over 25 FDA clearances. 
Key team members include: 
  • Darrel Drinan, MS | CEO
  • John Black, PhD | CTO
  • Jesse Cole, PhD | V/P Eng.
  • Noam Ziv | System Architect
  • Decky Goodrich | CCO
  • Elvira Cawthon | Director Clinical
Our Scientific and Clinical Advisory Board includes experts in oncology, otolaryngology, neurotology, optical engineering, regulatory affairs, auditory research, and clinical trial design. Their contributions have been instrumental in shaping our clinical protocols, navigating regulatory pathways, and supporting strategic partnerships.

Financial Projections:
RayBalance projects approximately $13 million in revenue by FY4, driven exclusively by the chemotherapy-induced hearing loss application during the initial commercialization phase. This revenue will be generated through a weekly subscription model, charging $300 per patient per week for a 14-week treatment cycle.

By FY5, revenue is projected to grow to approximately $19 million, still primarily from the oncology market, while revenue from noise-induced hearing loss is expected to begin contributing in late FY5 following pivotal trial completion and FDA clearance. The noise market will follow a similar subscription model, charging $50 per employee per week for a 50-week treatment cycle. Gross margins are projected to reach approximately 82%, with annual revenue per oncology patient estimated at $4,000 by FY5​ 


Use of Capital:
The proceeds from this $2M seed round will be allocated to support key development and validation milestones:
  • Product Validation (20%): Completion of MVP1 design and engineering verification.
  • Clinical Milestones (38%): Execution of the pivotal trial for chemotherapy-induced hearing loss, including patient recruitment, trial execution, and data analysis.
  • Regulatory Milestones (2%): FDA Q-Submission meeting in Q2 2025 and preparation for the De Novo submission.
  • Intellectual Property Expansion (4%): Additional patent filings and protection strategies.
  • Commercialization Preparation (36%): Preparation for market entry, including partnership development and pre-commercialization activities with key opinion leaders and hearing protection industry partners​.
 
Additionally, $3.5M in pending NIH and DoD grants will further support clinical validation for both chemotherapy-induced and noise-induced hearing loss applications​.

To date, RayBalance has raised $595K in PreSeed funding through a SAFE round, supporting early development milestones, including preclinical trials and initial device development. The company projects a total capital requirement of $35M in equity and non-dilutive funding to reach positive cash flow by FY5 and is actively engaged with hearing amplification and protection industry leaders for potential co-development and distribution collaborations​

Key Milestones in the Next 18 Months:
  • Completion of initial chemotherapy-induced hearing loss clinical trials.
  • FDA submission for chemotherapy application.
  • Initial market entry in the oncology sector.
  • Initiation of validation studies for occupational noise exposure.
  • Anticipated award of non-dilutive grants from NIH and DoD.
  • Launch of a Series A financing round.

Venture Highlights

Highlights
Over the past 24 months, RayBalance has made substantial progress in advancing its photonic energy treatment for hearing loss prevention and mitigation, focusing on ototoxic chemotherapy-induced hearing loss and occupational noise exposure-related hearing loss. 
 
Key Scientific and Clinical Milestones:
  • Photonic Energy Mechanism of Action: RayBalance has identified a novel cellular mechanism that supports cellular protection and repair in inner ear sensory cells, further strengthening the scientific foundation of its treatment​.
  • Preclinical Validation: Seven preclinical studies have been completed across both indications, confirming effective dosing ranges, safety profiles, and identifying thresholds to avoid potential hair cell damage​.
  • Optical Validation in Product Design: Benchtop optical studies have validated the optical delivery system, confirming it meets required specifications for safe and effective energy delivery​.
  • Clinical Study Design: Comprehensive pilot and pivotal trial designs have been completed for both indications. Chemotherapy hearing loss trials are scheduled for Q2 2025 (pilot) and Q3 2025 (pivotal), with noise-induced hearing loss trials following in Q4 2025 (pilot) and Q1 2026 (pivotal).  

 Intellectual Property and Funding: 
  • Intellectual Property: RayBalance has filed four patent applications, including three U.S. applications and one PCT international filing. These applications cover device design, treatment protocols, and therapeutic methods, with continuation filings underway.
  • Grant Submissions: The company has submitted $3.5M in NIH and DoD grant applications to support continued preclinical and clinical validation efforts​.
  • Fundraising: Successfully raised $595K in a Pre-Seed SAFE round and initiated a $2M-$5M Seed round to support ongoing clinical trials and regulatory milestones​.

