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Clot Knot device for individuals with Venous Thromboembolism

(Ref. No. 450-RU)
 

The Problem

Blood clots are a major cause of morbidity and mortality worldwide. Venous Thromboembolism (VTEs) including Deep Vein Thrombosis (DVT) and pulmonary embolism (PEs) are the third most common cardiovascular diagnosis with an incidence of about 1 per 1000 and increase with age. Each year over 10 million are affected by VTEs accounting for over 1 million deaths. This is twice the number of deaths from accidents, COPD, stroke, diabetes, Alzheimer's and pneumonia combined. VTEs cut across race and socioeconomic status. Primary risk factors include obesity, cancer, trauma, surgery, increased age, immobility and hospitalization. In the US, more than 500,000 hospitalized patients develop DVT annually with the majority occurring within 90 days of hospitalization. VTE is therefore a leading preventable cause of post-hospital associated death.

Current Standards

Recognizing the need and ability to prevent VTEs, hospitals and profession organizations have developed methods, risk calculators and guidelines for implementing VTE prophylaxis. The universal standard of care for hospitalized patients, supported by data and guidelines, are to use mechanical prevention measures to prevent VTEs with or without oral or injectable blood thinners as clinically indicated. However, once the patient is discharged, these preventive measures essentially stop.

The Market

Failure of physicians and hospitals to transition patients back to full health by instituting outpatient measures to avoid and prevent complications and unnecessary readmissions is now considered a significant gap in quality care delivery. Increasingly private and governmental payers are refusing to reimburse management of preventable events such as VTEs. The market opportunity for simple, cost effective, continuous, non-medicinal VTE preventions as patients’ transition out of the hospital is broad, given the universal use of these measures in nearly all inpatients. With over 50 million surgical inpatient procedures performed annually in the US and over 20 million cancer survivors, the market opportunity for transitional mechanical VTE prophylaxis among high risk targeted populations with cancer related surgeries alone is immense.

The Product

Clot Knot is a simple, economical solution for the continuation of mechanical VTE prevention in outpatients. On discharge, sequential compression devices (SCD) (a universal sunk cost for hospitalized patients) are simply disposed of given the current inability to use them effectively at home. Clot Knot is an easy to use, patient based solution to extend the use of SCD (stockings) which can be worked into a simple outpatient therapy physical recovery routine. Current strategies are to test patient and caregiver acceptance of the Clot Knot prototype at several high volume cancer centers in patients undergoing surgery for urologic and gynecologic cancers. Initial efforts focusing on bundling Clot Knot with SCD stockings currently provided to all inpatients and/or through pharma are underway.

IP Status: International patent application has been filed in January 2019.

For Partnering/Licensing information, please contact:
Inna Khartchenko, M.S., MBA
Director, Technology Transfer and New Ventures
Inna.Khartchenko@fccc.edu

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