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PMD-200™

PMD-200™

PMD-200™

Product catalog summary
The Need
Pain is a significant clinical, social, and economic issue, affecting millions globally. In Europe, chronic pain conditions cost billions annually, representing 3-10% of GDP. Current pain management relies on subjective patient assessments, posing challenges when patients cannot communicate, such as during anesthesia. Inadequate pain management can lead to complications, extended hospital stays, and increased costs. Medasense aims to optimize pain management through objective assessment.

The Solution
Medasense has developed the PMD-200™, a device using patented technology to objectively assess and quantify pain. It employs a non-invasive finger probe with sensors to record physiological signals related to pain. The device uses AI algorithms to analyze these signals and determine a Nociception Level Index (NOL™) on a scale from 0 to 100. This allows for continuous, real-time monitoring of pain levels.

The Benefits
The NOL™ index aids healthcare professionals in monitoring pain intensity and adjusting analgesic medication during anesthesia, aiming to reduce suffering and minimize adverse effects from improper medication use.

The Evidence
Over eight years, studies involving over 500 patients in Canada, Europe, and Israel demonstrated the NOL™ index's superiority over current methods. The technology effectively distinguishes between noxious and non-noxious stimuli with high specificity.

The Market
Following CE approval, the PMD-200™ targets institutions treating anesthetized surgical patients, with potential expansion through collaborations with monitoring companies and other stakeholders. With 234.2 million major surgeries annually worldwide, the market potential is vast.

The Company
Medasense Biometrics Ltd. is recognized for innovation in medical devices, with accolades from IATI Biomed and MedTech Strategist Magazine. The company has secured significant investment and is supported by a scientific advisory board of leading pain specialists.
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Catalog excerpts

PMD-200™-1

Pain Monitoring Device: PMD-200™ Medasense Biometrics Ltd The need Pain represents a major clinical, social and economic problem1 so it is no surprise that treating pain is at the epicentre of medicine and structures the aim of healthcare professionals. Pain affects hundreds of millions of people and, in Europe, national healthcare and socioeconomic costs of conditions associated with chronic pain run into billions annually and represents 3–10% of gross domestic product2. Currently there are no validated objective markers of nociception or pain that can be recommended for clinical use3 so treatment relies on patients’ subjective assessment and clinician interpretation, a particular issue when the patient cannot communicate (e.g. those who are anaesthetised). Postsurgical complications related to inadequate pain management negatively affect the patient’s welfare and the hospital performance because of extended lengths of stay and readmissions, both of which increase the cost of care4. Medasense’s vision is to optimise pain management through accurate and objective assessment of pain at hospitals, clinics and at home. The solution Medasense have developed a novel, multi-parametric, patented technology to objectively assess nociception (pain), quantify it and measure the analgesic effect. Due to the multifaceted nature of pain, Medasense’s solution focuses on the body’s physiological integrated response to pain, rather than individual pain pathways. The device consists of a non-invasive finger probe which continuously records multiple pain related physiological signals – using four sensors namely a photoplethysmograph, galvanic skin response, temperature and accelerometer. From the signals- dozen of pain related physiological parameters and derivatives are extracted and computed (heart rate, heart rate variability, skin conductance level, photoplethysmography pulse wave amplitude, a number of skin conduction fluctuations, skin temperature and more). The PMD200 bedside monitor uses composite artificial intelligence algorithms to analyze dozens of pain-related measurable changes in the physiological parameters and determine the individual’s nociception level index (NOL™). This NOL™ is visualized on the PMD200™ monitor using a scale of 0 to 100, where 0 represents no pain and 100, extreme pain. The device is calibrated to the individual’s baseline and provides continuous, real time monitoring. The benefits NOL™ helps healthcare professionals monitor pain intensity and titrate analgesic medication accordingly during anaesthesia5,6 with the aim to reduce suffering and minimise adverse events which can be caused by over or under usage

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PMD-200™-2

The evidence Over an 8 year research period, 8 studies were conducted in Canada, Europe and Israel, involving more than 500 patients. These patients were a combination of conscious, anaesthetised and those suffering from acute and chronic pain5-8 and included trials performed on patients undergoing surgery. Key results published and cited in peer reviewed medical journals (Pain, Anesthesiology, The Journal of Clinical Monitoring and Computing) have demonstrated the NOL™ index outperforms currently used parameters and methods. Results show the technology is able to discriminate between noxious...

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PMD-200™-3

3. Cowen R et al., (2015) Assessing pain objectively: the use of physiological markers. Anaesthesia, 70:828-847 4. Wells N et al., (2008) Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US) 5. Edry R et al., (2016) Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology, 125:193-203 6. Martini et al., (2015) Ability of the Nociception Level (NOL), a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia....

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