DermiSense develops a low-cost, zero-power, minimally invasive microneedle patch platform that extracts dermal interstitial fluid (ISF) for biomarker analysis.
This innovative technology simplifies diagnostic testing, reduces patient discomfort, and has the potential to replace traditional blood sampling.
DermiSense is a medical technology company revolutionizing diagnostic testing by offering a painless alternative to invasive blood draws.
Traditional blood sampling is expensive, resource-intensive, requires specialized training, and often causes patient anxiety—limiting frequent and decentralized testing.
DermiSense’s flexible, bio-inert microneedle patch painlessly extracts dermal interstitial fluid (ISF) from just below the skin in minutes. ISF contains over 90% of the proteins found in blood plasma, making it an ideal matrix for accurate diagnostic analysis.
This platform enables frequent, non-invasive biomarker monitoring across diverse applications—including trauma care, athletic performance, and general diagnostics—making testing more accessible, affordable, and patient-friendly.
Leadership Team
- John Strang – CEO
Drives overall strategy, fundraising, and commercial execution. Brings expertise in virtual healthcare and quality management for regulated manufacturing—critical for scaling production and building a sustainable business model. - Michael Daniele, Ph.D. – Chief Scientific Officer
Professor at NC State and primary inventor of the core microneedle technology. Leads R&D, ensures scientific rigor, and guides innovation to expand the platform’s diagnostic capabilities.
Together, the team combines deep technical expertise with proven commercialization experience to translate cutting-edge research into a market-ready diagnostic solution.
DermiSense’s go-to-market strategy is a phased regulatory and commercial roadmap designed to achieve FDA clearance and initial market entry.
Phased Timeline
- Year 1 (2026): Clinical Validation & Regulatory Preparation
Complete initial human validation and multi-site clinical trials with partners (UNC, ECU). Finalize Design for Manufacturing (DFM) and engage FDA via pre-submission. Target: Raise $2M private capital + apply for NIH STTR Phase II funding. - Year 2 (2027): Manufacturing Scale & Early Sales
Scale to 1,000 pilot units, achieve ISO 13485 certification, and prepare formal FDA filing. Enable initial sales to strategic diagnostic partners and research teams. - Long-Term: Full Commercial Rollout
Expand clinical trials, integrate additional diagnostic tests, and launch commercially with broader market adoption.
Key Partners
- Clinical institutions (UNC, ECU) for trial data
- Veranex for regulatory expertise
- Investors and grant bodies for funding support
DermiSense employs a razor-and-blade business model, generating recurring revenue through sales of low-cost, disposable microneedle patches—the consumable required for each test.
Primary Revenue Streams
- Direct Sales to Healthcare Providers
Patches sold to hospitals, clinics, and labs for painless biomarker testing, offering cost savings by eliminating trained phlebotomists and specialized equipment. - B2B Partnerships
Sales to pharmaceutical companies, government agencies, and CROs for frequent/decentralized monitoring in clinical trials, military health, and athletic performance applications. - Device & Expanded Testing
Revenue from reusable/connected reader devices and broader biomarker panels (starting with cortisol and expanding further).
Revenue will scale with manufacturing volume, biomarker menu expansion, and market penetration in both clinical and research settings.
Investment Opportunity
DermiSense is raising a $2.7 million Seed Round to provide an 18–24 month runway and achieve key de-risking milestones for regulatory submission and commercial readiness.
Use of Proceeds
| Focus Area | Allocation Priority | Key Objectives |
|---|---|---|
| Clinical Trials | Largest portion | Complete multi-site human studies with hospital partners to build robust data package for FDA submission. |
| Manufacturing Scale-Up | Significant portion | Finalize design for manufacturing, establish pilot production line, and achieve quality system certification. |
| Team & Partnerships | Remaining | Hire key roles (engineering, research, clinical, regulatory) and engage expert partners in design, regulatory affairs, and legal. |
Achieving these milestones will position DermiSense for NIH STTR Phase II funding and a subsequent Series A to drive full market launch—transforming diagnostics into a painless, accessible, and affordable standard of care.
DermiSense’s microneedle patch platform is currently at TRL 4.5, advancing through proof-of-concept, preliminary human studies, and active pilot testing.
Key Achievements
- Prototype Development
Fabricated over 50 working prototypes using scalable polymer-molding methods. - Testing & Validation
Completed third-party biocompatibility testing and IRB-approved human pilot studies at NC State (evaluating ISF vs. blood cortisol correlation). - Regulatory Progress
Initial consultation with Veranex defining FDA pathway. - Company Formation
Established as an NC State spinout headquartered in Research Triangle Park.
Supported by grants from NC State Chancellor’s Innovation Fund, SEMI-NBMC, and UK DSTL, the technology is progressing toward TRL 5 milestones required for clinical and commercial advancement.
Federal research grants from:
- SEMI
- NBMC
Additional support from NC State Chancellor’s Innovation Fund and UK DSTL.
