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Respicardia

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uuid0002m4l

Namestring
Respicardia
Legal namestring
ZOLL Respicardia, Inc.
Websiteurl
respicardia.com
Company typeenum
Private
Founded yearint
2006
Descriptiontext

Respicardia, operating as ZOLL Respicardia, Inc., is a Minnetonka, Minnesota-based medical device subsidiary of ZOLL Medical Corporation that develops and commercializes the remedē® System — an implantable Transvenous Phrenic Nerve Stimulation (TPNS) device for treating moderate to severe central sleep apnea (CSA) in adults. The product family (remedē, remedē EL, and remedē EL-X) functions as a diaphragm pacemaker: the implanted device automatically detects apneic events during sleep and stimulates the phrenic nerve to restore normal breathing, distinguishing it from mask-based CPAP therapy. The remedē System is the first FDA-approved non-mask therapy for moderate to severe CSA and has CE Mark approval for the model 1001, with Transvenous Phrenic Nerve Stimulation recommended as a treatment option in the 2025 AASM CSA clinical guidelines.

The company generates revenue primarily through Class III implantable hardware sales to hospitals, supplemented by clinical support, device programming, and follow-up services. Go-to-market follows a traditional medical device enterprise field-sales model targeting hospital-based electrophysiologists, cardiologists, and sleep specialists, with patient demand supported by a 'Find a Doctor' referral tool and patient screener on the remedē website. Respicardia sells to U.S. hospitals broadly, has expanded into selected European markets via CE Mark, and is broadening from academic medical centers into community health systems — Novant Health Forsyth Medical Center becoming the first non-academic U.S. center to offer the therapy. The company was founded in 2006, operates with 11–50 employees, and has raised approximately USD 160M across nine funding rounds (2006–2017) prior to operating as a wholly-owned ZOLL subsidiary.

Short descriptiontext

Respicardia, a ZOLL Medical subsidiary, develops the remedē® System, an FDA-approved implantable phrenic nerve stimulator that treats moderate to severe central sleep apnea in adults, sold to hospitals through electrophysiologists, cardiologists, and sleep specialists.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersMinnetonka, United States
HQ citystring
Minnetonka
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices1 record

Each record includes

City, Country, Type, Description, Source

Keyword5 values
implantable medical devices, sleep apnea treatment, phrenic nerve stimulation, central sleep apnea therapy, cardiac implantable devices
Industry1 code
1Sleep Apnea Therapy Devices (CPAP/APAP/BiPAP/ASV)
CodeHLAHAGAAPrimaryYes
NAICS code1 code
  • Electromedical and Electrotherapeutic Apparatus Manufacturing334510
SIC code1 code
  • Electromedical & Electrotherapeutic Apparatus3845
Product category
Implantable Sleep Apnea Devices
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model2 records
1Implantable Medical Device Sales
TypeHardware Sales
Description

Respicardia generates revenue through the sale of its remedē System implantable devices to hospitals and healthcare providers. The device is implanted surgically, generating one-time revenue per procedure along with associated follow-up services, device maintenance, and periodic adjustments.

novanthealth.org
2Clinical Support and Follow-up Services
TypeProfessional Services
Description

Ongoing clinical support, device programming adjustments, and patient monitoring services associated with the implanted remedē System, creating a recurring service relationship with implanting healthcare providers.

remede.zoll.com
Marketing channels4 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels2 records

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components5 values
Operations, Technology or R&D, Personnel, Marketing or Sales, Infrastructure
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Brand1 of 3 records shown
1rem.edē System
Description

FDA-approved implantable phrenic nerve stimulator for treating moderate to severe central sleep apnea in adults

remede.zoll.com
+2 more records
Core offering1 text field

Respicardia develops and sells the remedē® System, an FDA-approved implantable phrenic nerve stimulator that treats moderate to severe central sleep apnea (CSA) in adult patients. The device uses Transvenous Phrenic Nerve Stimulation (TPNS) to automatically detect breathing pauses during sleep and signal the diaphragm to restore normal breathing, serving as the first non-mask therapy for CSA. The company operates as a division of ZOLL Medical Corporation and sells its Class III implantable devices to hospitals and implanting physicians.

