Most patients skip this step, reducing effectiveness. • Technique dependency: Existing spacers rely on patients to breathe at the correct speed. Indicators like whistles confuse users, especially children or those with hearing impairments. The result? Over 90% of patients skip the spacer entirely, meaning medication coats the mouth and throat instead of reaching the lungs—reducing relief and increasing risks like infections from steroid residue.
The biggest challenge? Integration. “Everything was being developed independently, all the different features, the valve, the chamber, the interface, how the patient would interact with it. The biggest struggle all along was integrating every feature into a device that’s almost the size of a cell phone then doing it in such a way that’s mass manufacturable,” Hodgson explains.
“We were really trying to put ourselves in The solution: compact, intuitive, their shoes having an and effective attack while they were Hollo’s device addresses these pain points with a dishwasher-safe valved at home… trying to holding chamber made from a single take deep, slow breaths, material and one transformative feature: a FloCtrl that ensures patients but without, in that breathe properly each time. moment of panic, also The design also introduces haptic feedback, discovered during proto- having to worry about typing. “It was only during iteration technique.” that we discovered this unintentional feature—and we leaned into that,” Hodgson explains. Patients don’t want to have to think about breathing speed during an asthma attack. “A lot of times they’ll breathe in too quickly and the result of that is poor drug deposition to the lungs,” Hodgson says. The valve ensures slow, proper inhalation every time—without relying on visual or auditory cues. From 3D printing to market-ready design Early prototypes were 3D-printed— a cost-effective way to demonstrate the concept to investors, clinicians, and patients. “We were an extremely new start-up,” Fedullo notes. “3D printing is a fantastic technology to be able to bring your thoughts to life.”
Regulatory path and clinical validation Medical devices face strict regulatory scrutiny. Hollo’s is classified as a Class II device, meaning no full-scale clinical trials are required, but rigorous bench testing and documentation are essential. The team has already engaged the FDA for feedback and aligned their milestones with regulatory expectations. To validate design decisions, Hollo partnered with the IWK Health Centre for an observational study involving pediatric patients. While formal results are pending publication in 2026, early findings confirm strong patient preference for Hollo’s device and improved 17
performance of the flow control valve. “It was a great boost of confidence. We really wanted to make sure that before our product hit the shelves, we stayed focused on what was right,” Fedullo says. Looking ahead: personalization and empowerment Beyond functionality, Hollo aims to make inhaler spacers less clinical and more personal. “If you had to carry a chamber around all day, it is important that you actually like what it looks like!” Fedullo explains. Plans include aesthetic customization—colors, patterns— and functional personalization for patients with unique needs. A mission rooted in empathy For Hodgson, the mission is personal. His father developed chronic lung issues after severe pneumonia, transforming everyday tasks into exhausting challenges. “You take breathing for granted until you can’t do it anymore,” he reflects. “Seeing that struggle made this problem real.” Fedullo is grateful for the trust patients and clinicians have placed in them. “What I think truly keeps us going is knowing that there are patients who are looking forward to having this with them.” From a kitchen-table prototype to a near-market product, Hollo Medical exemplifies how engineering and empathy can solve overlooked problems. For patients living with asthma or COPD, that convergence could mean fewer barriers, better outcomes, and a breath of fresh air. For more information on Hollo Medical, visit: hollomedical.com