The unmet clinical need to treat severe asthmatics is immense. The acute, chronic asthma patient population is represented by more than 2 million severe asthma patients in the U.S. and 8 million worldwide.  In addition, a 25% overall increase in patient population is projected by 2025.*

Opportunity

Twenty-five million Americans and at least 350 million people worldwide are known to suffer from asthma. For most people, asthma can be controlled with medication. Asthmatics often need multiple medications, such as high amounts of inhaled corticosteroids and long-acting beta-agonists. Medications, known as bronchodilators, such as albuterol, serve to relax the airway muscles and allow the airway to widen so asthmatics can breathe. Yet, for the 5-10%  of asthmatics whose condition is severe, breathing is difficult, even with a doctor’s help. For those who don’t respond to traditional therapy, new interventional procedures, such as bronchial thermoplasty, are now being considered to modify the bronchial smooth muscle and related anatomy of the airways.

Treatment options include: (1) conventional medication; and, (2) bronchial thermoplasty, a new bronchoscopic procedure intended for the treatment of severe persistent asthma in 
patients 18 years and older whose asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonists.  Bronchial thermoplasty is used for severe asthma that doesn't improve with inhaled corticosteroids or other long-term asthma medications.

Americans spend nearly $18 billion on asthma, annually. The majority, of which, is spent on treating the illness through emergency hospital visits and multiple medications, according to the Asthma and Allergy Foundation.[1] Historically, the treatment of asthma has been addressed pharmacologically, through inhaled agents and drugs administered orally and/or intravenously.

As related, ten (10) to fifteen (15) percent of patients suffer with severe persistent asthma.  These patients do not respond to treatment. Patients with severe persistent asthma, who do not respond to treatment, and may be candidates for surgical intervention, are significant.

  • In the US, those who may be candidates for surgical intervention equates to 2,590,000 to 3,885,000 patients
  • Globally, those who may be candidates for surgical intervention equates to 30,000,000 to 40,000,000 patients

These emerging, global patient populations make the emerging Asthma market one of the largest and most significant patient populations in the world whose clinical needs, currently, are unmet.

Boston Scientific, who acquired AsthmatX, Inc. in 2012, estimates the market for their Bronchial Thermoplasty System called Alair at over $1 Billion by 2020.[2]

Given that there are 6-8 million patients with symptomatic severe asthma not well controlled by drug therapy, BSX estimates a $200M market in 2015, growing to over $500M-$1B in 2020. BSX has launched Alair in China, India, Brazil and targets Japan in 2017.

Boston Scientific Trained more than 500 physicians in over 240 centers across 18 countries on the proprietary Alair®Bronchial Thermoplasty System for the treatment of drug-resistant asthma, a high-growth adjacency market we are steadily developing. 

Validated Product Concept

PulmoGeniX™  revolutionary physiologic metric acquisition, biofeedback (‘Pulmotonometer’) and Bronchial Smooth Muscle Neutralizer™ technologies were conceived to provide an intelligent, evidence-based  method to diagnose and treat asthma in the severe asthma patient. The system is a first-in-kind therapy, offering a suite of diagnostic and therapeutic tools, intended to provide physicians better control and precision in charting bronchial smooth musle characteristics before, during, and after smooth muscle modification. These features provide inherent advantages that will benefit the physician's ability to provide therapy quickly and cost effectively.
 

Extensive IP Protection

 
PulmoGeniX has numerous patents and patents pending for its breakthrough physiologic metrics-acquisition and biofeedback device, Pulmotonometer™, and its Bronchial Smooth Muscle Neutralizer™. The Mayo Clinic has additional patented IP. Specific details are subject to restricted access.

 

[2] Source: BSX 2012 Annual ReportSCIENTIFIC, CLINICAL AND LEGAL ADVISORS