Differentiator
Functional benefit
Problem solved
Product overview1 text field

Respicardia (now a division of ZOLL Medical Corporation) offers the remedē® System family of products—consisting of the remedē® System, remedē® EL System, and remedē® EL-X System—as implantable medical devices for treating central sleep apnea. The remedē® System was the first FDA-approved non-mask therapy for moderate to severe CSA in adults. These devices function as diaphragm pacemakers using transvenous phrenic nerve stimulation (TPNS) to automatically restore normal breathing patterns during sleep.

Product and service1 record
1remedē® System
Scale indicator2 records

Each record includes

Type, Value, Description, Source

Partnership2 partners
Strategic tierCoreTypeStrategic or Co-development Partner
Description

Transvenous Phrenic Nerve Stimulation (TPNS), the technology underlying the remedē System, was recommended as a treatment option in the 2025 AASM CSA guidelines. This guideline inclusion positions TPNS as a clinically validated standard-of-care option and represents a deep strategic endorsement from the leading sleep medicine professional body.

Strategic tierCoreTypeOthers
Description

Respicardia operates as a division and subsidiary of ZOLL Medical Corporation, headquartered in Minnetonka, MN. The remedē System is marketed under the ZOLL Respicardia brand. ZOLL provides corporate infrastructure, distribution scale, and cross-selling opportunities within its broader medical device portfolio.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight6 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Inspire Medical Systems develops the Inspire UAS System, an implantable neurostimulator (hypoglossal nerve stimulation) for obstructive sleep apnea. It is the most direct comparable to Respicardia as a publicly-traded implantable neurostimulator targeting sleep-disordered breathing with a similar hospital-based, specialist-implanted commercial model.

TypeEmerging player
Description

Nyxoah is developing the Genio system, a bilateral hypoglossal nerve stimulator for OSA. It is an emerging neurostimulation peer in the sleep apnea implant space, competing for similar implanting physician specialists and hospital accounts as Respicardia.

TypeBroad incumbent
Description

ResMed is the global market leader in CPAP and sleep-disordered-breathing masks and devices. It competes broadly with Respicardia for sleep apnea patients, particularly as first-line CPAP therapy, and could expand into CSA-specific or implantable offerings over time.

TypeBroad incumbent
Description

Philips Respironics is a major incumbent in sleep apnea and respiratory care, with a broad CPAP and ventilation portfolio. It is the primary alternative to ResMed for first-line CSA treatment and a potential competitor should it move into implantable CSA therapy.

TypeBroad incumbent
Description

LivaNova is a neuromodulation and cardiac surgery company that acquired ImThera Medical, a phrenic nerve stimulation developer for sleep apnea. LivaNova is a broad incumbent peer with direct overlap to Respicardia's phrenic nerve stimulation technology platform.

TypeBroad incumbent
Description

Medtronic is the global leader in implantable neurostimulators (spinal cord, deep brain, sacral) and cardiovascular devices. Its broader neuromodulation and cardiac rhythm management franchises provide comparable technology platforms, and it could enter the CSA neurostimulation market.

TypeEmerging player
Description

Apnimed is developing pharmaceutical (pill-based) therapies for obstructive and central sleep apnea. While non-device, it represents an emerging alternative treatment pathway that competes with Respicardia for the same CSA patient population.

TypeBroad incumbent
Description

Fisher & Paykel Healthcare is a leading respiratory care and sleep apnea equipment manufacturer. It competes with Respicardia indirectly as a CPAP and nasal interface provider and is a relevant comparable for hospital-based respiratory care sales models.

TypeEmerging player
Description

Axonics develops implantable sacral neuromodulation devices for incontinence and overactive bladder. It is an emerging peer in Class III implantable neurostimulators with similar regulatory, manufacturing, and hospital sales dynamics to Respicardia.

TypeOthers
Description

ZOLL Medical, Respicardia's parent company and a subsidiary of Asahi Kasei, manufactures defibrillators, cardiac resuscitation devices, and respiratory care equipment. It is the corporate parent enabling Respicardia's commercialization infrastructure and is relevant for understanding Respicardia's go-to-market leverage.

