MLM Biologics

What MLM Biologics does

MLM Biologics Inc is a Delaware C-Corp medical device company headquartered in Alachua, Florida, founded around 2014 (firmographic data lists 2012), that develops and manufactures collagen-based wound care products. Its core commercial product is the bio-ConneKt Wound Matrix, an FDA 510(k)-cleared, terminally sterilized, reconstituted and stabilized Type I collagen matrix indicated for managing moderately to heavily exuding wounds across acute, chronic, trauma, surgical, burn, and ulcer indications. The underlying technology is a proprietary processing platform that stabilizes Type I collagen to resist premature proteolysis in the wound bed, producing a porous, hydrophilic scaffold with high fluid absorption (0.5 cc per square cm), room-temperature storage, and a 6-year shelf life.

The company's revenue model is direct and indirect product sales of bio-ConneKt to healthcare providers and facilities. All US sales are conducted through an exclusive distribution agreement with BioWound Solutions (announced December 1, 2023), while direct technical and customer service support remains in-house. Reimbursement is anchored by CMS HCPCS Level II Q-code Q4161, which classifies bio-ConneKt as a high-cost skin substitute eligible for Medicare Part B coverage in all 50 states effective April 1, 2017. Manufacturing occurs in a custom-built, ISO 13485-certified modular facility in Alachua, FL. Customer segments are wound care clinicians (doctors, podiatrists, surgeons), healthcare facilities (hospitals, surgery centers, LTACHs, SNFs, home health), and chronic wound patients, with case studies highlighting limb salvage and treatment-resistant ulcers.

Beyond the commercial wound matrix, MLM Biologics has disclosed a development pipeline spanning anti-microbial dressings, bio-active matrices, soft tissue repair, adhesion barriers, hard tissue/spine repair, and growth factor delivery, plus a veterinary extension (vetConneKt). A $1.5M USAMRDC grant (April 2023) is funding an anti-microbial battlefield wound infection prevention device with intended civilian crossover applications. The company remains privately held with a 1–10 person operating footprint concentrated in four named executives carrying 150+ combined years of medical device experience from Regeneration Technologies, Pegasus Biologics, Globus Medical, Tutogen, Smith & Nephew, and related firms.

Name

MLM Biologics

Legal name

MLM Biologics Inc

Website

https://mlmbiologics.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

MLM Biologics is a small, privately held medical device company that develops and manufactures the FDA-cleared bio-ConneKt Wound Matrix, a stabilized Type I collagen skin substitute for hard-to-heal wounds, sold in the US through an exclusive distribution agreement with BioWound Solutions.

Ownership category

akta.pro rank

Product category

Advanced Wound Care Medical Devices

NAICS

Medical Equipment and Supplies Manufacturing (3391), Surgical Appliance and Supplies Manufacturing (339113), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts) (HLAHALAE)

akta.pro secondary industries

Wound Healing & Skin Regeneration (advanced dressings, skin substitutes) (HLAAAGAG), Negative Pressure Wound Therapy (NPWT) Systems & Accessories (HLAHALAB)

Keywords

• Collagen wound matrix
• Advanced wound care
• Medical device manufacturing
• Skin substitute products
• Wound closure devices

Headquarters

HQ city

Gainesville

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Supply Chain

Revenue model

1. bio-ConneKt Wound Matrix Sales: Sale of FDA-cleared collagen wound matrix product to healthcare providers, facilities, and through distribution partners. Revenue generated through product sales with CMS reimbursement eligibility under HCPCS code Q4161 as a high-cost skin substitute.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

MLM Biologics develops, manufactures, and distributes bio-ConneKt Wound Matrix, an FDA 510(k)-cleared stabilized Type I collagen matrix for the local management of moderately to heavily exuding wounds. The product is indicated for full and partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, trauma wounds, and surgical wounds, and is produced at an ISO 13485-certified facility in Alachua, FL, with exclusive US sales and marketing handled through distribution partner BioWound Solutions.

Product overview

MLM Biologics offers a focused portfolio anchored by the bio-ConneKt Wound Matrix, its primary FDA-cleared collagen-based wound care product. The company also has veterinary applications (vetConneKt) and several pipeline products under development including anti-microbial dressings, bio-active matrices, soft tissue repair solutions, adhesion barriers, and hard tissue repair technologies.

