SelSym Biotech is pioneering hemostasis with SymClot, an innovative platelet-mimetic therapy that promises to dramatically improve patient survival and outcomes by rapidly stopping bleeding after severe trauma and high-risk surgeries.
SelSym Biotech is a preclinical-stage company focused on improving survivability after severe hemorrhage—the leading cause of death in populations under 45, both domestically and globally.
Most trauma-related deaths occur early due to ineffective bleeding interventions. Current options are limited:
- Blood transfusions and clotting factors require cold storage and are impractical in field or ambulance settings.
- Tourniquets cannot address non-compressible, internal, or junctional bleeding.
- Existing drugs carry safety risks and slow administration times.
These gaps are especially critical in rural areas, emerging markets, and crisis scenarios (wars, pandemics, mass casualties) that strain blood supplies.
SymClot is a synthetic platelet-inspired injectable therapy designed for austere and emergency environments:
- Highly targeted to injury sites
- Enhances native clotting responses to control severe bleeding rapidly
- Lyophilized for room-temperature storage
- Reconstitutes in under 1 minute
- IV administration treats bleeding regardless of location
SymClot enables simple integration into ambulance kits, field packs, and ER trauma protocols—delivering a transformative early-intervention solution where none exists today.
Leadership & Expertise
SelSym’s team brings over 300 years of combined experience in trauma care, manufacturing, regulatory affairs, R&D, clinical development, finance, legal, entrepreneurship, and business development across startups, government, academia, and multinational corporations.
Internal Leadership Team
- Dr. Seema Nandi
CEO, Co-Founder, and Chair of the Board - Dr. Kimberly Nellenbach-Willson
Chief Scientific Officer - Dr. L. Andrew Lyon
President, Co-Founder, and Director - Rob Hughes, MBA
Chief Financial Officer - Dr. Ashley Brown
Co-Founder, Senior Scientific Advisor, and Director - Dr. Tom Barker
Co-Founder, Senior Scientific Advisor, and Director - Heather Haworth, JD
Director
Key External Advisors
- Laurel Omert, MD (Clinical)
- Maurene Hoffmann, MD, PhD (Clinical)
- Rob Schutte, PhD (Manufacturing)
- Kathleen Beach, MD (Regulatory)
- Nina Guzzetta, MD (Clinical)
- Galen Robertson (Business Development)
This multidisciplinary team provides complete expertise to navigate regulatory pathways, manufacturing scale-up, clinical validation, and commercialization.
SelSym’s go-to-market strategy leverages three core pillars: clinical validation, strategic partnerships, and reimbursement/market access.
- Clinical & Regulatory Validation
Complete pivotal preclinical and early-human studies in penetrating trauma to demonstrate safety and efficacy. Engage key opinion leaders in trauma, surgery, and transfusion medicine to build advocacy and guide development. - Segmented Market Entry
Initial launch in early-adopter centers (military and university trauma centers), followed by expansion into surgical suites and wound-care markets via the broader hydrogel platform. - Partnership & Channel Strategy
Partner with major distributors of IV hemostatic and wound-care therapies to access hospital procurement and OR supply chains. - Reimbursement & Market Access
Highlight cost savings and improved outcomes to secure reimbursement under existing codes for hemostatic adjuncts. - Branding & Messaging
Position SymClot as the transformative early-stage hemorrhage solution through conferences, trade shows, and trusted KOL networks in military and civilian trauma care.
SelSym’s revenue model combines non-dilutive funding, strategic partnerships, and eventual product sales for sustainable growth.
- Early Stage: Non-Dilutive Funding
NIH SBIR/STTR grants and DoD/MTEC contracts to advance R&D with minimal dilution. - Mid Stage: Strategic Partnerships
Licensing and collaboration agreements with med-tech/biopharma partners, delivering upfront payments, milestones, and royalties while accessing established distribution networks. - Commercial Stage: Product Sales
Direct sales of SymClot as a high-value, donor-independent alternative to platelet transfusions. Recurring revenue from hospital consumables, bundled kits, and inventory programs. - Platform Expansion
Additional revenue from indication-specific products and licensing of the Hemostatic Healing Hydrogel (H3) platform.
Long-term scalability will come from global distribution, reimbursement adoption, and value-based contracts demonstrating reduced transfusions and faster recovery.
Investment Opportunity
SelSym is seeking $8 million to complete IND-enabling studies and launch a first-in-human Phase I trial.
Key Milestones & Use of Funds
- $1.5M – Non-GLP Preclinical Package Completion
Finalize ongoing studies to support regulatory submissions. - GMP-Compliant Scale-Up
Rapid advancement enabled by SymClot’s simple composition and high manufacturability. - IND-Enabling Studies
Anti-drug antibody testing, GLP toxicology, and pharmacology (2026). - Phase I Clinical Trial
First-in-human study in healthy volunteers targeted for 2027.
Established partnerships with contract manufacturers and research organizations ensure efficient execution of manufacturing, regulatory submissions, and clinical activities.
SymClot originated from research by Dr. Ashley Brown at Georgia Tech and North Carolina State University. The core composition-of-matter patent is owned by NCSU and exclusively licensed to SelSym.
Development Progress
- Completed: Formulation optimization, bench/top efficacy, shelf-life, non-GLP sterility, and extensive efficacy studies in small and large animal trauma models.
- FDA INTERACT meeting (September 2025) confirmed planned GLP models.
- Contract manufacturers engaged for IND-enabling and Phase I supply; initial scalability confirmed.
- Upcoming (2026): Maximum tolerated dose and drug-drug interaction studies (January), pre-IND meeting (February), GLP tox/pharm studies (summer).
- IND submission targeted for January 2027.
Pipeline expansion underway for surgical bleeding and topical wound management applications.
SelSym has secured the following non-dilutive funding for SymClot development:
| Source | Amount |
|---|---|
| National Institutes of Health Phase 1 SBIR (2 awards) | $250K |
| Department of Defense Combat Readiness Medical Research Program | $2M |
| MTEC Award | $1.2M |
| North Carolina Biotechnology Center Small Business Research Loan | $450K |
