Companies / Tides Medical

Regenerative medicine company profile

Tides Medical

Lafayette-based tissue graft manufacturer and regenerative-medicine supplier with amniotic wound and surgical products, contract manufacturing capabilities, and selected distributed technologies.

Biotechnology / Regenerative MedicineGeneral Medical & Patient CareOphthalmology & VisionWound Care

Headquarters🇺🇸Lafayette, Louisiana, United States

Founded2009

Commercial statusCommercially availableTissue products listed commercially; availability and regulatory status depend on the product.

EmployeesNot confirmed

Estimated revenueNot confirmed

Official websitewww.tidesmedical.com ↗Official careers ↗

Company overview

Tides Medical is a Lafayette, Louisiana company founded in 2009, according to Louisiana Economic Development. It describes an integrated tissue business spanning donated placental tissue acquisition, processing, manufacturing and nationwide distribution, supported by clinician service and reimbursement assistance.

Its catalog includes Artacent and AmnioHeal tissue grafts for wound, surgical and ocular applications. Tides also advertises contract manufacturing, packaging, labeling, validation, distribution and storage. The Aurix platelet-rich plasma system is a Nuo Therapeutics product that Tides distributes, rather than a Tides-manufactured tissue graft.

An FDA warning letter dated October 6, 2026 concerns APLICOR 3D. The product-specific notice below sets out the agency’s findings; tissue registration and accreditation are addressed separately.

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Portfolio overview

Covers the Tides Medical brand and six selected marketed product lines as of October 28, 2026. Tides-manufactured tissue, distributed devices and contract services are distinguished.

Tissue graft production and wound care

Tides describes an in-house chain from placental donation and acquisition through processing, manufacturing and distribution. Artacent AC is the selected tri-layer wound-covering example; Artacent Wound and Vericlen are additional catalog lines without separate snapshots. ^{[7][10][15][14]}

Surgical barriers and ocular applications

Flex, Connect and AmnioHeal Plus are selected surgical tissue lines. Artacent Ocular represents a distinct eye-care application. Patch dimensions and package variants are not separate products here. ^{[12][11][9][13]}

Contract manufacturing and private label

Advertised capabilities include tissue sourcing and aseptic processing, labeling, kitting, packaging, validation, distribution and storage. These are manufacturing services, not additional product families or guarantees of regulatory authorization. ^[21]

Distributed and other technologies

Aurix is explicitly a Nuo Therapeutics product distributed by Tides. The MLG Complete page attributes Retain processing to Samaritan Biologics. Supplier roles are not inferred solely from catalog placement. APLICOR 3D is addressed in the regulatory notice, rather than listed as a verified authorized offering. ^[16][20][3]

Shared tissue-processing methods are described alongside the relevant products.

Leadership

4 people

Joe SpellFounder and Chief Executive Officer ^[23]

Doug PayneChief Operating Officer ^[23]

Benjamin KimballVice President of Quality and Regulatory Affairs ^[23]

Andree GonsoulinVice President of Marketing ^[23]

Products & regulatory status How does MedTechIndex get this information?

Regulatory notices

FDA warning letter — APLICOR 3D

Issued October 6, 2026

FDA stated that Tides was distributing APLICOR 3D without the required marketing clearance or approval for its promoted wound-treatment uses. The agency rejected the claimed Class I exemption for those uses and requested that the relevant commercial distribution cease. No subsequent public resolution was established in the reviewed sources as of October 28, 2026. ^[3]

This is a product-specific enforcement letter, not a recall or a finding against every Tides tissue graft. The APLICOR product URL returned 404 during review; that does not establish correction, withdrawal or regulatory resolution.

Summary

Tides’s tissue operations and its distributed devices require different regulatory treatment. The manufacturer-hosted 2026 registration summary lists Tides Medical LLC and amniotic membrane brands. FDA explicitly states that accepting tissue registration and listing does not establish product approval or compliance; this profile does not independently certify that every graft meets all HCT/P criteria. ^[24][4]

AATB’s directory lists Harbinger Medical Group LLC dba Tides Medical, accreditation 00236, expiring March 4, 2028. It identifies specific birth-tissue activities and musculoskeletal storage/distribution. This accreditation is not blanket FDA approval, and the relationship between the legal entities should be confirmed for procurement. ^[1][19]

The single mapped 510(k) decision below, BK060007, is for the AutoloGel System under original applicant Cytomedix. Nuo documents the later Aurix name, and Tides identifies itself as distributor. That count must not be read as one FDA clearance for Tides’s own tissue grafts. ^[2][6][16]

FDA device authorization counts do not summarize the entire tissue business. PMA and De Novo reviews remain incomplete. Product coding, registration, accreditation and reimbursement support do not guarantee payer coverage or clinical outcomes. ^[4][22]

Regulatory snapshot How to read this snapshot

U.S. FDA

1+
510(k) clearances: —
De Novo grants: —
PMA approvals: —
Recall events

Latest recorded source review: 2026-10-28.

Scope: selected product families.

Commercial portfolio snapshot

View full catalog ↗

Documented commercial product families.

Amniotic wound covering

Artacent AC ↗

Tri-layer amnion–chorion–amnion tissue graft presented for acute and chronic wound covering. Sizes and package configurations are grouped in one line. Manufacturer clinical and reimbursement claims require product-specific evidence and payer review. ^[10][24][4]

Marketed tissue graft · registration is not FDA approval