Technology and hardware development to transform trauma care
Disclaimer: The device and methods discussed on this website are not approved by the FDA for clinical use, are not being marketed or promoted and are not available for commercial distribution. These devices are being currently investigated in nonsignificant risk studies at academic sites with appropriate local institutional review board approval. The information provided here about the ongoing development of these devices is for educational purposes only.

The Problem

Early detection of ongoing occult hemorrhage (OH) before onset of shock is a universally acknowledged unmet need in both trauma and surgery. Delays in the detection of OH are associated with a “failure to rescue” and a dramatic deterioration in prognosis once the onset of clinically frank shock has occurred. Death from hemorrhage occurs in approximately 60,000 patients each year in the United States, with trauma accounting for most cases. But postpartum hemorrhage, gastrointestinal bleeding, perioperative hemorrhage, and rupture of aneurysms account for thousands of other lives-lost and billions of dollars in medical costs.

No Current Solution

    • It has been known for decades that vital sign measurements are poor biomarkers in early hemorrhage. By the time they begin to change significantly, the patient may have progressed all the way to pre-shock.
    • Even if vital signs performed well, doctors and nurses cannot pay continuously at the bedside of patients who appear stable. This is true both in civilian and military situations.
    • Existing noninvasive measurements, such as the electrocardiogram and pulse oximetry, also perform poorly, often until it’s too late.

Current Technologies Will Never Work

Early in systemic disease, there is not robust enough signal-to-noise characteristics in single measurements taken at single locations. Put another way, “there’s not enough information in the measurement of tissue oxygen at your fingertip to allow doctors and nurses to make an early decision that you’re getting sicker…”

The Multivariate Systems Inc. Competitive Advantage

We utilize a broad array of existing noninvasive technologies to acquire multiple signals, and we do it in multiple anatomic locations. Our wearable sensors may look simple - but the total data acquired by our system is orders of magnitude greater than previous devices or currently marketed units. State-of-the-art “deep learning” knits together this vast data set into a usable algorithm.

Each Multivariate Systems device is a multitechnology-multiplex-electro-optical noninvasive system that continuously monitors patients and alarms when its algorithms detect progression of disease. The system is highly sensitive but with a low false positive rate. Our vision is this -- that medical personnel could apply the wearables and turn on the device, and then focus their effort on the already unstable patients, secure in the knowledge that our device will alarm if their stable patient deteriorates.