All posts by : Pneuma Respiratory

BOONE, N.C., July 18, 2018 /PRNewswire/ — Pneuma Respiratory, Inc., which has developed PNEUMAHALER™^,, the first breath-activated digital inhaler (BDI), has raised $8.3 million in a Series A financing round.

Pneuma Respiratory, Inc. (“Pneuma”) has developed the PNEUMAHALER™ Breath Activated Digital Inhaler (BDI) to solve the problems of existing metered dose, dry- powder, and soft-mist inhalers to improve the efficacy of currently available airway medications. PNEUMAHALER BDI (“PNEUMAHALER”) is the first pulmonary inhaler to merge advanced droplet ejector technology with digitally controlled breath-actuation, and package it in a lightweight, pocket-sized device. Pneuma’s go-to-market strategy is to marry the powerful technology of its digital platform with off-patent drugs and create more efficacious treatments for asthma and COPD. Pneuma’s strategy aims to de-risk its clinical and regulatory pathway and create value by rebranding off-patent therapeutic treatments within its patented PNEUMAHALER system to improve treatments for patients in the $39+ billion global asthma + COPD market.

Eric Hunter, CEO and Founder of Pneuma Respiratory stated, ” We are extremely gratified by the response to our Series A capital raise and look forward to continuing Pneuma’s mission of developing greatly improved therapeutic treatments for patients who suffer from asthma and COPD.”

About Pneuma Respiratory

Launched in 2015, Pneuma Respiratory is a pharmaceutical company based in Boone, North Carolina. With a global team of researchers, physicians, designers and engineers, Pneuma has created PNEUMAHALER™, the first fully integrated digital breath activated inhaler.  The inhaled delivery system has integrated Bluetooth technology to provide feedback on drug delivery to patients, family members and health care providers. Using Pneuma’s [proprietary/patented] digital droplet ejector technology, Pneuma’s device, although currently available for investigational purposes only, has the potential to ultimately deliver a spectrum of novel therapies, including biologics, through the lungs. For more information visit www.pneumarespiratory.com

BOONE, North Carolina., April 16, 2018/PRNewswire/– Pneuma Respiratory, Inc. (Pneuma), which has developed PNEUMAHALERTM, the first fully digital breath activated inhaler (DBI), has hired Rich Gimigliano as Chief Financial Officer.

Rich Gimigliano brings over thirty years of Wall Street experience across a wide variety of investment banking and capital markets roles to Pneuma. He has been involved in a significant number of securities transactions with a broad range of investors over the course of his career. He joins Pneuma as the company pursues FDA approval for a portfolio of therapeutics targeting asthma and chronic obstructive pulmonary disease (COPD).

Gimigliano started his financial career at Credit Suisse First Boston (CSFB) as a member of the New York institutional equity sales and trading desk. He quickly rose to a senior production position covering institutional investors and was subsequently asked to join CSFB’s West Coast effort. After helping grow that team, he was recruited by Lehman Brothers where he ultimately managed the firm’s US equity sales trading business. Senior positions at Montgomery Securities and Thomas Weisel Partners led to increasing involvement in investment banking and transaction origination and execution. Over the last decade he has continued to focus on helping fast-growing companies access the capital markets.

“I am extremely excited and honored to join Pneuma Respiratory. CEO Eric Hunter has assembled a strong operating and advisory team and I look forward to working with them as we build the business and explore the public markets,” stated Mr. Gimigliano.

Mr. Walt Robb, Pneuma’s Chairman of the Board, stated, “As Pneuma Respiratory matures as a company, we are in need of a Chief Financial Officer with the type of experience and expertise that Rich brings. We are fortunate to have Rich join our team.”

Rich Gimigliano has a Bachelor of Science in Electrical Engineering with honors from Lehigh University and a Master of Business Administration from the University of North Carolina at Chapel Hill.

About Pneuma Respiratory

Launched in 2015, Pneuma Respiratory is a pharmaceutical company based in Boone, North Carolina. With a global team of researchers, physicians, designers and engineers, Pneuma has created PNEUMAHALER™, the  first fully integrated digital breath activated inhaler.  The inhaled delivery system has fully integrated Bluetooth technology to provide feedback on drug delivery to patients, family members and health care providers. Using Pneuma’s [proprietary/patented] digital droplet ejector technology, Pneuma’s integrated device, although currently available for investigational purposes only, has the potential to ultimately deliver a spectrum of novel therapies, including biologics, through the lungs. For more information visit www.pneumarespiratory.com.

People with respiratory conditions such as asthma will already be quite familiar with inhalers – and perhaps they don’t see any way in which the things could be improved. Nonetheless, North Carolina-based Pneuma Respiratory has developed what it states is the world’s first fully-digital soft mist inhaler. Among other things, it’s claimed to deliver medication more reliably.

With a regular inhaler, the user has to manually press the device’s release valve as they breathe in, drawing a mist of medication into their lungs. If they don’t time it right, they may not receive a full dose.

The digital inhaler senses when the user is inhaling, then automatically releases a mist via an electronic ejector. This is said to take the “guesswork” out of the process, ensuring that the medication gets fully delivered, plus no propellant is required.

Additionally, the device can be synced with the user’s smartphone, to keep a record of their treatment and thus verify that they haven’t missed any doses.

There’s no word on when the digital inhaler may be approved for widespread use – it’s currently still considered an investigational device.

BOONE, N.C., Dec. 14, 2017 /PRNewswire/ — Pneuma Respiratory, which has developed the first fully digital, breath-activated soft mist inhaler, will make two presentations at the BioTech Showcase during the 2018 J.P. Morgan Healthcare Conference.

