High Flow Humidification Therapy (HfT)
High Flow Humidification Therapy (HfT) is an emerging technology, which is gaining acceptance for the treatment of multiple respiratory disorders in patient populations from newborns to adults (see Figure 1). HfT involves the delivery of warm, humidified air through a comfortably fitting nasal cannula at high flow rates, effectively providing respiratory support and increasing patient’s blood-oxygen concentration. Conditioning the breathing gases with heat and humidification is important as it eliminates the discomfort associated with the high flow rate and decreases the patient’s physiologic workload. The delivery of warm air affords the added clinical benefit of increasing body temperature.
Figure 1:
Prevalence of HFT-treatable disease in the U.S.
Source: CDC Summary Health
Statistics for U.S. Adults: National Health Interview Survey, 2005
Each year millions of people are hospitalized in the United States for respiratory diseases. Respiratory support for many of these patients uses invasive methods, which are associated with physical and psychological discomfort with significant morbidity and mortality. Each year 1.7 million patients require mechanical ventilation in the U.S. alone. This requires placement of an artificial airway in the trachea, which gives control over the airway and airflow. Unfortunately, 10% of these patients develop Ventilator Associated Pneumonia (VAP). This disease is costly in terms of recovery time, equipment, personnel, and is associated with high morbidity and mortality. Medicare is considering a policy of making the hospital responsible for all costs associated with VAP, as a method for promoting practices which decreasing the incidence of this complication. Non-invasive respiratory support can treat a large number of these patients, and for others it can help curtail the time they spend on a ventilator, and thus reduce their risks of VAP.
Respiratory
support is also required in many other patients with acute pulmonary
distress. Masks can deliver oxygen supplementation, but can be isolating for
the patients. Simple oxygen supplementation with a nasal cannula may not be
sufficient to oxygenate the patient. Chronic respiratory disease patients
may also require respiratory assistance for conditions such as upper airway
resistance syndrome, asthma, emphysema, or chronic obstructive pulmonary
disease (COPD). In addition, congestive heart failure patients have been
shown to benefit from HfT.
These conditions afflict a large portion of the US population. Heart disease
is the single leading cause of death in the U.S. If taken as a group,
however, emphysema, asthma and chronic bronchitis mortality rates exceed
those of heart disease. There are 13.5 million people in the US alone
diagnosed with COPD. Further, the number of deaths attributable to COPD
among women from 1980 to 2000 has nearly tripled.
Figure 2: Chronic obstructive pulmonary disease death rate, 1980-2000
Source: CDC, National Hospital Discharge Survey
HfT also has application for use in the treatment of OSA (a.k.a. treatment using nasal insufflation (TNI)) and during emergency admissions and post-operative recoveries. If established as a treatment for OSA, HfT devices could benefit from the favorable reimbursement provided by CMS to other CPAP therapy products.
Today, the
trend for respiratory intervention has shifted towards non-invasive
approach, whenever possible. Health care providers and insurance companies
have a strong preference to minimize invasive interventions as they are
linked to higher rates of infection, higher mortality and increased costs.
Furthermore, HfT may come to be preferred over conventional ventilation, as
the use of a non-sealing cannula, rather than an endotracheal tube, both
promotes patient comfort and therefore compliance, and lowers the risk of
ventilator-associated pneumonia (VAP), which currently accounts for nearly
half of all infections in intensive care units. As discussed above, the
incentive for health care providers to avoid VAP has increased with the
recent pronouncement that the associated liability will be shifted from CMS
to health care providers.
Furthermore, HfT can be used for weaning patients subsequent to extubation, during emergency admissions and post-operative recoveries. The disposables market will benefit from the numerous opportunities to treat (or attempt to treat) patients with HfT, as a new set of accessories will need to be used for each patient.
The Total U.S. Hospital Market
Mergenet Medical’s market research estimates place the potential hospital market demand for HfT at 237,000 systems —176,500 systems for hospitalizations requiring respiratory support, 10,000 for emergency department care, 20,000 for post-surgery treatment, and 30,000 for NICU therapy. The potential market demand for disposables is expected to grow to over 7 million sets per year in the next few years—3 million sets for hospitalizations requiring respiratory support, 500,000 for emergency department care, 3 million for post-surgery recovery, and 750,000 sets for the NICU market. The international hospital market is estimated to be four times the size of the U.S. hospital market.
Figure 3: Estimated HfT Systems: Total Market in the U.S. (thousands of units)
Source: Company estimates
Hospitalizations
There are
millions of hospitalizations for Respiratory Disease as primary diagnosis
every year. Some of the most prevalent have been for Asthma, COPD and
Pneumonia, which accounted for 484,000, 906,000, and 1,502,000
hospitalization in 2002.1 In addition, for every patient admission for COPD
as a primary diagnosis, four patients are admitted with COPD as a secondary
diagnosis. Those with both Heart Failure or Ischemic Heart Disease and COPD
have mortality rates 2 to 4 times higher than those without the COPD2, and
therefore such patients often require respiratory support.
The current trend in hospital care is to transfer patents to Long Term Acute
Care facilities rather than maintain them in a hospital environment after
intensive treatment is no longer required. Many of these patients are
transferred while still dependent on respiratory support.
In 1999, there were 2.8 million hospital transfers to long term care
facilities. Over 400,000 of these were for respiratory related diseases.
Thus, the number of hospitalizations of patients requiring respiratory
support is estimated to be in excess of 4.5 million each year in the U.S.
alone. If two thirds of them used HfT during their hospitalization, and the
utilization rate was similar to that for mechanical ventilators (17 patients
per ventilator per year), it would require approximately 176,500 systems to
serve this market, and 3,000,000 disposable sets.
Emergency Rooms
There were over 110 million emergency room visits in the U.S. in 2004.
Nearly 11 million of these were for symptoms of the respiratory system. Of
these 3.9 million patients had dyspnea or shortness of breath as their
principal complaint.
Mergenet Medical estimates there is a market for 8,000-10,000 HfT units for the
several thousand emergency departments and free standing acute care centers.
The Wave’s self-contained air supply gives considerable advantage over other
units. Each of these 10,000 units used once a week requires 520,000
disposable sets.
General Surgery
CPAP and other forms of respiratory support have been found to be effective in lowering the number of complications after surgery. Patients who are obese or otherwise at risk may benefit from respiratory support prior to surgery to improve respiratory function. After abdominal surgery respiratory support has been found to decrease complication rates and improve healing. Mergenet Medical estimates the Surgery Recovery Room market to be 20,000 systems. Being used an estimated 150 times a year, these units would require 3,000,000 disposable sets.
Figure 4: Estimated HfT
Disposables: Total Market in the U.S. (thousands of units)
Source: Company estimates
Neonatal
Intensive Care Units
Currently, HfT is more actively used in the NICU than in any other area
or the hospital. There are about 3000 NICUs in the U.S. Mergenet estimate
that the market for HfT system in the NICU is about 30,000 systems. The
disposables market to support these units is estimated to be 750,000
disposable sets.
HfT also has a number of effective acute care applications outside of
hospital facilities in the alternative care and long-term care markets.
Mergenet Medical also expects a solid growth rate in the critical care market of 20%
to 30% per year and an equally large home care market to develop in the next
2 to 3 years.
1 Centers for Disease
Control and Prevention, National Center for Health Statistics, National
Hospital Discharge Survey
2 Holguin, F et al. Chest 2005;128;2005-2011
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