Press Kit
Organizational facts, FDA-status overview, available spokesperson, approved quotes, and press contact.
About ASH
The American Society of Hirudotherapy (ASH) is a U.S. 501(c)(3) public charity dedicated to evidence-based, FDA-aware education on medicinal leech therapy. We curate clinical research, publish protocolized educational materials, and document the regulatory pathway for hirudotherapy in the United States.
ASH is independent of leech suppliers, pharmaceutical companies, and medical device manufacturers. We do not deliver clinical care through this website and do not take referral payments. Donations are tax-deductible to the fullest extent permitted by law.
Status
501(c)(3) public charity
EIN
92-2997844
Founded
March 2023 (California)
Quick fact sheet
These facts are vetted against primary FDA, IRS and peer-reviewed sources and safe to quote. Last source-verification pass: May 6, 2026.
- Medicinal leech therapy is FDA 510(k)-cleared for management of venous congestion in surgical grafts, flaps, and replants. The device is classified as Unclassified Pre-Amendment (FDA product code NRN), regulated through 510(k) premarket notification, with CBER as the regulating center as of December 30, 2024.
- Three active 510(k) clearances cover U.S.-distributed medicinal leeches: K040187 (Ricarimpex SAS, June 21, 2004), K132958 (Biopharm UK Ltd., February 19, 2014), K140907 (Carolina Biological Supply Co., August 7, 2015). After the December 30, 2024 transfer to CBER, the same clearances are tracked as BK251211, BK251217, and BK251218 respectively.
- FDA regulatory authority transferred from CDRH to CBER on December 30, 2024. The transfer is administrative; all clearances and indications remain unchanged.
- Hirudin, the leech-derived thrombin inhibitor, seeded a class of direct thrombin inhibitors. Bivalirudin (2000) is FDA-approved and currently marketed; lepirudin (1998) and desirudin (2003) were FDA-approved historically but are no longer actively marketed in the U.S. Dabigatran (2010) is a synthetic small-molecule DTI inspired by hirudin pharmacology.
- Liu et al. (2019) catalogued 434 full-length proteins in the leech salivary gland secretion proteome; the count expanded to 440+ with 2025 discoveries.
- Off-label hirudotherapy uses are legal in the United States but are explicitly labeled as such on this site and do not represent FDA-cleared indications.
- ASH publishes Form 990-N (e-postcard) for tax years 2023 and 2024 (verifiable via IRS Tax-Exempt Organization Search).
Each fact is sourced and dated on the Regulatory Status (USA) and Annual Report pages.
FDA & regulatory status
ASH adheres to strict FDA-terminology accuracy. The site distinguishes 'cleared' (medicinal leeches as devices) from 'approved' (drug derivatives) and labels off-label and investigational uses explicitly.
FDA 510(k)-cleared medical device
Cleared indication: Venous congestion in grafts, flaps, and replants (microsurgical salvage).
Active 510(k): K040187 · K132958 · K140907
Center assignment (Dec 30, 2024): FDA transferred regulatory responsibility for medicinal leeches from CDRH to CBER. The transfer is administrative; all active clearances and indications remain in effect unchanged.
FDA clearance is a finding of substantial equivalence to a predicate device for the cleared indication. It is not a finding of efficacy across all uses, and it does not authorize use outside the cleared indication.
Full regulatory pathway and CDRH→CBER crosswalk: /regulatory-status-usa
Available spokesperson
Andrei Dokukin, MD
Chief Executive Officer, Chief Financial Officer & Clinical Director
Dr. Andrei Dokukin is the public officer of record per the California Statement of Information filed 04/13/2026 and the named primary reviewer for all clinical content on this site. He is available for press interviews on FDA pathway, evidence-based hirudotherapy, and clinical-safety topics.
Topics for interview
- Hirudotherapy
- Medicinal leech therapy
- FDA 510(k) regulatory compliance
- Microsurgical flap salvage
- Patient safety & Aeromonas prophylaxis
- Evidence-based medicine
To book, contact the press email below. We respond within 2 business days. Topics outside Dr. Dokukin's expertise are referred to the Editorial Board where appropriate.
Approved quotes
These quotes are pre-approved for journalistic use without further verification, provided they are not edited materially. Please credit Dr. Andrei Dokukin and the American Society of Hirudotherapy.
“FDA 510(k) clearance is a finding of substantial equivalence to a predicate device for a specific cleared indication. It is not a finding of clinical efficacy across all uses. We label off-label and investigational discussions explicitly so that clinicians and patients can distinguish what is FDA-cleared from what is not.”
Andrei Dokukin, MD — Clinical Director, ASH
On the importance of regulatory-language precision
“Medicinal leech therapy is administered by a licensed clinician under sterile conditions with patient monitoring. It is not a home remedy. Self-application carries serious risks of uncontrolled bleeding and Aeromonas infection — a point we communicate clearly across all patient-facing materials.”
Andrei Dokukin, MD — Clinical Director, ASH
On patient-safety boundaries
“Three FDA-approved drugs — bivalirudin, dabigatran, and desirudin — trace their pharmacology to compounds first characterized in the leech salivary gland. The leech is, in that sense, one of the more underappreciated translational platforms in modern anticoagulation.”
Andrei Dokukin, MD — Clinical Director, ASH
On translational science from leech biology
Resources & linkable references
Each page below is linkable as a primary source for press citations. We maintain dated correction logs on every change to material facts.
- Annual report — /annual-report
- Editorial policy & review process — /editorial-policy
- Regulatory status (USA) — full pathway documentation — /regulatory-status-usa
- Public correction log — /corrections
- Research Library (peer-reviewed publications) — /research
Branded assets (logos, headshots) are available on request from the press email below.
Press policy & quote-approval
- Approved quotes (above) may be used without further verification. Other quotes from Dr. Dokukin require email approval prior to publication.
- ASH does not pay for placement, sponsored content, or affiliate-style endorsements. We accept no payment for press appearances.
- Corrections requests on published ASH-attributed content are routed to the press email below; we aim to respond within 5 business days.
- ASH does not comment on individual practitioners, patient cases, or supplier disputes. Such inquiries are declined or referred to appropriate authorities.
Press contact
Email (press inquiries)
info@hirudotherapysociety.orgPhone
+1 917 647 5031Website
hirudotherapysociety.orgResponse time
Within 2 business days
For deadline-driven requests, mark the email subject [PRESS — DEADLINE: <date>] and include outlet, topic, and word count if applicable.
Last updated: March 18, 2026