Summary

• Edinburgh-based 1nhaler has secured £2.2 million in follow-on funding led by Archangels, supported by Scottish Enterprise and BBB Investments.
• Its lead product combines a predominantly cardboard, single-dose dry powder inhaler with salbutamol, an established asthma medicine.
• The funding will support manufacturing transfer, a small clinical trial, and a regulatory submission targeted for late 2027.

Edinburgh-based medical technology company 1nhaler has secured £2.2 million to advance its predominantly cardboard inhaler into clinical testing, supporting the transition from device development towards a regulated pharmaceutical product.

The follow-on investment was led by Archangels, with participation from Scottish Enterprise and BBB Investments. It will finance further development of 1nhaler Salbutamol, which combines the company’s patented dry powder delivery system with an established medicine used to relieve asthma symptoms.

The programme includes transferring manufacturing to an external production partner, preparing material for a small clinical trial, and undertaking the work needed for a regulatory filing targeted for late 2027. Funding will also support a manufacturing engineering study with German pharmaceutical equipment specialist Harro Höfliger.

The device differs from conventional inhalers in both its construction and operation. Made predominantly from cardboard, it is designed to remain flat until needed, then unfold into a three-dimensional inhaler capable of delivering a single dose of powdered medication.

Device design changes the delivery mechanism

Inhaled medicines are widely used to treat respiratory conditions because they can deliver medication directly to the lungs. Different inhaler designs achieve that delivery in different ways, with requirements determined by the formulation, intended dose, and characteristics of the patient using the device.

Pressurised metered-dose inhalers use a propellant to deliver medication, while dry powder inhalers rely on the movement of air and the device’s dispersion mechanism to make powdered medicine available for inhalation.

1nhaler’s single-dose platform uses a patent-protected membrane system intended to disperse the powder when the device is operated. Its flat format measures approximately the size of a credit card before being expanded for use.

Reducing the amount of plastic and the number of components could change the manufacturing and distribution requirements associated with the device. However, the materials must still maintain the characteristics needed for dependable medicine delivery throughout storage, transport, and patient use.

Cardboard is sensitive to environmental conditions, making packaging, moisture protection, and mechanical integrity relevant considerations during development. The unfolding mechanism must also operate consistently so that a patient can prepare the device correctly.

The medicine delivery system presents separate requirements. Dry powder formulations must disperse appropriately, with the resulting dose and particle characteristics suitable for the intended treatment.

These properties cannot be established from the device’s size or materials alone. Development testing must demonstrate that the complete product delivers medication reliably under the conditions in which it is expected to be used.

Salbutamol provides the initial application

1nhaler has selected salbutamol for its first product, allowing the company to develop the platform around a medicine with an established therapeutic role.

Using a familiar medicine provides a basis for evaluating the new delivery system, but it does not remove the need to demonstrate the performance of the proposed formulation and device combination.

The amount of medication reaching the patient depends on the device, the powder formulation, and how it is operated. Regulatory evaluation must therefore address the characteristics of the complete product rather than relying exclusively on the existing evidence for salbutamol delivered through other inhalers.

The latest financing will support production of clinical trial material through a contract manufacturing arrangement. Transferring a process into a different manufacturing environment requires the company and its partner to establish consistent methods for producing, assembling, packaging, and testing the device.

Manufacturing procedures also need to provide traceability and quality controls suitable for clinical development. These requirements become more demanding as a product moves from laboratory preparation towards batches intended for use in patients.

The proposed small clinical study will contribute evidence for the regulatory programme. Its detailed design, participant numbers, and assessment measures have not been disclosed in the funding announcement.

The company’s late-2027 filing target is consequently a development milestone, not a confirmed regulatory approval date. Any subsequent authorisation will depend on the evidence submitted and the review undertaken by the relevant regulator.

Manufacturing scale becomes a separate test

Alongside clinical preparation, 1nhaler is working with Harro Höfliger on the engineering requirements for commercial manufacturing.

Producing a medical device at substantial volume requires more than repeating a successful prototype. Components must be manufactured within defined tolerances, materials must remain consistent, and assembly processes must produce devices that function reliably.

The intended advantages of a predominantly cardboard construction will depend partly on whether these requirements can be achieved using efficient equipment and materials suitable for pharmaceutical production.

A simple physical design may reduce some manufacturing operations, although total costs also include quality assurance, packaging, testing, and the handling of components that do not meet specification.

The engineering study will help establish how the device can be produced at commercial volumes and what changes may be necessary before the manufacturing process is ready for wider use.

1nhaler has previously worked with pharmaceutical manufacturing partners, and its development team includes experience from established inhaled medicine programmes. Chief scientific officer Helen Muirhead formerly led GSK’s Respiratory Centre of Excellence, while chief medical officer Lars Larsson has held senior clinical development roles at AstraZeneca and Novartis.

That expertise is relevant as the company moves into clinical and manufacturing validation, although the eventual commercial outcome will depend on the performance of the product submitted for approval.

Environmental benefits require lifecycle evidence

1nhaler is also positioning its device as an alternative to inhalers containing substantial plastic components or propellants.

The predominantly cardboard construction and absence of a propellant could reduce particular material and environmental impacts. However, the total footprint of the device will depend on material sourcing, production energy, protective packaging, transportation, and disposal.

Its single-use format introduces another consideration because each administered dose requires a separate device. Comparisons with established products must therefore account for the number of doses delivered and the complete lifecycle of the equipment involved.

The company has not disclosed a comprehensive comparative lifecycle assessment in the latest funding announcement, so the environmental proposition remains a development and commercial consideration rather than a quantified benefit independently established for every application.

The platform could also be adapted for medicines beyond salbutamol. 1nhaler has identified potential applications involving other respiratory treatments, pain relief, and vaccines, although each would require suitable formulation development and regulatory evidence.

Commercial partners will need to assess whether single-dose delivery offers practical advantages for particular treatments, taking account of patient needs, dosing frequency, storage, and manufacturing requirements.

The £2.2 million investment provides resources for the next phase of that work. Manufacturing transfer, clinical testing, and preparation of the planned regulatory submission will determine how far the company can advance its lead product towards approval and establish a foundation for further applications of the inhaler platform.