When a baby is born too early, doctors need to know immediately whether its lungs are ready to breathe on their own. Right now, that answer takes too long and often isn't accurate enough, so doctors end up treating every premature baby as high-risk — which is expensive and sometimes unnecessary. This project built a small digital device that analyses a tiny fluid sample at the bedside and gives a clear answer within 10 minutes of birth. Think of it like a rapid COVID test, but for a newborn's lung readiness — fast, portable, and usable right in the delivery room.
Premature babies are at high risk of Respiratory Distress Syndrome, but doctors currently have no fast, accurate bedside test to assess lung maturity at the moment of birth. This forces a reactive treatment approach — putting babies on ventilators and extended NICU stays even when it may not be necessary — driving up costs and worsening outcomes.
A digital point-of-care spectrometer device with cloud-based software that analyses small bodily fluid samples to predict lung maturity within 10 minutes. Deliverables included production tooling and a sample batch of spectrometers, plus the working prototype validated at 95% accuracy against established lab methods.
If you are a hospital NICU dealing with the cost and uncertainty of treating premature infants for Respiratory Distress Syndrome — this project developed a point-of-care digital test that predicts lung maturity within 10 minutes of birth. The technology could reduce mechanical ventilation use by 60% and hospital stay by 10 days, translating to estimated savings of €1.5m per 100 cases.
If you are a medical device distributor looking for next-generation neonatal diagnostics — this project created a cloud-based spectrometer device targeting 3,400 NICUs across the US and EU. With an estimated annual market of 916,000 tests and €375m revenue potential, this represents a significant new product line in a market with no existing rapid digital alternative.
If you are a health insurer facing rising neonatal intensive care costs — this project developed a rapid diagnostic that shifts treatment from reactive to preventative. The overall healthcare savings opportunity has been estimated at more than €3.4bn total, driven by shorter NICU stays and reduced need for mechanical ventilation.
The project data does not specify a per-test price. However, with an estimated market of 916,000 tests per year and €375m annual revenue potential, the implied price point is roughly €400 per test. Actual pricing would depend on the final commercial model from SIME Diagnostics.
The project targeted 2,000 NICUs in the US and 1,400 in the EU as the initial market. Production tooling and a sample batch of spectrometers were part of the deliverables, indicating preparation for manufacturing scale-up. The cloud-based software component would scale independently of hardware production.
SIME Diagnostics Limited is the sole partner and coordinator, meaning all IP stays within one UK-based SME. This simplifies licensing negotiations considerably. Any licensing or distribution deal would be directly with SIME Diagnostics.
The project was generating Level 4 through Level 1 clinical evidence during its funding period. Medical devices for neonatal diagnostics require CE marking in the EU and FDA clearance in the US. Based on available project data, the regulatory pathway was being pursued but final approval status is not confirmed.
The project ran from 2015 to 2017 under the SME Phase 2 instrument, which funds close-to-market innovation. A working prototype was validated at 95% accuracy against established lab methods. Post-project commercialization timeline would depend on regulatory clearance and manufacturing readiness.
The test is designed as a standalone point-of-care device that analyses small bodily fluid samples at the bedside. It uses cloud-based software for data processing, meaning it operates independently of existing lab infrastructure. This makes it an add-on to current workflows rather than a replacement of existing equipment.
This is a single-company project by SIME Diagnostics Limited, a UK-based SME that received EU SME Phase 2 funding — a competitive instrument reserved for close-to-market innovations with strong commercial potential. The 100% industry composition with no university or research partners signals that the core science was already done and the focus was squarely on product development and commercialization. For a business partner, this means one point of contact, simplified IP ownership, and a company whose entire strategy depends on bringing this product to market. The risk is concentration: all expertise, manufacturing, and go-to-market capability sits within a single small company.
SIME Diagnostics Limited (UK) — contact via SciTransfer for introductions
Want to explore partnership, licensing, or distribution of the SIME-LMT rapid lung maturity test? SciTransfer can connect you directly with the development team.
