Nuevocor Taps Top Cardiologist for Novel Heart Gene Therapy Trial

SINGAPORE – April 28, 2026 – Clinical-stage biotechnology company Nuevocor has appointed Dr. Monica Shah, a distinguished heart failure cardiologist and gene therapy veteran, as its new Chief Medical Officer. The move signals a critical transition for the company as it prepares to launch a first-in-human clinical trial for NVC-001, its lead candidate for one of the most aggressive forms of genetic heart disease.

The appointment comes at a crucial inflection point for Nuevocor, which is focused on developing therapies for life-threatening cardiomyopathies. Dr. Shah will now helm the company’s global clinical development and medical affairs, bringing a wealth of experience to a team on the verge of testing a potentially transformative treatment for LMNA-associated dilated cardiomyopathy (DCM), a condition with devastatingly few options for patients.

"Monica is an exceptional clinical development leader who brings precisely the right combination of cardiovascular expertise, gene therapy execution and regulatory experience to Nuevocor," said Al Gianchetti, Chief Executive Officer of Nuevocor. "As we prepare to initiate the first-in-human clinical trial of NVC-001 in LMNA DCM... we look forward to her leadership in bringing novel therapeutics to patients with serious unmet medical need."

A New Hope for a Devastating Disease

LMNA-associated dilated cardiomyopathy is a relentless genetic disorder that affects an estimated 100,000 people in the United States and Europe. Caused by mutations in the LMNA gene, the disease leads to a rapid weakening of the heart muscle, life-threatening arrhythmias, and progressive heart failure. For many, the diagnosis comes in the prime of their lives, with the disease often progressing to end-stage heart failure or causing sudden cardiac death by their 40s or 50s.

Current medical care is limited to managing symptoms. Patients are often prescribed a cocktail of heart failure medications and may require implantable devices like defibrillators to prevent sudden death from arrhythmias. However, these treatments do not address the underlying genetic defect. The ultimate therapeutic option for many remains a heart transplant, a major surgical procedure with its own significant risks and limitations. The clear and urgent unmet need for a disease-modifying therapy has made LMNA DCM a key target for next-generation genetic medicines.

This is the challenging landscape Nuevocor aims to disrupt with NVC-001. The company's approach represents a significant departure from conventional strategies.

"LMNA DCM is a devastating disease with very limited options for patients, and Nuevocor's mechanobiology-driven approach represents a genuinely differentiated opportunity to intervene at the level of disease biology," Dr. Shah stated upon her appointment.

Targeting the Mechanical Root of a Genetic Problem

Nuevocor's strategy is built upon its proprietary PrOSIA mechanobiology platform. Rather than pursuing traditional gene replacement, which aims to supply a working copy of a faulty gene, Nuevocor's platform focuses on correcting the functional consequences of the mutation. In LMNA DCM, the genetic defect disrupts the structural integrity of the cell's nucleus, making it vulnerable to the constant mechanical stress of a beating heart. This leads to a cascade of cellular damage and, ultimately, heart failure.

NVC-001, an AAV-based gene therapy, is designed to restore this nuclear integrity. By introducing a therapeutic protein, it aims to reduce the harmful forces exerted on the nucleus, effectively treating the root biomechanical cause of the disease. This "mechanobiology" approach could potentially be applied to multiple cardiomyopathies that share similar pathways of mechanical dysfunction, even if they are caused by different gene mutations.

The scientific promise of this strategy is supported by compelling preclinical data. In a high-fidelity mouse model of LMNA DCM, a single treatment with NVC-001 resulted in a remarkable eight-fold increase in survival. Treated mice lived beyond 300 days, compared to less than 40 days for their untreated counterparts. The therapy also halted disease progression, stabilized heart function, and reduced fibrosis, or scarring, of the heart muscle. The U.S. Food and Drug Administration (FDA) has since cleared the Investigational New Drug (IND) application for NVC-001, paving the way for the first human trials slated to begin this year.

A Leader Forged in Gene Therapy's Front Lines

To navigate the complex journey from preclinical promise to clinical proof-of-concept, Nuevocor has brought in a leader with a uniquely tailored resume. Dr. Monica Shah is not only a board-certified heart failure and transplant cardiologist but also a seasoned executive who has operated at the highest levels of the cell and gene therapy industry.

Her career reflects a deep commitment to advancing cardiovascular medicine. Before joining Nuevocor, she was Chief Medical Officer at CTI Clinical Trial & Consulting, a specialty contract research organization (CRO), where she provided medical oversight for complex programs in rare disease and gene therapy. Prior to that, she was a key leader at Rocket Pharmaceuticals, serving as Senior Vice President and AAV Global Program Head, where she launched and steered pivotal clinical programs in cardiovascular gene therapy.

Her experience also includes a tenure as Vice President and Global Head of Cell and Gene Therapy at the major CRO IQVIA, where she established the company’s CGT Center of Excellence. Earlier in her career, she spent nearly a decade at the National Institutes of Health (NIH), serving as Deputy Chief of Heart Failure and Arrhythmias at the National Heart, Lung, and Blood Institute. This combination of academic rigor, regulatory insight from the NIH, and industry execution makes her an ideal fit to lead Nuevocor's clinical ambitions. Her decision to join the smaller, focused biotech underscores a broader industry trend where top talent is drawn to companies with highly innovative platforms and the potential for profound patient impact.

Global Ambition Fueled by Strategic Investment

Nuevocor's clinical leap is built on a solid financial and strategic foundation. In May 2025, the company closed a $45 million Series B financing round co-led by Kurma Partners and Angelini Ventures, with strong support from existing investors including EDBI, ClavystBio, and the Boehringer Ingelheim Venture Fund.

The funding is expressly dedicated to advancing NVC-001 through its Phase 1/2 clinical trial to establish clinical proof-of-concept. This financial backing from a syndicate of sophisticated international investors provides a crucial runway for the complex and costly process of human gene therapy trials.

Headquartered in Singapore, a burgeoning global biotech hub, Nuevocor also maintains offices in the U.S. and Europe, with plans to establish a new presence in Paris, France. This global footprint is strategic, allowing the company to tap into diverse talent pools, engage with regulatory bodies across key jurisdictions, and manage multicenter clinical trials efficiently. For a company tackling a rare disease, this international structure is essential for accessing patient populations and navigating the global path to potential drug approval. With a validated scientific approach, strong financial backing, and now, a highly experienced clinical leader at the helm, Nuevocor is poised to make a significant impact in the fight against genetic heart disease.

The initiation of the NVC-001 trial will be a closely watched event, not only for the thousands of families affected by LMNA DCM but also for the entire field of cardiovascular medicine, which eagerly awaits the next breakthrough in genetic therapies.