Team and Advisory Expertise:
RayBalance’s leadership team has extensive experience, collectively securing over 25 FDA clearances. The Scientific and Clinical Advisory Board includes recognized experts in oncology, otolaryngology, regulatory compliance, and auditory research, contributing to clinical design, regulatory strategies, and industry partnerships. 

Business Model

Business Model
RayBalance has developed treatment device-enabled, service-based business models tailored to the unique needs of both the ototoxic chemotherapy-induced hearing loss and occupational noise-induced hearing loss (NIHL) markets. These models combine a proprietary photonic energy treatment device with a subscription-based service, ensuring ongoing clinical oversight, compliance monitoring, and device support.

Ototoxic Chemotherapy Application: 
RayBalance targets oncology clinics and healthcare systems treating patients undergoing cisplatin chemotherapy through a direct sales model. The service is offered as a weekly subscription priced at $300 per patient per week for 14 to 20 weeks of treatment. It includes pre, peri (during), and post-chemotherapy care, with three 30-minute treatment sessions per week administered either in a clinical setting or at home with remote monitoring to ensure compliance.

This pricing strategy offers a cost-effective alternative compared to sodium thiosulfate, an FDA-approved pediatric treatment priced at approximately $1,800 per week, which requires in-clinic infusion. RayBalance's model balances clinical value and affordability while aligning with reimbursement structures, offering a scalable and patient-centric solution during a critical phase of cancer care​ 

Occupational Noise-Induced Hearing Loss (NIHL) Application:
 RayBalance sells directly to large employers, occupational health groups, and safety organizations in industries with high noise exposure, such as construction, manufacturing, defense, and public safety. This service operates under an annual subscription model priced at $50 per employee per week for up to 50 weeks per year and covers: 
  • Use of the RayBalance treatment device.
  • Regular hearing assessments.
  • System maintenance and updates.
  • Remote compliance monitoring by safety officers and/or audiologists.
This subscription model encourages consistent use of the treatment, which is crucial for hearing loss prevention, while eliminating upfront capital costs for device purchases. This model also accommodates direct-to-consumer and small business sales through an online sales channel, ensuring scalability for smaller employers and individual users seeking hearing protection solutions. 

Summary:  RayBalance’s treatment device-enabled models are designed to ensure accessibility, clinical value, and financial sustainability in both healthcare and occupational settings. These models focus on cost-effective, preventative care while emphasizing patient compliance, remote monitoring, and long-term health impact. 

Competitive Advantage

Quote
RayBalance occupies a unique position in the market by offering a treatment device-enabled, service-based solution targeting both ototoxic chemotherapy-induced hearing loss and occupational noise-induced hearing loss (NIHL). Our competitive advantage stems from a combination of scientific differentiation, a scalable business model, strong intellectual property, and a world-class advisory network, positioning RayBalance for long-term success in the hearing loss market.

Novel Photonic Energy Cellular Response Mechanism of Action:
RayBalance’s proprietary photonic energy treatment activates several novel cellular response mechanisms that supports cellular protection and repair in inner ear sensory cells, which builds on established mitochondrial modulation and oxidative stress reduction pathways. This scientifically validated mechanism contributes to our treatment’s efficacy in preventing and mitigating hearing loss across both clinical and occupational settings​ 

Scalability of Our Treatment System:
 The RayBalance treatment system is designed for scalability across both clinical and occupational environments, featuring:
  • A treatment device designed for easy replication and distribution.
  • A weekly subscription model with predictable, recurring revenue streams.
  • A HIPAA-compliant cloud platform enabling remote compliance monitoring and treatment management.
  • Flexible use cases, supporting at-home, clinic-based, and workplace treatments without compromising quality or oversight​.
This service-based model ensures accessibility while supporting long-term revenue growth in both the oncology and occupational health sectors. 
 
Intellectual Property Strength:
RayBalance maintains a strong intellectual property portfolio with four patent applications (three U.S. and one PCT international filing) covering treatment devices, dosing protocols, and therapeutic methods. Continuation filings are underway to further strengthen market exclusivity​. 

Strong Market Differentiation in Both Target Applications:
   Ototoxic Chemotherapy Market:
  • Direct sales model targeting oncology clinics and healthcare systems.
  • A $300 per patient per week subscription, a cost-effective alternative compared to sodium thiosulfate, which costs approximately $1,800 per week and requires in-clinic infusions.
  • 14 to 20 weeks of treatment covering pre, peri, and post-chemotherapy care.

