Advancing wound care
through innovation

COMAS – Cutaneous Oxygen Monitoring And Stimulation

– Pioneering medical technologies that improve patient outcomes and enhance their quality of life

The COMAS System- hindering and healing chronic skin ulcers

The convergence of an aging global population and escalating healthcare costs is creating an unprecedented demand for automated, preventative medical technologies that reduce manual intervention, lower systemic costs, and improve patient outcomes

COMAS will establish automated tissue perfusion management as the global standard of care, transforming chronic ulcers from a common, costly, painful and sometimes fatal complication into a rare, preventable, and manageable condition.

COMAS combines established and FDA CE MDR approved technologies with our own proprietary software and electronics and designs in a revolutionary wound care product.​ A smart, wearable, disposable prophylactic dressing that continuously monitors deep tissue oxygenation and delivers automated gentle electrical stimulation when needed to maintain oxygenated blood flow, preventing the cell death that leads to ulcer formation.

Safety

“For example, with transplant patients that develop a pressure ulcer, it becomes a big issue! For these patients, I’d put the patch on no matter the price”

– ICU surgeon Mayo Clinic – US​

Finance

“The financial penalties from CMS for HAPIs are a significant threat to our bottom line, not to mention the risk of litigation. We are investing in prevention, but current methods are reactive and insufficient.”

– US Hospital Chain CFO​

Patient Risk

“We know the problem: we can’t turn these patients, and the risk of pressure ulcers increases by the hour. If this works, it would be fantastic – every sore we prevent is a win”

– Sahlgrenska University Hospital – Sweden​

Personnel

“We are constantly understaffed. Manually repositioning every patient every two hours is a guideline we struggle to meet, and we still see ulcers develop. It’s a losing battle.”​

– Registered Nurse, ICU Personal​

Patients tested in a successful proof-of-concept clinical study (including double-blind/placebo) validating the core technology on high-risk spinal cord injury (SCI) patients in a US hospital.

Annual cost of hospital-acquired pressure injuries (HAPI) in the US alone, a figure projected to grow.

Annual deaths in the US directly attributed to pressure ulcer complications, rivaling other major public health crises.

%

Increase in nursing workloads caused by current, manual-intensive pressure ulcer management protocols. Huge budget implications.

COMAS Perfusion Patch
Innovative by design

“COMAS is an interesting disruptive technology.”​
– Masimo Inc., joint development partner and global leader in medical sensor devices.​

Focus on Perfusion, Not only Pressure and Tissue Deformation:We address the root physiological cause of ulcers – poor tissue oxygenation – rather than the well known contributing factor of reduced micro-motions in tissue that are due to sustained external pressure and the presence of vasoconstrictive drugs. This is a fundamental paradigm shift in preventative care.​

Closed-Loop Diagnostic Automation: COMAS is the first device to move beyond passive risk assessment to active, automated prevention. COMAS creates a closed-loop diagnostic system that continuously monitors tissue perfusion to capture the “distress signal” sent by the cells in the form of falling oxygen perfusion levels in the blood and delivers a therapeutic response precisely when needed.​

Platform Technology for In- & Out-Patient Care:  The wearable, wireless design serves both ICU and post-op bed-bound hospital patients and mobile individuals (e.g., wheelchair users, diabetics), unlocking a much larger market than in-hospital-only solutions. ​

Assortment of supporting articles from healthcare industry & academia

“The assumption that external pressure is the only cause of pressure ulcers has led to ignoring other pathogenic causes of pressure ulcers, which usually lead to failure of the prevention and treatment process. Therefore, identifying the causative agents and preventive measures may lead to implementing more effective interventions.[13] In order to deliver better nursing care and to reduce the incidence of pressure ulcers, it is important to study its incidence rate and the factors influencing it in different wards, as well as to identify the factors that cause early diagnosis and prevention of the complication.[14]”

Link to: US National Institute of Health article: The Incidence of Pressure Ulcers and its Associations in Different Wards of the Hospital: A Systematic Review and Meta-Analysis

