De Motu Cordis Praises FDA Approval of Neffy® by ARS Pharma for Needle-Free Epinephrine

BRISBANE, Australia, Aug. 16, 2024 -- De Motu Cordis (DMC) has announced its strong approval and commendation for the U.S. FDA's recent approval of ARS Pharma's Neffy®, the first needle-free intranasal epinephrine delivery device for treating anaphylaxis. This landmark approval, revealed on August 9, signifies a major advancement in emergency treatment options for patients vulnerable to severe allergic reactions.

DMC regards this approval as a crucial validation of the 505(b)(2) regulatory pathway's relevance for anaphylaxis treatments. This pathway is particularly essential for emergency conditions like anaphylaxis, where extensive Phase 3 clinical trials may not be feasible. This development not only reinforces DMC's commitment to advancing its own clinical program, which aims to enable faster epinephrine absorption through inhalation (IH) administration, but also highlights the importance of offering more patient-friendly alternatives.

"We welcome the approval of a needle-free treatment alternative," stated Professor John Fraser, Founder, CMO, and Director at DMC. "The approval of Neffy® motivates DMC and the broader drug delivery community to continue innovating. We believe that quicker epinephrine absorption via inhalation could prove to be a valuable delivery method not only for anaphylaxis but also for other emergency medical treatments."

As DMC continues its development efforts, the approval of Neffy® boosts their dedication to providing advanced solutions to enhance patient care and safety in critical situations. "We anticipate more approvals of improved treatments for anaphylaxis over the next 3 to 5 years, driven by ongoing innovation and approvals of better delivery technologies," noted Peter O'Neill, Chief Executive Officer at DMC. "With these advancements, we expect the addressable patient market to grow by two to three times. Currently, in the U.S. alone, only 8% of individuals with type 1 severe allergic reactions have an active auto-injector prescription, indicating a significant unmet need."

DMC is actively developing DMC-IH1, a proprietary drug-device inhaler platform tailored for emergency medicine in community settings. This platform is designed for easy use by non-medically trained individuals, offering a more accessible and effective treatment option, particularly in scenarios where a rapid response is crucial.

About DMC
DMC is a clinical-stage pharmaceutical company founded in Brisbane, Australia, by Professor John Fraser, an Intensivist and pioneering clinician, researcher, and company founder. John is also the founder of the Critical Care Research Group and co-founder of BIVACOR Pty Ltd. Additionally, he co-founded the COVID-19 Critical Care Consortium, which collected over 35 million data points from ICU units worldwide and assisted in developing treatment pathways.

Since its inception, DMC has raised over US $21 million in Seed rounds, primarily in Australia. Most of the funding has been secured through the Queensland Business Development Fund, high net worth individuals, and Australian family offices. A Series A financing round is planned for the first half of 2025, ideally anchored by a U.S.-based venture capital firm.

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