FDA Clears 2 New Propeller Health Devices That Track Respiratory Meds

Xconomy Wisconsin — 

Propeller Health has received FDA clearance to sell two new devices to help chronic respiratory disease patients track their medication usage and better follow their recommended treatment regimens.

Founded in 2010, the Madison, WI-based company makes data-collecting devices that snap on to medication inhalers used by asthma and chronic obstructive pulmonary disease (COPD) patients. The devices can note the time and location for each use, information that is stored and wirelessly transmitted to a user’s smartphone or a Qualcomm base station plugged into the wall at home. Propeller says its system—which combines sensors, mobile apps, analytics, and individualized feedback for patients and their caregivers—can help lower healthcare costs associated with asthma and COPD by helping patients and doctors better understand the diseases, predict attacks, and reduce hospitalizations.

The FDA actions announced today extend Propeller’s market reach to new classes of inhalers not covered by prior agency clearances.

In July 2012, Propeller received FDA clearance to market its system for use with respiratory medications delivered via pressurized metered-dose inhalers, which propel aerosol-based medicine into the lungs. Medicines administered with such inhalers include albuterol, the most commonly used asthma medication, says Propeller co-founder and CEO David Van Sickle.

Two years later, the FDA gave Propeller the green light to sell its system with two new features: a low-energy inhaler sensor that requires no charging, and improved software analytics that the company says can help predict respiratory “exacerbations and identify worsening patients.”

Today, Propeller announced two more FDA decisions. One allows the company to market its system for use with asthma and COPD medications administered through GlaxoSmithKline’s Diskus dry powder inhaler. The other approval, which Propeller received in March, allows the company to market its system for use with COPD medications delivered by Boehringer Ingelheim’s Respimat inhaler.

The two new approvals represent “a big expansion of the potential market” for Propeller’s products, Van Sickle says. For example, asthma and COPD medication Advair—one of several medications that can be delivered with the Diskus inhaler—was prescribed 14 million times last year in the U.S., according to IMS Health data cited by Propeller. Spiriva, one of several medications administered with a Respimat inhaler, is one of the most common COPD treatments, Van Sickle says. (He didn’t have Spiriva prescription data readily available.) Both Advair and Spiriva are taken daily and used to proactively control the diseases, unlike so-called rescue inhalers that are used to relieve symptoms during a respiratory attack.

The FDA clearances spell an opportunity for Propeller to help more patients take better control over their respiratory diseases; collect more healthcare data for care providers and insurers; and, of course, potentially bring in more revenue for the company.

Advair and Spiriva “are both market-leading medications for patients with chronic respiratory disease,” Van Sickle says. “It’s increasingly important to capture this info about daily medications that are so important for controlling symptoms.”

Previously, a patient might be using Propeller’s system to monitor their albuterol use, while also taking Advair, for example. But Propeller wasn’t tracking the use of that second medication, Van Sickle says. With the additional FDA clearance, “we’re able to get both signals, which really gives us the most comprehensive picture of their daily approach to” managing respiratory disease, he says.

There are still more respiratory medication devices on the market and in development, and Propeller intends to continue seeking approvals to integrate its system with them, Van Sickle says. But the company is now much closer to its goal of using its data-tracking system to help deliver comprehensive population health programs for respiratory diseases, he adds.

The purple Diskus inhaler snaps into an electronic device developed by Propeller Health. Photo courtesy of Propeller.

The purple Diskus inhaler snaps into an electronic device developed by Propeller Health. Photo courtesy of Propeller.

Propeller’s team worked for more than a year developing the two new FDA-cleared devices, preparing them to attach to Diskus and Respimat inhalers and accurately track their usage, Van Sickle says. The process was trickier than with the company’s first product because the Diskus and Respimat inhalers are more complicated than traditional metered-dose inhalers. Dry powder inhalers, like Diskus, involve a patient clamping their lips around a mouthpiece and quickly breathing in the powder medicine. Respimat inhalers deliver a metered dose of medication in the form of a “fine mist,” without propellants like those used in traditional metered-dose inhalers.

An electronic device developed by Propeller Health snaps on to a Respimat inhaler. Photo courtesy of Propeller.

An electronic device developed by Propeller Health snaps on to a Respimat inhaler. Photo courtesy of Propeller.

With the two new devices, Propeller had to move from detecting mechanical actions—such as a patient pressing down on the top of the inhaler to release the medicine—to detecting the inhalation of the medication with an electronic sensor.

Propeller also added features with the two new devices, including a beeping noise and a flashing, multi-color LED light that alert patients when it’s time to take the medication, Van Sickle says.

He wouldn’t share revenue figures, but says the company is not profitable. Its business model is to partner with hospital systems, health insurers, employers, municipal governments, and other customers, who pay for the use of the devices and related services by their patients, members, employees, and citizens. Propeller’s products have been used by patients through more than 35 commercial programs across the U.S., and the company’s clients include Dignity Health in California, the Wyckoff Heights Medical Center in New York, and the city of Louisville.

The company has raised $23 million from investors including Safeguard Scientifics, The Social+Capital Partnership, Kapor Capital, the California HealthCare Foundation, Walgreen’s, and angel investors. It currently employs 42 people full time, up from 34 in September. Two-thirds of the employees are located in Madison, and the rest are mostly based in San Francisco, Van Sickle says.