PuffIDO

Worldwide, more than 450 million people suffer from asthma and COPD—severe, chronic respiratory diseases. Yet, the inhalers currently available have critical limitations.

Non-pressurised inhalers require a high inspiratory effort that is often unattainable for children, the elderly, or patients experiencing an acute respiratory crisis, when inhaling deeply is virtually impossible. On the other hand, conventional pressurised inhalers can run out abruptly, without warning.

Beyond clinical shortcomings, there is an alarming environmental impact. Every year, millions of inhalers are discarded. Because most cannot be reused or recycled, they are incinerated. This creates a troubling paradox: to treat respiratory patients, we pollute the very air they breathe.

PUFFIDO solves these challenges.

PUFFIDO is an active, and the first world pressurised inhaler designed for universal ease of use: the puff actively propels the medication into the lungs, eliminating reliance on patient inspiratory force. However, unlike traditional pressurised inhalers, PUFFIDO does not use a pre-filled, disposable canister. It cannot run out unexpectedly, and it is fully reusable, refillable, and manufactured with bio-based materials.

To refill the device, PUFFIDO utilizes standard dry-powder formulations already widely available from specialized manufacturers. These capsules are repacked directly into our proprietary fast-refill cartridge system. Thanks to a modular architecture, replacing a single internal component allows us to support multiple product lines, making the platform highly versatile and scalable.

PUFFIDO unifies the core advantages of modern inhaler technology:

The effortless administration of a pressurised inhaler (under 30L/min standard inhaler deliver near 10% of drug, compared with more than 60% of PuffIDO);

The precise single- or multi-drug dosing of a dry-powder inhaler (DPI);

The sustainability of a multi-dose refillable system.

While existing refillable inhalers typically deliver only one dose per refill, PUFFIDO provides up to 200 inhalations per cartridge. Furthermore, the underlying technology is versatile enough to support powders, liquids, and gases.

Moreover, the therapy can be managed by a dedicated AI-based App.

The market opportunity is substantial. The global market for asthma inhaler devices alone exceeds €5 billion, with Italian patients spending over €145 million annually. Beyond asthma, our long-term vision includes reformulating selected oral therapies into fast-acting inhalable treatments, unlocking an addressable global market exceeding €500 billion.

Our commercial strategy relies on strategic partnerships with pharmaceutical companies and contract manufacturers, leveraging their established commercial networks while supplying them with finished, packaged, ready-to-sell products. We are collaborating with specialized medical-grade component manufacturers and powder-formulation CDMOs. PUFFIDO S.r.l. oversees device assembly, cartridge filling, and secondary packaging, enabling patients to access the system as a reimbursable therapy through public healthcare channels.

Our financial projections are grounded and low-risk:

Year 2: Break-even achieved at just 4% penetration of the Italian market.

Year 3: Full payback reached with a 12% market share.

Year 4 onwards: A steady, conservative growth rate of 2% annually.

Following funding, our roadmap is structured across clear milestones:

Year 1: Device validation and engineering freeze.

Year 2: Preclinical phase completion, paving the way for commercial launch by 2028.

Post-2028: Expansion into the liquid-formulation version of PUFFIDO.

This initiative is driven by a multidisciplinary team combining deep technical and clinical expertise:

Prototyping & Medical Device Engineering: 3D printing and hardware development.

Prof. Alessandra Rossi: Inhalation device performance analysis and physico-chemical testing.

Prof. Stefano Rossi: Preclinical pulmonary models and biological evaluation.

Alessandro Bortolani: Financial strategy and modeling.

Antonio Izzi: Legal affairs and intellectual property.

Giuseppe Avventuroso: Logistics and operations.

Despite being in our early stages, PUFFIDO has already gained significant industry validation, winning First Place at the Rotary Innovation Award and Second Place at the COPD Contest hosted by Sanofi and Regeneron.