Monarch Medical Technologies gets FDA clearance for new glucose management solution

Monarch Medical Technologies, the pioneer and leader in mitigating risk associated with drugs and processes of concern in hospitalized patients, today announced the U.S. Food and Drug Administration clearance of its new glucose management solution, EndoTool IV™. EndoTool IV is part of the EndoTool platform, a market-leading suite of blood glucose management software solutions recognized for the ability to provide unsurpassed patient-specific glycemic control across a broad population of patients.

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, the company's chief executive officer. "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," Dr. 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 launch EndoTool IV commercially in June 2014. The company is also actively developing a subcutaneous version of EndoTool, which will be submitted to FDA for review in 2014.