South African Innovator Aims to Disrupt US Allergy and Asthma Care Market

BALTIMORE, MD – May 12, 2026 – A Cape Town-based healthcare company is poised to challenge the multi-billion-dollar US market for allergy and asthma treatments, armed with innovative devices designed to be more affordable, reusable, and user-friendly. Impulse Biomedical has officially been accepted into the Maryland Global Gateway Soft Landing Program, a strategic move that provides the company a crucial foothold for its American expansion.

The company is the developer of the ZiBiPen®, a world-first reloadable epinephrine auto-injector, and the Easy Squeezy®, an ergonomic sleeve for asthma inhalers. By establishing a US presence at The LaunchPort, a Baltimore-based Medtech manufacturing accelerator, Impulse Biomedical is taking its first concrete steps toward introducing its patient-centric solutions to American consumers and healthcare providers.

“We are truly honoured to be part of the program as establishing our US presence through the Maryland Global Gateway program is a pivotal milestone for Impulse Biomedical,” said Co-Founder Giancarlo Beukes in a statement. “The strategic support from the Maryland Department of Commerce and the specialised expertise at The LaunchPort will be key in smoothing our transition into the US market, ensuring we are well positioned for long-term success and impact.”

A New Prescription for Accessibility and Cost

Impulse Biomedical's product lineup directly addresses some of the most persistent criticisms of the current US market for allergy and asthma devices: high costs, single-use waste, and usability challenges.

The flagship product, the ZiBiPen®, is designed to disrupt a market long dominated by single-use devices like the EpiPen. The US epinephrine auto-injector market, valued at over $1.8 billion, has faced public scrutiny for the high price of its life-saving devices. Impulse's globally patented technology allows users to replace only the medication cartridge upon expiry, rather than disposing of the entire device. This reloadable model promises to significantly reduce long-term costs for patients and cut down on medical waste.

Complementing the ZiBiPen is the Easy Squeezy®, a patented sleeve that fits over standard metered-dose inhalers. It is designed to reduce the force needed to activate the inhaler by up to four times. This innovation tackles a common but often overlooked problem: many patients, particularly children, the elderly, and those with arthritis, struggle with the grip strength and coordination required for proper inhaler use. According to the company, the device is clinically proven to improve lung function and asthma control. With over 22,000 units already sold in South Africa and a recent launch in the UK, the Easy Squeezy has demonstrated a clear market demand.

Maryland's Global Gateway: A Strategic Launchpad

The decision to anchor its US entry in Maryland was a calculated one. The state has cultivated a robust life sciences ecosystem, and its Global Gateway Program is specifically designed to attract and support international companies. The program provides vital resources, including access to facilities, capital, and a network of industry advisors, effectively de-risking the complex process of entering the American market.

Impulse Biomedical has taken up residence at The LaunchPort, a Medtech accelerator that provides prototyping, small-batch manufacturing, and sterilization partnership opportunities. This residency gives the company immediate access to the physical infrastructure and industry expertise needed to advance its products through the rigorous US regulatory process.

Co-Founder Gokul Nair echoed the strategic importance of the location. “We believe that Maryland is the ideal launchpad for the ZiBiPen® in particular,” he stated. “The ecosystem offers a direct line to regulatory expertise, manufacturing infrastructure, and commercial partners essential for market disruption and of course, impact.”

Navigating the Gauntlet of FDA Regulation

Despite the warm welcome, Impulse Biomedical faces a challenging road ahead, particularly in navigating the U.S. Food and Drug Administration (FDA) approval process. Their products fall into different regulatory categories, each with its own set of hurdles.

The ZiBiPen®, as a drug-device combination product, will likely require a New Drug Application (NDA) or a 505(b)(2) application. This is a complex and lengthy process that involves intense scrutiny of both the drug (epinephrine) and the novel delivery device. The company will need to provide extensive data from human factors testing to prove that the reloadable mechanism is safe, effective, and intuitive for patients to use during a high-stress anaphylactic emergency. Ensuring the stability of the drug cartridge within the reusable device will also be a critical point of review.

The Easy Squeezy® faces a more straightforward, though still demanding, path. As an accessory to an existing device, it would likely be classified as a Class II medical device, requiring a 510(k) premarket notification. For this, Impulse must demonstrate that its device is “substantially equivalent” in safety and effectiveness to a legally marketed predicate device. This will involve performance data and biocompatibility testing to ensure the sleeve assists in medication delivery without compromising the drug's efficacy or patient safety.

From Cape Town to the World Stage

Impulse Biomedical's journey from a South African startup to a potential US market disruptor highlights a growing trend of innovation emerging from the African continent. The company's expansion has been significantly enabled by its investors, particularly ANZA Capital, a firm focused on backing African founders with global ambitions.

ANZA Capital facilitated the company’s move to Baltimore, leveraging its network to create a bridge to the US market. “ANZA is proud to back bold African Founders like Giancarlo and Gokul,” said Audrey Verhaeghe, CEO of ANZA Capital. “Through our Board Director, Robert E. Williams, we are pleased to facilitate this bridge to the U.S. for our portfolio companies, with Impulse leading the way.”

This strategic backing provides more than just capital; it offers the network and guidance necessary to navigate international expansion. During its residency at The Launchport, Impulse will focus on establishing local operations, engaging with regulators, and exploring manufacturing partnerships. The success of this venture could not only provide American patients with more accessible and affordable treatment options but also pave the way for more African-led innovation to make its mark on the global stage.