Synotrac

vs.

MedicusTek USA Corp.

Describe your device and how it will benefit healthcare.

Around 1.4 million total joint replacements will be performed in the United States this year, and more than 50,000 patients will have their prosthetic joints fail due to infection, costing the U.S. healthcare system over $4 billion.

Synotrac is an implantable sensor that actively detects infection after joint replacement surgery and wirelessly communicates with surgeons and their patients through a smartphone app. The device is installed during surgery and detects infection at its source, helping to avoid the revision surgeries that are required when implants fail. With the shift from a fee-for-service model to value-based care and bundled payments, hospitals are now incentivized to prevent these revision surgeries, making this a critical time to bring Synotrac to market.

By detecting infection early, Synotrac enables treatment with antibiotics rather than harmful, costly revision surgeries. This disruptive approach will improve patient outcomes and save the US healthcare system billions of dollars.

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?

There are no implantable devices capable of detecting infection on the market. Currently, patients are only tested for infection after they develop general symptoms like fever and swelling. If these do present, patients are tested with some combination of blood tests, x-rays, and bacterial culture. X-rays and blood tests are prone to false negatives, and are not specific to infection. Culture is the gold standard, but it takes days and still often misses infections. This system is highly ineffective: over 60% of patients never develop symptoms, and even the ones who do are left with unacceptable diagnostic choices. The key problem with the status quo is that every available test is reactive; they are only performed in response to an infection that has already set in.

Synotrac's key value is in continuous monitoring post-surgery such that infection is identified in a timely manner. Earlier detection and treatment diverts the patient away from revision surgery and toward less invasive and costly treatment alternatives.

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?

We are in the process of obtaining clearance from FDA.

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?

We have raised $250,000 in pre-seed funding.

We have raised approximately $9M to date.

Who are your investors?

Our early investment has come from the founders, angels, and accelerator programs and their funds: Venture for America and Dreamit Ventures.

What is the next milestone for your device?

We are preparing for our first in vivo studies, which will prove Synotrac's safety and biocompatibility in a small animal model.

We are piloting our device in hospitals in Southern California. We will be starting at Kaiser's Downey Medical Center in Q2 2017.