N8 Medical

What N8 Medical does

N8 Medical, LLC is a clinical-stage medical device company developing and commercializing the CeraShield platform, a proprietary antimicrobial coating technology based on ceragenins (CSAs), which are synthetic non-peptide mimics of endogenous host defense peptides such as LL-37. The lead product, the CeraShield Endotracheal Tube (ETT), is an FDA-designated Breakthrough Device intended to prevent ventilator-associated pneumonia (VAP) by inhibiting biofilm formation on indwelling medical devices; it is approved for routine clinical use in Canada, Brazil, Colombia, and the UAE, with US marketing approval pending. The company's pipeline extends the same CeraShield chemistry to additional indwelling and implant devices, including pacemaker envelopes, hemodialysis catheters, pedicle screws, dermal fillers, and wound irrigation products, while its wholly-owned subsidiary Kinnear Pharmaceuticals advances CSA-131 as an inhaled drug for Pseudomonas lung infections in cystic fibrosis patients under FDA QIDP designation.

The business model centers on hardware sales of CeraShield-coated medical devices (manufactured by contract partner Flexicare and coated by N8 Medical) distributed through enterprise hospital procurement in ex-US markets, supplemented by drug development economics through Kinnear Pharmaceuticals and biodefense programs via a CRADA with USAMRIID. Revenue is not publicly disclosed and the company is primarily funded through NIH/NHLBI SBIR grants (over $2.5 million cumulative) and a strategic investment from Leonid Capital Partners. N8 Medical operates as part of the holding company N8 Biosciences, is based in Dublin, Ohio, employs 1-10 people, and pursues FDA regulatory pathways in parallel with ex-US market entry to drive adoption among hospital intensive care units, cardiology, nephrology, and orthopedic surgery end-markets.

Name

N8 Medical

Legal name

N8 Medical, LLC

Website

https://n8medical.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

N8 Medical is a clinical-stage medical device company commercializing CeraShield, a proprietary ceragenin-based antimicrobial coating for endotracheal tubes and other indwelling medical devices, aimed at preventing hospital-acquired infections for hospital ICUs, cardiology, nephrology, and orthopedic surgery markets.

Ownership category

akta.pro rank

Product category

Antimicrobial Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Noninvasive Ventilation Interfaces & Consumables (Masks, Tubing, Humidifiers, Filters) (HLAHAGAG)

akta.pro secondary industry

Inhalation & Nebulization Devices (Nebulizers, Spacers, Inhaler Accessories) (HLAHAGAE)

Keywords

• Antimicrobial medical devices
• Biofilm prevention coatings
• Hospital-acquired infections
• Ventilator-associated pneumonia
• Ceragenin technology

Headquarters

HQ city

Dublin

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Sales of CeraShield-coated medical devices including endotracheal tubes. The company manufactures and commercializes its FDA-designated breakthrough device through direct hospital procurement and distribution partnerships in approved markets (Canada, Brazil, Colombia, UAE).
2. Licensing Royalties: Technology licensed from Brigham Young University (BYU) for ceragenin applications. N8 Medical holds exclusive licensing rights for certain fields of use including medical device applications.
3. Subsidiary Drug Development (Kinnear Pharmaceuticals): Through subsidiary Kinnear Pharmaceuticals, developing CSA-131 as an inhaled drug for cystic fibrosis patients to prevent/treat Pseudomonas lung infections. Drug development follows pharmaceutical revenue model with QIDP designation providing regulatory exclusivity.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

N8 Medical develops and commercializes medical devices enhanced with proprietary ceragenin (CSA) antimicrobial coatings, applied through its CeraShield platform. The lead commercial product is the CeraShield Endotracheal Tube (ETT), designed to prevent ventilator-associated pneumonia in ICU patients by inhibiting biofilm formation on device surfaces. The company also advances a pipeline of ceragenin-coated devices including pacemaker envelopes, hemodialysis catheters, pedicle screws, wound care products, and develops CSA-131 as an inhaled therapeutic for cystic fibrosis through its subsidiary Kinnear Pharmaceuticals.

Product overview

N8 Medical is a clinical-stage medical device company commercializing CeraShield, a proprietary coating technology platform based on ceragenins - synthetic mimics of the body's innate immune system antimicrobial peptides. The core product is the CeraShield Endotracheal Tube (ETT), FDA-designated Breakthrough Device for preventing ventilator-associated pneumonia. The platform extends across a pipeline including CeraShield-coated pacemaker envelopes, hemodialysis catheters, pedicle screws, and other indwelling medical devices. Through subsidiary Kinnear Pharmaceuticals, the company develops CSA-131 as an inhaled therapeutic for cystic fibrosis patients with Pseudomonas infections. The company also advances biodefense applications via USAMRIID CRADA testing. The CeraShield technology prevents biofilm formation that causes ~65% of hospital-acquired infections, addressing a critical unmet need in antimicrobial resistance.

Differentiator

Problem solved

Functional benefit

Brands

• CeraShield: Proprietary antimicrobial coating technology for medical devices that prevents biofilm formation and hospital-acquired infections
• Kinnear Pharmaceuticals

Products and services

• CeraShield Endotracheal Tube (ETT) Biofilm-resistant endotracheal tube with proprietary ceragenin coating designed to prevent ventilator-associated pneumonia (VAP) in mechanically ventilated ICU patients intubated for 24 hours or more. FDA-designated as Breakthrough Device and cleared for routine clinical use in Canada, Brazil, Colombia, and UAE.

Quantifiable outcome

• Prevents bacterial and fungal biofilm growth on ETT surfaces for up to 14 days (vs. extensive biofilm growth on uncoated tubes after 24 hours)
• +6 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature4 records

Partnerships

Twelve partnerships are on record, tiered core and supporting.

