MedicusTek USA Corp.
Describe your device and how it will benefit healthcare.
In the last three decades, diabetes incidence has more than tripled. Meanwhile, techniques for controlling glucose levels in hospitalized patients have remained unchanged, relying on a nurse to a perform a repeating cycle of imprecise, labor-intensive, error-prone tasks. High glucose levels prevent healing, increase complications, and lengthen hospital stays, driving up care costs. Low glucose levels risk seizures, coma, and even death. Precision is necessary for high-quality outcomes. Repeatability at scale is needed for cost control.
Admetsys has developed the first artificial pancreas system specifically for the needs of hospital and surgical care. The system attaches to a patient's intravenous line, and automatically measures blood glucose concentration in real time and with no blood loss. From this, it creates an adaptive, computational model of each patient's metabolism, evolving as patient condition does, and delivers precisely-optimized, treatment - insulin to reduce high glycemic levels and glucose to raise and support falling levels.
MedicusTek has developed the Sensable Care System, a sensor technology solution in the form of a sensor mattress or pad to detect patient bed movement. The collected data is used to inform clinicians of potential patient safety scenarios such as a bed fall or a pressure injury before they occur and alert caregivers when it is time to reposition a patient. As sensors detect activity on the bed, this data is sent wirelessly to the nursing station monitor (dashboard) for analysis. If a safety issue is detected, appropriate alerts are sent to caregivers' mobile devices.
The Sensable Care System uses predictive algorithms to detect potential bed exits in four stages: stirring, sitting up, leaving and out of bed. The system can also detect pressure between the patient and the sensors, and visually maps the pressure points for clinicians to view at the dashboard or on their mobile device. When a potential bed exit or a need for repositioning is detected, the system sends an alert to the dashboard and nurses' mobile devices, prompting caregivers to intervene.
How does your product differ from the competition?
Admetsys' system is the first fully- automated glucose control device designed for hospital care; no competitive closed-loop systems presently exist. Moreover, it is the only technology that provides an active safeguard against hypoglycemia in hospital patients.
Current bed alarm systems usually are triggered when the patient is leaving the bed or is already out of the bed. As a result, nurses often have insufficient time to intercept a bed fall. Since the Sensable Care System can detect potential bed exits in multiple stages, it is able to provide nurses with an actionable response time to intercept potential bed falls before they occur.
The system also addresses alarm fatigue faced by nursing staff. According to our clinical studies, more than seven out of 10 alerts generated by our innovation are true alerts. This rate is much higher than many of the patient monitoring systems currently in place at healthcare facilities. We also reduce alarm fatigue by making alerts customizable per patien to reduce the number of unnecessary alerts nurses receive, so that each alert triggered by the Sensable Care System elicits an actionable response.
In many hospitals, nurses are required to reposition their patients every two hours. However, it is difficult for the nursing staff to determine if the pressure in one area has been fully relieved during repositioning. The Sensable Care System provides a visual map of each patient's positioning on the bed, and indicates the pressure accumulated between the patient's body and the sensors. Nurses can reference this map when repositioning the patient to ensure that pressure is properly relieved.
The Sensable Care System also frees caregivers to perform other tasks by continuously monitoring any unrelieved pressure between the patient and the mattress. If a patient moves and successfully repositions themselves, the timer resets and the nurse can concentrate on taking care of the patient in other ways. Similarly, our system allows for automatic documentation of repositioning events, freeing up additional nurse time and effort.
Our Sensable Care System can help to diagnose the workflow efficiency of healthcare institutes by tracking when and how often each alert is triggered, and how long it took for nursing staff to respond. The system also tracks when and how each patient is repositioned. This increases accountability in the nursing workflow, and can inform management on staffing quality and levels. Our data analysis generates regular reports that can be referenced in making decisions about hospital operations and staffing.
The Sensable Care System reduces the amount of time a caregiver needs to spend watching over a patient. In hospitals, sitters are hired to ensure that a high fall risk patient doesn't hurt themselves when they try to get out of bed. By continuously monitoring a patient 24/7, the Sensable Care System does not get tired and it can alert a caregiver with enough time to intervene before a patient is out of bed.
The technology saves money by giving an excellent return on investment. It can prevent bed falls and pressure injuries before they occur, which typically costs on average $14,000 and $44,000 per respective incident. CMS no longer reimburses hospitals for injuries that occur when a patient is injured while under the care hospital's care. By using Sensable Care to prevent bed falls and pressure injuries, hospitals can prevent these charges from occurring and can lower the likelihood that they be assessed a penalty for having lower quality scores than their peers.
Do you have customers yet?
Admetsys has conducted three FDA approved clinical trials using fully-engineered prototype devices, demonstrating 97% target glucose control (80-125 mg/dL) and 100% prevention of hypoglycemia (<70 mg/dL). Pivotal trials to support market clearance will begin in 2017.
Our product is currently being piloted. Because going into hospitals requires getting into a GPO to make direct sales, we are currently doing pilots to enter these healthcare facilities.
We are coming out of clinical trials, most recently a 6000 patient-day studio in a Joint Commission International accredited hospital in Taiwan and a teaching hospital in Massachusetts.
How much money have you raised?
Admetsys has raised a $1.5M convertible debt round led by Blue Cross & Blue Shield and Baptist Health System to accelerate its production engineering and support its European clinical trials. A subsequent series A raise of $12 million will be required to achieve market clearance both in the Europe and the United States, with commercial launch in select European markets. These objectives would position the company strongly to raise future growth capital, as well as make the company highly attractive to potential acquirers.
We have raised approximately $9M to date.
Who are your investors?
Blue Cross & Blue Shield, Baptist Health System, Dreamit Ventures, University of Michigan Zell Early-Stage Fund
What is the next milestone for your device?
ISO 13485 and CE certification to support a market launch in the European Union is expected in Q4 2017.
We are piloting our device in hospitals in Southern California. We will be starting at Kaiser's Downey Medical Center in Q2 2017.