Market position
Strengths4 records

Each record includes

Headline, Details, Source

Weaknesses4 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Named customers2 records

Each record includes

Name, Industry, Type, Use case, Source, UUID

Segment1 record

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile1 record

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature3 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles4 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
Compliance2 records

Each record includes

Name, Class, Description

Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds9 records

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors11 records

Each record includes

Name, Type, Date of entry, Rounds participated, Website

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

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

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

Respicardia

Implantable Sleep Apnea Devicesrespicardia.com

Respicardia, a ZOLL Medical subsidiary, develops the remedē® System, an FDA-approved implantable phrenic nerve stimulator that treats moderate to severe central sleep apnea in adults, sold to hospitals through electrophysiologists, cardiologists, and sleep specialists.

What Respicardia does

Respicardia, operating as ZOLL Respicardia, Inc., is a Minnetonka, Minnesota-based medical device subsidiary of ZOLL Medical Corporation that develops and commercializes the remedē® System — an implantable Transvenous Phrenic Nerve Stimulation (TPNS) device for treating moderate to severe central sleep apnea (CSA) in adults. The product family (remedē, remedē EL, and remedē EL-X) functions as a diaphragm pacemaker: the implanted device automatically detects apneic events during sleep and stimulates the phrenic nerve to restore normal breathing, distinguishing it from mask-based CPAP therapy. The remedē System is the first FDA-approved non-mask therapy for moderate to severe CSA and has CE Mark approval for the model 1001, with Transvenous Phrenic Nerve Stimulation recommended as a treatment option in the 2025 AASM CSA clinical guidelines.

The company generates revenue primarily through Class III implantable hardware sales to hospitals, supplemented by clinical support, device programming, and follow-up services. Go-to-market follows a traditional medical device enterprise field-sales model targeting hospital-based electrophysiologists, cardiologists, and sleep specialists, with patient demand supported by a 'Find a Doctor' referral tool and patient screener on the remedē website. Respicardia sells to U.S. hospitals broadly, has expanded into selected European markets via CE Mark, and is broadening from academic medical centers into community health systems — Novant Health Forsyth Medical Center becoming the first non-academic U.S. center to offer the therapy. The company was founded in 2006, operates with 11–50 employees, and has raised approximately USD 160M across nine funding rounds (2006–2017) prior to operating as a wholly-owned ZOLL subsidiary.

Respicardia firmographics

Firmographics
Name
Respicardia
Legal name
ZOLL Respicardia, Inc.
Website
https://respicardia.com
Company type
Private
Founded year
2006
Operating status
Operating
Headcount range
11–50 employees
Short description
Respicardia, a ZOLL Medical subsidiary, develops the remedē® System, an FDA-approved implantable phrenic nerve stimulator that treats moderate to severe central sleep apnea in adults, sold to hospitals through electrophysiologists, cardiologists, and sleep specialists.
Ownership category
akta.pro rank

Respicardia industry classification

Industry
Product category
Implantable Sleep Apnea Devices
NAICS
Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
SIC
Electromedical & Electrotherapeutic Apparatus (3845)
akta.pro primary industry
Sleep Apnea Therapy Devices (CPAP/APAP/BiPAP/ASV) (HLAHAGAA)

Keywords

  • Implantable medical devices
  • Sleep apnea treatment
  • Phrenic nerve stimulation
  • Central sleep apnea therapy
  • Cardiac implantable devices

Where Respicardia is headquartered

Location

Headquarters

HQ city
Minnetonka
HQ country
United States
HQ region
North America

Offices1 record

Markets served

Respicardia business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Operations, Technology or R&D, Personnel, Marketing or Sales, Infrastructure

Revenue model

  1. Implantable Medical Device Sales: Respicardia generates revenue through the sale of its remedē System implantable devices to hospitals and healthcare providers. The device is implanted surgically, generating one-time revenue per procedure along with associated follow-up services, device maintenance, and periodic adjustments.
  2. Clinical Support and Follow-up Services: Ongoing clinical support, device programming adjustments, and patient monitoring services associated with the implanted remedē System, creating a recurring service relationship with implanting healthcare providers.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Respicardia product offering

Product offering

Core offering

Respicardia develops and sells the remedē® System, an FDA-approved implantable phrenic nerve stimulator that treats moderate to severe central sleep apnea (CSA) in adult patients. The device uses Transvenous Phrenic Nerve Stimulation (TPNS) to automatically detect breathing pauses during sleep and signal the diaphragm to restore normal breathing, serving as the first non-mask therapy for CSA. The company operates as a division of ZOLL Medical Corporation and sells its Class III implantable devices to hospitals and implanting physicians.

