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CE Class I Medical Textiles (EU MDR 2017/745)
CE-marked reusable medical textile products designed for hospital, surgical, neonatal application
Hospital-Wide Medical Textile Platform
Single textile technology deployed across scrubs, patient gowns, blankets, linens, neonatal warmer
Broad-Spectrum Antimicrobial Protection
Validated efficacy against MRSA, VRE, CRE, Acinetobacter, Candida—key pathogens responsible for HAIs
Clinically Evaluated Neonatal Thermal Care
Clinical studies demonstrate improved thermal stability in NICU, transport, and KMC care
THERMAISSANCE
See us at WHX Dubai 2026 (formerly Arab Health) · Booth: S11.F11,S11.F11A,S11.F13,S11.F13A,S11.F15,S11.F15A,S11.F17
Thermaissance is a CE Class I medical textile innovation company developing clinically validated antimicrobial and thermoregulating fabrics for neonatal, surgical, and critical-care environments.
Charlotte, North Carolina, United States
Healthcare, Defense & Security
Products & Services
Thermaissance® ThermaSling - Kangaroo Care Device
Thermaissance
ThermaSling® – Kangaroo Mother Care (KMC) Support Device
Making Kangaroo Mother Care longer, safer, and clinically more effective
Kangaroo Mother Care (KMC) is one of the most powerful interventions for neonatal thermal stability, infection reduction, weight gain and early discharge. Yet, in real-world hospital settings, KMC is often inconsistent and suboptimal due to maternal fatigue and physical discomfort, lack of ergonomic support, interrupted sessions in high-load wards, hygiene and infection-control concerns and dependence on continuous staff supervision
As a result, KMC hours are limited and its full clinical potential is not realized.
ThermaSling is a CE-certified Class I medical device by Thermaissance designed to strengthen the quality, safety, and continuity of Kangaroo Mother Care, without adding infrastructure or nursing workload. It enables hands-free, upright, thermally stable skin-to-skin care—in NICUs, post-natal wards, step-down units, and even after discharge.
Key Clinical & Functional Benefits
a. Improved thermal regulation during prolonged KMC
b. Hands-free ergonomic design, reducing maternal fatigue
c. Enables longer, uninterrupted KMC sessions
d. Antimicrobial fabric, reducing pathogen exposure during close contact
e. Reusable & hygienic, compatible with hospital workflows
ThermaSling does not just increase KMC duration—it improves the effectiveness of every hour of KMC. Evidence Highlights (80 neonates)
a. ~37% longer daily KMC duration compared to cotton KMC gowns
(3.6 vs 2.6 hours/day, p < 0.001)
b. Superior weight outcomes: Cotton group: –11.0 g/day average weight loss; ThermaSling group: +2.5 g/day net weight gain
c. On active KMC days: +9.6 g/day vs –5.2 g/day (p < 0.001)
d. 60% of ThermaSling infants gained weight at discharge vs 30% in control group
e. Multivariable regression confirmed an independent ThermaSling effect of ~11 g/day additional weight gain, even after adjusting for KMC hours.
Making Kangaroo Mother Care longer, safer, and clinically more effective
Kangaroo Mother Care (KMC) is one of the most powerful interventions for neonatal thermal stability, infection reduction, weight gain and early discharge. Yet, in real-world hospital settings, KMC is often inconsistent and suboptimal due to maternal fatigue and physical discomfort, lack of ergonomic support, interrupted sessions in high-load wards, hygiene and infection-control concerns and dependence on continuous staff supervision
As a result, KMC hours are limited and its full clinical potential is not realized.
ThermaSling is a CE-certified Class I medical device by Thermaissance designed to strengthen the quality, safety, and continuity of Kangaroo Mother Care, without adding infrastructure or nursing workload. It enables hands-free, upright, thermally stable skin-to-skin care—in NICUs, post-natal wards, step-down units, and even after discharge.
