BOSTON — IMMEDIATE Therapeutics has added a former U.S. Food and Drug Administration cardiovascular division director to its scientific advisory board and appointed two industry veterans to leadership roles as it advances IMT-358, a late-stage therapy for acute coronary syndromes and other ischemic emergencies.
The Boston-based clinical-stage biotechnology company said Norman L. Stockbridge, M.D., Ph.D., former FDA Cardiovascular Division Director, has joined its scientific advisory board. The company also named Bradley Newman as global head of manufacturing and supply chain and Chia-Wen Lee, Ph.D., as global head of market access.
IMT-358 is designed as a first-in-class therapy that can be administered at the point of care in prehospital and in-hospital settings. The company said the therapy is intended to stabilize ischemic injury before irreversible damage occurs.
“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 death and serious illness in the U.S. and worldwide. IMMEDIATE Therapeutics said more than 1.5 million patients in the U.S. experience an acute coronary syndrome each year, with an estimated 3 million to 4 million patients presenting with symptoms that could make them eligible for early intervention.
The company said a significant share of myocardial injury occurs before treatment begins, often before patients reach definitive care. That early injury can contribute to complications including cardiogenic shock, arrhythmias, recurrent hospitalizations and heart failure.
IMT-358 has received FDA Breakthrough Therapy Designation and is being advanced under a Special Protocol Assessment with the FDA through the Biologics License Application pathway. IMMEDIATE Therapeutics said it plans a single pivotal trial evaluating endpoints including in-hospital cardiac arrest, mortality and infarct size.
Stockbridge spent more than three decades at the FDA’s Center for Drug Evaluation and Research, including more than 20 years as director of the Division of Cardiovascular and Renal Products. The company said he helped shape regulatory frameworks for 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.
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.
“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.”
Lee is an epidemiologist with experience in global market access strategy across NICE, Pfizer, Biogen, Sanofi, Moderna and Viatris. The company said she has led reimbursement and evidence-generation strategies in closely 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.”
