Spiral Therapeutics, Inc.

Hugo Peris

Signe R Erickson

Eugene De Juan, Jr

Andrew Ayoob

Vrad Levering

Charles Limb

Eugene De Juan

Kevin W Sacherman

Justin Scot Hanes

Nikhil Talreja

Carmen Herrero

Jr Eugene De Juan

Devices, systems, and methods can be employed to facilitate performing procedures in the outer, middle, and/or inner ear in order to diagnose and/or treat disorders including, but not limited to, hearing loss and other ear disorders. For example, this document describes devices, systems and methods that include instruments and techniques to minimize the invasiveness and/or to enhance the efficacy of procedures that are performed in the outer, middle, and/or inner ear spaces such as mastoidectomy, tympanoplasty, cholesteatoma treatments, otosclerosis treatments, and Eustachian tube treatments.

Devices, systems, and methods for otology

Intra-tympanic injections of therapeutics into the inner ear can be used to treat conditions such as hearing loss. One or more stabilizing devices that define working channels can be temporarily implanted in the tympanic membrane. Purpose-built instruments such as endoscopes, forceps, and injections instruments can be passed through the working channels of the stabilizer devices to access the inner ear where the therapy can be administered. Afterwards, the stabilizing devices can be removed from the tympanic membrane and the tympanic membrane can heal, typically without the need for sutures.

Minimally-invasive tools and methods for accessing the middle and inner ear through the tympanic membrane

A system for delivering one or more therapeutics to a region of the ear, the region being internal to a tympanic membrane. The system includes a canal guide configured to be inserted within and fittingly engaged with walls of the ear canal and needle assembly having a flexible shaft sized to extend through the canal guide. The canal guide provides alignment of the needle assembly within the ear canal relative to the tympanic membrane. The canal guide includes a viewing lumen extending between a proximal end to a distal-most end of the canal guide and is sized to remain external to the tympanic membrane. The canal guide includes a guide lumen extending to a distal opening near the distal-most end of the canal guide. The guide lumen curves from a first axis to a second axis. Related devices, systems, and methods are provided.

Intratympanic injector devices and needles for delivery of drugs and methods of use

An implantable device for delivering a therapeutic agent to treat an ear of a patient includes a body having a distal end region and a proximal end region. The body defines, at least in part, a reservoir configured to contain the therapeutic agent. The device includes a shaft attached to the distal end region of the body and a lumen extending through the shaft having at least one inlet at a proximal end region in fluid communication with the reservoir and at least one outlet at a distal end region. Upon implantation of the body in a region of the ear, a length of the shaft is sufficient to extend from the body to at least the round window membrane of the ear. The device is configured to deliver the therapeutic agent to the ear from the reservoir via passive diffusion. Related devices and methods are described.

Inner ear drug delivery devices and methods of use

Systems and methods can be employed for trans-tympanic membrane access to the middle ear for delivery of a formulation or implant device to a target location under direct visualization. The systems and methods can also be used to improve accessibility and visualization for various otological surgical procedures, such as, but not limited to, cholesteatoma removal, tympanic membrane repair and ossicular chain repair.

Devices, systems, and methods for treating ear disorders

Systems and methods can be employed for trans-tympanic membrane access to the middle ear for delivery of a therapeutic agent, for example, to the round window niche adjacent to the cochlea under direct visualization. The systems and methods can also be used to improve accessibility and visualization for various otological surgical procedures, such as, but not limited to, cholesteatoma removal, tympanic membrane repair and ossicular chain repair.

Systems and methods for treating hearing loss

A formulation for sustained release of an apoptosis inhibitor in the inner ear to protect from hearing loss, especially due to exposure to chemotherapy with drugs such as cisplatin. The formulation can be injected through a small gauge needle into the inner ear, where it gels to form a sustained release depot for controlled delivery of drug over a few days. In the preferred embodiment, the formulation includes a thermoresponsive sol-gel polymer such as POLOXAMER 407 and an apoptosis inhibitory agent, preferably an inhibitor of apoptotic protease activating factor-1 (APAF-1), in an effective amount to prevent hearing loss, for example, due to the administration of platinum-based chemotherapeutic agents. As demonstrated by the examples, the hydrogel provides sustained release of an apoptosis inhibitory agent, LPT99, an anti-apoptosis agent that inhibits apoptotic protease activating factor-1 (APAF-1), as well as safety and efficacy in in vitro and in vivo models.

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Brisbane, CA, United States of America

Hugo Peris