Our Technology

The Discovery

Inducing Cardiac Regeneration in Humans

The devastating impact of myocardial infarction is a result of the inability of the adult human heart to regenerate after injury.  Cells in some other tissues, such as skin and bone, will proliferate to rebuild damaged tissue.  In the heart, however, once damage occurs, it is permanent...until now.

The founders of Regencor have discovered that a non-glycosylated variant form of FSTL1, which is not normally present in humans, can promote cardiac regeneration.  This proprietary protein can drive human cardiac muscle proliferation in vitro, and heart regeneration in adult mammals after myocardial infarction.

  • The regenerative protein safely promotes:

  • New cardiac muscle growth

  • New myocardial blood vessel formation

  • Significant scar reduction

  • Significant recovery of cardiac function

Our Product

Subcutaneous Sustained Delivery via Pump

We are developing a Subcutaneous Sustained Release Fomulation for the API (Non-Glycosylated FSTL1). The pump can deliver the API over 30 days as an outpatient.

Evolution of the subcutaneous pump formulation

01 EpicaPatch

Proof of concept for the regenerative activity of our API was first demonstrated in mice and adult pigs using a depot collagen patch (EpicaPatch) applied over the surface of the infarct zone. The EpicaPatch was designed to be a back-up formulation compatible with coronary artery bypass surgery (CABG).

02 MyoBeads

The regenerative activity of our API was confirmed in adult pigs using a second developmental depot formulation, PLGA microparticles (MyoBeads) infused through the infarct related artery directly into the infarct zone. The MyoBeads were designed to be a back-up formulation compatible with percutaneous coronary intervention (PCI).

03 Subcutaneous Sustained Delivery via Pump

The successful demonstration of regenerative activity in both the acute MI and the chronic heart failure settings using the EpicaPatch and the MyoBeads led to the development of the commercial API formulation that can be delivered via a pump as an outpatient.The pump delivery formulation will be used to treat both acute MI and chronic heart failure patients.

• If you are interested in learning more about the science behind our tech,check out our selected literature

The unique elements of regencor’s therapeutic approach:

Potential to cure heart failure

Our recombinant protein reverses tissue damage, restores cardiac function, and prevents progression to heart failure after MI.

Candidate for accelerated FDA approval

Likely designated as regenerative medicine advanced therapy.

Simple critical path for development

Does not utilize complex biologicals that must be delivered by injected vectors or cells.

Straightforward clinical implementation

Outpatient subcutaneous administration.

Deep market penetration

Our formulation is designed for use in both the acute MI & the chronic heart failure markets.

Established proof of safety & efficay

Demonstrated in both small and large animal studies.

Intellectual Property

US 8,975,230 B2  & US 8,329,650 B2

Inventors: Walsh et al. Method of treating ischemic injury with follistatin-like 1 polypeptide.

Abstract: Described herein are methods and compositions related to the discovery that the Follistatin-like 1 protein (Fstl-1) has metabolic and cardioprotective effects in vivo. Fstl-1 and portions and derivatives or variants thereof can be used to treat or prevent metabolic diseases or disorders and to treat or prevent cardiac damage caused by interrupted cardiac muscle blood supply.

US 10,149,922 B1

Inventors: Ruiz-Lozano et al. Engineered collagen matrices for myocardial therapy.

Abstract: Disclosed is a patch system for use in a patient with a damaged heart. The patch comprises both a biodegradable engineered collagen scaffold to provide structural support to the injured heart and therapeutic agents, which are delivered by the patch to the heart. The scaffold consists of a dense collagen lamella produced by plastic compression with biomechanical properties that make it compatible with beating heart tissue, e.g. stiffness in a predefined range. One therapeutic agent, Fstl1, is shown to induce cardiomyocyte proliferation and enhance cardiac regeneration after injury. The patch can also be loaded with functionalized nanoparticles to yield multi-modal imaging capabilities in vivo. Also disclosed is a method for implanting the patch onto a patient's heart.

US 10, 682,416

Inventors: Ruiz-Lozano et al. Epicardial-derived paracrine factors for repairing cardiac tissue.

Abstract: Provided herein, inter alia, are compositions and kits comprising epicardial-derived paracrine factors (such as, hypoglycosylated follistatin-like 1 (FSTL1)) for treating and repairing damage to cardiac tissue caused by cardiovascular disease, myocardial infarction (MI), other ischemic events, or cardiac-growth deficiency, as well as methods for using the same.

  • Highlights of this patent family:

  • Composition of Matter, Pharmaceutical Compositions and Uses of Hypoglycosylated FSTL1 issued in the US, Japan and Australia

  • Clean ISR & WO by International Search Authority

  • Entered National Phase: US, Canada, Europe, Australia, Japan, China (Oct 9th, 2017)

  • Will provide COM protection for the API until at least 2035