MLM Biologics
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.
- Company typePrivate
- Founded2014
- HeadquartersGainesville, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
MLM Biologics firmographics
Firmographics- 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
MLM Biologics industry classification
Industry- 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
Where MLM Biologics is headquartered
LocationHeadquarters
- HQ city
- Gainesville
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
MLM Biologics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Supply Chain
Revenue model
- 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
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Catalog sizes from 1.5cm x 1.5cm to 6cm x 7cm with corresponding billing units |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
MLM Biologics product offering
Product offeringCore 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
Companies that use MLM Biologics
Customer profileNamed customers4 records
Segments4 records
Ideal customer profiles3 records
MLM Biologics technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
MLM Biologics partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core and minor.
- BioWound SolutionscoreBioWound 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 PartnersminorMLM 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
MLM Biologics competitors and assessment
Company assessmentDirect 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
MLM Biologics social profiles
Digital presenceMLM Biologics compliance and trust
Trust signalCompliance2 records
MLM Biologics financial estimates
Financial estimateRevenue estimate
Valuation estimate
MLM Biologics leadership team
Management profileNumber of profiles
Profiles4 records
MLM Biologics funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
MLM Biologics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about MLM Biologics
What does MLM Biologics do?
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.
Is MLM Biologics a public or private company?
MLM Biologics is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was MLM Biologics founded?
MLM Biologics was founded in 2014. It employs 1 to 10 people.
Where is MLM Biologics based?
MLM Biologics is headquartered in Gainesville, United States, in the North America region.
How does MLM Biologics make money?
One revenue line is on record: bio-ConneKt Wound Matrix Sales.
Who are MLM Biologics's main competitors?
Direct peers on record are Organogenesis Holdings, ConvaTec, MiMedx Group and Coloplast. Emerging players are Aroa Biosurgery and AlloSource. Broad incumbents are Smith & Nephew (Advanced Wound Management), Molnlycke Health Care, Integra LifeSciences and 3M Health Care (Acelity/KCI).
Does MLM Biologics have an API?
No public API is recorded for MLM Biologics.
What industry is MLM Biologics in?
MLM Biologics's product category is Advanced Wound Care Medical Devices. Its primary akta.pro industry code is HLAHALAE, Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts), with a secondary code of HLAAAGAG, Wound Healing & Skin Regeneration (advanced dressings, skin substitutes). Its NAICS code is 3391 and its SIC code is 3841.