Product overview

Respicardia (now a division of ZOLL Medical Corporation) offers the remedē® System family of products—consisting of the remedē® System, remedē® EL System, and remedē® EL-X System—as implantable medical devices for treating central sleep apnea. The remedē® System was the first FDA-approved non-mask therapy for moderate to severe CSA in adults. These devices function as diaphragm pacemakers using transvenous phrenic nerve stimulation (TPNS) to automatically restore normal breathing patterns during sleep.

Differentiator

Problem solved

Functional benefit

Brands

  • rem.edē System: FDA-approved implantable phrenic nerve stimulator for treating moderate to severe central sleep apnea in adults
  • rem.edē EL System
  • rem.edē EL-X System

Products and services

  • remedē® System

Companies that use Respicardia

Customer profile

Named customers2 records

Segments1 record

Ideal customer profiles1 record

Respicardia technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature3 records

Respicardia partnerships and signals

Strategic signal

Partnerships

Two partnerships are on record, tiered core.

  • American Academy of Sleep Medicine (AASM)coreStrategic or Co-development PartnerTransvenous Phrenic Nerve Stimulation (TPNS), the technology underlying the remedē System, was recommended as a treatment option in the 2025 AASM CSA guidelines. This guideline inclusion positions TPNS as a clinically validated standard-of-care option and represents a deep strategic endorsement from the leading sleep medicine professional body.
  • ZOLL Medical CorporationcoreOthersRespicardia operates as a division and subsidiary of ZOLL Medical Corporation, headquartered in Minnetonka, MN. The remedē System is marketed under the ZOLL Respicardia brand. ZOLL provides corporate infrastructure, distribution scale, and cross-selling opportunities within its broader medical device portfolio.

Scale indicators2 records

Recent moves6 records

Expansion highlights6 records

Respicardia competitors and assessment

Company assessment

Direct peers

  • Inspire Medical Systems: Inspire Medical Systems develops the Inspire UAS System, an implantable neurostimulator (hypoglossal nerve stimulation) for obstructive sleep apnea. It is the most direct comparable to Respicardia as a publicly-traded implantable neurostimulator targeting sleep-disordered breathing with a similar hospital-based, specialist-implanted commercial model.

Emerging players

  • Nyxoah: Nyxoah is developing the Genio system, a bilateral hypoglossal nerve stimulator for OSA. It is an emerging neurostimulation peer in the sleep apnea implant space, competing for similar implanting physician specialists and hospital accounts as Respicardia.
  • Apnimed: Apnimed is developing pharmaceutical (pill-based) therapies for obstructive and central sleep apnea. While non-device, it represents an emerging alternative treatment pathway that competes with Respicardia for the same CSA patient population.
  • Axonics: Axonics develops implantable sacral neuromodulation devices for incontinence and overactive bladder. It is an emerging peer in Class III implantable neurostimulators with similar regulatory, manufacturing, and hospital sales dynamics to Respicardia.

Broad incumbents

  • ResMed: ResMed is the global market leader in CPAP and sleep-disordered-breathing masks and devices. It competes broadly with Respicardia for sleep apnea patients, particularly as first-line CPAP therapy, and could expand into CSA-specific or implantable offerings over time.
  • Koninklijke Philips (Philips Respironics): Philips Respironics is a major incumbent in sleep apnea and respiratory care, with a broad CPAP and ventilation portfolio. It is the primary alternative to ResMed for first-line CSA treatment and a potential competitor should it move into implantable CSA therapy.
  • LivaNova: LivaNova is a neuromodulation and cardiac surgery company that acquired ImThera Medical, a phrenic nerve stimulation developer for sleep apnea. LivaNova is a broad incumbent peer with direct overlap to Respicardia's phrenic nerve stimulation technology platform.
  • Medtronic: Medtronic is the global leader in implantable neurostimulators (spinal cord, deep brain, sacral) and cardiovascular devices. Its broader neuromodulation and cardiac rhythm management franchises provide comparable technology platforms, and it could enter the CSA neurostimulation market.
  • Fisher & Paykel Healthcare: Fisher & Paykel Healthcare is a leading respiratory care and sleep apnea equipment manufacturer. It competes with Respicardia indirectly as a CPAP and nasal interface provider and is a relevant comparable for hospital-based respiratory care sales models.

