Infants born extremely prematurely present significant clinical and population health challenges. Advances in clinical vital sign monitoring can drive improvements in survival and long-term outcomes in this vulnerable population. Our company develops a multifunctional feeding tube that simultaneously provides vital sign monitoring by sensors embedded in a feeding tube indwelling inside the patient's esophagus instead of using irritant skin-mounted sensors. Trinity tube is the next-generation solution for neonatal vital sign monitoring.
Imagine Devices Inc. specializes in minimally invasive solutions for vital sign monitoring in clinical care. Our flagship product, the Trinity Tube, is a sterile, multifunctional feeding catheter designed to address critical unmet needs in neonatal intensive care units (NICUs). It enhances safety, accuracy, and efficiency in the care of premature infants by integrating feeding, abdominal gas venting, and vital sign monitoring into a single device. The Trinity Tube enables internal monitoring of heart rate and core body temperature, eliminating the need for skin-mounted sensors and thereby reducing the risk of skin damage and infection in preterm infants. Additionally, it provides a more precise method for monitoring airway pressure, improving the effectiveness of High-Flow Nasal Cannula therapy. This capability helps clinicians maintain optimal airway pressure, enhancing non-invasive respiratory support. The device's ability to vent excess abdominal gas also mitigates gastrointestinal complications, such as "CPAP Belly." Beyond its clinical benefits, the Trinity Tube addresses daily challenges faced by healthcare professionals, including the complexity of managing multiple devices in the NICU. By streamlining these functions into a single solution, it improves patient comfort and safety, reduces nursing workload, and enhances overall care efficiency. This innovation originated from direct feedback from clinicians and NICU staff in Austin, TX. Its development was a collaborative effort between engineers at the University of Texas at Austin and clinicians at Dell Medical School.
- Iman Salafian, MS, PMP – President, CEO, Co-founder, and Co-inventor: A certified project manager and mechanical engineer with over 15 years in product design, medical device innovation, strategic planning and product launch. He oversees company operations, commercialization, and fundraising while contributing technical expertise.
- Dr. Alan Groves, MD, – CMO, Co-founder, and Co-inventor: A neonatologist with 30+ years in clinical research. He identifies technology gaps in neonatal care, driving innovation and intellectual property generation.
- Dr. Christopher Rylander, PhD – CTO, Co-founder, and Co-inventor: A seasoned biomechanical engineer with more than 30 years of experience specializing in medical device design . He leads the technology development work.
- Angie Englert, RN– Chief Nursing Officer: A NICU specialist with 20+ years of nursing experience, focused on neonatal care.
- Joe Skraba, MS, MBA– Senior Advisor: With 30 years in medical device commercialization, he has developed products generating $5B+ in sales and raised substantial venture funding.
The following major milestones need to be accomplished in order for Trinity Tube to successfully get into the market and bedside.
- Proof of concept prototyping and benchtop testing (done)
- Primary and secondary market research (done)
- Animal studies (done)
- Peer review publications (done)
- MVP development and benchtop testing (done)
- Human clinical data and clinical evidence using MVPs (done)
- FDA pre-sub and regulatory pathway development (done)
- Contract manufacturing (in progress)
- Verification, validation, design history file development, and performance testing for FDA 510k clearance (late 2025)
- FDA 510k filing and clearance (early 2026)
- More clinical evidence using multi-site studies in front-end partnership with NICUs across the US. (mid-2026)
- Market launch in partnership with well-established distributors or larger medical device companies that already have market access and contracts with major hospital systems and local NICUs. (early 2027)
- Possible exits: acquisition by or merging with large medical device companies such as Avenos, Philips, Getinge and GE Healthcare that have major market share in NICU similar products. (early 2028)
We will generate revenue through direct sales of our product Trinity Tube to hospitals when Imagine Devices has a contract in place or through distributors who already established contracts with hospital systems or local NICUs. With a price target of $300 and a cost per unit of $100, we are expecting a gross margine of $4M with only 2% market share, equal selling about 21000 units in one year with 2 to 5% growth year over year. Trinity Tube dweling time (time per each unit used in one patient) is 7 days, meaning that each patient can receive 4 to 10 tubes per stay in average depnding on their condition.
We are currently raising our seed round for a total of $2.5M to let us reach milestone 10 in the list above. We are open to both angel investments through convertible notes or a priced round if there are interested VCs. Our seed round will let us have an FDA-cleared product in hand ready to launch to market. Our series A round will be focused on more clinical evidence data collection through multi-site partnerships. This step significantly facilitates the adoption process and market readiness.
We will be using our seed fund in the following categories:
- Contract Manufacturing
- Quality management system and FDA compliance
- Administration and operations
- R&D and new IP development
- Early marketing and partnership development
- Regulatory testing and application preparation
The University of Texas at Austin has done independent due diligence work on our technology and is interested in co-investing with angel investors in our seed round. A letter of intent can be provided upon request. Our team is currently working on preparing a fast-track NIH SBIR application to supplement our fundraising efforts.
We filed our provisional patent in 2022 and converted it to a PCT patent in 2024. We developed fully functional prototypes, which underwent bench testing and evaluation in an animal model. Additionally, we published two papers in medical device conferences to share our findings from the benchtop and animal experiments. We did comprehensive market research, needs validation, and customer discovery with over 250 interviews with key stakeholders such as bedside NICU nurses, parents, NICU nursing managers, NICU directors, regulatory and reimbursement experts, and GPO and value committee members. The interview data guided multiple phases of design optimization, alongside in-depth secondary market research and regulatory evaluation. We have received more than 30 grants and awards highlighting the consciousness of how important our product is for NICU patients and the nursing team. We submitted our FDA presubmission request on August 30th and received the FDA response on November 8th, 2024. We are currently conducting two phases of clinical studies under IRB approval at Ascension Seton Medical Center in Austin, TX, to obtain clinical evidence for the included features. We are using already FDA-cleared MVPs to conduct these studies while our device goes through the manufacturing and regulatory process. These studies also help us to inform our final design specifications such as electrode and sensor placements to receive optimal data.
We have secured approximately $200k through non-dilutive grants and competition awards. Below is a curated list of these achievements. Currently, we are raising our seed round through dilutive investment.
Health Innovation Award, Texas Venture Labs Investment Competition, Texas Venture Labs, UT-Austin -Elevator Challenge Award, Texas Venture Labs Investment Competition, Texas Venture Labs, UT-Austin -SEC Pitch Competition, Southeast Conference -Tech Transfer Office Showcase and Pitch Competition, 2024 iC³® Life Science & Healthcare Innovation Summit -VentureWell E-Team Propel Program, VentureWell -Texas Superstar Award, Texas Venture Labs Investment Competition, Texas Venture Labs, UT-Austin -Commercialization Award, Texas Venture Labs Investment Competition, Texas Venture Labs, UT-Austin -Tiger Launch Investment Competition Award, Tiger Launch Investment Competition -VentureWell E-Team Pioneer Program, VentureWell -Avnet Judge's Award, ASU Innovation Open pitch competition, Arizona State University -"Make Your Medical Device Pitch For Kids!" Award, Alliance for Pediatric Device Innovation (APDI) at Children’s National Hospital -Proof of Concept Award, UT Austin Discovery to Impact -National NSF I-Corps Grant, National Science Foundation (NSF)
