HELP Therapeutics Announces Nature Medicine Has Published HiCM-188 Clinical Trial Data for Advanced Ischemic Heart Failure

NANJING, CHINA, August 20, 2026 - (ACN Newswire) - Aug 19, HELP Therapeutics today announced the Nature Medicine publication of 12-month results from the HEAL-CHF clinical trial evaluating HiCM-188, an investigational allogeneic human iPSC-derived cardiomyocyte (hiPSC-CM) therapy for the treatment of severe ischemic heart failure. The randomized controlled trial enrolled 20 patients, assigned 1:1 to receive either coronary artery bypass grafting (CABG) alone or CABG combined with transepicardial HiCM-188 injection. The study achieved both pre-specified primary safety endpoints, demonstrating no treatment-related tumor formation through 12 months and no sustained ventricular tachycardia through 6 months. At 12 months, 90% of patients receiving transepicardial HiCM-188 injection combined with (CABG improved to NYHA Class II, versus 60% of patients in the CABG-only group..

"HEAL-CHF provides the first clinical evidence that delivering HiCM-188 intraoperatively during CABG may combine the benefits of revascularization with myocardial regeneration," said Professor Dongjin Wang, Lead Author and Director of the Department of Cardiothoracic Surgery at Nanjing Drum Tower Hospital. "Over 12 months, we observed no serious cell-related adverse events alongside encouraging signs of reverse cardiac remodeling. Given the substantial global burden of heart failure and the persistent shortage of donor hearts, regenerative approaches like HiCM-188 have the potential to fill a critical unmet need for patients living with end-stage disease."

"The publication of the HEAL-CHF study in Nature Medicine reflects years of dedication to advancing breakthrough stem cell technologies into clinically validated therapies," said Dr. Eugene Jiaxian Wang, Chief Executive Officer of HELP Therapeutics. "With our pivotal Phase III trial now enrolling patients in China and our Phase I program initiating in the U.S., we are eager to maintain this momentum as we work toward bringing a new regenerative medicine breakthrough to heart failure patients worldwide."

About HiCM-188

HiCM-188 is an investigational allogeneic human induced pluripotent stem cell-derived cardiomyocyte (hiPSC-CM) therapy designed as a standardized, off-the-shelf product for scalable manufacturing and distribution. HiCM-188 is the first iPSC-derived cardiomyocyte therapy worldwide to obtain Investigational New Drug (IND) clearances from both the U.S. FDA and China's NMPA. It is currently being evaluated in a multicenter Phase III trial in China led by TEDA International Cardiovascular Hospital, and a Phase I trial in the United States at the Texas Heart Institute.

About HELP Therapeutics

Founded in 2016, HELP Therapeutics is a global clinical-stage biopharmaceutical company developing iPSC-based cell therapies for cardiovascular and other degenerative diseases. The company leverages proprietary off-the-shelf cell therapy platforms and national iPSC bank infrastructure to ensure scalable clinical and commercial delivery. HELP Therapeutics has established a commercialization partnership with China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. (SZSE: 000999) to build out distribution infrastructure in China. For more information, please visit https://en.helptherapeutics.com.

Disclosure Notice

The information contained in this release is as of August 19, 2026. HiCM-188 is an investigational product and has not been approved for commercial use by the U.S. Food and Drug Administration, China National Medical Products Administration, or any other regulatory authority. This release contains forward-looking statements regarding HiCM-188, including potential clinical benefits and regulatory development timelines, which involve substantial risks and uncertainties that could cause actual results to differ materially.

References & Publication Details

1.Journal: Nature Medicine (2026) DOI: 0.1038/s41591-026-04605-1
2.Clinical Trial Registry: ClinicalTrials.gov (NCT03763136)
3.Ethics Approval: Nanjing Drum Tower Hospital IRB (No. SC202000102); National Health Commission of China (MR-32-21-014649)