Regulatory & Clinical Strategy
Develop a clear regulatory, clinical, and market access strategy designed to support long-term growth and scalability.
Four-month accelerator for startups in tissue restoration and regenerative medicine with validation, mentoring, and investment opportunities.
Catalyst is a strategic accelerator designed for startups at the frontier of tissue restoration and regenerative medicine. We provide more than just capital. We offer a hands-on architectural approach to growth. Through deep technical validation, strategic regulatory mapping, and industry connections, we ensure your breakthrough is market-ready and investor-aligned.
Catalyst seeks TRL 3+ startups in tissue restoration and advanced wound care seeking applications from medical device, biologics, or drug sectors, ready to commercialize across global markets through a focused four-month accelerator.
Identify and define an unmet clinical need and the scientific rationale.
Commercialization Path: Assess high level market opportunity
Formulate hypothesis; identify targets or approaches, develop initial assays.
Commercialization Path: Validate clinical relevance and competitive landscape
Demonstrate proof-of-concept in vitro and/or in vivo.
Commercialization Path: Define preliminary value proposition and economic impact
Optimize lead product, prototype, or formulation; establish safety and performance in relevant preclinical or bench models.
Commercialization Path: Define use case and engage early partners/payers
Complete GLP studies; define CMC and manufacturing strategy, confirm regulatory plan.
Commercialization Path: Establish regulatory pathway
Initiate first-in-human studies and generate initial safety data.
Commercialization Path: Begin collecting clinical and health data
Conduct clinical trials; efficacy signals emerge.
Commercialization Path: Develop reimbursement strategy and CPT plan.
Complete pivotal studies; submit for regulatory approval.
Commercialization Path: Finalize go-to-market plan and secure coverage strategy.
Product on the market; real-world use and revenue established.
Commercialization Path: Drive adoption and expand indications/value
*Innovation doesn't always fit into a category. These areas are illustrative, not exhaustive. We welcome breakthrough technologies and novel approaches that can meaningfully improve wound care and patient outcomes.
Develop a clear regulatory, clinical, and market access strategy designed to support long-term growth and scalability.
Validate your technology, strengthen your business strategy, and prepare for real-world adoption with support from industry experts.
Work directly with clinicians, founders, investors, and life sciences executives who help accelerate critical decisions and reduce costly missteps.
Gain insight into the world's largest wound care market and build relationships with key stakeholders across the healthcare ecosystem.
Access up to $200K in investment, Demo Day exposure, and opportunities for deeper collaboration with EmeraNova.

We start with a comprehensive diagnostic, evaluating technology, market opportunity, IP, team, and regulatory and clinical readiness, alongside financial and investment potential. Startups work with experts to prove efficacy, stress-test assumptions, and build a fact-based foundation for every decision ahead.
Turning diagnosis into direction, we help startups build a Product Development Plan, a Go-to-Market Plan, and a Commercialization Roadmap, the clearest path from product development to commercial scale. Together, these define priorities, milestones, and resources for reimbursement models, regulatory pathways, and pathways to industry pilots.
Getting investor ready. We help startups craft a compelling investment memo and investor pack, close due diligence gaps, and structure a data room so investors can quickly and confidently validate the opportunity.
The program's capstone. Mentors deliver a final assessment and executive summary while startups finalize their Demo Day deck, culminating in a live presentation to EmeraNova leadership, partners, and investors, with potential investment of up to $200K.
Submit your startup for evaluation.
Applications are reviewed by the selection committee. Applicants advancing from the primary review will schedule a video pitch call.
Extending offers to the top startups.
Intensive four-month validation and mentoring program.
Presentation to global investors and partners.
Term Sheet & Investment Discussions for selected startups.
This phase applies only to startups selected for potential investment.
Ongoing support including fundraising, investor introductions, mentor access, and Catalyst Alumni network for scaling and growth.
Our mentors bring decades of experience across medtech, biotech, healthcare, and other transformative industries, from early-stage startups to established industry leaders. Their backgrounds span clinical practice, commercialization, sales, and building companies from the ground up.

The field of regenerative medicine is rapidly evolving, offering groundbreaking solutions to some of the most challenging health issues.

Starting a wound care startup can be both an exciting and daunting venture.

Wound care is a critical aspect of healthcare, impacting millions of lives globally.