IMMEDIATE Therapeutics adds Industry and Scientific Leaders to Advance IMT-358 Breakthrough Ischemic Therapy

Former FDA Cardiovascular Division Director Norman Stockbridge, M.D., Ph.D. joins SAB

Bradley Newman named Global Head of Manufacturing and Supply Chain

Chia-Wen Lee, Ph.D. appointed Global Head of Market Access

BOSTON--(BUSINESS WIRE)--IMMEDIATE Therapeutics, a clinical-stage biotecnology company, today announced key additions to its Scientific Advisory Board (SAB) and leadership team as it advances IMT-358, a late-stage therapy designed as a first-in-class therapy for acute coronary syndromes and other ischemic emergencies. IMT-358 is designed to enable immediate intervention at the point of care across prehospital and in-hospital settings. Joining the company’s SAB is Norman L. Stockbridge, M.D., Ph.D., former FDA Cardiovascular Division Director. IMMEDIATE has named industry veterans, Bradley Newman as Global Head of Manufacturing and Supply Chain, and Chia-Wen Lee, Ph.D. as Global Head of Market Access.

“We are developing IMT-358 to address a critical gap in acute cardiac care by enabling immediate treatment at the point of care — whether in prehospital or in-hospital settings — to stabilize ischemic injury before irreversible damage occurs,” said Atul Deshpande, Ph.D., MBA, CEO of IMMEDIATE Therapeutics.

“As we advance toward our pivotal Phase 3 trial with IMT-358, the key additions to our team will ensure clinical and regulatory alignment, a product that is readily accessible, can be administered in emergency settings, and integrates seamlessly into clinical care pathways and reimbursement frameworks.”

Acute coronary syndromes remain a leading cause of mortality and morbidity in the United States and worldwide. In the United States alone, more than 1.5 million patients experience an acute coronary syndrome each year, with an estimated 3–4 million patients presenting with symptoms potentially eligible for early intervention. While current therapies have improved survival, a significant portion of myocardial injury occurs before treatment begins — and in many cases, before patients reach definitive care. This early injury drives a broad range of downstream complications, including cardiogenic shock, arrhythmias, recurrent hospitalizations, and heart failure, which develops in 20–30% of patients.

Differences in infarct size are closely linked to long-term clinical outcomes. Patients with smaller infarcts are less likely to develop complications that lead to recurrent hospitalizations, long-term morbidities and healthcare utilization, contributing to tens of billions of dollars in annual healthcare costs. IMMEDIATE Therapeutics’ proprietary, field-deployable therapeutic system integrates formulation, delivery, and deployment to ensure that metabolic support is immediately available wherever ischemia occurs — enabling consistent early intervention and reducing the extent of damage patients carry with them to the hospital. Earlier attempts to address this biology were limited by delayed treatment timing and the lack of deployable systems; advances in both understanding of ischemic injury and field-ready delivery now make early intervention feasible at scale.

IMT-358 has received FDA Breakthrough Therapy Designation and is being advanced under a Special Protocol Assessment (SPA) with the FDA, within the Biologics License Application (BLA) pathway, with a single pivotal trial planned to evaluate clinically meaningful endpoints including in-hospital cardiac arrest, mortality, and infarct size.

Dr. Stockbridge brings more than three decades of experience at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, including over 20 years as Director of the Division of Cardiovascular and Renal Products. In that role, he helped shape the regulatory frameworks governing clinical trial design, cardiac safety evaluation, and benefit-risk assessment in cardiovascular medicine.

“The opportunity to intervene earlier in the ischemic cascade is both scientifically compelling and clinically important,” said Dr. Stockbridge. “The development strategy for IMT-358 reflects a clear understanding of both the underlying biology and the practical considerations required to evaluate it rigorously. I look forward to working with this team to help translate this approach into meaningful improvements in patient care,” he added.

Mr. Newman brings more than 30 years of experience in sterile solutions manufacturing, IV and injectable commercialization, and global supply chain strategy. He previously held leadership roles at Baxter BioPharma Solutions, where he supported large-scale partnerships and commercialization efforts for complex injectable therapies.

“IMT-358 represents a shift from a theoretical or compounded intervention to a rigorously engineered, field-deployable therapeutic system designed for consistent reliable use at the point of first medical contact,” said Mr. Newman. “Delivering on that vision requires more than a formulation — it requires a supply chain built for speed, reliability, and scale. Our focus is ensuring manufacturing readiness keeps pace with clinical and regulatory progress, so that when approval comes, we are ready to deliver.”

Dr. Lee is an epidemiologist with extensive experience in global market access strategy across NICE, Pfizer, Biogen, Sanofi, Moderna and Viatris. She has led the development of reimbursement and evidence-generation strategies in highly scrutinized therapeutic areas.

“IMT-358 presents a compelling opportunity to align clinical impact with healthcare system value,” said Dr. Lee. “We are proactively engaging with payers and health systems to ensure the therapy integrates seamlessly within existing care pathways and reimbursement frameworks, enabling broad and rapid adoption as clinical data continue to emerge.”

About IMMEDIATE Therapeutics

IMMEDIATE Therapeutics is a clinical-stage biotechnology company focused on redefining the treatment of acute ischemic conditions through early intervention. Its lead program, IMT-358, is a Phase 3–ready therapy designed for rapid deployment at the point of care across prehospital and in-hospital settings, with the goal of improving survival and preserving organ function across a range of acute care indications. Learn more at: www.immtx.com

Download the white paper THE UNPROTECTED WINDOW - Why the first hours of ischemia remain untreated — and how that may finally change.

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Media Contact
Atul Deshpande, Ph.D., MBA
CEO, IMMEDIATE Therapeutics
Phone: 908-210-3347, email: adeshpande@immtx.com
www.immtx.com