A proprietary protein, delivered subcutaneously, that stimulates heart
regeneration after cardiac injury
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
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
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.
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).
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).
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.
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.
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
Will provide COM protection for the API until at least 2035