   Occupational Noise-Induced Hearing Loss Market:
  • Direct sales to large employers, occupational health groups, and safety organizations in industries like construction, manufacturing, defense, and public safety.
  • An annual subscription model priced at $50 per employee per week for up to 50 weeks annually.
  • Designed to integrate into existing PPE programs and reduce hearing-related health and legal risks​.
 
Strategic Collaborations and Exit Potential:
RayBalance is actively pursuing strategic collaborations with oncology clinics, medical device distributors, and occupational health networks to accelerate market entry and broaden distribution channels. Potential acquirers include:
  • Hearing aid manufacturers such as Sonova, GN Store Nord, and WS Audiology.
  • Cochlear implant companies such as Cochlear Ltd., Med-El, and Advanced Bionics.
  • Pharmaceutical and oncology groups seeking adjunct therapies for chemotherapy patients.
  • Occupational PPE manufacturers and worker's compensation insurers.
 
Risk Mitigation Strategy:
RayBalance has proactively addressed development and regulatory risks through:
  • Extensive preclinical validation: Seven preclinical studies have confirmed treatment efficacy and dosing safety.
  • Well-defined regulatory pathway: A De Novo submission is planned for chemotherapy-induced hearing loss following pivotal trials, with a 510(k) for noise-induced hearing loss using the chemotherapy submission as a predicate​.
  • Non-dilutive funding strategies: $3.5M in grant applications submitted to NIH and DoD to reduce financial risk​
 
Experienced Leadership and Scientific Expertise:
RayBalance’s leadership team brings decades of experience in medical device commercialization, regulatory affairs, and clinical development, collectively holding over 25 FDA clearances. The Scientific and Clinical Advisory Board comprises distinguished experts across oncology, otolaryngology, neurotology, auditory research, regulatory affairs, and clinical trial design, ensuring scientific rigor and strategic execution​.
   Key Team Members:
  • Darrel Drinan, MS | CEO
  • John Black, PhD | CTO
  • Jesse Cole, PhD | V/P Eng.
  • Noam Ziv | System Architect
  • Decky Goodrich | CCO
  • Elvira Cawthon | Director Clinical

Our Scientific and Clinical Advisory Board is an additional cornerstone of our competitive positioning. Composed of renowned professionals in fields such as oncology, otolaryngology, neurotology, optical engineering, regulatory compliance, auditory research, and clinical study design, this board has been pivotal in guiding our clinical protocols and regulatory strategies. Their collective wisdom not only enriches our approach but also facilitates access to essential industry networks, further enhancing our competitive standing.
   Key Scientific / Medical Advisors:
  • Hernan Goldsztein, MD | Scripps Clinic / Pacific ENT
  • Lee Schwartzberg, MD, FACP | Renown / One Oncology
  • Todd Austin, MD | Medical Director – Scripps Clinic
  • Andrew Beros, MD | Scripps Clinic (ENT)
  • Claus-Peter Richter, MD, PhD | Northwestern Vice Chair ENT Research
  • Pete Weber, MD, MBA: CMO of Decibel Therapeutics.
  • Naresh Bhavaraju, PhD | SVP Eng. – Biolinq
  • Gunnar Trommer, PhD | Partner / Managing Director BCG X
 
Summary of Competitive Advantage
RayBalance’s treatment device-enabled, service-based approach offers a novel cellular mechanism, a differentiated business model, and a scalable treatment platform backed by strong intellectual property and scientific rigor. Combined with a high-value market opportunity and a clearly defined regulatory pathway, RayBalance is strategically positioned to lead the market in hearing loss prevention and treatment. 

Revenue

Revenue To Date
N/A
MRR
N/A
Revenue YTD
N/A
Burn Rate
$25K

Users

Total Users
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Total Users (Past 30 Days)
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Daily Active Users
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Monthly Active Users
N/A
Total Paying Users
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MoM Growth Users
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Customer Costs

CAC
N/A
LTV
$5K
Churn
N/A
Margins
88%

Go-To Market Strategy

Business Strategy
 RayBalance is strategically positioned to enter two distinct yet underserved markets: ototoxic chemotherapy-induced hearing loss and occupational noise-induced hearing loss (NIHL). Our phased go-to-market approach balances direct sales strategies, regulatory milestones, and partnership development to ensure a successful market launch and sustained growth. While our initial focus is on launching our commercialization efforts in the U.S., we have a vision for international expansion. Through strategic partnerships, we aim to introduce our therapy in the European Union and select Southeast Asian countries, including Singapore, Japan, Australia, and South Korea.