In the first presentation, Pneuma leaders will showcase their integrated device’s ability to deliver multiple types of medicines, which could include large-molecule drugs used to treat non-small cell lung cancer. Such a development would allow Pneuma to disrupt the biologics market. Biologics have garnered significant attention due to their potential cancer-fighting abilities.

The Biotech Showcase presentation is scheduled for 10:15 a.m., Jan. 8 as part of the Franciscan – C track (ballroom level) at Hilton San Francisco Union Square, 333 O’Farrell St., San Francisco. James Bauler, Pneuma’s vice president of business development, will co-present with Dr. Steven Kesten, a pulmonologist with expertise in drug and device development.

The second presentation will highlight details of the novel technology that allows Pneuma to precisely deliver pulmonary drugs such as those used to treat asthma and COPD in a digital breath activated system. The system incorporates Bluetooth technology to monitor exactly when and how often medication is delivered. That presentation is scheduled for 2 p.m., Jan. 9 as part of the Digital Medicine & Medtech Showcase at BioTech. The presentation is part of the B-Cyril Magnin III track.

In recent months, Pneuma has garnered early attention from industry publications, including Mobi Health News, New Atlas and medGadget, due to its one-of-a-kind delivery system.

“The beauty of the Pneuma inhaler is its ability to deliver multiple types of medications through its use of disposable ampoules, breath actuation and electronic ejection,” Bauler said. “Our initial research has shown success delivering off-patent asthma and COPD medications, but we see tremendous potential to lead the successful delivery of large-molecule drugs through the lungs.”

“The enhanced device capability of knowing how often pulmonary drugs are actually delivered has the potential to improve compliance and health outcomes in patients suffering from asthma and COPD,” Kesten said.

As Bauler and Kesten will discuss at the conference, a novel part of Pneuma Respiratory’s digital soft mist device is its ability to deliver different sized droplets of medicine via its droplet ejector technology. This is the technology critical to potentially targeting different areas of the lungs in order to deliver biologics.

Pneuma’s technology allows medication droplets to ride into the lungs on the patient’s breath, without propellants. As a patient inhales, the ejector senses the breath and activates automatically. Early clinical studies have shown that the platform and this technology can effectively deliver a number of different types of medicines to the lungs.

Paired with a mobile app, the device is capable of delivering real-time dose verification data. Dose verification is important for health systems, doctors and patients who are concerned with drug use and compliance.

About Pneuma Respiratory
Launched in 2015, Pneuma Respiratory is a pharmaceutical company based in Boone, North Carolina. With a global team of leading researchers, physicians, designers and engineers, Pneuma has created the world’s first fully integrated digital soft mist inhaler. Using exclusive digital droplet ejector technology, Pneuma’s integrated device has the potential to ultimately deliver a spectrum of novel therapies, including biologics, through the lungs. For more information visit www.pneumarespiratory.com.

Formed just two years ago, pharma startup Pneuma Respiratory is developing a digital inhaler that it touts as the first of its kind.

The company is looking to bring its technology to the more than 40 million people who suffer from asthma or chronic obstructive pulmonary disease in the U.S. They’re stepping into a highly competitive market, largely dominated by companies like GlaxoSmithKline (NYSE:GSK) and Merck (NYSE:MRK).

“Pneuma Respiratory is made up of a team of really seasoned executives coming out of General Electric (NYSE:GE), Cree (NSDQ:CREE), Merck, Pfizer (NYSE:PFE) – there are a lot of big company names involved with the team,” director of business development James Bauler told Drug Delivery Business News. “So, while we’re a somewhat early-stage pharma [company], the team of executives have years of experience in the industry bringing new products to market and growing very successful companies. It’s really a great team to be a part of.”

Although there are other groups looking to digitize and connect inhalers, like Propeller Health, Bauler said that Pneuma Respiratory’s technology stands out.

“If you’re take another smart inhaler that’s on the market, what you’d find is that you actually purchase the inhaler itself separately and then there’s a couple of different approaches out there, but you’re going to get an add-on device that you snap on, maybe to the top of your inhaler or maybe to the end of your inhaler, and that little snap on device does nothing to alter the way that the drug itself is delivered.”

Pneuma Respiratory’s inhaler pairs with a mobile app, giving patients real-time dose verification data. It also features electronic breath actuation – the device is triggered when the user begins to inhale, drawing the medicine into the user’s lungs.

Most inhalers on the market have a propellant built into the device to shoot droplets of medicine into the user’s mouth, Bauler explained. But that can result in droplets hitting the back of the patient’s throat or depositing into the patient’s mouth.

Pneuma Respiratory’s device doesn’t use a propellant, instead relying on the device’s breath actuation feature to help the droplets ride on the user’s breath and into the lungs.

The company has completed two proof-of-concept trials so far, Bauler said, comparing its device in COPD patients with published data for devices made by competitors.

The team has arranged pre-submission meetings with the FDA for the first quarter of 2018, according to Bauler, and hopes to bring their product to market by 2020.

“We’re planning to build out in the asthma and COPD space, and so we have a portfolio of therapies over the next several years that we plan to bring to market. What’s really, really exciting about the platform is that we set out to disrupt the inhaler space, but then what we found along the way is that we’ve also delivered three large molecule biologics,” Bauler said.

“So, we have a go-to-market strategy that’s focused on asthma and COPD, but we have the upside potential of ‘what does it look like to deliver large module biologic therapies through the lungs through our platform?’ That’s the long-term growth opportunity that we have in front of us.”