AffloVest

What AffloVest does

AffloVest is a U.S.-based prescription medical device brand — operated as a product line of privately held Tactile Medical (Tactile Systems Technology Inc., headquartered at 3701 Wayzata Blvd, Suite 300, Minneapolis, MN) — that manufactures and distributes a portable, battery-operated high-frequency chest wall oscillation (HFCWO) therapy vest. Its proprietary Direct Dynamic Oscillation™ technology uses eight mechanical oscillating motors to deliver percussion, vibration, and drainage modes that mobilize pulmonary secretions across all lung lobes. The device is FDA 510(k) cleared, weighs 4.3-7.8 lbs in its 6th generation (2023), is offered in five sizes from pediatric (6 months) to adult XL, and supports Bluetooth/Wi-Fi-based treatment tracking via a companion mobile app.

The business model is hardware sales through an authorized network of U.S. Durable Medical Equipment (DME) and Home Medical Equipment (HME) retailers, with all prescriptions reimbursable under HCPCS code E0483 through Medicare, Medicaid, private insurance, and the U.S. Department of Veterans Affairs/Tricare. A complementary managed-services revenue stream comes from the INSIGHT platform, which gives DME distributors API and portal access to adherence data and payer reporting tools. The customer base is fragmented across individual patients with three primary conditions: bronchiectasis, cystic fibrosis, and neuromuscular diseases (with secondary use in COPD-bronchiectasis overlap patients). Demand generation is supported by the IMPACT program — non-branded educational resources developed with multidisciplinary HCPs — and clinical evidence campaigns citing 93% patient preference and 54.4% reduction in annualized respiratory hospitalizations. The company has accumulated a 10,000+ installed clinical base since its 2013 introduction.

Name

AffloVest

Legal name

Tactile Systems Technology Inc.

Website

https://afflovest.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

AffloVest is a U.S. medical device brand (under Tactile Medical) that manufactures and distributes the portable, battery-operated AffloVest HFCWO therapy vest using patented Direct Dynamic Oscillation™ technology for airway clearance in patients with bronchiectasis, cystic fibrosis, and neuromuscular diseases, sold via DME distributors under HCPCS code E0483.

Ownership category

akta.pro rank

Product category

Respiratory Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Chest Physiotherapy & Airway Clearance Devices (PEP, Oscillatory PEP, HFCWO, Cough Assist) (HLAHAGAJ)

akta.pro secondary industries

Respiratory & Sleep Therapy Equipment (Oxygen, CPAP/BiPAP, Nebulizers) (HSABAKAD), Home Ventilation, Oxygen Therapy & Respiratory DME Clinical Management (HLAKANAM)

Keywords

• Airway clearance therapy
• HFCWO therapy vest
• Respiratory medical devices
• Bronchiectasis treatment
• Cystic fibrosis therapy

Headquarters

HQ city

Austin

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales through DME Distributors: AffloVest is sold through Durable Medical Equipment (DME) and Home Medical Equipment (HME) retailers to patients with valid prescriptions. The device is reimbursed under HCPCS code E0483 for High Frequency Chest Wall Oscillation through Medicare, Medicaid, private health insurance, and U.S. Department of Veterans Affairs/Tricare.
2. INSIGHT Care Navigation Platform: Platform for DME distributors to manage patient communication and engagement, with treatment data available through INSIGHT API or portal for tracking adherence and supporting payer requirements.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels8 records

Core offering

AffloVest manufactures and sells a portable, battery-operated high-frequency chest wall oscillation (HFCWO) therapy vest that delivers airway clearance therapy for patients with chronic respiratory conditions including bronchiectasis, cystic fibrosis, and neuromuscular diseases. The vest uses patented Direct Dynamic Oscillation™ technology with eight oscillating motors to mobilize lung secretions and is distributed through Durable Medical Equipment (DME) providers under physician prescription. The device is FDA 510(k) cleared and reimbursed by Medicare, Medicaid, private insurance, and VA/Tricare under HCPCS code E0483.

Product overview

AffloVest is a medical device company offering a portfolio of respiratory therapy products centered around its core AffloVest HFCWO (High Frequency Chest Wall Oscillation) therapy vest. The flagship AffloVest product is a portable, battery-operated vest that provides airway clearance therapy for patients with bronchiectasis, cystic fibrosis, and neuromuscular diseases. The portfolio includes the 6th generation AffloVest device, the AffloVest companion mobile app for Bluetooth/Wi-Fi connected treatment tracking, the INSIGHT platform for clinical data management and payer reporting, and the IMPACT educational program for patient airway clearance therapy education. The AffloVest uses proprietary Direct Dynamic Oscillation technology with eight oscillating motors and is distinguished by its mobility during use, unlike traditional compressor-based HFCWO vests.