Ototoxic Chemotherapy Market Strategy:

Target Customers:
 RayBalance will target oncology clinics, healthcare systems, and oncologists who treat patients undergoing cisplatin chemotherapy. These customers are motivated by improving patient care while reducing long-term hearing loss impacts.

Incidence and Prevalence: 
  • TAM: 924,000 U.S. patients receiving cisplatin treatment annually, valued at $3.8B.
  • SAM: 714,000 U.S. patients with solid tumors (breast, lung, prostate, ovarian), valued at $3B.
  • SOM: 178,000 U.S. patients (25% of SAM), valued at $750M. 
    • Sources: International Agency for Research on Cancer, WHO​

Service Offering and Pricing: 
  •  Direct sales model with a weekly subscription priced at $300 per patient per week for 14 to 20 weeks.
  • Treatment includes three 30-minute sessions per week administered in-clinic or at home with remote monitoring. . 

Competitor Benchmark:
 A cost-effective alternative to sodium thiosulfate priced at $1,800 per week, which is FDA-approved for pediatric patients only and requires in-clinic infusion. 

Sales and Customer Acquisition Channels: 
  • Direct engagement with oncology KOLs, clinics, and healthcare networks.
  • Educational marketing and participation in oncology conferences.
  • Pilot programs with leading cancer centers to demonstrate clinical impact and build early adoption.
  • Collaboration with oncology care navigation platforms to expand treatment accessibility and referral networks. .

Reimbursement Strategy: 
  • Leveraging existing CPT/HCPCS codes for treatment and monitoring.
  • Targeting regional CMS MAC entities for coverage and billing compatibility.
  • A multi-session treatment model ensures consistent revenue streams while aligning with clinical best practices. 

Occupational Noise-Induced Hearing Loss (NIHL) Market Strategy:

Target Customers:
RayBalance will directly engage large employers, occupational health groups, safety organizations, and workers' compensation insurers in industries with chronic noise exposure risks, such as construction, manufacturing, defense, and public safety. 

Incidence and Prevalence:
  • TAM: 22 million U.S. workers exposed to dangerous noise levels (>85dB), valued at $52.8B.
  • SAM: 2 million workers in high-risk industries using PPE programs, valued at $4.8B.
  • SOM: 464,000 workers (23% of SAM) adopting preventative strategies, valued at $1.1B.
    Sources: U.S. Department of Labor, OSHA, WHO.

Service Offering and Pricing:
  • Annual subscription: $50 per employee per week for up to 50 weeks annually.
  • Service coverage includes:
    • Use of the RayBalance treatment device.
    • Regular hearing assessments and system updates.
    • Remote compliance monitoring by safety officers and/or audiologists.

Sales and Customer Acquisition Channels:
  • Direct sales to large, self-insured employers prioritizing employee health and legal risk reduction.
  • Pilot programs with early adopters in high-risk industries.
  • Strategic partnerships with trade associations, unions, and safety organizations to promote NIHL prevention as part of existing PPE programs.

Who Will Pay for the Service?
The primary payers for the NIHL market include:
  • Self-insured employers seeking to reduce long-term hearing-related liabilities and improve workforce health.
  • Occupational health programs with budgets allocated for employee wellness and risk reduction.
  • Workers' compensation insurers who can offset long-term claim payouts by preventing hearing loss incidents.
  • Direct-to-consumer model: Smaller employers and individual workers will also be able to access the treatment device and service directly through an online sales channel, further expanding market reach.

Regulatory and Clinical Strategy:
  • RayBalance is actively pursuing FDA clearance through a De Novo submission for chemotherapy-induced hearing loss and a 510(k) for NIHL, using the chemotherapy treatment as the predicate device.
  • Clinical trials are designed to validate efficacy and treatment safety, with pilot trials scheduled for Q2 2025 and pivotal trials for Q3 2025 (chemotherapy) and Q4 2025/Q1 2026 (NIHL).
 
Global Expansion Plans:
While initial commercialization will focus on the U.S. market, RayBalance is preparing for international expansion into:
  • Europe (EU markets projected at 1.5x the U.S. TAM).
  • Southeast Asia, including Japan, Singapore, Australia, and South Korea.
    Expansion efforts will be supported through strategic distribution partnerships and additional regulatory submissions.

Long-Term Growth and Strategic Partnerships: 
  • Medical Device Distributors: Partnerships with oncology care navigation providers and hearing aid distributors to expand adoption.
  • Pharmaceutical Companies: Collaborations to integrate hearing preservation strategies alongside cisplatin chemotherapy protocols.
  • Occupational Health Networks: Expanding workplace-based NIHL prevention initiatives with workers' compensation insurers. 

