Restoring self through the science of cellular renewal
Next-Generation Topical Therapy for Alopecia
Renovaris Ltd. , is a pre-clinical stage biopharmaceutical company developing a novel, patent-pending topical therapeutic for Alopecia Areata (AA) and Androgenetic Alopecia (AGA). Our proprietary Nano-gel technology overcomes fundamental skin barrier limitations to deliver a synergistic combination of drugs directly to the hair follicle, offering a safe, effective, and long-term treatment solution where current standards of care fall short.
Renovaris aims to become the First-Line Therapy for the underserved majority (mild-moderate cases) of alopecia patients, and the Safe Maintenance Therapy for severe cases stepping down from toxic oral drugs.
The Unmet Need & Market Gap
Alopecia Areata (AA) is a prevalent autoimmune disease affecting ~2% of the global population. It is estimated that AA affects up to 147 million people worldwide, with as many as 6.8 million people in the United States. Its market is projected to reach $6.92 billion by 2034. AA is associated with high rates of depression and anxiety (~27%). The profound psychosocial impact drives a high urgency for treatment, especially among the pediatric and adolescent population where safety concerns are a major barrier. Despite this, the treatment landscape is polarized and insufficient:
- The Gap: There is no safe, effective, long-term topical (non-systemic) treatment for the majority of patients (mild-to-moderate cases), nor a safe maintenance therapy for severe cases.
The Solution: R01 CORE (Cellular Optimization & Renewal Engine) Nano-gel
Current treatments force a choice between efficacy and long-term safety. Renovaris bridges this gap, enabling safe, long-term maintenance of hair growth without systemic toxicity or skin atrophy.
Renovaris has developed a proprietary Nano-gel formulation containing Cyclosporine A (0.1%) and Tempol (0.5%)
Strategic Positioning and Competitive Advantage
Capturing the “White Space” – While the AA market is projected to reach $6.92B by 2034, current innovation is skewed towards the severe segment with expensive, risky systemic drugs. We target this massive gap with a topical, non-systemic, and affordable therapy designed for safe and chronic use, aiming to become the first-line standard of care for the broad patient population and the safe maintenance choice for severe cases. Renovaris positions its product to disrupt the market by bridging the gap between safety and efficacy. Unlike JAK inhibitors, Renovaris offers a therapy suitable for chronic use without the need for blood monitoring or fear of systemic malignancies, making it the ideal first-line therapy for mild/moderate cases and a maintenance therapy for patients tapering off oral drugs.
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Renovaris’ R01 CORE Nano-gel strategic positioning |
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Feature |
JAK Inhibitors (Oral) |
Corticosteroids (Topical) |
Renovaris (Topical Nano-gel) |
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Efficacy |
High (Severe AA) |
Moderate/Low |
High (Targeted/local Delivery) |
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Safety Profile |
“Black Box” Warnings Increased risk for serious infections, cancer, blood clots, Major Adverse Cardiovascular Events, and all-cause mortality |
Skin Atrophy risk, Systemic Safety Issues (Oral Administration), including: Metabolic and Organ Damage, osteoporosis, infection risk, general toxicity |
Excellent (Localized – non-systemic, Non-toxic). Very low API dose |
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Primary Indication |
Severe AA only |
Mild AA |
Mild-to-Moderate & Maintenance of AA and AGA |
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Route |
Systemic (Oral) |
Topical |
Topical |
Regulatory Strategy
Renovaris intends to pursue the US FDA 505(b)(2) pathway, leveraging the established safety profiles of both CysA and Tempol
Leadership Team
- Amos Ofer, PhD, MBA (CEO & Co-Founder): Over 25 years of experience in the biotech industry, including executive roles CEO/COO/CDO in small-medium-size, private and public-traded startups (e.g., Cellect Biotherapeutics, PamBio). Experienced in leading multidisciplinary teams from concept to clinical trials.
- Prof. Taher Nassar (CSO & Co-Founder): Senior Lecturer at the School of Pharmacy, Hebrew University of Jerusalem. A world-renowned expert in drug delivery systems and nano-formulations, with over 25 years of experience and participation in establishing >12 startups (e.g., Seligman, Medwell).
- Supported by: NGT Healthcare II Incubator.
- For more information please contact: Amos Ofer, PhD, MBA, CEO: ofera@renovarispharma.com or go to the company website at renovarispharma.com