iNOvodel is a medical technology company commercializing a novel system for delivering inhaled nitric oxide (iNO) therapy.
Our proprietary platform generates highly concentrated iNO using safe, low-cost chemicals and rapidly mixes it to minimize harmful NO₂ formation—offering improved safety, portability, ease of use, and lower cost compared to existing hospital-based systems.
iNOvodel aims to expand iNO therapy to broader patient populations and new clinical settings.
The Problem
Inhaled nitric oxide (iNO) is a critical therapeutic gas with vasodilatory, anti-inflammatory, and antimicrobial properties, used to treat life-threatening conditions like pulmonary hypertension.
Current delivery systems are complex, costly, and restricted to major medical centers. They rely on highly diluted NO in nitrogen, require specialized scrubbers for toxic NO₂, frequent consumable changes, and large, non-portable equipment—limiting broader adoption and increasing care complexity.
iNOvodel’s Solution
iNOvodel’s proprietary system generates highly concentrated (~95% pure) nitric oxide using safe, low-cost chemicals and a rapid mixing chamber that minimizes harmful NO₂ formation through high-velocity mixing.
- Eliminates complex purification and frequent consumable changes
- Smaller, lighter, and more portable than existing platforms
- Broad dosing range (1–300 ppm) for additional pulmonary indications
- Longer therapy hours per canister for improved ease of use and new revenue models
By reducing cost, enhancing safety, and enabling portability, iNOvodel expands iNO therapy beyond hospitals to address unmet needs in acute and chronic respiratory care.
Leadership & Core Team
- Gary Lessing – CEO
Provides business leadership and drives company growth. - Dr. Nagababu Enika – Chief Scientific Officer
Brings deep expertise in scientific research and nitric oxide technology. - Dr. Dan Berkowitz – Chief Medical Officer
Offers clinical medicine leadership and domain knowledge. - George Crothall – VP Engineering
Leads product design and technical development. - Mark Adolphus – Senior Product Development Engineer
Manages engineering execution. - Pallavi Ekbote – Product Development Engineer
Supports product development efforts.
Supported by high-value partners including Novo Engineering and the University of Alabama at Birmingham (UAB), plus consultants with extensive nitric oxide and medical device experience. This multidisciplinary team delivers robust product development, regulatory strategy, and commercialization capabilities.
Initial Focus: Hospital Market Entry
iNOvodel will commercialize the iNOstar hospital-based system via the expedited 505(b)(2) pathway for persistent pulmonary hypertension in newborns (PPHN) and cardiovascular surgery.
- Leverage safety, cost-effectiveness, and simplicity to capture share of the existing hospital iNO market.
- Enter with a small, focused sales force while remaining open to strategic distribution partners for greater reach and resources.
Long-Term Expansion
Extend iNO therapy into new indications and settings, including:
- Obstructive lung diseases (ARDS, COPD, bronchitis)
- Interstitial lung diseases (pulmonary fibrosis, idiopathic pulmonary fibrosis)
- Antibiotic-resistant infections (cystic fibrosis)
- COVID-related acute respiratory injury
Portability and cost advantages enable treatment beyond traditional hospital environments.
iNOvodel employs a classic razor/razor-blade model:
- Capital equipment: iNOstar system sales/placement in hospitals.
- Recurring revenue: High-purity (~95%) NO canisters providing more therapy hours per canister than competitors (<0.5% NO).
Pricing follows industry standards (per therapy hour) in the $700 million iNO market. Higher purity enables lower overall costs for providers, greater convenience, and pricing flexibility to drive adoption and profitability.
Investment Opportunity
iNOvodel is seeking Series A funding (amount TBD) to advance the iNOstar system through FDA approval and develop the portable iNOstarX platform.
Funds will support:
- Final design, regulatory submission, and approval via the 505(b)(2) pathway (leveraging existing safety/efficacy data).
- Development of the portable iNOstarX for outpatient and home care.
- Demonstration of efficacy/safety in PPHN, ARDS, and COVID-related respiratory injury.
- Scale-up of manufacturing and initial commercialization.
This investment positions iNOvodel to broaden iNO therapy access, achieve key regulatory milestones, and address significant unmet needs in respiratory care.
Key Achievements
- Developed system generating ~95% pure pharmaceutical-grade iNO using safe, low-cost chemicals.
- Proprietary rapid nozzle enables high-velocity mixing, minimizing toxic NO₂ formation.
- Validated precise dosing (1–300 ppm) and purity through analytical testing.
- Enables smaller, lighter, portable devices with longer therapy hours per canister.
Regulatory & IP Progress
- Targeting 505(b)(2) FDA pathway with experienced consultants.
- Planned FDA INTERACT meeting in early 2026.
- Provisional patents filed; technology licensed from leading institutions.
Clear advantages in safety, portability, and cost position iNOvodel for regulatory submission and market expansion.
iNOvodel has secured $3.35 million in funding:
| Source | Amount |
|---|---|
| Angel Investment | $100,000 |
| Phase II STTR Grant | $3,000,000 |
| Alabama Supplemental Grant | $250,000 |
