We are a scientist-led innovation company focused on non-invasive methods and devices for human brain physiological monitoring and neuro-protection against insults during cardiac bypass surgeries and secondary insults after traumatic brain injuries.
Mission
We aim to set the future standard of precise, personalized medicine for cardiac bypass surgeries and neuro-intensive care
Current medical guidelines are evidence-based and do not refer to patient-specific cerebral autoregulation (CA) impairments during cardiac bypass surgery. As a result, up to 73% of patients develop postoperative cognitive deficit (POCD) or delirium. Delirium caused by cardiac bypass surgery costs 2.4 billion annually for health insurance system in the US. The presence of POCD and delirium negatively affects the lives of millions of patients and their families all around the world. Our technology extends the current surgical equipment, minimizing the durations and frequency of CA impairments protecting the patients’ brains from ischemic and hyperaemic insults caused by CA impairments, and providing confidence for the surgical team. Almost real-time optimization of individual patient specific brain perfusion is a way to optimally perfuse all individual patient’s organs during bypass surgeries.
Neuroprotection during cardiac surgery with cardio-pulmonary bypass (CPB)
Our inventions (patented in the EU, US, etc.) propose a novel mode for operating a heart-lung machine to produce regular rectangular pulsations for real-time estimation of cerebral autoregulation status. The invention’s implementation involves modifying the heart-lung machine by incorporating a mechatronic blood flow modulation device, which generates rectangular waves in blood flow with a pulse period of 15 to 20 seconds. Such waves induce transient CA responses (transient functions) in cerebral blood flow at each rectangular pulse’s rising and falling fronts. Non-invasive CA status monitoring is used to continuously record transient functions of an individual patient specific cerebral autoregulation system and classify CA status into intact or impaired according to the shapes of recorded CA transient functions. The specialized software detects a start moment of CA impairment. It generates an alarm to take steps to minimize the duration of the CA impairment event by patient-specific arterial blood pressure management. Our technology restores optimal patient-specific brain perfusion in almost real-time.
The proposed technology, which includes a novel mode of heart and lung machine operation and an algorithm for restoring intact CA, was successfully validated by a prospective clinical study of 108 CPB patients. (ClinicalTrials.gov Identifier: NCT04943458).
https://clinicaltrials.gov/study/NCT04943458?term=NCT04943458&rank=1
Schematic diagram of cardiac bypass technological system which protects the patient‘s
brain from ischemic and hyperemic insults:
Novel components and connections which transform a heart and lung machine into the brain neuroprotection device.
Project of brain protection during CPB timeline & milestones
1990’s
Our research history
Our research in the field of secondary insults after traumatic brain injuries began in the early 90s, and our team is well-experienced in the field for over 30 years.
2014
First R&D, D&D and clinical validation project in cardiac bypass surgery
We created and clinically validated (65 patients’ observational one centre clinical trial) novel technology for heart&lung machine blood flow modulation.
2020
R&D, D&D and second clinical validation project in cardiac bypass surgery
Proposed, developed and implemented novel mode of heart&lung machine operation. Clinically validated the system of brain protection against ischemic and hyperaemic insults during cardiac bypass surgery (108 patients’ observational clinical trial).
2022
Patents pending
Five patent applications filed in the USA and the EU in 2022-2024 on our invented methods and devices for brain protection during cardiac bypass surgeries.
2023
R&D, D&D of prototype devices and clinical validation
Initial clinical evidence on an added value and feasibility of proposed technology for reduction of the rates of POCD and delirium after cardiac bypass surgery and clinical validation of proposed innovative technology.
2025 – 2027
Multicentre randomized controlled trial
Final clinical evidence on an added value and effectiveness of proposed technology for reduction of the frequencies of POCD and delirium after cardiac bypass surgery.
2027
CE & FDA approval
Final clinical evidence on an added value of proposed technology for reduction of the rates of POCD and delirium after cardiac bypass surgery will support CE&FDA approval process.
2027
TRL-9
Our device will reach TRL-9 and will be ready for manufacturing.
Non-invasive CA system’s transient functions’ and ICP wave monitor
Our novel CA status monitor’s transient function sensor is entirely passive – no transmission of some signals (electric, electromagnetic, or ultrasonic) to the intracranial media and no application of pressure to the eye or orbit. It monitors ICP(t) waves, trends and transient functions of patients’ CA systems. CA status identification is based on the real-time analysis of the continuously recorded CA transient functions by using special AI algorithm and software and rectangular pulsation of blood flow of the heart and lung machine. This monitor is applicable in a wide range of clinical practices outside of cardiac surgery theatre or neuro-intensive care unit.
Non-invasive brain volumetric and ICP wave monitor’s project timeline & milestones
2023
Patents pending
Patent applications filed in the USA and the EU.
2024 – 2025
Prospective clinical study No.1
Prospective comparative clinical study on normal tension glaucoma patients and healthy volunteers.
2024 – 2025
Prospective clinical study No.2
Prospective comparative ICP pulse wave morphology clinical study on comatose patients with implanted invasive ICP sensors.
Application
Trauma Patients
For the first time, it is possible to monitor fully non-invasively and dynamically what happens in the healthy and injured hemispheres of the human brain simultaneously using fully passive and disposable sensor.
Glaucoma diagnosis
Early diagnosis of normal tension glaucoma as a two-pressure disease (intraocular pressure (IOP) is normal, but intracranial pressure (ICP) is abnormally low) and monitoring of glaucoma treatment effectiveness.
Surgical Operations
Non-invasive monitoring of ICP waves and cerebral blood flow autoregulation (CA) status. Identification of start moments of CA impairments almost in real-time.
Sports Medicine
Fast and non-invasive diagnosis of brain injury type, such as haemorrhage or brain swelling, as well as its severity.
Aviation and space
Neuro-ocular syndrome’s (NOS) research.
About us
President and co-founder Prof. Arminas Ragauskas (DSC, FBC, FLSHD) authored or co-authored more than 220 scientific articles (more than 8800 citations according to Google Scholar). Arminas holds more than 100 inventor’s certificates and patents in the EU, US, Japan, Canada, etc.
Most team members are PhDs, co-authors of multiple inventions, experienced in developing non-invasive brain monitoring technologies and administrating clinical trials in the EU and the US.
Board of directors
Valentinas Šventoraitis
Chief Financial Officer (Lithuania)
Board of advisors
Team
