What Spiral Therapeutics does

Spiral Therapeutics, Inc. is a clinical-stage biopharmaceutical company headquartered in South San Francisco, California, developing therapeutics for inner ear disorders with an initial focus on Ménière's disease and broader hearing-loss indications. The company's core technology is the proprietary MICS™ (Minimally-Invasive Cochlear System) drug-delivery platform, which combines what the company describes as the world's smallest clinical microendoscope for the ear with sustained-release crosslinking gel formulations to deliver anti-inflammatory, otoprotective, and neuroprotective drugs directly to the round window membrane of the cochlea, achieving an estimated two months of continuous drug exposure from a single administration in a clinic setting. Its lead program, SPT-2101 (a 6% dexamethasone sustained-release formulation), completed a Phase 1b/2a trial in 21 Ménière's disease patients across Australia in September 2024, reporting statistically significant reductions in vertigo frequency and severity (p<0.05), a 78.7% reduction in Definitive Vertigo Days at Month 3 in placebo crossover patients, no serious adverse events, and no negative impact on hearing.

Spiral's pipeline beyond SPT-2101 includes the OTO-510 otoprotectant and OTO-413 sustained-exposure BDNF programs acquired from Otonomy, Inc. in March 2023 alongside OTO-104 (OTIVIDEX) data and patent rights, with the company targeting the 600,000+ US Ménière's disease population and a 40M US hearing-loss treatment-eligible population where, per the company, no FDA-approved drug treatments currently exist. The business model is pre-commercial: Spiral has raised roughly $40M+ in venture capital across multiple rounds (most recently a $27M Series B in April 2026 led by Gund Investment with strategic participation from Advanced Bionics and an unnamed global pharma) and plans future revenue from specialty pharmaceutical sales targeting neurotology/ENT prescribers post-approval, supplemented by potential licensing, royalty, or co-development economics from its strategic R&D collaboration with Advanced Bionics (a Sonova subsidiary) for drug-device bundling with cochlear implant procedures. Go-to-market currently relies on scientific conference participation, KOL engagement, patient advocacy partnerships (VeDA), and press release-driven visibility rather than direct sales.

Name

Spiral Therapeutics

Legal name

Spiral Therapeutics, Inc.

Website

https://spiraltx.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

1–10 employees

Short description

Spiral Therapeutics is a clinical-stage biopharmaceutical company developing minimally invasive, sustained-release drug therapies for inner ear disorders, with a lead program (SPT-2101) targeting Ménière's disease and a proprietary MICS™ delivery platform for broader hearing-loss indications.

Ownership category

akta.pro rank

Product category

Otology Pharmaceuticals — Inner Ear Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Otology & Neurotology (Ear/Hearing/Balance) (HLAKAMAC)

akta.pro secondary industry

General Otolaryngology (ENT) (HLAKAMAA)

Keywords

• Inner ear therapeutics
• Cochlear drug delivery
• Ménière's disease treatment
• Otology pharmaceuticals
• Hearing loss therapeutics

Headquarters

HQ city

San Francisco

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Pre-revenue Clinical Development: Spiral is a clinical-stage biotechnology company with no products currently approved or commercialized. Revenue is not yet generated; future revenue will come from commercialization of SPT-2101 (and broader pipeline) once registrational trials and regulatory approvals are secured for inner ear disorder indications.
2. Future Pharmaceutical Product Sales: Upon approval, SPT-2101 (long-acting dexamethasone for Meniere's disease) is expected to generate specialty pharmaceutical revenue targeting neurotology/ENT prescribers and their patients; broader pipeline (including neurotrophic approaches) will contribute additional product revenue.
3. Strategic R&D Collaboration / Future Co-Commercialization: R&D collaboration with Advanced Bionics (cochlear implant leader) creates a pathway toward joint development of drug-delivery solutions for cochlear implant recipients, which may include future co-commercialization, licensing, or royalty structures.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels5 records

Core offering

Spiral Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of therapeutics for inner ear disorders, anchored by its proprietary MICS™ (Minimally-Invasive Cochlear System) drug delivery platform that enables minimally invasive, precise, and durable delivery of drugs to the cochlea. The lead program, SPT-2101, is a 6% dexamethasone sustained-release gel formulation delivered via MICS™ to the round window membrane for the treatment of Ménière's disease, with a broader pipeline including neurotrophic and otoprotective approaches for hearing loss.

Product overview

Spiral Therapeutics is a clinical-stage biopharmaceutical company offering a platform-plus-candidates product architecture: its core MICS™ (Minimally-Invasive Cochlear System) drug delivery platform underpins a pipeline of inner ear therapeutics. The lead program, SPT-2101, is a sustained-release 6% dexamethasone formulation delivered precisely to the round window membrane via MICS™ for the treatment of Meniere's disease, having demonstrated statistically significant vertigo reduction in Phase 1b/2a and advancing toward a registrational trial. Beyond SPT-2101, the company is advancing neurotrophic hearing loss programs (e.g., neurotrophic approaches targeting fundamental disease pathobiology) and the acquired Otonomy assets OTO-104 (OTIVIDEX), OTO-510, and OTO-413, all leveraging the MICS™ delivery technology. Strategic R&D collaboration with Advanced Bionics extends MICS™ into sustained local drug delivery at the time of cochlear implantation.

