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Acacia Designs is a medical device company whose products and solutions are specifically designed to address perioperative monitoring of physiologic data in surgical patients receiving sedation or general anesthesia. Specifically, Acacia targets monitoring of muscle function in surgical patients receiving neuromuscular blocking agents (NMBAs). One of the first such innovative solutions is the TetraGraph™ System (that includes the TetraGraph™ monitor, TetraSens™ disposable electrosensors and TetraCord™ connecting cable).

 

Monitoring of neuromuscular function is critically important for patients undergoing general anesthesia for surgical procedures. Since patients receive NMBAs during general anesthesia to facilitate surgery, monitoring of the effects of NMBAs is paramount.

 

Currently, measurement of neuromuscular function is performed rarely (in less than 25% of cases), and 20-45% of patients may experience weakness in the recovery room. There are several available portable neuromuscular block monitors, and several other monitors that are built into the existing anesthesia workstations. All of the existing monitors (both stand-alone, portable ones as well as those that are integrated into large workstations) are based on movement: acceleromyography (AMG) or motion (KMG). Electromyography (EMG) measures electrical events at the muscle, not movement, and is an established technique to measure the function of the receptors that determine muscle strength.

 

EMG was developed over 70 years ago, but has not been used in the clinical setting with much success because of multiple limitations: the equipment to stimulate the nerve and monitor the muscle response is bulky, very expensive, and the responses are very susceptible to all of the extra electrical noise and interference inherent in an operating room.

 

The advances in computer technology and electronic miniaturization have recently allowed Acacia to design and develop a miniaturized, portable LED-screen monitor that can deliver stimulations to a nerve and record, measure, analyze and report muscle electrical activity (compound muscle action potentials, cMAPs) to determine muscle function. All of these monitoring functions are performed in real-time, the system requires less than 30 seconds for set-up and calibration, and monitoring involves techniques that are non-invasive: the System is connected to the patient by single-use skin electrodes, minimizing cross-contamination between patients (vertical bacterial transmission).

 

Introducing the TetraGraph system: and old idea – improved by leading-edge minds and technology 

Acacia Designs’ TetraGraph System is a newly developed EMG-based device that is light, compact and portable, battery operated, and can aid the clinician in making decisions regarding the adequacy of neuromuscular function in real-time. Acacia has secured global patent applications for protecting the system, the electrosensors, the user interface etc.

 

Acacia has collaborated with Mayo Clinic to develop the products and holds an IP license. Mayo Clinic is the largest integrated and highest ranked nonprofit medical group practice in the world.

 

A major leap in ease-of-use and accuracy vs. the current gold-standard monitor.

The TetraGraph adresses the well-known issues of neuromuscular monitoring by means of acceleromyography (AMG). The unique applications of the TetraGraph System are varied, and they solve the limitations of the other existing monitoring technologies: both acceleromyography (AMG) and kinetomyography (KMG) require that the stimulated muscle be free to move. However, in a majority of surgeries (laparoscopic, bariatric, robotic, neurosurgical, orthopedic, and thoracic), unencumbered access to the patient’s hand is unavailable, as the patient’s arms are tucked under the surgical drapes. In such surgeries, neuromuscular monitoring is simply not practical. In contrast, EMG monitoring with the TetraGraph is possible, since the technology records electrical activity, not movement.

 

The key benefits are as listed below:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Clear cost benfit

The literature has documented that, for the past 40 years, up to 45% of patients will exhibit residual weakness in the PACU (Murphy GS, 2010a; Brull SJ, 2010b). Other postoperative complications associated with this residual block include a median increase in the PACU length-of-stay (LOS) of 80 minutes (which translates to in an increase in the cost of care of $480 per patient, excluding more serious complications, such as tracheal re-intubation, pulmonary aspiration and pneumonia). The easy-to-implement change in clinical care that can solve the problem of residual neuromuscular block is finally here: the TetraGraph System offers the healthcare facility a quick return-on-investment of under a month, and hard-cost savings of more than $500,000/year, all while facilitating an increase in surgical caseload and operating room utilization of up to 10%.

 

Clinical validation of the TetraGraph

The TetraGraph System has undergone successful critical evaluation: laboratory testing was followed by environmental testing (in the operating room) to ensure the appropriate shielding and design. These tests were followed by phase III clinical testing in surgical patients, at two leading European health care centers and universities in The Netherlands and Hungary. The results have been presented and published.

 

Presented studies:

 

Clinical use of electromyography to monitor neuromuscular function

Nemes R. et al. Abstract 1AP5-2. Euroanaesthesia 2015

 

Electromyographic and acceleromyographic assessment of onset and recovery of neuromuscular block

G . Murphy et al. Anesthesia Analgesia 2013; 116; S-1 – S-390

 

Repeatability and Performance of the T4-EMG and TOF-Watch Evoked Neuromuscular Responses in Volunteers

Brull S. et al. American Society of Anesthesiologists 2012. Abstract A1160

 

Consistency of Ulnar and Median Nerve Electromyographic Evoked Responses

Brull S. et al. American Society of Anesthesiologists 2012. Abstract A634

 

Generation of Electromyographic Evoked Response Curves Over a Range of Stimulating Currents

Brull S. et al. American Society of Anesthesiologists 2012. Abstract A633

 

Subjective Evaluation of Discomfort to Train-of-Four Monitoring in Volunteers

Brull S. et al. American Society of Anesthesiologists 2012. Abstract A632

 

Design and Development of a New Electromyographic Neuromuscular Monitor

Brull S. et al. American Society of Anesthesiologists 2012. Abstract A620

 

Welcoming global commercialization partners

Acacia is currently in the process of transfering its first designs to manufacturers, and application for CE-marking and FDA-clearance is expected in 2016, followed by market introduction. Acacia’s first licensing Agreement was signed in August 2014. Acacia is now welcoming licensing and commercialization partners to bring the solutions to the market. For a discussion, please contact Philip Siberg at philip@acaciadesigns.eu

 

The Market Opportunity

There is a large and available global medical device market for a simple and reliable objective neuromuscular monitor that can indicate the depth of neuromuscular relaxation and evaluate when postoperative patients are able to breathe without assistance at the end of surgery. The global market for anesthetic and respiratory devices was $12.4 billion in 2013 and it is projected to grow to $19.6 billion by 2018, with a compound annual growth rate (CAGR) of 9.5% (Report Buyer, 2014).

 

Of the total of approximately 405,000 operating rooms worldwide (Funk LM, 2010), Acacia conservatively estimates a realistic opportunity for a market of 140,000 operating rooms in which NMBAs are used annually – operating rooms in which portable and integrated solutions for objective neuromuscular monitors will be used. Acacia estimates the market value for neuromuscular monitoring to increase to $1 billion by year 2020.