Post-Market Surveillance:
 RayBalance will implement data-driven post-market surveillance to collect real-world feedback, refine treatment protocols, and strengthen reimbursement positioning. .

Summary:
RayBalance’s go-to-market strategy leverages a phased market entry, direct sales models, and strategic partnerships across two underserved market segments: ototoxic chemotherapy-induced hearing loss and occupational noise-induced hearing loss (NIHL).
The treatment device-enabled service model, combined with a clear regulatory pathway and a focus on reimbursement strategies, ensures scalable market penetration with both direct sales and strategic collaborations. RayBalance’s approach is designed for both U.S. commercialization and global expansion through strategic partnerships in Europe and Southeast Asia, positioning the company as a leader in hearing loss prevention and treatment. 

Team

Darrel Drinan
Darrel Drinan

CEO

Competitive Analysis

Competitive Analysys
The hearing loss treatment market is expansive, with established players primarily focusing on symptom management rather than targeting the underlying biological causes of hearing loss. The global hearing aid market is valued at approximately $17 billion and continues to grow due to an aging population and increasing noise exposure​. Similarly, the cochlear implant market is projected to exceed $3 billion by 2030​.

RayBalance differentiates itself from these established markets with a treatment device-enabled, service-based model targeting both ototoxic chemotherapy-induced hearing loss and occupational noise-induced hearing loss (NIHL) using a novel photonic energy treatment aimed at prevention and mitigation. 
 
Ototoxic Hearing Loss:
 
Current Treatment Landscape:
  • Sodium Thiosulfate: FDA-approved for pediatric patients with cancer that cannot metastasize only, with no established efficacy in adult populations.
  • Statins: Under investigation for cisplatin ototoxicity prevention but not FDA-approved.
  • Corticosteroids: Used off-label with limited effectiveness across hearing loss indications.
  • Pharmaceutical Pipelines: Sensorion and Pipeline Therapeutics are in early clinical trials with no approved treatments​.

RayBalance’s Competitive Advantage:
  • Root-Cause Treatment: Unlike symptom-management solutions, RayBalance targets cellular protection and repair using a photonic energy treatment device.
  • Dual Action Approach: Designed for both prevention and mitigation of chemotherapy-induced hearing damage.
  • Cost Efficiency: Compared to $1,800 per week sodium thiosulfate, RayBalance’s treatment is priced at $300 per week with the flexibility for in-clinic or remote treatment.
 
 
Key Differentiators Across Both Markets:
  1. Market Size and Growth Potential:
    • Global Hearing Aid Market: Estimated at $17 billion by 2030​
    • Cochlear Implant Market: Projected to exceed $3 billion​
  2. Scientific Differentiation: RayBalance targets cellular repair mechanisms rather than sound amplification.
  3. Scalable Business Model: Treatment device-enabled service with a recurring subscription revenue model.
  4. Regulatory Progress: Active pursuit of FDA De Novo clearance for ototoxic hearing loss and a 510(k) for NIHL, leveraging the chemotherapy submission as a predicate​
  5. Strong IP Position: Four filed patents (three U.S., one PCT) with continuation filings underway​
  6. Proven Preclinical Efficacy: Seven completed preclinical studies showing 20dB hearing improvement in speech frequency ranges
  
Conclusion:
RayBalance’s treatment device-enabled, service-based model offers a fundamentally differentiated approach compared to the hearing aid and cochlear implant markets. With a novel photonic energy treatment, scalable revenue models, and strong IP protection, RayBalance is uniquely positioned to lead in the prevention and mitigation of ototoxic and noise-induced hearing loss. 

Competitor Website
GN Group www.gn.com
William Demant www.demant.com
Sonova Group (Phonak, Unitron) www.sonova.com

Networking

Networking
We are open to meeting up to grab a coffee, or just to chat. We would really enjoy your feedback and insight into our venture and would be happy to discuss anything that you are currently working on to see if we can be of service!

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Capital

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Name Amount
Amount Left $1,850,000.00
Amount Raised (This Round) $150,000.00
Amount Raise To Date $595K
Investment Type N/A
Type of Raise SAFE or Convertible Note
Valuation
$12M
Preseed
$595K

TAM SAM SOM

TAM
$3.8B
SAM
$3B
SOM
$750M

Business Stage

Business Stage
Mvp Built

Business Type

Business Types
Investor-Backed

Categories

Healthcare