Enterra Medical

What Enterra Medical does

Enterra Medical, Inc. is a privately held, Minnesota-incorporated medical device manufacturer that was formed in 2022 to commercialize the Enterra Therapy System — an implanted neurostimulator originally developed by Medtronic and authorized by the FDA under a Humanitarian Device Exemption in 2000 for chronic, drug-resistant nausea and vomiting associated with gastroparesis of diabetic or idiopathic origin in patients aged 18 to 70. The core technology is Gastric Electrical Stimulation (GES): the Enterra II Neurostimulator (Model 37800) — a 45-gram implantable pulse generator approximately 60 × 55 × 11.4 mm containing a non-rechargeable battery — delivers mild electrical pulses through leads to the stomach muscle, with therapy parameters tuned non-invasively by a clinician programmer. The product portfolio was extended in January 2026 with Enterra ReliaStim, an FDA-approved next-generation stimulation lead with expanded suture holes, opaque fixation disc, precision insertion needle, and silver-core conductor. The device received FDA MR Conditional approval in March 2024, enabling MRI under specified conditions, and is CE Marked for European markets.

The company reaches patients and clinicians through a hybrid GTM: a network of more than 250 US implant centers staffed by trained GI specialists and implanter physicians is the primary enterprise sales channel, supplemented by direct-to-consumer infrastructure including a Candidate Screener tool, Patient Liaison phone support, and a Patient Ambassador peer-to-peer program. Target customers are adult gastroparesis patients unresponsive to pharmacologic and dietary management and the referring/implanting physicians (gastroenterologists and surgeons) who prescribe and place the device. Therapy economics are structured around one-time hardware sales of the neurostimulator and lead system to providers, with a recurring replacement-revenue tail driven by the non-rechargeable battery, and the company actively supports prior authorization for insurer reimbursement.

Enterra Medical operates from a headquarters in St. Louis Park, Minnesota, employs 11-50 people, and maintains a European Authorized Representative in Arnhem, Netherlands, with localized websites serving the United States, United Kingdom, Germany, and France. Beyond the current HDE label, the company is pursuing label expansion via the NAVIGATE IDE study (FDA Breakthrough Device designation, enrollment of 148+ subjects), targeting chronic nausea patients with normal gastric emptying, which represents a meaningfully broader addressable population than gastroparesis of diabetic or idiopathic origin.

Name

Enterra Medical

Legal name

Enterra Medical, Inc.

Website

https://enterramedical.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

11–50 employees

Short description

Enterra Medical, Inc. is a privately held Minnesota-based medical device company that manufactures the Enterra Therapy System, an FDA Humanitarian Device Exemption-authorized Gastric Electrical Stimulation neurostimulator for drug-resistant chronic nausea and vomiting in gastroparesis patients aged 18 to 70, sold through a network of 250-plus US implant centers and three European markets.

Ownership category

akta.pro rank

Product category

Implantable Neurostimulators

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)

akta.pro secondary industry

General Gastroenterology (HLAKAEAA)

Keywords

• Gastric electrical stimulation
• Implantable neurostimulator devices
• Gastroparesis treatment systems
• Medical device manufacturing
• Neurostimulation therapy

Headquarters

HQ city

Minneapolis

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Implantable Medical Device Sales: Sale of Enterra Therapy System components including neurostimulator and leads to healthcare providers and implant centers. The device is surgically implanted and requires battery replacement through additional procedures.
2. Healthcare Provider Support Services: Supporting healthcare providers with training, educational resources, prior authorization assistance, and clinical resources for patient selection and referral.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

Enterra Medical manufactures and markets the Enterra Therapy System, an implanted neurostimulator (Enterra II, Model 37800) and lead system that delivers mild electrical pulses to the stomach muscles to treat chronic, drug-resistant nausea and vomiting associated with gastroparesis caused by diabetes or unknown origin in patients aged 18-70. The portfolio includes the Enterra II Neurostimulator, the Enterra ReliaStim stimulation lead, and an external clinician programmer that allows physicians to non-invasively adjust stimulation levels. The company also provides patient education, ambassador support, and healthcare provider training resources.

Product overview

Enterra Medical offers a focused portfolio of medical device products centered on Gastric Electrical Stimulation (GES) therapy for gastroparesis. The core offering is the Enterra Therapy System, which comprises the Enterra II Neurostimulator (Model 37800) and leads, used together with an external clinician programmer. The company recently launched the Enterra ReliaStim stimulation lead (January 2026) as an enhanced lead option. Patient-facing tools include a candidate screener, find-a-provider locator, and Patient Ambassador peer support program. The therapy is authorized by FDA under Humanitarian Device Exemption and CE marked for international markets.

