Monarch Medical Wins FDA Approval for Insulin Tool

Monarch Medical Technologies of Charlotte has won clearance from the U.S. Food and Drug Administration (FDA) for the EndoTool IV, part of its glucose-management software platform.

The tool tracks glucose in the blood of hospitalized patients, which allows for customization of insulin dosing.

Management of patients suffering from acute-glycemic crisis states often requires the precise introduction of fluids, electrolytes and insulin to avoid further complications. The software facilitates care for patients with elevated levels of residual extracellular insulin and includes pediatric-dosing capability and an Intranet cloud-based option.

The latest system incorporates new functionality that improves treatment by allowing for an unparalleled level of customization of insulin dosing in individual patients.

Some of the additional benefits of EndoTool IV include:

• EndoX™, an enhanced customization feature for patients suffering from extreme health conditions, requiring higher goal ranges and a more structured step-down process;
• Estimated residual extracellular insulin (EREI), functionality that estimates the presence of residual extracellular insulin that impacts the calculation of the next dose recommendation;
• Availability in both cloud-based (“thin client”) and “thick client” formats;
• Pediatric dosing in children as young as 2 years old who weigh at least 12 kg.;
• Improved flexibility of transition orders; and,
• A completely redesigned user interface that streamlines and improves the user experience
   

“The mission of Monarch Medical Technologies is to transform the way drugs of concern are dosed and processes of concern are handled in a hospital setting,” said Dr. Wilson Constantine, chief executive. “EndoTool IV is the first step in a larger strategic plan to harness our proprietary model predictive control technology platform and provide 360-degrees of glycemic control for patients.”

Many of the design enhancements built into EndoTool IV were developed based on healthcare professional requests. Two of the most important – EndoX and EREI – have been in development for more than two years.

The EndoTool system works by constantly calculating how much insulin is needed based on a patient’s unique physiology and individual response. EndoX is a proprietary customization module that allows healthcare providers to structure dosing and clinical decision support messages to reinforce best practices for insulin dosing in the treatment of patients experiencing acute glycemic crisis states. Management of such conditions often requires the precise and regulated introduction of fluids, electrolytes and insulin to avoid further complications.

The amount of residual extracellular insulin present in a person’s body is another important variable that must be taken into account to achieve correct insulin dosing, maintain glucose control and avoid hypoglycemia. EndoTool IV helps account for this by offering estimated residual extracellular insulin – or EREI – functionality to ensure proper patient-specific dosing. If the patient has more residual extracellular insulin than can be supported by circulating glucose, EndoTool IV can adapt the dosing recommendations, and if desired, recommend a counter-balancing dextrose dose.

“Monarch is committed to providing the ultimate customer care experience, and we have taken great care in developing EndoTool IV, including optimal design for improved efficiency in the user interface,” Constantine said. “In addition to enhanced EndoX and EREI functionality, the pediatric dosing capability and a private intranet cloud-based option make EndoTool IV the most comprehensive and powerful glucose management system on the market.”

Monarch Medical Technologies expects to submit another component to the EndoTool IV to the FDA later this year. It said the software was developed based on requests from health-care professionals.

Privately held Monarch Medical Technologies used to be the EndoTool division of Hospira Worldwide. It was acquired in September 2012 by private-equity firm Eigen Capital of Palo Alto, Calif.