Key Clinical & Functional Benefits
a. Improved thermal regulation during prolonged KMC
b. Hands-free ergonomic design, reducing maternal fatigue
c. Enables longer, uninterrupted KMC sessions
d. Antimicrobial fabric, reducing pathogen exposure during close contact
e. Reusable & hygienic, compatible with hospital workflows
ThermaSling does not just increase KMC duration—it improves the effectiveness of every hour of KMC. Evidence Highlights (80 neonates)
a. ~37% longer daily KMC duration compared to cotton KMC gowns
(3.6 vs 2.6 hours/day, p < 0.001)
b. Superior weight outcomes: Cotton group: –11.0 g/day average weight loss; ThermaSling group: +2.5 g/day net weight gain
c. On active KMC days: +9.6 g/day vs –5.2 g/day (p < 0.001)
d. 60% of ThermaSling infants gained weight at discharge vs 30% in control group
e. Multivariable regression confirmed an independent ThermaSling effect of ~11 g/day additional weight gain, even after adjusting for KMC hours.
Thermaissance® Baby Hugg (Passive Baby Warmer)(CE Class I)
Thermaissance
Clinically validated, electricity-free neonatal thermoregulation & infection-prevention solutions—designed for real-world NICU, Transport, and Kangaroo Mother Care settings.
Thermaissance develops CE-certified, CDSCO-registered medical devices that address two of the biggest contributors to neonatal morbidity and mortality globally:
thermal instability and infection risk, especially among preterm and low-birth-weight (LBW) infants.
1) Baby Hugg® – Passive Neonatal Warmer / Thermal Transport Wrap
Baby Hugg is an electricity-free, CE-certified passive neonatal warmer, designed to prevent admission hypothermia and thermal stress across the care continuum.
Key Clinical & Functional Benefits
a. Maintains normothermia (36.5–37.5 °C) without power or batteries
b. 50–70% reduction in torso heat loss during transport
c. Continous warm chain during step-down NICU care
d. Self-regulating thermal profile – no risk of hyperthermia
e. Adjunct to radiant warmers—reduces heater dependency by ~57%
f. Antimicrobial, skin-safe fabric, reducing cross-infection risk
f. Lightweight, portable, ambulance-ready
g. Reusable for 50+ wash cycles
Clinical Evidence Highlights
I) Randomized Controlled Trial (Calcutta Medical College, India):
a. 0 hypothermia cases in Baby Hugg group (n=122)
b. Control group: 67 hypothermia episodes, 18 hyperthermia episodes, 1 neonatal death
c. Higher mean temperatures (36.97 °C vs 36.71 °C, p < 0.0001) at 57% lower radiant heat
d. Staff feedback consistently highlighted Baby Hugg as:
“Ideal after warmer removal”
“Easier than managing room temperature”
“More predictable than cotton wraps”
Multi-site pilots at various government and private health facilities have shown zero transport-related hypothermia, even over 1–1.5 km transfers
Use Across the Neonatal Care Continuum
1. Transport & Transfers
2. Step-Down Care
3. Resource-Variable Settings
Baby Hugg ensures thermal continuity beyond the NICU— during transport, step-down care, and discharge.
Thermaissance develops CE-certified, CDSCO-registered medical devices that address two of the biggest contributors to neonatal morbidity and mortality globally:
thermal instability and infection risk, especially among preterm and low-birth-weight (LBW) infants.
1) Baby Hugg® – Passive Neonatal Warmer / Thermal Transport Wrap
Baby Hugg is an electricity-free, CE-certified passive neonatal warmer, designed to prevent admission hypothermia and thermal stress across the care continuum.
Key Clinical & Functional Benefits
a. Maintains normothermia (36.5–37.5 °C) without power or batteries
b. 50–70% reduction in torso heat loss during transport
c. Continous warm chain during step-down NICU care
d. Self-regulating thermal profile – no risk of hyperthermia
e. Adjunct to radiant warmers—reduces heater dependency by ~57%
f. Antimicrobial, skin-safe fabric, reducing cross-infection risk
f. Lightweight, portable, ambulance-ready
g. Reusable for 50+ wash cycles
Clinical Evidence Highlights
I) Randomized Controlled Trial (Calcutta Medical College, India):
a. 0 hypothermia cases in Baby Hugg group (n=122)
b. Control group: 67 hypothermia episodes, 18 hyperthermia episodes, 1 neonatal death
c. Higher mean temperatures (36.97 °C vs 36.71 °C, p < 0.0001) at 57% lower radiant heat
d. Staff feedback consistently highlighted Baby Hugg as:
“Ideal after warmer removal”
“Easier than managing room temperature”
“More predictable than cotton wraps”
Multi-site pilots at various government and private health facilities have shown zero transport-related hypothermia, even over 1–1.5 km transfers
Use Across the Neonatal Care Continuum
1. Transport & Transfers
2. Step-Down Care
3. Resource-Variable Settings
Baby Hugg ensures thermal continuity beyond the NICU— during transport, step-down care, and discharge.