Others

  • ZOLL Medical Corporation (Asahi Kasei): ZOLL Medical, Respicardia's parent company and a subsidiary of Asahi Kasei, manufactures defibrillators, cardiac resuscitation devices, and respiratory care equipment. It is the corporate parent enabling Respicardia's commercialization infrastructure and is relevant for understanding Respicardia's go-to-market leverage.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Respicardia social profiles

Digital presence

Respicardia compliance and trust

Trust signal

Compliance2 records

Respicardia financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Respicardia leadership team

Management profile

Number of profiles

Profiles4 records

Respicardia funding detail

Funding detail

Funding overview

Funding rounds9 records

Investors11 records

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

Respicardia M&A and investment

M&A and investment

M&A

Investments

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

Frequently asked questions about Respicardia

What does Respicardia do?

Respicardia develops and sells the remedē® System, an FDA-approved implantable phrenic nerve stimulator that treats moderate to severe central sleep apnea (CSA) in adult patients. The device uses Transvenous Phrenic Nerve Stimulation (TPNS) to automatically detect breathing pauses during sleep and signal the diaphragm to restore normal breathing, serving as the first non-mask therapy for CSA. The company operates as a division of ZOLL Medical Corporation and sells its Class III implantable devices to hospitals and implanting physicians.

Is Respicardia a public or private company?

Respicardia is a private company. It is classified as corporate owned and is currently operating.

When was Respicardia founded?

Respicardia was founded in 2006. It employs 11 to 50 people.

Where is Respicardia based?

Respicardia is headquartered in Minnetonka, United States, in the North America region.

How does Respicardia make money?

Two revenue lines are on record. Implantable Medical Device Sales are the primary driver. The others are clinical Support and Follow-up Services.

Who are Respicardia's main competitors?

Inspire Medical Systems is listed as a direct peer. Emerging players are Nyxoah, Apnimed and Axonics. Broad incumbents are ResMed, Koninklijke Philips (Philips Respironics), LivaNova, Medtronic and Fisher & Paykel Healthcare. ZOLL Medical Corporation (Asahi Kasei) is listed as an others.

Does Respicardia have an API?

No public API is recorded for Respicardia.

What industry is Respicardia in?

Respicardia's product category is Implantable Sleep Apnea Devices. Its primary akta.pro industry code is HLAHAGAA, Sleep Apnea Therapy Devices (CPAP/APAP/BiPAP/ASV). Its NAICS code is 334510 and its SIC code is 3845.

