ADDED
There were 10,940,372 shares of the registrant s Common Stock issued and outstanding as of March 24, 2026.
Our CardiAMP autologous mononuclear cell therapy platform is being advanced clinically for two cardiac clinical indications based on the mechanism of action of treating microvascular dysfunction demonstrated by these cells in preclinical studies of enhanced microvascular density and reduced fibrosis: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI).
Our allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced clinically as an off the shelf cell therapy based on the immunomodulatory mechanism of action for the treatment of ischemic inflammatory HFrEF.
Our program for these same cells in acute respiratory distress syndrome has had its investigational new drug (IND) approved by FDA, but we have not yet advanced this program in the clinic.
Our therapeutic candidates intended for cardiac indications are enabled by our Helix transendocardial biotherapeutic delivery system, which enables minimally invasive catheter-based intramyocardial therapeutic delivery.
In 2024, the American Heart Association, or AHA, report on heart disease statistics estimated that nearly 6.7 million American adults ages 20 and older have heart failure and the prevalence of heart failure is expected to increase by 55% from 2012 to 2030, affecting greater than 8.5 million people aged 18 and above.
Our Product Candidates CardiAMP Cell Therapy System The CardiAMP Cell Therapy System is currently being advanced for two clinical indications: ischemic heart failure of reduced ejection fraction and chronic myocardial ischemia.
In the screening process, the physician extracts a small sample of the patient's bone marrow in an outpatient procedure performed under local anesthesia and tests for identified biomarkers to generate a cell population score for the patient.
Our Phase III randomized double-blind sham-controlled study (CardiAMP HF) data was presented at the Late-Breaking Clinical Trials symposium at the American College of Cardiology (ACC) Scientific Sessions in March 2025, with echocardiography clinical results presented at the Late Breaking Clinical Trial session at the Technology and Heart Failure Therapeutics conference in March 2026.
CardiAMP Phase III Trial in Ischemic HFrEF: The CardiAMP Cell Therapy Heart Failure Trial (CardiAMP HF) The CardiAMP Heart Failure Trial was a randomized, double-blinded, placebo procedure controlled, multi-center pivotal clinical trial for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).
REMOVED
There were 4,680,005 shares of the registrant s Common Stock issued and outstanding as of March 26, 2025.
We are advancing two cell therapy platforms derived from the bone marrow in clinical trials today.
Our CardiAMP autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI).
Our immunomodulatory allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced as an off the shelf cell therapy for two clinical indications: ischemic HFrEF (CardiALLO ), which is actively enrolling, and acute respiratory distress syndrome (PulmALLO ).
Our autologous CardiAMP and our allogeneic CardiALLO cell therapies intended for cardiac indications of HFrEF and CMI are enabled by our Helix minimally invasive intramyocardial therapeutic delivery platform.
In 2022, the American Heart Association, or AHA, report on heart disease statistics estimated that 6.0 million American adults ages 20 and older have heart failure based on data from 2015 to 2018 and the prevalence of heart failure is expected to increase by 46% from 2012 to 2030, affecting greater than 8 million people aged 18 and above.
Our Product Candidates CardiAMP Cell Therapy System The CardiAMP Cell Therapy System is currently being advanced for two clinical indications: ischemic HFrEF and CMI.
In the screening process, the physician extracts a small sample of the patient's bone marrow in an outpatient procedure performed under local anesthesia.
The clinic sends the sample to a centralized diagnostic lab, which tests for identified biomarkers from which we generate a cell population score for the patient.
In the fourth quarter of 2023, we completed enrollment in a Phase III randomized double-blind sham-controlled study (CardiAMP HF) and presented interim results in the first quarter of 2024.