Differentiator

Problem solved

Functional benefit

Brands

• Enterra ReliaStim: FDA-approved stimulation lead designed to make Gastric Electrical Stimulation (GES) lead placement more precise, consistent, and efficient. Features expanded suture holes, opaque fixation disc, precision insertion needle, and silver core conductor.

Products and services

• Enterra Therapy System An implanted medical device system providing gastric electrical stimulation (GES) to treat chronic, drug-resistant nausea and vomiting associated with gastroparesis caused by diabetes or unknown origin in patients aged 18 to 70. The system comprises an implantable neurostimulator, leads placed in the stomach, and an external clinician programmer. Authorized by FDA under Humanitarian Device Exemption (HDE) since 2000.
• Enterra II Neurostimulator (Model 37800) The implantable pulse generator component of the Enterra Therapy System. Measures 2.4 inches (60mm) long, 2.2 inches (55mm) high, 0.5 inches (11.4mm) thick and weighs 1.6 ounces (45 grams). Contains a non-rechargeable battery and a battery indicator for device replacement timing. Delivers mild electrical pulses through leads to stimulate stomach muscles.
• Enterra ReliaStim Stimulation Lead FDA-approved next-generation stimulation lead for gastric electrical stimulation. Features expanded suture holes (2.5x), an opaque fixation disc for enhanced visibility, a precision insertion needle, and a silver core conductor engineered to reduce electrical impedance — designed to make GES lead placement more precise, consistent, and efficient.
• Enterra External Clinician Programmer Handheld external programming device used by physicians to non-invasively adjust the neurostimulator settings, enabling optimization of stimulation levels for individual patients without requiring additional surgery.

Quantifiable outcome

• 87% patient satisfaction at 1 year with Enterra Therapy
• +2 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• MedtroniccoreStrategic or Co-development Partner · 1 January 2022Enterra Therapy was originally developed by Medtronic and approved by FDA in 2000 under a Humanitarian Device Exemption. Enterra Medical was formed in 2022 to focus exclusively on Enterra Therapy, while Medtronic continues to be an important partner. This spinoff allowed the new company to dedicate resources specifically to advancing gastric electrical stimulation therapy.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Nevro: Sells implanted spinal cord stimulators for chronic pain, running an enterprise field-sales model through pain-specialty implanters. Strongly comparable in commercial motion (specialty implant centers, prior authorization, MR-conditional product evolution).
• Axonics: Markets implanted sacral neuromodulation devices for bladder and bowel dysfunction. Operates with a similar model — implanted neurostimulator + leads, specialty implanting physicians, prior-authorization-dependent reimbursement, and ongoing device/lead iteration.
• Inspire Medical Systems: Sells an implanted neurostimulator (hypoglossal nerve stimulation) for obstructive sleep apnea through a specialty center network with prior-authorization-driven reimbursement — directly analogous to Enterra's model of an implanted neurostimulator for a chronic condition, distributed through trained centers and supported by patient-liaison infrastructure.

Emerging players

• Saluda Medical: Emerging implanted spinal cord stimulation company with closed-loop/feedback technology. Comparable as a smaller, innovation-driven neuromodulation pure-play competing against larger incumbents with next-generation lead/IP platforms.
• Nalu Medical: Markets a miniaturized, battery-free implanted peripheral nerve stimulation system. Comparable as a smaller neuromodulation pure-play focused on smaller-format, easier-to-implant next-generation hardware — analogous to Enterra's ReliaStim lead miniaturization/ease-of-use thesis.
• ElectroCore: Develops non-invasive vagus nerve stimulation (nVNS) therapies for headache, representing a potential non-implanted alternative approach to neurostimulation in chronic conditions and a possible future adjacency to Enterra's gastroparesis franchise.

Broad incumbents

• Medtronic: Original developer of Enterra Therapy and current 'important partner' after the 2022 spin-off. Operates one of the largest neuromodulation franchises globally (spinal cord, deep brain, sacral nerve, vagus nerve stimulation), making it the most natural benchmark for an implanted neurostim platform serving specialty indications.
• Boston Scientific: Owns a broad neuromodulation portfolio (spinal cord, deep brain, radiofrequency ablation) alongside significant GI/endoscopy franchises, positioning it as a possible strategic entrant adjacent to gastric electrical stimulation.
• LivaNova: Sells the Vagus Nerve Stimulation (VNS) Therapy System for epilepsy and treatment-resistant depression — an implanted neurostimulator in a rare/chronic specialty indication with HDE- or limited-population dynamics and dedicated implant-center networks.
• Abbott (Neuromodulation): Through its St. Jude legacy, Abbott operates a large neuromodulation business (spinal cord and dorsal root ganglion stimulation). Comparable as a broad incumbent in implanted neurostimulators with extensive specialty sales coverage.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/EnterraMedical
• Facebookfacebook.com/Enterra-Medical-Inc
• LinkedInlinkedin.com/company/enterra-medical

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Enterra Medical