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Live signals
NovanthealthImplantable device offers hope and improved quality of life for patients with central sleep apneaDr. Michael Drucker of Novant Health Heart & Vascular Institute completed his 100th implantable device procedure using the remedē® System to treat central sleep apnea at Novant Health Forsyth Medical Center in Winston-Salem, North Carolina. The device, developed by Respicardia Inc., functions like a diaphragm pacemaker, automatically signaling the muscle to resume breathing when pauses occur during sleep. Novant Health Forsyth Medical Center was the first hospital in the Southeast and the first nonacademic medical center in the U.S. to offer this treatment.PR NewswireRespicardia Announces Highmark Coverage for the remedē® System in Patients with Central Sleep ApneaRespicardia announced that Highmark Blue Cross Blue Shield and its affiliates will provide immediate coverage for the company's remedē® System, an implantable therapy for central sleep apnea. This decision expands commercial insurance access to the treatment, bringing the total covered lives under policies including the device to nearly 28 million across the United States.PR NewswireTransvenous phrenic nerve stimulation (The remedē System) shows sustained safety and efficacy through 5 yearsRespicardia has announced 5-year results from the Post Approval Study of its remedē System, an FDA-approved implantable device that uses transvenous phrenic nerve stimulation to treat moderate to severe central sleep apnea. The data, presented at the HFSA 2020 and CHEST 2020 conferences, showed sustained efficacy with a 96% reduction in central apneas, a 22 events/hour reduction in overall AHI, and a 14 events/hour reduction in arousals, alongside consistent safety profiles over five years. The company highlighted these findings as an important milestone demonstrating durable long-term effectiveness for heart failure patients with central sleep apnea, a chronic and progressive condition.GlobeNewswireSleep Apnea Devices Market to Exhibit a CAGR of 6.8% by 2027; Rapid Shift from CPAP Devices to Oral Appliance to Drive Market, states Fortune Business Insights™Fortune Business Insights has published a market research report projecting the global sleep apnea devices market to grow from USD 7.81 billion in 2019 to USD 13.24 billion by 2027, representing a compound annual growth rate (CAGR) of 6.8%. The report attributes growth to rising cases of cardiovascular disorders and diabetes among the geriatric population, a shift from CPAP devices to oral appliances due to patient discomfort, and increasing adoption of telehealth and homecare models amid the COVID-19 pandemic. Notable company-specific developments include Oventus launching telehealth and homecare services for obstructive sleep apnea patients in March 2020, and Respicardia receiving U.S. FDA approval for its remedē System to treat central sleep apnea in October 2017.PR NewswireSleep Apnea Implants Market - Global Industry Analysis and Opportunity Assessment, 2019-2029Reportlinker published a global market study on the sleep apnea implants market covering historical data from 2014-2018 and forecasts through 2029, offering industry analysis and opportunity assessment across product types, indications, end users, and geographic regions. The report provides market value analysis in US$ millions, volume analysis, pricing analysis, and market dynamics including Porter's five forces and value chain analysis. Key market players identified include Inspire Medical Systems, Respicardia, Medtronic Plc, LinguaFlex LLC, Siesta Medical, and Pillar Palatal LLC, with regional coverage spanning North America, Latin America, Europe, East Asia, South Asia, Oceania, and the Middle East & Africa.PR NewswireTreatment Benefits of the remedē® System Sustained Through 36 Months in Patients with Central Sleep ApneaRespicardia, Inc. announced publication of 24- and 36-month data from the remedē® System Pivotal Trial in the peer-reviewed journal SLEEP, demonstrating sustained safety and efficacy of phrenic nerve stimulation for central sleep apnea. The results show a 99% reduction in central apnea index, 93% of patients had reduction in AHI from baseline, and 90% were free from serious adverse events through 24 months, with improvements sustained at 36 months. The company also announced initiation of the rēST Study, a multi-center prospective study enrolling approximately 500 patients in the United States and Europe, with first enrollments on July 9, 2019 at Novant Health Forsyth Medical Center.PR NewswireCMS Grants Outpatient Pass-through Payment to the remedē® System for the Treatment of Central Sleep ApneaCMS has approved an outpatient Transitional Pass-through Payment for Respicardia's remedē System, an implantable phrenic nerve stimulation device that treats central sleep apnea. The payment, effective January 1, 2019, will provide hospitals with additional reimbursement for outpatient procedures, following an earlier inpatient New Technology Add-on Payment granted in August. Respicardia's CEO stated that CMS again recognized the system as a substantial clinical improvement, extending supplemental reimbursement coverage to the majority of procedures performed in the outpatient setting.PR NewswireRespicardia Announces First U.S. Commercial Case With The remedē® SystemRespicardia, Inc. announced the completion of the first U.S. commercial case using its FDA-approved remedē System to treat central sleep apnea, performed at The Ohio State University Wexner Medical Center by Dr. Ralph Augostini. The company also appointed Peter Sommerness, a former Boston Scientific executive with 20 years of medical device experience, as its new CEO to lead the U.S. commercial launch. The remedē System, which received FDA approval in October 2017, uses transvenous neurostimulation to stimulate the phrenic nerve and restore normal breathing patterns in adult patients with moderate to severe central sleep apnea.PR NewswireRespicardia Closes $58.5 Million In Financing To Treat Central Sleep ApneaRespicardia has closed a $58.5 million financing round led by ZOLL Medical Corporation to support the commercialization and development of its remedē System for treating central sleep apnea. The proceeds will fund U.S. market release efforts for the FDA-approved implantable neurostimulation device, which received approval in October 2017.PR NewswireRespicardia's remedē® System Receives FDA ApprovalRespicardia, Inc. announced that its remedē System received U.S. Food and Drug Administration (FDA) approval for the treatment of moderate to severe central sleep apnea in adult patients. The approval is based on pivotal trial data showing significant reduction in apnea severity and high patient satisfaction rates. The company plans an initial limited release followed by broader market commercialization.