Thermaissance® Smart Scrubs, Underscrubs & Lab Coats | CE Class I
Thermaissance
Thermaissance® brings together science, comfort, and sustainability to create the next generation of medical apparel trusted by hospitals, defense forces, and healthcare leaders worldwide.
CE Class I (EU MDR): Complies with EU MDR 2017/745 as a CE Class I Medical Device, for clinical-grade safety and performance.
Antimicrobial Validations: Proven efficacy against multidrug-resistant organisms (MRSA, VRE, CRE, E. coli, etc.).
Smart Thermoregulation: Maintains optimal body temperature in fluctuating environments — reducing fatigue and improving focus during long shifts.
Biocompatible & Skin-Safe: pH balanced materials that are biocompatible , ensuring comfort even on sensitive skin.
Autoclavable & Washable 100+ Times: Retains color, fit, and antimicrobial protection after repeated sterilization cycles.
Sustainable & Durable: Reduces textile waste and replacement frequency for hospitals.
Field-Proven Performance: Approved by the Directorate General Armed Forces Medical Services (DGAFMS)
“Lightweight, comfortable, and breathable – ensuring comfort in fluctuating room temperatures.”
“Durable – maintaining shape and fit even after multiple washes.”
Trusted in Military Medicine for comfort, hygiene, and thermal stability across diverse climates.
Endorsed by Physicians Worldwide
“I have asked physicians in academic centers and other hospitals throughout the United States to wear the Thermaissance scrubs because I believe the antiviral and body temperature properties of their products address an important issue for healthcare professionals. The feedback I received is extremely positive... I highly recommend the Thermaissance product with no reservations.” — Dr. Randall Lee, MD, Assistant Professor, George Washington University School of Medicine
info@thermaissance.com
www.thermaissance.com
CE Class I (EU MDR): Complies with EU MDR 2017/745 as a CE Class I Medical Device, for clinical-grade safety and performance.
Antimicrobial Validations: Proven efficacy against multidrug-resistant organisms (MRSA, VRE, CRE, E. coli, etc.).
Smart Thermoregulation: Maintains optimal body temperature in fluctuating environments — reducing fatigue and improving focus during long shifts.
Biocompatible & Skin-Safe: pH balanced materials that are biocompatible , ensuring comfort even on sensitive skin.
Autoclavable & Washable 100+ Times: Retains color, fit, and antimicrobial protection after repeated sterilization cycles.
Sustainable & Durable: Reduces textile waste and replacement frequency for hospitals.
Field-Proven Performance: Approved by the Directorate General Armed Forces Medical Services (DGAFMS)
“Lightweight, comfortable, and breathable – ensuring comfort in fluctuating room temperatures.”
“Durable – maintaining shape and fit even after multiple washes.”
Trusted in Military Medicine for comfort, hygiene, and thermal stability across diverse climates.
Endorsed by Physicians Worldwide
“I have asked physicians in academic centers and other hospitals throughout the United States to wear the Thermaissance scrubs because I believe the antiviral and body temperature properties of their products address an important issue for healthcare professionals. The feedback I received is extremely positive... I highly recommend the Thermaissance product with no reservations.” — Dr. Randall Lee, MD, Assistant Professor, George Washington University School of Medicine
info@thermaissance.com
www.thermaissance.com
Thermaissance® Smart Patient Gowns & Uniforms | CE Class I
Thermaissance
Thermaissance Patient Gowns & Uniforms (CE Class I under EU MDR 2017) are designed to combine advanced infection control with superior patient comfort in clinical and critical care environments.
These gowns actively break the chain of infections by reducing microbial contamination on fabric surfaces, supporting infection prevention protocols in high-risk settings such as transplant units and ICUs. The fabric’s advanced thermoregulation maintains optimal body temperature through 54 % faster sweat absorption and 2× faster heat dissipation than cotton.
Moisture-wicking technology keeps skin dry, lowering the risk of fungal infections and pressure ulcers. The pH-balanced, chemical-free fabric ensures softness and skin friendliness, while the lightweight, flexible design provides all-day comfort and freedom of movement.
