Imagine Devices develops Trinity Tube, a multifunctional neonatal feeding tube that integrates feeding, vital signs, and respiratory monitoring into one device to improve safety, reduce clinical workload, and enhance care for premature infants.
Imagine Devices Inc. is a medical device company revolutionizing neonatal and pediatric critical care.
Each year, over 13 million premature infants are admitted to Neonatal Intensive Care Units (NICUs) worldwide, where they are connected to more than 20 wires, tubes, and sensors for feeding, respiratory support, and vital sign monitoring. These conventional systems pose serious risks—nasal and skin injuries, infections, respiratory complications, and high clinical workload.
Premature infants’ fragile skin is often damaged by adhesive sensors, and current respiratory devices fail to measure internal airway pressure, leaving clinicians unable to precisely monitor or adjust respiratory support.
Imagine Devices' solution, Trinity Tube, is the first multifunctional neonatal feeding tube that integrates feeding, vital sign, and respiratory monitoring into a single device. By embedding temperature, ECG, and airway pressure sensors into a standard nasogastric feeding tube, Trinity Tube provides comprehensive, non-invasive monitoring while eliminating most skin-mounted sensors and external wires.
Key Benefits
- Reduces skin damage by up to 80%
- Decreases hospital supply costs by 50%
- Lightens nursing workload by 20%
Imagine Devices has validated the technology through clinical studies in NICUs and two FDA pre-submission meetings, confirming a Class II 510(k) pathway with no clinical trials required. With over $800k raised in grants and strategic investments, the company is advancing toward FDA clearance and market entry to transform neonatal care with safer, smarter, and more efficient 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 a strong record 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.
Together, this team combines clinical insight, technical depth, and operational execution, supported by regulatory advisors, academic collaborators, and commercialization consultants.
Imagine Devices will launch the Trinity Tube through a phased market entry strategy focused on early clinical adoption, strategic distribution, and scalable manufacturing.
Key Elements
- Distribution
Enter hospitals via a distribution agreement with a strategic partner, a neonatal device company with national reach and existing GPO contracts. - Early Adopters
Target Level 3 and Level 4 NICUs, academic medical centers, and innovation-oriented hospitals. These sites will serve as reference accounts for clinical validation and peer-to-peer advocacy. - Manufacturing
Handled by ISO 13485-certified partners to ensure scalability and regulatory compliance. - Partnerships
Developing alliances with pediatric device consortia, hospital networks, and distributors to support clinician training, post-market validation, and expansion into pediatric and adult ICUs.
Revenue will come from direct sales and distribution of the Trinity Tube to hospitals.
Business Model
- Pricing & Margins
Each single-use unit has an estimated cost of goods of $100 and a target price of $300, delivering high margins while offering hospitals significant cost savings over multiple separate devices. - Sales Channels
Early sales leverage the distribution partner’s established sales channels and GPO contracts, with direct engagement focused on key accounts and early adopters. - Growth Strategy
Scalable, recurring revenue model positions the company 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 FDA market authorization for the Trinity Tube.
The capital will enable the company to transition from prototype to commercial-ready manufacturing, finalize regulatory documentation, and execute its initial market entry.
Use of Funds
| Allocation | Percentage | Purpose |
|---|---|---|
| Product Development & Manufacturing Scale-Up | 40% | Complete design lock, verification and validation testing, and prepare for ISO 13485 production with the contract manufacturer. |
| Regulatory & Quality Activities | 25% | Finalize FDA 510(k) submission, conduct required biocompatibility and performance tests, and maintain compliance with quality management systems. |
| Commercial & Clinical Operations | 20% | Establish pilot programs with key hospitals, initiate post-market studies, and prepare sales and marketing materials for early adoption. |
| Team Growth & Operations | 15% | Expand the engineering, clinical, and quality teams with key hires to support scale-up and product launch. |
This funding will position Imagine Devices to obtain FDA clearance and launch the Trinity Tube within 18 months, enabling the company to achieve first revenue and establish strategic distribution partnerships across NICUs nationwide.
Imagine Devices is a seed-stage company with protected intellectual property, validated prototypes, and two FDA pre-submission meetings completed.
Prototype Development
- Full-feature prototype tested in animal models, successfully capturing temperature, airway pressure, and ECG signals.
- Two limited-feature versions tested on premature infants in NICUs under IRB-approved studies, demonstrating feasibility and safety.
- These studies resulted in two peer-reviewed publications.
- A second iteration integrating ECG and heart rate monitoring is in development, to be validated in parallel for faster regulatory clearance.
Regulatory Status
- FDA classified Trinity Tube as a Class II Traditional 510(k) device with no clinical trials required for market authorization.
- FDA recommended patient-simulated tests only, covering biocompatibility, feeding flow rate, temperature accuracy, airway pressure precision, and sterilization validation according to ISO standards.
- Finalizing documentation for a second FDA pre-submission supplement and preparing for design lock and verification testing with ISO 13485-certified manufacturing partner, Midwest Interventional Systems.
In summary, the technology is clinically validated, FDA-guided, and nearing manufacturing readiness, with commercial launch projected within 18 months of final regulatory clearance.
Imagine Devices has raised over $1.08 million in grants, awards, and equity investments.
Grants & Awards ($629,209 non-dilutive)
- National Science Foundation (NSF) I-Corps and STTR programs
$100,000 - Texas Health Catalyst and Discovery to Impact
$126,674 - Alliance for Pediatric Device Innovation (APDI)
$30,000 - Southwest Pediatric Device Consortium (SWPDC)
$25,000 - VentureWell Pioneer and Propel Grants
$25,000 - Multiple startup competition awards
Over $200,000 from Tiger Launch, Biofest Invest, Heartland Challenge, and Texas Venture Labs.
Equity Investments
- Strategic investment from a pediatric medical device company
$200,000 - Committed matching investment from The University of Texas at Austin Seed Fund
$250,000
