Milestones & Timeline
Our trajectory from founding to institution-building
Organizational Timeline
The American Society of Hirudotherapy was founded in 2024 to fill a critical gap: the absence of an independent, evidence-based professional organization for hirudotherapy in the United States. Below is a timeline of key milestones in our development and in the broader regulatory environment that shapes our work.
Regulatory Milestones
FDA 510(k) Clearance — Ricarimpex SAS
The FDA clears medicinal leeches (Hirudo medicinalis) as a medical device via 510(k) K040187, establishing the U.S. regulatory framework for hirudotherapy. Product code NRN assigned.
510(k) Clearance — Biopharm Leeches
Biopharm receives 510(k) clearance (K132958) for medicinal leeches, expanding the supply chain for FDA-cleared leeches in the U.S.
510(k) Clearance — Carolina Biological
Carolina Biological Supply Company receives 510(k) clearance (K140907), further diversifying the cleared supply chain.
CBER Transfer
Effective December 30, 2024, regulatory oversight of medicinal leeches transfers from CDRH to CBER (Center for Biologics Evaluation and Research) per Federal Register notice.
ASH Milestones
Organization Founded
American Society of Hirudotherapy, Inc. established in California. 501(c)(3) tax-exempt status obtained (EIN 92-2997844). Mission defined: evidence-based education, safety standards, and supply chain integrity for hirudotherapy.
Website Launch
Launch of hirudotherapysociety.org with peer-reviewed clinical evidence reviews, leech biology reference library, safety protocols, and regulatory guidance. Initial content: 60+ evidence-based pages.
Content Expansion
Expansion to 150+ evidence-based pages covering clinical conditions, leech biology, aquaculture, pharmacology, and regulatory frameworks. Research article library with 31 indexed studies.
Advisory Board Formation
Recruitment of clinical and scientific advisors across six disciplines: plastic surgery, vascular medicine, infectious disease, regulatory affairs, bioethics, and aquaculture science.
Governance Hardening
Implementation of institutional-grade governance framework: conflict-of-interest policies, financial transparency, FDA compliance linting, and investor-readiness infrastructure.
Planned Initiatives
Continuing Medical Education (CME) Pathway
Development of accredited CME modules for physicians and advanced practice clinicians.
Research Grant Program
Establishment of a small grants program to fund pilot studies in hirudotherapy.
Aquaculture Facility
Development of a controlled-environment aquaculture facility for medical-grade leech production in Stanton, California.
National Conference
Planning for the first annual ASH national conference for practitioners, researchers, and stakeholders.