The Company is developing two different formulations for delivery of human hypo-glycosylated FSTL1 (hgFSTL1) to the human heart after infarction. These formulations enable integration with current standard-of-care coronary revascularization procedures, thereby transforming coronary revascularization into cardiac regeneration.
Delivery does not require new equipment or physician training and ensures rapid uptake of the therapy after FDA approval.
EpicaPatch: DIABETIC CARDIAC SURGERY MARKET
EpicaPatch delivers hgSTL1 in a collagen-based, sustained release formulation that is uniquely suited for diabetic heart attack patients who are usually treated with coronary artery bypass grafts (CABG).
Indications: Diabetes creates unique risks that render patients highly susceptible to cardiovascular events and with poor outcomes after revascularization compared to non-diabetics.
Diabetic patients with heart disease are five times more likely than the non-diabetic population to undergo coronary artery bypass graft (CABG) surgery. This provides a large existing clinical opportunity to apply the EpicaPatch to the heart at the time of CABG revascularization without adding surgical risk. Successful application of the EpicaPatch will add regenerative activity to the existing benefits of the CABG revascularization procedure, thereby improving cardiac function and reducing progression to heart failure.
There are 350,000 CABG surgeries per year in the US with annual costs of over $20 B.
MyoBead (microencapsulated hgFSTL1): INTERVENTIONAL CARDIOLOGY MARKET
MyoBead is a PLGA-based microsphere, sustained release formulation of hgFSTL1 that allows delivery of the regenerative protein during non-invasive percutaneous intervention.
Indications: Percutaneous Coronary Interventions (PCI) are utilized to open the obstructed coronary artery by balloon angioplasty and/or stent placement. Over 1.3 M PCI procedures are performed each year in the US with annual costs over $70 B. It is anticipated that most of these patients are candidates for Regencor’s combined revascularization/regeneration therapy that will include microencapsulated hgFSTL1 infused during the PCI procedure through the same catheter that performs the balloon angioplasty. Successful application of the MyoBead will add regenerative activity to the existing benefits of the PCI revascularization procedure, thereby improving cardiac function and reducing progression to heart failure.