Differentiator

Problem solved

Functional benefit

Brands

• AffloVest: Mobile high-frequency chest wall oscillation (HFCWO) therapy vest designed to provide patients freedom and mobility, help mobilize lung secretions, and promote treatment adherence for patients with bronchiectasis, cystic fibrosis, and neuromuscular diseases.
• AffloVest App
• INSIGHT Care Navigation
• IMPACT (Individual Management of Patient Airway Clearance Therapy)

Products and services

• AffloVest HFCWO Therapy Vest A portable, battery-operated high-frequency chest wall oscillation (HFCWO) therapy vest using patented Direct Dynamic Oscillation technology with eight oscillating motors to mobilize lung secretions in patients with bronchiectasis, cystic fibrosis, and neuromuscular diseases. Available in five sizes (XS–XL) covering pediatric (6 months) through geriatric patients, with three therapy modes (Percussion, Vibration, Drainage) and three intensity levels. Prescribed by physicians and dispensed through DME/HME distributors under HCPCS code E0483.
• AffloVest 6th Generation The latest generation of the AffloVest HFCWO therapy vest featuring improved portability (4.3-7.8 lbs, up to 15% lighter than the prior version), enhanced adjustability with new shoulder/side straps and large buckles, improved controller navigation, and built-in Bluetooth and Wi-Fi connectivity for digital engagement and treatment tracking via the AffloVest mobile app.
• AffloVest Mobile App A companion mobile application for iOS 18+ and Android 14+ that connects to the AffloVest controller via Bluetooth and Wi-Fi, automatically recording treatment data including session length, mode, number of treatments, and intensity to help patients track therapy progress and feel more confident discussing therapy with their care team.
• INSIGHT Care Navigation Platform A care navigation and data management platform for DME distributors and clinicians that provides treatment data through INSIGHT API or portal access, enabling tracking of patient adherence and supporting payer requirements for respiratory care coordination.

Quantifiable outcome

• 93% overall preference for AffloVest over bladder-style vests (Wetherby et al., RT Magazine, May/June 2023)
• +6 more outcomes

Named customers9 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

Feature6 records

Partnerships

Three partnerships are on record, tiered core and minor.

• IMPACT Program - Healthcare Professional PartnerscoreStrategic or Co-development PartnerThe Individual Management of Patient Airway Clearance Therapy (IMPACT) Program was created in close collaboration with a multidisciplinary team of physicians and other healthcare professionals. The program develops non-branded educational resources for bronchiectasis care teams across the country for use with patients new to airway clearance or those considering different options. The IMPACT program is informed by evidence-based approaches and best practices from across the pulmonary care category.
• BreatheStrong+minorGTM or Marketing PartnerPartnership with BreatheStrong+ for product giveaways to support patients with cystic fibrosis. BreatheStrong+ is an organization focused on supporting the CF community.
• Independence-U (Independence Plus, Inc.)minorStrategic or Co-development PartnerNon-profit research section of Independence Plus, Inc. that conducted the Inception Study on 3 months of AffloVest use with two 17-year-old female cystic fibrosis patients, measuring FEV1, CPF, and RV improvements.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Hill-Rom (Bates Group): Hill-Rom's The Vest System is one of the longest-standing HFCWO products and a primary competitor. Hill-Rom is a broad medical-technology incumbent with a much larger portfolio, deeper hospital relationships, and longer clinician tenure, but offers a tethered, generator-based HFCWO vest in the same airway clearance category.
• ResMed: Global leader in sleep and respiratory care (CPAP, ventilation). Although not an HFCWO competitor, ResMed is the dominant respiratory DME brand and shapes payer and clinician expectations around digital connectivity and adherence-tracking — capabilities AffloVest is now layering in.
• Inogen: US DME-channel respiratory company primarily known for portable oxygen concentrators. Comparable as a prescription-based respiratory DME business model that sells through DME distributors and relies on Medicare/HCPCS reimbursement, though serving oxygen rather than airway clearance.
• Vyaire Medical: Global respiratory care company offering ventilation, airway clearance adjuncts, and pulmonary diagnostics. Relevant as a broad incumbent adjacent to the HFCWO category though it does not field a direct HFCWO vest equivalent.

Direct peers

• Philips RespirTech: Philips-owned RespirTech offers the InCourage airway clearance system, the most established HFCWO competitor. Like AffloVest, it targets bronchiectasis, CF, and neuromuscular patients and sells via prescription through DME channels under HCPCS E0483.
• Electromed: Electromed manufactures the SmartVest, a directly competing HFCWO airway clearance vest system. Both companies target the same clinical indications (bronchiectasis, CF, neuromuscular disease), use the same HCPCS E0483 reimbursement code, and sell through DME distributors in the US market.

Others

• Cigna / Evernorth: Major US payer covering HCPCS E0483 reimbursement for HFCWO therapy. Listed as an ecosystem/OTHERS peer because payer coverage policies materially shape AffloVest's commercial environment.
• Tactile Systems Technology (Tactile Medical): Tactile Medical is the parent entity operating the AffloVest product line and also runs other at-home therapy businesses (e.g., lymphedema). Included as an ecosystem participant given its corporate parent role over AffloVest.

Emerging players

• Monaghan Medical: Monaghan Medical offers handheld airway clearance devices (Acapella, Aerobika) that compete with HFCWO vests for the same patient populations but at lower price points and via different reimbursement codes. They represent an alternative modality rather than a direct HFCWO substitute.

Regional players

• Löwenstein Medical: European respiratory device manufacturer offering airway clearance and ventilation products. Comparable product overlap with AffloVest but primarily serves EMEA, providing an international analog rather than a US-market competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UC5rwXZ7bPQ0js-_mPdVn33Q
• Facebookfacebook.com/AffloVest
• LinkedInlinkedin.com/company/afflovest
• Xx.com/afflovest

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

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 AffloVest