Effect of high voltage pulsed galvanic stimulation on sacral transcutaneous oxygen tension levels in the spinal cord injuries- Mawson et al

Evidence is mounting that spinal cord injured (SCI) persons may be at increased risk of pressure ulcers due to prolonged immobilization together with the injury-induced loss of sympathetic tone and decreased vascular resistance. With a view to developing a new method of preventing pressure ulcers, the objective of this study was to determine whether high voltage pulsed galvanic stimulation (HVPGS) could increase sacral transcutaneous oxygen tension (PtcO2) in SCI persons lying prone and supine. In experiment 1, HVPGS applied to the back at spinal level T6 led to a sustained, dose-related increase in sacral PtcO2in 3 subjects lying prone. In experiment 2, carried out on 29 subjects lying supine on egg-crate mattresses, HVPGS (75 volts, 10 Hz) produced a 35% increase in sacral PtcO2, from a baseline level (Mean ± SD) of 49 ± 21 mmHg to 66 ± 18 mmHg after 30 minutes of stimulation (F = 39.4, p < .00001). In experiment 3, simulated HVPGS was found to have no effect on sacral PtcO2 in 5 subjects lying supine. In experiment 4, HVPGS was repeated on 10 subjects and its effects found to be highly reproducible. It is hypothesized that HVPGS restores sympathetic tone and vascular resistance below the level of the spinal cord lesion, thereby increasing the perfusion pressure gradient in the capillary beds. Randomized controlled trials are now indicated to determine the efficacy of HVPGS for preventing pressure ulcers.

Link to: Effect of high voltage pulsed galvanic stimulation on sacral transcutaneous oxygen tension levels in the spinal cord injured | Spinal Cord

National cost of hospital acquired pressure –

Our objective was to estimate the US national cost burden of hospital-acquired pressure injury (HAPI) using economic simulation methods. We created a Markov simulation to estimate costs for staged pressure injuries acquired during hospitalisation from the hospital perspective.

Link to: The national cost of hospital-acquired pressure injuries in the United States – PubMed

Clinical Practice Guideline (CPG) on Prevention and Treatment of Pressure Ulcers/Injuries; Gefen et al

In 2019, the third and updated edition of the Clinical Practice Guideline (CPG) on Prevention and Treatment of Pressure Ulcers/Injuries has been published. In addition to this most up-to-date evidence-based guidance for clinicians, related topics such as pressure ulcers (PUs)/pressure injuries (PIs) aetiology, classification, and future research needs were considered by the teams of experts. To elaborate on these topics, this is the third paper of a series of the CPG articles, which summarises the latest understanding of the aetiology of PUs/PIs with a special focus on the effects of soft tissue deformation. Sustained deformations of soft tissues cause initial cell death and tissue damage that ultimately may result in the formation of PUs/PIs. High tissue deformations result in cell damage on a microscopic level within just a few minutes, although it may take hours of sustained loading for the damage to become clinically visible. Superficial skin damage seems to be primarily caused by excessive shear strain/stress exposures; deeper PUs/PIs predominantly result from high pressures in combination with shear at the surface over bony prominences, or under stiff medical devices. Therefore, primary PU/PI prevention should aim for minimising deformations by either reducing the peak strain/stress values in tissues or decreasing the exposure time.

Link to: Our contemporary understanding of the aetiology of pressure ulcers/pressure injuries – Gefen – 2022 – International Wound Journal – Wiley Online Library

High-Voltage Pulsed Current Electrical Stimulation in Wound Treatment: Polak et al

A range of studies point to the efficacy of electrical stimulation (ES) in wound treatment, but the methodology of its application has not been determined to date. This article provides a critical review of the results of clinical trials published by researchers using high-voltage pulsed current (HVPC) to treat chronic wounds. 

Link to: High-Voltage Pulsed Current Electrical Stimulation in Wound Treatment – PubMed

Why investing in prevention makes financial sense – HFMA article

Hospital-acquired pressure injuries (HAPIs) affect 2.5 million patients per year in the United States. With the cost of treating a single instance as high as $70,000, and because many payers, including Medicare and Medicaid, are not covering them, the business case for prevention is apparent. HAPIs also are the second most common hospital lawsuit claim after wrongful death, claiming 60,000 patients each year, according to a study published by Ostomy/Wound Management. Although the health-related complications associated with PIs are high, there have been no comprehensive assessments of PI costs, including both direct and indirect costs, on an individual hospital basis.