Differentiator

Problem solved

Functional benefit

Brands

• bio-ConneKt® Wound Matrix: An FDA-cleared, all collagen, advanced wound care product indicated for healing a wide range of wounds including acute, chronic, trauma, surgical, and burn wounds.

Products and services

• bio-ConneKt Wound Matrix An all-collagen, FDA 510(k)-cleared advanced wound care product (bio-ConneKt Wound Matrix) indicated for the local management of moderately to heavily exuding wounds, including full and partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, trauma wounds, and surgical wounds. It is comprised of reconstituted, stabilized Type I collagen sterilized to SAL 10-6, manufactured in an ISO 13485-certified facility in Alachua, FL, and reimbursed by CMS as a high-cost skin substitute under HCPCS Q4161. It is sold to healthcare providers and facilities through exclusive US distributor BioWound Solutions.

Quantifiable outcome

• Over 6 years of adverse event free clinical history
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered core and minor.

• BioWound SolutionscoreChannel Partner/ Reseller/ Distributor · 1 December 2023BioWound Solutions acquired exclusive sales and marketing rights to MLM Biologic's bio-ConneKt Wound Matrix in the United States and its territories on December 1, 2023. BioWound Solutions handles all US customer sales, marketing, reimbursement and billing assistance for the product.
• Veterinary Industry PartnersminorChannel Partner/ Reseller/ DistributorMLM is expanding product line to include veterinary applications. The company is developing vetConneKt product for the veterinary market with interested parties invited to send queries to customer service.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Organogenesis Holdings: Organogenesis is a direct peer — a leader in regenerative medicine and skin substitutes (Apligraf, Dermagraft, PuraPly, AmnioMatrix) competing for the same chronic wound and surgical reconstruction accounts that bio-ConneKt targets. Both sell biologics reimbursed under CMS skin substitute Q-codes.
• ConvaTec: ConvaTec is a direct peer in advanced wound care with collagen and skin-substitute products (Avelle, ConvaMax, AQUACEL family) targeting the same chronic wound continuum (DFU, VLU, pressure injuries) served by MLM, with established hospital and home health distribution.
• MiMedx Group: MiMedx is a direct peer in skin substitutes and bioactive wound care (EpiFix, AmnioFix, AmnioCord). It targets the same diabetic foot ulcer, venous leg ulcer, and surgical wound segments served by MLM's bio-ConneKt and competes head-to-head for CMS high-cost skin substitute reimbursement.
• Coloplast: Coloplast's Wound & Skin Care business competes in the chronic wound matrix and dressing space (Biatain, Triad) serving the same patient segments, and is one of the global wound care incumbents MLM's distribution partner BioWound Solutions must displace at the account level.

Emerging players

• Aroa Biosurgery: Aroa Biosurgery is an emerging player in bioengineered collagen-based wound care (Endoform, Myriad) targeting chronic wounds with similar single-application, ECM-derived scaffold value propositions that closely mirror bio-ConneKtlg behavior.
• AlloSource: AlloSource is a regenerative tissue company producing allograft-based skin and wound care products (AlloSkin, AlloPatch) that compete in the same hospital and wound care channel as MLM's collagen matrix.

Broad incumbents

• Smith & Nephew (Advanced Wound Management): Smith & Nephew's Advanced Wound Management division offers collagen-based dressings, NPWT systems, and skin substitutes (e.g., PICO, RENASYS, OASIS) addressing identical wound healing indications as bio-ConneKt, with broader geographic reach and global sales scale.
• Molnlycke Health Care: Molnlycke is a global wound care incumbent with advanced dressings and single-use products (Mepilex, Mepitel, Avance NPWT) competing for the same chronic and surgical wound accounts and procurement contracts that bio-ConneKt targets.
• Integra LifeSciences: Integra LifeSciences is a broad incumbent with deep wound care exposure (Integra Dermal Regeneration Template, PriMatrix, AmnioExcel, Cytal wound matrix portfolio plus Derma Sciences acquisitions) and competes with MLM in the same surgical and chronic wound call points across hospitals.
• 3M Health Care (Acelity/KCI): 3M's acquisition of Acelity/KCI brought V.A.C. NPWT and advanced dressings into the same wound care call points. bio-ConneKt is explicitly positioned as an adjunct with NPWT, making 3M/KCI both a potential complement and a competitive incumbent.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/MLM-Biologics-Inc-118606996641776
• LinkedInlinkedin.com/company/mlm-biologics-inc.

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about MLM Biologics