• USAMRIID (United States Army Medical Research Institute of Infectious Diseases)coreStrategic or Co-development Partner · 17 August 2023N8 Medical entered into a CRADA (Cooperative Research and Development Agreement) with USAMRIID to test CSA compounds against biodefense pathogens. USAMRIID will test 6 different CSA compounds against 5 biodefense pathogens (30 strains each) including anthrax, to determine efficacy for animal testing models and potentially FDA approval under the 'Animal Rule'. This supports the Core Antibiotic Screening Program.
• Brigham Young University (BYU)coreTechnology or IntegrationDr. Paul B. Savage's research and invention of ceragenin technology at BYU. BYU has licensed the ceragenin technology to N8 Medical for certain fields of use including medical device applications. N8 Medical works with Dr. Savage on ongoing research and development.
• DaVinci Biomedical Research Products, Inc.supportingStrategic or Co-development PartnerN8 Medical working with DaVinci Biomedical Research Products on development of resorbable antimicrobial pacemaker envelope under NHLBI grant.
• MCRA (Medical Device Consulting Firm)supportingImplementation/ SI/ Consulting PartnerMr. Michael John of MCRA, VP of Cardiovascular Regulatory Affairs, serving as consultant on pacemaker envelope project. Previously served as Chief of Interventional Cardiology Devices Branch at FDA.
• Southwest Research Institute (SwRI)supportingStrategic or Co-development PartnerN8 Medical working with Southwest Research Institute (SwRI) on STTR Phase I grant for development of resorbable envelope to prevent pacemaker surgical site infections.
• University of North Carolina (UNC)supportingStrategic or Co-development PartnerDr. Prabir Roy-Chaudhury from UNC providing consultation on hemodialysis catheter project. Research in uremic vascular biology and kidney disease.
• University of Southern California (USC)supportingStrategic or Co-development PartnerDr. Jeffrey Wang from USC providing consultation on pedicle screw project. Professor of Orthopedic Surgery and Neurosurgery, Chief of USC Orthopedic Spine Services.
• Hydromer, Inc.supportingTechnology or IntegrationHydromer, Inc. supplies the hydrogel film coating used in CeraShield ETT that contains CSA-131. Provides controlled slow release of ceragenin compound.
• Kinnear PharmaceuticalscoreStrategic or Co-development PartnerSubsidiary of N8 Medical focused on therapeutic research and drug development. Advancing treatments for cystic fibrosis and Kostmann's disease using ceragenin compounds. CSA-131 drug for CF received QIDP designation.
• FlexicaresupportingOEM/ Whitelabel/ Licensing PartnerFlexicare manufactures and supplies standard adult cuffed endotracheal tubes (sizes 7.0mm-8.5mm) which N8 Medical then coats with proprietary CeraShield technology for commercialization.
• Kingston General HospitalcoreStrategic or Co-development PartnerDr. John Muscedere at Kingston General Hospital conducting CEASE-VAP clinical trial comparing CeraShield ETT vs uncoated ETT. Over 125 patients enrolled with target of 400. Also received Health Canada Emergency Use Authorization for COVID-19 patients.
• Prime Hospital (UAE)supportingStrategic or Co-development PartnerClinical study underway at Prime Hospital in UAE with additional studies planned in Saudi Arabia, Panama and Colombia for CeraShield ETT.

Scale indicators8 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Teleflex: Teleflex is a global leader in airway management, manufacturing endotracheal tubes and other critical care devices. Directly comparable as a primary competitor to N8 Medical in the ETT market where Teleflex holds established share.
• ICU Medical: ICU Medical manufactures medical devices for critical care applications including infusion and connection devices. Comparable to N8 Medical in targeting ICU hospital customers with safety-focused clinical devices.
• Smiths Medical (now ICU Medical): Smiths Medical (recently acquired by ICU Medical) is a leading manufacturer of airway management products including endotracheal tubes. Direct competitor in the same ETT product category as N8 Medical's lead offering.
• Intersurgical: Intersurgical manufactures respiratory and airway management products including endotracheal tubes for ICU use. Directly comparable as a European-based competitor in the same ETT and ventilation consumables market.

Broad incumbents

• Becton Dickinson (BD): BD is a global medical device giant that acquired CR Bard, bringing antimicrobial coating programs and broad ICU device portfolios. Highly comparable as a broader incumbent competing across multiple of N8 Medical's pipeline categories.
• Medtronic: Medtronic is a broad medical device incumbent with extensive critical care and cardiac device franchises. N8 Medical's leadership includes former Medtronic/Covidien executives, indicating direct competitive overlap in ICU and cardiac markets.
• Cook Medical: Cook Medical is a privately-held medical device company with critical care and catheter product lines. CEO Robert Mitchell's prior SVP role at Cook Medical reflects direct competitive and customer overlap with N8 Medical's catheter and ICU device applications.
• 3M Health Care: 3M's Health Care division includes infection prevention products and medical device components. Comparable as a broad incumbent in HAI prevention with substantially greater R&D and commercialization resources.

Emerging players

• Kane Biotech: Kane Biotech is an emerging antimicrobial technology company developing biofilm-disrupting therapies for medical devices and wound care. Closely comparable as a small-cap peer pursuing similar antimicrobial coating and infection prevention applications.
• NoBACZ: NoBACZ is a UK-based early-stage company developing antimicrobial coatings for medical devices, particularly for catheter-associated infections. Comparable emerging player with similar coating-based approach to N8 Medical's CeraShield platform.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/n8-medical-inc-

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles20 records

Subsidiaries2 records

Funding overview

Funding rounds1 record

Investors1 record

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 N8 Medical