Link to: Why investing in hospital-acquired pressure injury prevention technology makes financial sense

The Incidence of Pressure Ulcers and its Associations in Different Wards of the Hospital: A Systematic Review and Meta-Analysis – Borojeny et al

Pressure ulcer is a health problem worldwide that is common among inpatients and elderly people with physical-motor limitations. To deliver nursing care and prevent the development of pressure ulcers, it is essential to identify the factors that affect it. This global systematic review and meta-analysis was conducted with the aim of evaluating the incidence of pressure ulcers in observational studies. In this study, databases including Web of Science, Embase, PubMed, Scopus, and Google Scholar were searched to collect data. Articles published from 1997 to 2017 about the factors influencing the incidence of pressure ulcers were retrieved and their results were analyzed using meta-analysis according to the Random-Effects Model. The heterogeneity of studies was investigated using the I2 statistic. Data were analyzed using the R and Stata software (version 14). In this study, 35 studies were included in the final analysis. The results showed that the pooled estimate of the incidence rate of pressure ulcer was 12% (95% CI: 10–14). The incidence rates of the pressure ulcers of the first, second, third, and fourth stages were 45% (95% CI: 34–56), 45% (95% CI: 34–56), 4% (95% CI: 3–5), and 4% (95% CI: 2–6), respectively. The highest incidence of pressure ulcers was observed among inpatients in orthopedic surgery ward (18.5%) (95% CI: 11.5–25). According to the final results, better conditions should be provided to decrease the incidence of pressure ulcers in different wards, especially orthopedics, and in patients with diabetes.

Link to: The Incidence of Pressure Ulcers and its Associations in Different Wards of the Hospital: A Systematic Review and Meta-Analysis – PMC

How it works

A screenshot from the COMAS mobile APP showing actual live data analysis and diagnosis of a patient’s deep tissue O2 perfusion level and the HVPGS electrical stimulation treatment placed in the sacrum area.

The COMAS Patch monitors perfusion levels while the COMAS Main Unit maintains the patient’s O2 perfusion at healthy levels and helps prevent the formation of chronic wounds

The ulcer prevention
window closes very fast!

Why now?

Technology Readiness: The confluence of miniaturized, low-cost sensors, advanced printed electronics, and wireless connectivity now makes a device like COMAS technically and commercially viable for the first time.​

Market Pull (Economic Shift): Healthcare payment models are shifting from fee-for-service to value-based care. Systems like US Medicare now penalize hospitals for HAPIs, creating a powerful economic incentive for true prevention, not just treatment.​

Behavioral Shift (Wearable Tech): Patients and providers are increasingly comfortable with wearable health monitors. This acceptance lowers the barrier to adoption for a wearable therapeutic device like COMAS. ​

COMAS compared to current “standard of care”

Description of function

COMAS

Standard treatment-Turn oatient & change their dressings

Special mattress

Special beds

NWPT vacuum type bandages

Bedside devices or Handheld Perfusion monitors

02 Perfusion monitoring-

Yes

No

No

No

No

Yes

Active wound prevention or treatment provided

Yes

No

No

No

Yes

No

Connected to telecomms bluetooth

Yes

No

No

No

No

Yes/No

Data gathered for analysis

Yes

No

No

No

No

Yes

Light portable & patient friendly

Yes

No

No

No

Yes

No

Can be used outside hospital

Yes

No

No

Yes

Yes

Yes

Can be used in home- care

Yes

Yes

Yes

Yes

Yes

Yes

Disposable/Recyclable

Yes

No

No

Yes

Yes

No

Prevent or treat many wound types

Yes

No

No

Yes/No

No

No

Expensive infrastructure

No

Yes

Yes

Yes

No

Yes

Requires trained personnel to operate

No

Yes

Yes

Yes

Yes

Yes

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