To commercialize a simple mixture, the company built an IP portfolio around the timing, delivery, and indications for GIK. Crucially, they secured a 'trifecta' of FDA support: Special Protocol Assessment, Breakthrough Designation, and a Biologic License Application, which grants 12 years of market exclusivity, creating a strong competitive barrier without a traditional drug patent.
The GIK solution (glucose, insulin, potassium) was known for decades and worked in animal studies where it was given immediately. It failed in human trials because it was administered six or more hours after a heart attack began. The key innovation was realizing the therapy's success hinges on immediate administration at the first sign of symptoms.
To ethically enroll patients in crisis (e.g., having a heart attack) who cannot provide informed consent, researchers use an FDA-approved method called 'Exception from Informed Consent' (EFIC). This involves pre-trial community outreach, interviewing likely patients and community groups to get their approval for the study to be conducted in their area, sidestepping the need for on-the-spot paperwork.
After a successful trial showed GIK could halve cardiac arrest and mortality, researchers were surprised it wasn't adopted. Pharmaceutical companies refused to manufacture the simple glucose, insulin, and potassium mixture because it didn't fit their business model of patenting a new drug and marketing it heavily. This forced the researchers to form their own company.
Of 7 million Americans annually who think they are having a heart attack, only a fraction are. Because the GIK therapy is extremely safe and non-toxic, it can be administered to all 3.5 million people with convincing symptoms. Treatment can be safely stopped for those not having an attack, ensuring the ~1.5 million who are get protected immediately, a strategy of 'treat broadly, then confirm'.