Acacia Designs is a clinical innovation company developing solutions that make surgery safer

Acacia Designs is a clinical innovation company developing solutions that make surgery safer. Founded by industry leaders in the field of anesthesia, we are establishing a new set of clinical standards of patient monitoring during the three phases of surgery: preoperative, intraoperative, and postoperative.

Every year, more than 20 million patients are affected by postoperative complications related to the use neuromuscular blocking agents (NMBAs) and inadequate monitoring during and after surgery. Acacia is on a mission to reduce the high rate of complications and make surgery safer, to improve patient safety while also reducing risk and expenses for hospitals, to increase operating room utilization, and to ensure higher patient satisfaction.

We have completed phase III clinical studies (in surgical patients) with excellent results that have been presented at meetings and published. Acacia’s next step is to develop integrated versions of our technology that will be offered to large medical companies with wide exposure in the surgery and anesthesia world.

What does this new world of safer surgery look like? Read on to find out!

Most of these life-threatening events are related to inadequate patient monitoring before, during, and after surgery. Globally, critical respiratory events (CREs) add costs in excess of $10 billion.

Objective monitoring that precisely measures patients’ muscle function is used in only 24% of all patients who undergo general anesthesia. The low adoption rate is due to lack of user-friendly monitors, time-consuming set-up procedures, and a lack of consistent guidelines and education. These are easily addressable problems that Acacia Designs is ready and able to address.

Reducing neuromuscular blocking agents (NMBA)-related complications and the associated costs that are in excess of $10 billion every year is one of the most frequently discussed topics at global anesthesia meetings and in the medical literature. Acacia has developed the solution.

TetraGraph™ is Acacia’s first monitoring system intended to reduce complications following surgery.

• The first hand-held, portable, and disposable accessory-based monitoring system that measures patients’ neuromuscular function and indicates when it is safe to extubate the trachea (remove the breathing tube and allow the patient to breathe spontaneously).
• Measurements are based on a verified technique (electromyography) for best-in-class accuracy and ease-of-use.
• Patent-pending, developed by medical device industry and clinical leaders.
• Phase III clinical (surgical patients) studies completed with excellent results that were presented at international meetings and published.
• Next steps: integrated versions of TetraGraph™ to be offered to large medical device companies with exposure in the anesthesia world.

The TetraGraph™ monitoring systen is set to deliver:

• 75% reduction in NMBA-related complications.
• Improved patient satisfaction.
• Reduced hospital length of stay.
• Reduced recovery time.
• A return on investment in under a month, with hard cost savings of $500,000 per year.

TetraGraph™ is what’s called a TOF (train-of-four) ratio monitor, a device used to measure the level of relaxation (muscle paralysis) induced by paralytic drugs (NMBAs) that patients receive to facilitate surgery. When the patient has received no NMBAs, the muscle function is normal, and the TOF ratio is 1.0 (100%). With maximal paralysis, the TOF ratio is 0.0 (0%).  As muscle function recovers, the TOF ratio increases slowly from 0% toward 100%. The minimal recovery necessary for safe spontaneous breathing is 90%, but this level of recovery can ONLY be measured, it cannot be assessed subjectively by the clinician. Over 90% of the existing monitors in use clinically today cannot measure the TOF ratio, so the clinician is left to subjectively “guess” the level of recovery. Because of this limitation, 30-40% of patients still have residual paralysis even after the clinician has deemed them “fully recovered.” This mis-evaluation leads to respiratory complications (“critical respiratory events,” CREs), prolonged stay in the postoperative care unit, prolonged hospital stay, and increased healthcare costs (a minimum increase of almost $2,000 per episode).

Currently, there are around 40,000 TOF monitors in existence, all based on technology that was developed in the late 1980s and 1990s (acceleromyography, AMG). These monitors can measure the actual TOF ratio, but have significant limitations: they are very difficult to place on the patient and require a 10-15 minute set-up (see figure below); they require the hand to be available and able to move during surgery in response to nerve stimulation (this is not possible in almost half of surgeries); the measured TOF ratio is susceptible to large variation (up to 50%). For these reasons, AMG-based TOF monitors are used by a small proportion of clinicians (25%).

