What Passy-Muir does

Passy-Muir, Inc. is a privately held medical device company headquartered in Irvine, California, founded in 1984 by David Muir — a quadriplegic patient with muscular dystrophy who invented the original bias-closed position no-leak speaking valve — together with Patricia Passy. The company's core technology is a family of Tracheostomy and Ventilator Swallowing and Speaking Valves (PMV) that, when placed on the hub of a tracheostomy tube or in-line with a ventilator circuit, redirect exhaled air through the vocal folds, mouth, and nose to restore voice and speech while delivering secondary clinical benefits such as improved swallowing, secretion management, and support for ventilator weaning and decannulation. The product portfolio comprises five valve models (PMV 2001 Purple, PMV 007 Aqua, PMV 2000 Clear, PMV 005 White, PMV 2020 for metal tracheostomy tubes), a suite of adapters and accessories (PMA 2000 oxygen adapter, PMV AD22 flexible silicone adapter, PMV Secure-It, PM-APF15 viral/bacterial filter, PM-HME heat moisture exchanger, DigiSil finger-occlusion adapter), educational tools (Tracheostomy T.O.M., Pocket T.O.M., Pediatric Airway Model, Toby Tracheasaurus activity book, Toby Tracheapuppet), and the TRACHTOOLS mobile app. All valves are manufactured in a US cleanroom using certified medical-grade non-latex materials, are sold as prescription devices, and carry ISO 13485:2016 certification and CE Marking of Conformance.

Revenue is generated through three streams: hardware sales of prescription speaking valves and accessories to hospitals, rehabilitation centers, long-term acute care facilities, and patients via medical-supply channels; direct e-commerce sales of educational products to clinicians and patients through store.passy-muir.com; and a professional-services stream from paid in-person seminars ($149-$199 per attendee), 3-hour workshops, and free CEU self-study webinars hosted through the company's education portal. Go-to-market is sales-led and event-driven, executed by clinical education specialists (respiratory therapists and speech-language pathologists including VP of Clinical Education & Research Dr. Kristin King and Director of Clinical Education-Respiratory Mike Harrell) who conduct facility in-services, remote live webinars, and full-day seminars. International distribution is handled through a network of resellers supported by a localized Spanish-language portal. The company has no institutional investors, no parent company, and no disclosed M&A activity, operating as a bootstrapped specialty manufacturer with 11-50 employees.

Name

Passy-Muir

Legal name

Passy-Muir, Inc.

Website

https://passy-muir.com

Company type

Private

Founded year

1984

Operating status

Operating

Headcount range

11–50 employees

Short description

Passy-Muir is a privately held medical device company that designs, manufactures, and sells patented bias-closed no-leak speaking valves and accessories for tracheostomy and ventilator-dependent patients. Founded in 1984 and headquartered in Irvine, California, the firm sells prescription devices, educational tools, and clinical training to hospitals, rehabilitation facilities, and clinicians worldwide.

Ownership category

akta.pro rank

Product category

Tracheostomy & Ventilator Speaking Valves

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Airway Management Devices (ET Tubes, LMAs, Tracheostomy, Suction) (HLAHAGAF)

akta.pro secondary industries

Noninvasive Ventilation Interfaces & Consumables (Masks, Tubing, Humidifiers, Filters) (HLAHAGAG), Anesthesia & Respiratory Gas Delivery Equipment (Breathing Circuits, Vaporizers, Gas Mixers) (HLAHAGAK)

Keywords

• Tracheostomy speaking valves
• Ventilator swallowing solutions
• Medical device accessories
• Airway protection filters
• Clinical education courses

Headquarters

HQ city

Irving

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Passy Muir Valves are prescription medical devices sold to healthcare facilities and patients through medical supply channels. All valves are made in the USA using medical-grade, non-latex materials. Revenue is generated through product orders from hospitals, clinics, and patients with tracheostomies.
2. Educational Products: Sale of educational tools including Tracheostomy T.O.M. models, Pocket T.O.M., Tracheostomy P.A.M. pediatric models, Toby Tracheapuppet plush toys, Toby Tracheasaurus coloring books, and Patient Education Handouts. These products support clinician and patient education.
3. Continuing Education Courses: Most self-study webinars and Remote Live In-Services are free. Revenue is generated through 3-hour workshops (fee varies) and full-day in-person seminars ($149 early bird, $199 regular registration). CEU credits offered for ASHA, AARC, and California Board of Registered Nursing.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels8 records

Core offering

Passy-Muir designs, manufactures, and sells a portfolio of patented Tracheostomy & Ventilator Swallowing and Speaking Valves (PMV 2001, PMV 007, PMV 2000, PMV 005, PMV 2020) that redirect exhaled airflow through the vocal folds to enable voice production for tracheostomy and ventilator-dependent patients. The company also sells supporting accessories (oxygen and step-down adapters, Secure-It retention device, airway protection filter, heat moisture exchanger), educational anatomical models and patient/pediatric education materials, and the TRACHTOOLS mobile app, complemented by free CEU courses and paid seminars/workshops for respiratory therapists, speech-language pathologists, nurses, and physicians.