Built for reusability, these gowns retain antimicrobial performance, thermoregulation, and structural integrity even after 100+ washes, ensuring long-term value and safety.
Key Benefits:
CE Class I (under EU MDR 2017) compliant product
Reduces microbial load
54 % faster sweat absorption & 2× faster heat dissipation
Moisture-wicking, breathable, and skin-friendly
Soft, flexible, and comfortable design
100+ wash durability
Biocompatible
These gowns actively break the chain of infections by reducing microbial contamination on fabric surfaces, supporting infection prevention protocols in high-risk settings such as transplant units and ICUs. The fabric’s advanced thermoregulation maintains optimal body temperature through 54 % faster sweat absorption and 2× faster heat dissipation than cotton.
Moisture-wicking technology keeps skin dry, lowering the risk of fungal infections and pressure ulcers. The pH-balanced, chemical-free fabric ensures softness and skin friendliness, while the lightweight, flexible design provides all-day comfort and freedom of movement.
Built for reusability, these gowns retain antimicrobial performance, thermoregulation, and structural integrity even after 100+ washes, ensuring long-term value and safety.
Key Benefits:
CE Class I (under EU MDR 2017) compliant product
Reduces microbial load
54 % faster sweat absorption & 2× faster heat dissipation
Moisture-wicking, breathable, and skin-friendly
Soft, flexible, and comfortable design
100+ wash durability
Biocompatible
Connect with us at
WHX Dubai 2026 (formerly Arab Health)
About
Thermaissance — Advanced Medical Textiles for Infection Control and Thermal Stability Across Healthcare
Thermaissance is a medical textile innovation company focused on improving infection control, patient comfort, and thermal stability across healthcare environments.
Our proprietary textile platform integrates broad-spectrum antimicrobial protection with adaptive thermoregulation, engineered directly into reusable medical fabrics—designed for continuous clinical use without coatings, leaching agents, or disposable dependency.
Thermaissance products are CE-marked Class I medical devices under EU MDR 2017/745, developed to meet the safety, durability, and performance expectations of modern hospitals and surgical environments.
Our technology is applied across a wide range of hospital textiles including clinical scrubs, patient gowns, blankets, bed linens, neonatal wraps, and infection-control fabrics for operating rooms and high-risk wards. Antimicrobial efficacy has been validated against multi-drug-resistant organisms such as MRSA, VRE, CRE, Acinetobacter, and Candida, addressing key contributors to healthcare-associated infections (HAIs).
In neonatal care—where thermal regulation is critical—our solutions have been evaluated through government-hospital clinical studies, demonstrating improved thermal stability and reduced cold stress in NICU and SNCU settings. These studies serve as clinical validation of our platform’s performance in one of the most demanding care environments.
By combining material science, regulatory compliance, and real-world clinical evidence, Thermaissance delivers a scalable medical textile platform suitable for both high-acuity hospitals and resource-constrained healthcare systems globally.
Thermaissance is a medical textile innovation company focused on improving infection control, patient comfort, and thermal stability across healthcare environments.
Our proprietary textile platform integrates broad-spectrum antimicrobial protection with adaptive thermoregulation, engineered directly into reusable medical fabrics—designed for continuous clinical use without coatings, leaching agents, or disposable dependency.
Thermaissance products are CE-marked Class I medical devices under EU MDR 2017/745, developed to meet the safety, durability, and performance expectations of modern hospitals and surgical environments.
Our technology is applied across a wide range of hospital textiles including clinical scrubs, patient gowns, blankets, bed linens, neonatal wraps, and infection-control fabrics for operating rooms and high-risk wards. Antimicrobial efficacy has been validated against multi-drug-resistant organisms such as MRSA, VRE, CRE, Acinetobacter, and Candida, addressing key contributors to healthcare-associated infections (HAIs).
In neonatal care—where thermal regulation is critical—our solutions have been evaluated through government-hospital clinical studies, demonstrating improved thermal stability and reduced cold stress in NICU and SNCU settings. These studies serve as clinical validation of our platform’s performance in one of the most demanding care environments.
By combining material science, regulatory compliance, and real-world clinical evidence, Thermaissance delivers a scalable medical textile platform suitable for both high-acuity hospitals and resource-constrained healthcare systems globally.