Figure: An AMG-based TOF monitor, the TOF-Watch. Note the intricate set-up.

Acacia’s solution, the TetraGraph™ is based on a different technology, electromyography (EMG). This technology is superior, becuse it measures directly the function of muscles. It does not require the intricate set up of AMG-based monitors, it can be used in situations where the hand is not available for assessment by the clinician, it is consistent and reproducible, and requires literally 20-30 seconds to set up.

Because we are replacing an established device (AMG-based monitors) and not introducing a new practice, the acceptance and adoption of the TetraGraph™ will be much easier. It will be clear to all clinicians that the TetraGraph™ is simply a better solution than the cumbersome and time-consuming TOF-Watch monitors.

TetraGraph™ integrates easily into any surgical team’s current process. Simply open the package, place the single electrode strip on the skin, and start monitoring the NMBA levels. This can be done by the anesthesiologist, a nurse anesthetist, or any other member of the team.

The financial benefits of TetraGraph™ are undeniable, from both the patient and hospital’s perspective.

We already have 250 soft letters of intent to buy the technology once the system has regulatory approval and is ready for market distribution.

We hold a IP license agreement with the Mayo Clinic Foundation covering the core technology of our product. In September 2015, we acquired T4Analytics, LLC, further strengthening our IP portfolio.

We have partnerships with many of the leading anesthesiologists across the globe to ensure quick and cost-effective market access. Our network is extensive and supportive of our mission. Due diligence with key opinion leaders from 4 continents unequivocally supports the need for the TetraGraph™.

We plan to place the TetraGraph™ into operating rooms through leading suppliers of anesthesiology products and solutions. We already have several on-going discussions with manufacturers and distributors.

The tasks remaining to complete before entry into hospitals are:

• Finalize some of the product development.
• Move into regulatory phase: compile paperwork; do final regulatory tests; and apply for FDA approval (6-9 months process).
• In parallel, continue to do more clinical studies.

Make sure to request access to the business plan tab of this profile to see how you can get in on the ground floor of Acacia!

Acacia was founded by a world leading clinician in the field of anesthesiology. Our leadership team consists of individuals with vast experience in building global medical device companies and in developing cutting edge solutions. Acacia’s founders helped develop the TOF-Watch in the 1990s, the product TetraGraph™ is replacing. TetraGraph™ is set to become the new gold-standard.

Philip has extensive experience as an international CEO in the medical device sector, including his latest venture heading up a NASDAQ First North-listed Medical Device company. He has raised over $20 million in growth capital and completed a number of successful exits, spent six years in private equity/venture capital, and has extensive experience in globally commercializing life science projects inclusive of R&D, production, and international sales. Philip holds an MSc in Industrial Economics and Engineering from the Royal Institute of Technology in Stockholm, Sweden.

Dr. Brull has 30 years of medical experience, including his current role as a Professor of Anesthesiology at the Mayo Clinic and Examiner at the American Board of Anesthesiology. Educated at Yale and Brandeis Universities, he is a former FDA Consultant, Section Editor for Anesthesia & Analgesia journal, and has over 40 federally- and industry-funded research projects totaling $2.5M in funding. Dr. Brull has authored over 400 publications, and is a recognized expert speaker, having delivered 60 national and international University Visiting Professorships, 150+ departmental lectures, and almost 200 national and international invited lectures. Dr. Brull is considered to be among the world’s leaders in the development and implementation of anesthesia monitoring systems, patient safety, and neuromuscular physiology and pharmacology.

Dr. Hampton has 30 years of medical device development experience, most recently as a Director and Fellow with Medtronic. He was formerly a Senior Associate and Lecturer at Cambridge University and has significant expertise in medical device engineering and innovation management. He holds 23 issued patents and has founded two successful startups.

Dr.Polisner has had a clinical foot and ankle surgery practice for 30 years. He is a practice management specialist, having been either a founder or managing partner in seven diagnostic and musculoskeletal treatment centers. He attended Case Western Reserve University and Loyola Law School.