Asthmatx Following the Leaders In Defining Alair Sales Strategy

Asthmatx is adopting the commercial strategy of high profile successes including Kyphon, Acclarent, Novacept, Fox Hollow Technologies to roll out its Alair broncial thermoplasty system, which recently received approval from the FDA.

Asthmatx Inc. hasn't taken any chances in its seven-year pursuit of a Premarket Approval of its Alair Bronchial Thermoplasty System as a treatment for the most severe cases of asthma . In 2007, the company withdrew its plans to attempt an IPO in a rocky market and accepted a $50 million investment from Olympus Medical Systems Group, a division of Olympus Corp., in exchange for 15% of the company. [See Deal] [See Deal] ( See "Asthmatx Breathes Easier," IN VIVO, October 2007. (Also see "Asthmatx Breathes Easier" - In Vivo, 1 Oct, 2007.)) Earlier on, the company wanted to leave nothing up to an advisory panel's discretion so it negotiated a rigorous clinical trial regimen for its catheter and bronchoscope, putting the Alair system through four separate clinical trials, with three of them randomized and controlled, just to prove beyond a doubt that the device worked.

The hard work paid off. Last fall, an FDA panel found the results of the trial to be conclusive enough to recommend approval. ( See "Asthmatx Positive Panel Outcome Good Sign for Pulmonology Companies," IN VIVO, November 2009 (Also see "Asthmatx Positive Panel Outcome Good Sign for Pulmonology Companies" - In Vivo, 1 Nov, 2009.).) The FDA followed the recommendation last month, awarding Asthmatx the first high-profile approval for a therapeutic medical device in the interventional pulmonology field. CEO Glen French is understandably proud of the approval, particularly because of the company's extensive clinical trial regimen. "None of the other [high profile device companies] had the amount of data that we have," he says. "Not even close. None of them did a sham-controlled study, which is what our pivotal was."

With FDA approval in hand, Asthmatx's commercialization strategy will also play it safe, French says. The innovative nature of Alair, which slips a catheter into the lung's airways, where it delivers radiofrequency energy to burn the lung tissue that swells and causes asthma attacks, lends itself to same path as several high profile medical device companies that recently commercialized unique and novel products. French is following the playbook employed by Johnson & Johnson's Acclarent Inc. ( Sinuplasty), ev3 Inc.'s FoxHollow Technologies Inc. ( SilverHawk), Medtronic PLC's Kyphon Inc. ( KyphX), and Hologic Inc.'s Novacept Inc. ( NovaSure), four companies that he considers "best in class" in "driving rapid adoption" of novel new treatments. Asthmatx, French says, will start with a relatively small sales force – just seven people – to begin selling to a handful of influential interventional pulmonologists. Once a center is in place, Ashtmatx will work to drive traffic to their clinic, doing so by educating physicians in the immediate and surrounding geographies of a "really revolutionary new approach" to provide some relief to people with severe asthma.

French says Asthmatx already enjoys a degree of notoriety in bronchial circles. "Our research suggests that at least 80% of pulmonologists – and approximately half of the allergists – in the United States are well aware of what we're doing," he says. Physicians began calling Asthmatx as soon as the company received positive news from the FDA, and several hospitals issued press releases announcing their offering of the Alair system. Virginia Hospital Center in Arlington, VA, declared itself to be the first hospital in the US to offer the bronchial thermoplasty device. David Duhamel, MD, Director of Pulmonary Special Procedures and the Lung Cancer Center at Virginia Hospital Center, says the center had served as a clinical site in Asthmatx's second clinical trial. "We were very comfortable with it," Duhamel says. "We treated a lot of our own patients and hospital employees here who have severe asthma. We were very comfortable with the patient response; it's a miraculous type of response."

Duhamel cautions that patients undergoing the procedure aren't going to be running marathons or throwing away their rescue inhalers, but it does alleviate symptoms by burning away the smooth muscle that constricts airway passages. French says asthma generates 10 million unscheduled office visits every year in the US. "All of these physicians are experiencing every day the impact of patients not being well controlled on their asthma medications," he says. "So we're really delivering not only a solution for their patients, but also something that allows them to realize greater efficiency in the management of their practice, in addition to being able, for the first time, to offer a solution to those patients who are taking high dose drugs and yet are still symptomatic."

French says Alair will also provide pulmonologists – who have been watching the success and failures of interventional pulmonology start-ups – the potential for increased traffic. "One of the things that they find most interesting is the potential volume of patients that these disease areas can bring to them. Right now the folks doing interventional procedures for pulmonology aren't realizing great efficiency because the volume is not there," French says. A gastrointestinal endoscopist could find him or herself performing 10 or 20 procedures today, thanks in part to the recommendation of regular colonoscopies for men over 50. At the moment, a pulmonary endoscopist "might do a procedure or two, and then go back to his office, and then maybe do some procedures the next day or later on that week." Duhamel says the addition to his armamentarium is welcome, adding that interventional pulmonologists or bronchoscopists have seen a rise in tools available to them including superDimension Ltd.'s Electromagnetic Navigation Bronchoscopy, Accuray Inc.'s CyberKnife and the endobronchial ultrasound procedure by Olympus.

The only uncertainty facing Asthmatx is who is going to pay for the device. Asthmatx hasn't secured reimbursement codes or insurance coverage for the procedure. French says the novelty of the procedure provided Asthmatx with no comparable treatments to establish reimbursement so it couldn't secure codes without FDA approval. He's convinced Asthmatx can justify the expense to CMS, doctors groups and private payors as a regimen of treatments with Alair can reduce the number of asthma attacks, visits to the ER, hospitalizations and days lost from work. Asthmatx has had a vice president-level person in charge of securing payment for five years. The Alair system itself costs $30,000, he says, and can be secured through a number of financing options. Each of the catheters used in the three-stage device costs $1,500, so the entire procedure costs $4,500. With annual payments for high-powered prescription drugs at $20,000 per year, it won't be difficult for insurers to justify the cost of the procedure. If Asthmatx successfully follows the example of those four first-in-class companies, perhaps it will follow their ultimate path as well: lucrative acquisition by strategic buyers.

--Tom Salemi