Product overview

Passy-Muir is a medical device company offering a portfolio of Tracheostomy & Ventilator Swallowing and Speaking Valves (PMV) along with accessories and educational products. The core product line consists of five speaking valve models: PMV 2001 (Purple Color), PMV 007 (Aqua Color), PMV 2000 (Clear), PMV 005 (White), and PMV 2020 (Clear), each designed for specific clinical applications including attachment to standard tracheostomy tube hubs and inline ventilator use. Supporting accessories include oxygen adapters (PMA 2000), adapter kits (PMA 2020-S, PMV AD1522, PMV AD22, PM-DB15), the Secure-It retention device, DigiSil finger occlusion adapter, PM-APF15 viral/bacterial filter, and PM-HME heat moisture exchanger. Educational products include anatomical models (Tracheostomy T.O.M., Pocket T.O.M., Tracheostomy P.A.M. for pediatric use), Toby Tracheasaurus activity materials (coloring book, Toby Tracheapuppet), and patient education handouts in English and Spanish. The digital offering includes the TRACHTOOLS mobile app for patient communication. All valves are prescription devices, latex free, and manufactured in the USA.

Differentiator

Problem solved

Functional benefit

Brands

• Passy Muir Valves: Tracheostomy & Ventilator Swallowing and Speaking Valves including PMV 2001, PMV 007, PMV 2000, PMV 005, PMV 2020
• TRACHTOOLS
• Tracheostomy T.O.M.
• Toby Tracheasaurus
• Toby Tracheapuppet

Products and services

• PMV 2001 (Purple Color) Tracheostomy & Ventilator Speaking Valve Flaghip 15mm I.D., 23mm O.D. bias-closed position no-leak speaking valve that attaches to a standard 15mm tracheostomy tube hub. Low profile and lightweight with Secure-It connection to prevent loss; supports supplemental low-flow oxygen via PMA 2000 adapter and ventilator connection via PMV AD22 adapter. Intended for tracheostomy and ventilator-dependent adult and pediatric patients assessed by a healthcare professional.
• PMV 007 (Aqua Color) Tracheostomy & Ventilator Speaking Valve 15mm I.D., 22mm O.D. speaking valve designed for insertion into standard disposable tubing in a ventilator circuit. Aqua-colored for identification; can be attached to a standard 15mm tracheostomy tube hub or connected to in-line suction systems through a step-down adapter; for use on or off the ventilator.
• PMV 2000 (Clear) Tracheostomy & Ventilator Speaking Valve 15mm I.D., 23mm O.D. clear-material speaking valve that attaches to a standard 15mm tracheostomy tube hub. Lightweight, low profile, supports supplemental low-flow oxygen delivery via PMA 2000 adapter.
• PMV 005 (White) Tracheostomy & Ventilator Speaking Valve 15mm I.D., 23mm O.D. white speaking valve that attaches to a standard 15mm tracheostomy tube hub or connects to a ventilator via PMV AD22 adapter.
• PMV 2020 (Clear) Tracheostomy Speaking Valve for Metal Tubes 15mm I.D., 23mm O.D. clear speaking valve designed to attach to metal Jackson Improved tracheostomy tubes (sizes 4 or 5 equivalent) via PMA 2020-S adapter. Not for in-line use with mechanical ventilator.
• PMA 2000 O2 Adapter Small, lightweight adapter that snaps onto PMV 2000 and PMV 2001 to deliver low-flow supplemental oxygen (up to 6L/min) to the face of the Passy Muir Valve for portable oxygen delivery.
• PMV Secure-It Retention Device Connects PMV 2000, PMV 2001, and PMV 2020 to the tracheostomy tie to help prevent valve loss; package of 5 replacement units.
• PMV AD22 Flexible Silicone Adapter Flexible silicone adapter for use within ventilator circuits; color-coded for use with PMV 2001 (Purple Color), also compatible with PMV 2000 and PMV 005; stretches to fit 22mm.
• PM-APF15 Airway Protection Filter Non-sterile, lightweight, single-patient-use viral and bacterial airway filter for non-mechanically ventilated tracheostomy patients; provides >99.9% bacterial and viral filtration efficiency and >99% airborne particulate filtration.
• PM-HME Heat Moisture Exchanger Non-sterile, lightweight, single-patient-use device for warming and humidifying inhaled gases for spontaneously breathing tracheostomy patients.
• Tracheostomy T.O.M. (Tracheostomy Observation Model) Portable, durable polyurethane model depicting midsagittal view of adult head and neck anatomy with tracheostomy. Includes demonstration valves, cuffed tracheostomy tube, and syringe for clinician and patient education and practice.
• Pocket T.O.M. Portable tracheostomy observation model small enough to fit in a lab coat pocket, demonstrating tracheostomy placement and complications; latex-free ABS plastic with antimicrobial finish.
• Tracheostomy P.A.M. (Pediatric Airway Model) Pediatric airway model for educating on tracheostomy and Passy Muir Valve application in children; includes demonstration valves, cuffed tracheostomy tube, nasogastric tube, and accessories.
• Toby Tracheasaurus Coloring & Activity Book 28-page coloring and activity book with Toby mazes, dinosaur connect the dots, vocalization exercises, and coloring pages of Toby and friends; paperback and free PDF download.
• Toby Tracheapuppet Plush therapy toy featuring a pediatric tracheostomy tube and Passy Muir Valve for demonstration and education; available as therapist kit (with removable valve) and caregiver kit.
• Patient Education Handouts Tear-off sheets (33 per pad) illustrating head and neck anatomy with tracheostomy placement and airflow with/without the Passy Muir Valve, including clinical benefits, application instructions, and space for notes; English and Spanish versions available.
• TRACHTOOLS Mobile App Tracheostomy patient-friendly mobile communication app featuring an intuitive menu, user-defined voice options, pre-recorded phrases in English and Spanish, custom phrase recording, patient videos, and easy access to resources; available on iOS and Android.
• Passy Muir Continuing Education Courses, Seminars, and Workshops Clinical education programs delivered as free CEU self-study webinars, fee-based 3-hour virtual workshops, and full-day in-person seminars (e.g., $149-$199), with CEU credits for ASHA, AARC, and California Board of Registered Nursing; taught by clinical specialists and supplemented by remote live in-services and the Passy Muir Podcast.