Differentiator

Problem solved

Functional benefit

Products and services

• SPT-2101 Clinical-stage lead drug candidate: a sustained-release 6% dexamethasone crosslinking gel formulation designed for precise intratympanic delivery to the round window membrane via Spiral's MICS™ platform to treat Ménière's disease. Demonstrated statistically significant reduction in vertigo frequency and severity in Phase 1b/2a (p<0.05) with no SAEs and no negative impact on hearing.
• OTO-104 (OTIVIDEX) Sustained-exposure formulation of dexamethasone acquired from Otonomy for Ménière's disease. Spiral acquired the data and a right of reference to support SPT-2101's late-stage clinical development and pathway.
• OTO-510 Otoprotectant program acquired from Otonomy, Inc., including patent rights, data, and know-how. Part of Spiral's expanded inner-ear disorders pipeline beyond SPT-2101.
• OTO-413 Sustained-exposure formulation of Brain-Derived Neurotrophic Factor (BDNF) acquired from Otonomy, Inc., along with preclinical and clinical data and inventory. Part of Spiral's neurotrophic approaches to inner-ear disorders.

Quantifiable outcome

• Statistically significant reduction in vertigo frequency and severity in Meniere's disease patients (p<0.05)
• +4 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered flagship strategic partner, patient advocacy partnership and asset acquisition partner (one-time).

• Advanced Bionics (Sonova Group)flagship strategic partnerStrategic or Co-development Partner · 15 April 2026Advanced Bionics (AB), a developer of cochlear implant technology and a subsidiary of Sonova Group, announced an equity investment and R&D collaboration with Spiral Therapeutics. The collaboration will explore integrating Spiral's MICS drug-delivery platform with AB's cochlear implant development to investigate sustained local drug delivery at the time of cochlear implantation. The partnership combines AB's global leadership in cochlear implant technology with Spiral's expertise in novel therapeutics for inner ear disorders, representing an early-stage R&D effort with potential future patient benefits.
• Vestibular Disorders Association (VeDA)patient advocacy partnershipGTM or Marketing Partner · 31 October 2023Spiral entered a strategic partnership with the Vestibular Disorders Association (VeDA) to improve the lives of patients with balance disorders such as Meniere's Disease. The collaboration grants Spiral access to VeDA's Patient Registry on Meniere's patients and facilitates targeted outreach to Meniere's clinicians and patients in the United States and Australia, plus co-developed patient education programs (including placebo-effect education).
• Otonomy, Inc.asset acquisition partner (one-time)Strategic or Co-development Partner · 29 March 2023In March 2023, Spiral acquired selected assets from Otonomy following Otonomy's stockholder-approved dissolution. The transaction included preclinical and clinical data, patent rights, data, know-how, and inventory related to OTO-104 (OTIVIDEX, sustained-exposure dexamethasone), OTO-510 (otoprotectant), and OTO-413 (sustained-exposure BDNF). Spiral also obtained a right of reference to OTO-104 data, leveraging Otonomy's 15 years of inner ear disorder experience to accelerate SPT-2101's path to late-stage trials.

Scale indicators9 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Cochlear Limited: Global cochlear implant market leader and Advanced Bionics' main competitor. Comparable as a hearing-loss treatment incumbent and the most likely alternative bundled-implant-plus-drug partner if Advanced Bionics collaboration does not deliver.
• MED-EL: Global cochlear and hearing implant manufacturer. Comparable to the Advanced Bionics side of Spiral's strategic channel and a potential alternative partner for any drug-delivery-plus-implant therapy.
• Oticon Medical (Demant): Hearing implant business of Demant, a major audiology conglomerate. Comparable to the Advanced Bionics collaboration partner as another large hearing-implant incumbent that could pursue a bundled drug-device model in cochlear implantation.

Direct peers

• Sound Pharmaceuticals: Clinical-stage biopharma developing novel therapeutics (e.g., SPI-1005, SPI-3005) for hearing loss, tinnitus, and ototoxicity. Comparable as an inner-ear-focused small-molecule biotech targeting similar indications with novel drug candidates.
• Frequency Therapeutics: Clinical-stage regenerative medicine company developing therapies for hearing loss (FX-322). Directly comparable in targeting hearing restoration with a novel inner-ear modality and a similar clinical-stage risk/reward profile.
• Otonomy, Inc. (historical): Previously a leading clinical-stage inner-ear therapeutics company (OTO-104, OTO-413) that dissolved in 2023 after a series of clinical setbacks. Spiral acquired its assets and is the de-facto successor; highly comparable historical peer in both technology (sustained-exposure steroid) and indication focus.
• Decibel Therapeutics: Clinical-stage biotech developing therapeutics for hearing loss and inner-ear disorders (gene therapy for OTOF, etc.); historically the most direct peer to Spiral in the inner-ear therapeutic space before being acquired by Regeneron in 2023. Highly comparable therapeutic focus and patient population.
• Pipeline Therapeutics: Clinical-stage biotech developing small-molecule therapeutics for inner-ear disorders including hearing loss and balance disorders. Closely comparable in mechanism (small-molecule inner-ear targeting) and clinical stage to Spiral.

Emerging players

• Acousia Therapeutics: German clinical-stage biotech developing small-molecule therapeutics (e.g., ACOU085) for sensorineural hearing loss and otoprotection. Comparable in therapeutic area and modality, though earlier-stage and with a different delivery approach.

Regional players

• Kyorin Pharmaceutical: Japan-listed specialty pharmaceutical company with a focus on otolaryngology and inner-ear disorders, including Meniere's disease therapies. Comparable as a regional player in the Meniere's therapeutics market that Spiral ultimately targets in the US.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/spiral-therapeutics
• Xx.com/spiraltx

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

Funding overview

Funding rounds6 records

Investors11 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Spiral Therapeutics