Unmet Clinical Need

Inadvertent Perioperative Hypothermia is the sudden drop of core temperature below 36C pre-, intra-, or post-operatively. A lack of preoperative warming combined with the vasodilatory effects of anesthesia leads to a precipitous reduction in core temperature that is often too difficult to remedy during surgery.

Causes

Patients are exposed to cold environments, surfaces, and liquids throughout surgical care.

Loss of peripheral vascular tone due to anesthesia results in redistributive hypothermia – cold peripheral blood recirculating at rates of -2°C per hour.1

Prevalence

Despite existing interventions, there remains a 38-56% incidence of inadvertent perioperative hypothermia (IPH).2,3

Approximately 50% of patients are hypothermic prior to start of surgery and 33% at end.4

Complications

IPH clinically linked to higher odds of SSI (4x), cardiac events (2.2x), mechanical ventilation (1.58x), and bleeding (1.2x), all drivers of preventable costs.5,6

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Market Opportunity

Currently, no warming solution helps maintain normothermia in a timely manner without impeding surgical site access and increasing the risk of surgical site contamination.

Over 100M patients annually undergo invasive or therapeutic surgical procedures at risk for developing inadvertent hypothermia. Patient warming and dynamic compression represent a $4.6 billion worldwide market with attractive growth rates and room for margin expansion.7,8 In the U.S. alone, over 58M procedures are at moderate to high risk for developing complications due to DVT and IPH.9

Leading healthcare regulators and organizations like CMS, NHS, NICE, and WHO remain unequivocally focused on reducing these complications.

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Flotherm Thermal Compression Device (TCD)

Flotherm TCD is a medical device that combines the power of dynamic compression with lower-limb warming to deliver greater control over perioperative safety. The TCD is the only non-invasive and non-surface area dependent solution to manage patient risk for IPH and DVT, driving perioperative compliance without changing existing surgical workflows.

Patient Safety and Usability

Engineered to maintain normothermia while delivering venous thromboembolism (VTE) prophylaxis in a single, patient-friendly solution

Clinical Workflow Integration

Novel design intended to obviate the risk of unintended surgical site contamination while preserving clinical access.

Clinical Evidence

Early clinical validation demonstrates superior management of normothermia compared to forced air warming.

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Contact Us

If you would like to inquire about a partnership opportunity or learn more about Flotherm and our technology, please submit the form below or email us directly.

General Inquiries: info@flothermtcd.com

References
  1. Díaz M, Becker DE. Thermoregulation: Physiological and Clinical Considerations during Sedation and General Anesthesia. Anesthesia Prog, 2010;57(1)
  2. John M et al. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia Br. J Anaesth. 2016;116(2)
  3. Torossian A et al. Active perioperative patient warming using a self-warming blanket (BARRIER EasyWarm) is superior to passive thermal insulation: a multinational, multicenter, randomized trial. J Clin Anesth. 2016;34
  4. Forbes SS et al. Evidence-based guidelines for prevention of perioperative hypothermia. J Am Coll Surg. 2009;209(4)
  5. Weirich TL. Hypothermia/Warming Protocols: Why Are They Not Widely Used in the OR? AORN J. 2008;87(2)
  6. NCCNSC. The Management of Inadvertent Perioperative Hypothermia in Adults. Royal College of Nursing. London (2008)
  7. Technavio. Global Patient Warming Devices Market, 2017-2021. (2017)
  8. Technavio. Global Compression Therapy Market, 2017-2021. (2017)
  9. Definitive Healthcare. All-Payor Inpatient Procedures by ICD-10 Code, Outpatient Procedures by HCPCS Code, and ASC Procedures by HCPCS Code. (2017)

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