Quantifiable outcome

• Patient spoke for first time in two years after receiving in-line speaking valve
• +1 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators2 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Atos Medical: Atos Medical (Coloplast) specializes in voice and pulmonary rehabilitation, including Provox voice prostheses and tracheostomy/ventilator accessories. It is a direct peer in restoring speech and pulmonary rehabilitation for trach and laryngectomy patients.
• Insight Medical Products: Insight Medical Products develops and distributes specialty respiratory and airway products, including alternative speaking valves and tracheostomy accessories that compete with Passy-Muir for hospital and home-care trach patient prescriptions.
• Boston Medical Products: Boston Medical Products supplies tracheostomy tubes, voice prostheses, and airway accessories, overlapping with Passy-Muir in the speaking valve and trach accessories space for head and neck and ventilator-dependent patients.
• TRACOE Medical: TRACOE Medical is a German specialist manufacturer of tracheostomy tubes and accessories, including speaking valves. It is a direct competitor to Passy-Muir in the bias-closed speaking valve and trach consumables category, particularly in Europe.
• Fahl Medizintechnik: Fahl Medizintechnik is a German manufacturer of tracheostomy and laryngectomy products, including speaking valves. It is a direct peer offering comparable speaking valve and tracheostomy consumable products to the same clinical end markets as Passy-Muir.

Broad incumbents

• Medtronic (Airway & Ventilation): Medtronic's Patient Monitoring & Respiratory Interventions business serves ventilated and trach patients with circuits, filters, and HMEs. It is a broad incumbent with overlapping consumables (HME, bacterial/viral filters) that compete with Passy-Muir's PM-HME and PM-APF15.
• Smiths Medical (ICU Medical): Smiths Medical (now part of ICU Medical) offers Portex tracheostomy tubes and a range of airway management accessories. It is a broad incumbent competing in the same trach/airway ecosystem where Passy-Muir's speaking valves are prescribed, often bundled with the underlying tube.
• Teleflex Incorporated: Teleflex is a major airway management player (LMA, Rusch, ISO-Gard) with a global footprint. Its bundled trach and airway portfolios overlap with Passy-Muir at the bedside and compete for hospital formulary slots where speaking valves are also prescribed.
• Fisher & Paykel Healthcare: Fisher & Paykel Healthcare is a global leader in respiratory humidification and heated wire circuits, with HMEs and filters used in ventilated and trach patients. It competes directly with Passy-Muir's PM-HME and PM-APF15 in the consumables layer around the trach/vent circuit.

Emerging players

• Pulmodyne: Pulmodyne (an O2 Concepts company) develops specialty airway and respiratory products including speaking valve-adjacent technologies for trach and ventilated patients. It is an emerging player with overlapping technology and clinical positioning to Passy-Muir's speaking valves and accessories.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/PassyMuir
• YouTubeyoutube.com/channel/UCrJ_BmcqlCosF1heNCiLWKg
• Facebookfacebook.com/passymuir
• Instagraminstagram.com/passymuir
• LinkedInlinkedin.com/company/passy-muir

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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 Passy-Muir