MedTech Innovative Auto-Injectable Drug Device

XYMF1G - MedTech Innovative Auto-Injectable Drug Device

Broker is pleased to introduce an opportunity to invest in an innovative medical device company that has created a technologically disruptive, patent-protected emergency-use auto-injector on the cusp of FDA approval, as well as life-saving formulations to be used in its auto-injector. The Company’s first therapeutic indication is using epinephrine in its auto-injector for treating anaphylactic shock, with a plan to displace and ultimately replace EpiPen. The Company is pursuing both civilian (private sector) and military use of its auto-injector.

The Company’s auto-injector operates as a drug delivery platform that can deliver a wide range of injectable medications that range from relatively thin liquids to very thick biologic products and vaccines. This elegant technology has reinvented auto-injectors. In addition, the Company has developed a system to protect glass cartridges from breakage, and the technology can be out-licensed to other companies, potentially saving manufacturers millions of dollars in losses. Additionally, they have proprietary internal technology to extend the shelf-life of many drugs. The Company is also developing new formulations of emergency drugs to be delivered by auto-injector.

The auto-injector device is technologically superior, durable, easier to use, and less expensive than other auto-injectors on the market. As the world’s smallest (2.5”) wearable and lightweight, it is a game-changing solution for the military, first responders, and people who need to carry injectable medications for chronic conditions and emergencies. Marketing studies show it is preferred by patients and the military for its compact size and ease of use.

The Company will realize economies of scale by using the same basic design for multiple medications, including epinephrine, ketamine, hydromorphone, tranexamic acid (TXA), and the more challenging highly viscous biologics and vaccines. It expects to be able to profitably underprice competitors’ auto-injectors.

The worldwide auto-injector market size was estimated at $54.55 billion in 2021 and is projected to grow at a CAGR of 17.9% during the forecast period 2021-2030. Auto-injectors are usually used for self-administration of epinephrine (to mitigate anaphylaxis), by migraine sufferers who want quick relief of headaches, or even by the military and emergency services workers to combat the effects of nerve agents. North America led the global market in 2022 and accounted for a revenue share of over 30%.

The Company’s team includes a world formulations expert on epinephrine and other injectable drugs, a former Global Marketing Vice President of a leading auto-injector firm, and a retired General who led the military’s worldwide health services. The Department of Defense has awarded the Company 13 contracts to develop its auto-injector. These R&D contracts give the Company sole sourcing rights, which gives them the ability to sell the auto-injector to the US military without competitive bidding. These contracts are valued at $6.9 million, with $5 million currently active.

The Company is seeking $15 million of growth capital for the FDA approval process and manufacturing/operational start-up costs. The epinephrine product launch is expected in 2025, and the Company is forecasting $144 million in revenues in 2027 with a 37% EBITDA margin.