Imagine Devices develops Trinity Tube, the first multifunctional neonatal feeding tube that integrates feeding, vital signs, and respiratory monitoring into a single device.
This innovative solution improves safety, reduces clinical workload, and enhances care for premature infants in NICUs worldwide.
Imagine Devices Inc. is revolutionizing neonatal and pediatric critical care with a safer, smarter approach to monitoring premature infants.
Each year, over 13 million premature infants are admitted to Neonatal Intensive Care Units (NICUs) worldwide, connected to more than 20 wires, tubes, and sensors for feeding, respiratory support, and vital signs. Conventional systems create serious risks—including nasal and skin injuries, infections, respiratory complications, and high clinical workload.
Trinity Tube addresses these challenges by embedding temperature, ECG, and airway pressure sensors directly into a standard nasogastric feeding tube. This single-device solution provides comprehensive, non-invasive monitoring while eliminating most skin-mounted sensors and external wires.
Key benefits include:
- Up to 80% reduction in skin damage from adhesives
- 50% decrease in hospital supply costs
- 20% lighter nursing workload
Validated through clinical studies in NICUs and two FDA pre-submission meetings confirming a Class II 510(k) pathway with no clinical trials required, Imagine Devices is advancing toward FDA clearance. With over $800k raised in grants and strategic investments, the company is poised to transform neonatal care with more efficient, patient-centered monitoring systems.
Leadership Team
Imagine Devices is led by a multidisciplinary team with deep expertise in neonatal medicine, biomedical engineering, and medical device commercialization.
- Iman Salafian – CEO
Mechanical engineer and entrepreneur with proven success in medical device development, project management, and securing non-dilutive funding. - Dr. Alan Groves – CMO
Professor of pediatrics and neonatologist with decades of clinical experience and leadership in neonatal intensive care innovation. - Dr. Chris Rylander – CTO
Biomedical engineer and serial entrepreneur specializing in medical device design, manufacturing, and regulatory strategy. - Angie Englert – CNO
Experienced neonatal and pediatric critical care nurse with extensive NICU leadership and workflow expertise.
Supported by regulatory advisors, academic collaborators, and commercialization consultants, this team combines clinical insight, technical depth, and operational execution to drive Trinity Tube to market.
Imagine Devices will launch Trinity Tube through a phased, partnership-driven market entry strategy designed for rapid clinical adoption and scalable growth.
Core Elements
- Distribution Partnership
Strategic agreement with an established neonatal device company providing national reach and existing GPO contracts. - Target Early Adopters
Level 3 and Level 4 NICUs, academic medical centers, and innovation-focused hospitals to build reference sites and peer advocacy. - Manufacturing
ISO 13485-certified contract partners ensuring regulatory compliance and production scalability. - Expansion Pipeline
Developing partnerships with pediatric device consortia, hospital networks, and distributors to support training, validation, and future growth into pediatric and adult ICUs.
Imagine Devices will generate revenue through direct sales and distribution of the single-use Trinity Tube to hospitals.
- Pricing & Margins
Estimated COGS of $100 per unit with target pricing of $300, delivering strong margins while providing hospitals substantial cost savings versus separate devices. - Sales Channels
Early revenue through distribution partner’s established channels and GPO contracts, complemented by direct engagement with key accounts and early adopters. - Model
Scalable, recurring revenue from high-volume single-use device sales, positioned for sustainable growth and rapid market penetration.
Investment Opportunity
Imagine Devices is seeking $2.5 million in seed funding to complete product development, validation testing, and achieve FDA market authorization for Trinity Tube.
This capital will enable the transition from prototype to commercial-ready manufacturing, finalize regulatory submission, and execute initial market entry—targeting FDA clearance and first revenue within 18 months.
Use of Proceeds
| Allocation | Percentage | Purpose |
|---|---|---|
| Product Development & Manufacturing Scale-Up | 40% | Complete design lock, verification/validation testing, and prepare ISO 13485 production with contract manufacturer. |
| Regulatory & Quality Activities | 25% | Finalize FDA 510(k) submission, conduct biocompatibility/performance tests, and maintain quality systems compliance. |
| Commercial & Clinical Operations | 20% | Establish hospital pilot programs, initiate post-market studies, and develop sales/marketing materials. |
| Team Growth & Operations | 15% | Expand engineering, clinical, and quality teams to support scale-up and launch. |
Imagine Devices is a seed-stage company with protected IP, clinically validated prototypes, and a clear FDA regulatory pathway.
Trinity Tube has progressed through multiple prototype iterations:
- Full-feature prototype successfully tested in animal models, capturing temperature, airway pressure, and ECG signals.
- Limited-feature versions tested on premature infants in NICUs under IRB-approved studies, demonstrating feasibility and safety—resulting in two peer-reviewed publications.
FDA feedback confirms Class II Traditional 510(k) classification with no clinical trials required—only patient-simulated tests for biocompatibility, flow rate, accuracy, and sterilization.
Current status: Finalizing documentation for second FDA pre-submission, preparing design lock and verification testing with ISO 13485 manufacturing partner (Midwest Interventional Systems). A second iteration integrating ECG and heart rate monitoring is in parallel development for accelerated clearance.
Commercial launch projected within 18 months of final regulatory clearance.
Imagine Devices has secured $1.08 million in total funding (grants + committed investments).
Funding Breakdown
| Category | Amount | Key Sources |
|---|---|---|
| Non-Dilutive Grants & Awards | $629,209 | NSF I-Corps/STTR ($100k), Texas Health Catalyst/Discovery to Impact ($126k), APDI ($30k), SWPDC ($25k), VentureWell ($25k), startup competitions (> $200k) |
| Equity Investment | $200,000 | Strategic investment from pediatric medical device company |
| Committed Matching Investment | $250,000 | University of Texas at Austin Seed Fund |
