N8 Medical
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.
- Company typePrivate
- Founded2015
- HeadquartersDublin, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
N8 Medical firmographics
Firmographics- 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
N8 Medical industry classification
Industry- 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
Where N8 Medical is headquartered
LocationHeadquarters
- HQ city
- Dublin
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
N8 Medical business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Operations, Marketing or Sales, Others
Revenue model
- 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).
- 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.
- 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
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | CeraShield Endotracheal Tube - Quote-based enterprise pricing |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels5 records
N8 Medical product offering
Product offeringCore 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
Companies that use N8 Medical
Customer profileNamed customers3 records
Segments5 records
Ideal customer profiles3 records
N8 Medical technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability3 records
Feature4 records
N8 Medical partnerships and signals
Strategic signalPartnerships
Twelve partnerships are on record, tiered core and supporting.
- USAMRIID (United States Army Medical Research Institute of Infectious Diseases)coreN8 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)coreDr. 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.supportingN8 Medical working with DaVinci Biomedical Research Products on development of resorbable antimicrobial pacemaker envelope under NHLBI grant.
- MCRA (Medical Device Consulting Firm)supportingMr. 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)supportingN8 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)supportingDr. Prabir Roy-Chaudhury from UNC providing consultation on hemodialysis catheter project. Research in uremic vascular biology and kidney disease.
- University of Southern California (USC)supportingDr. Jeffrey Wang from USC providing consultation on pedicle screw project. Professor of Orthopedic Surgery and Neurosurgery, Chief of USC Orthopedic Spine Services.
- Hydromer, Inc.supportingHydromer, Inc. supplies the hydrogel film coating used in CeraShield ETT that contains CSA-131. Provides controlled slow release of ceragenin compound.
- Kinnear PharmaceuticalscoreSubsidiary 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.
- FlexicaresupportingFlexicare 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 HospitalcoreDr. 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)supportingClinical 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
N8 Medical competitors and assessment
Company assessmentDirect 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
N8 Medical social profiles
Digital presenceN8 Medical compliance and trust
Trust signalCompliance4 records
N8 Medical financial estimates
Financial estimateRevenue estimate
Valuation estimate
N8 Medical leadership team
Management profileNumber of profiles
Profiles20 records
N8 Medical subsidiaries and ownership
Company hierarchySubsidiaries2 records
N8 Medical funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
N8 Medical M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about N8 Medical
What does N8 Medical do?
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.
Is N8 Medical a public or private company?
N8 Medical is a private company. It is classified as venture growth investor backed and is currently operating.
When was N8 Medical founded?
N8 Medical was founded in 2015. It employs 1 to 10 people.
Where is N8 Medical based?
N8 Medical is headquartered in Dublin, United States, in the North America region.
How does N8 Medical make money?
Three revenue lines are on record. Medical Device Sales are the primary driver. The others are licensing Royalties and subsidiary Drug Development (Kinnear Pharmaceuticals).
Who are N8 Medical's main competitors?
Direct peers on record are Teleflex, ICU Medical, Smiths Medical (now ICU Medical) and Intersurgical. Broad incumbents are Becton Dickinson (BD), Medtronic, Cook Medical and 3M Health Care. Emerging players are Kane Biotech and NoBACZ.
Does N8 Medical have an API?
No public API is recorded for N8 Medical.
What industry is N8 Medical in?
N8 Medical's product category is Antimicrobial Medical Devices. Its primary akta.pro industry code is HLAHAGAG, Noninvasive Ventilation Interfaces & Consumables (Masks, Tubing, Humidifiers, Filters), with a secondary code of HLAHAGAE, Inhalation & Nebulization Devices (Nebulizers, Spacers, Inhaler Accessories). Its NAICS code is 339112 and its SIC code is 3841.