Intracochlear access via ultrasharp-microneedles (R42DC021128) – Project Grant to Haystack Medical, Inc.

Abstract: Hearing loss and balance disorders will affect more than 2.5 billion people globally by 2050, yet effective treatments remain limited because the inner ear is both encased in dense bone and protected by the blood- labyrinth barrier. These barriers prevent systemic drugs from reaching therapeutic levels in the cochlea and make direct access unsafe with current tools. As a result, there are no clinically accepted methods to directly sample cochlear fluid or deliver drugs into the inner ear. Haystack medical, a columbia university spin-out, is developing a precision microneedle system to safely perforate the round window membrane (RWM) and provide minimally invasive access to the cochlea. Over the past decade, we have demonstrated in animal models and human temporal bones that ultrasharp, hair-thin microneedles can enable aspiration and injection without anatomic or audiologic harm. In our phase i, we established feasibility of controlled RWM perforation and aspiration in cadaveric temporal bones, providing strong translational evidence. This phase II sttr will conduct the first-in-human clinical trial of microneedle-mediated inner ear access. In aim 1, we will establish the safety of perilymph aspiration in cochlear implant patients, with outcomes including hearing preservation, biomarker yield, and procedural feasibility. In aim 2, we will establish the safety of pressure-neutral, dual-lumen microneedle drug delivery in a parallel patient cohort, using dexamethasone sodium phosphate (DEX-p) as a model therapeutic. Together, these studies will provide the first clinical demonstration of safe, controlled aspiration and injection across the RWM. The expected outcome is proof that microneedle aspiration and injection are safe, feasible, and compatible with surgical workflows, enabling ≥90% procedural success with no significant hearing loss. This will establish a first-in-class platform for both biomarker-driven diagnostics and direct therapeutic delivery. The commercial opportunity is significant: the U.S. Market for devices enabling aspiration and therapeutic injection alone exceeds $3 billion, and the global hearing loss treatment market is projected to surpass $15 billion. Our system will initially target surgical settings and expand to outpatient and office-based use, with partnerships spanning hospitals, otolaryngology clinics, and pharmaceutical companies seeking precise delivery mechanisms. By overcoming the barriers that have historically prevented inner ear access, this technology has the potential to transform hearing and balance care through precision diagnostics and targeted therapeutics.

Intracochlear access via ultrasharp-microneedles

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