Regencor, Inc.
733 Industrial Road
San Carlos, CA USA 94070
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
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.
• If you are interested in learning more about the science behind our tech,check out our selected literature
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.
Issued Patents
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