NeXtGen Biologics

What NeXtGen Biologics does

NeXtGen Biologics Inc. is a private medical device company founded in 2014 and headquartered in Alachua, Florida. The company develops and manufactures extracellular matrix (ECM) biomaterial products derived from the dermal tissue of the axolotl (Ambystoma mexicanum), a salamander with documented scar-free regenerative capabilities. Its sole commercial product, NeoMatriX® Wound Matrix, is an FDA 510(k)-cleared collagen wound matrix provided as sterile, gamma-irradiated acellular sheets in multiple sizes for the management of partial and full-thickness wounds, including diabetic foot ulcers, venous ulcers, pressure ulcers, surgical wounds, and trauma wounds. The product is stored at room temperature and conforms to the wound bed upon hydration with sterile saline.

The company's business model is hardware sales of a single 510(k) medical device to healthcare providers, wound care clinics, and federal healthcare systems, distributed through direct sales and through a channel partnership with Lovell Government Services that targets the Veterans Health Administration, Military Health System, and Indian Health Service. Clinical evidence includes multi-site abstracts reporting 64% closure of a chronic diabetic foot ulcer in one week and successful use in Moh's surgery closures and surgical dehiscence cases. The firm holds three issued US patents and seven international patents covering decellularized biomaterial from non-mammalian tissue, which were upheld when the USPTO declined to initiate Inter Partes Review in response to petitions filed by RegenX Science in late 2025.

NeXtGen raised over $13 million in cumulative startup capital across multiple funding events between 2014 and 2024, including a round led by SINC Fund in July 2024, and completed its first FDA inspection with zero Form 483 observations in October 2025. The leadership team is anchored by co-founder and CEO Jonelle Toothman (20+ years commercializing medical devices, former Pfizer) and co-founder Jamie Grooms, who previously co-founded and led RTI Surgical and AxoGen to IPO. The company is described as an emerging startup with 1–10 employees, operating exclusively in North America with the wound matrix positioned as the initial clinical application of a broader ECM platform.

Name

NeXtGen Biologics

Legal name

NeXtGen Biologics Inc.

Website

https://nextgenbiologics.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

NeXtGen Biologics is a private Alachua, Florida medical device company that develops and sells NeoMatriX, an FDA 510(k)-cleared wound matrix derived from axolotl extracellular matrix, serving wound care specialists and federal healthcare systems including the VA, military, and IHS.

Ownership category

akta.pro rank

Product category

Wound Care Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

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

Keywords

• Wound care matrix
• Regenerative medicine
• Extracellular matrix
• Biomaterial devices
• Collagen wound dressing

Headquarters

HQ city

Alachua

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. NeoMatriX Wound Matrix Sales: NeXtGen Biologics generates revenue through the sale of its FDA-cleared NeoMatriX Wound Matrix medical device. The product is sold in various sizes (disks, ellipses, strips) as a one-time-use wound care device to healthcare providers, wound care specialists, and federal healthcare systems. The company distributes through direct sales and channel partners (Lovell Government Services for federal contracts).

Go-to-market motion3 records

Distribution channels2 records

Marketing channels6 records

Core offering

NeXtGen Biologics manufactures and sells NeoMatriX, an FDA-cleared collagen wound matrix derived from the extracellular matrix (ECM) of the axolotl. The sterile acellular dermal membrane is provided in sheet form in multiple sizes for placement on wound beds to manage partial and full-thickness wounds including diabetic foot ulcers, venous ulcers, pressure ulcers, surgical wounds, and trauma wounds. The product is sold as an off-the-shelf medical device to hospitals, wound care clinics, surgical centers, and federal healthcare systems.

Product overview

NeXtGen Biologics operates as a single-product company focused on regenerative medicine, with its core offering being the NeoMatriX® Wound Matrix. This FDA-cleared medical device is fabricated from the dermal extracellular matrix of axolotl and is provided in sheet form for placement on wound beds to help manage the wound environment. The company is built on a platform technology derived from the axolotl's regenerative biology, with wound care serving as the initial clinical proving ground for potential expansion into other therapeutic domains.

Differentiator

Problem solved

Functional benefit

Products and services

• NeoMatriX Wound Matrix FDA-cleared collagen wound matrix derived from the extracellular matrix (ECM) of the axolotl, designed for management of partial and full-thickness wounds including pressure ulcers, venous ulcers, diabetic foot ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post Moh's surgery, post-laser surgery, dehiscence), and trauma wounds (abrasions, lacerations, partial thickness burns, skin tears). Provided in sheet form in various sizes (2x3cm ellipse, 1x3cm strip, 1x2cm ellipse, and disk formats from 8mm to 20mm). Stored at room temperature (15-30°C) in a dual pouch system with gamma irradiation sterilization at 20-24kGy to a sterility assurance level of 10^-6. Clinical evidence includes 64% diabetic foot ulcer closure in one week.

Quantifiable outcome

• 64% diabetic foot ulcer closure in one week
• +1 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Lovell Government ServicescoreChannel Partner/ Reseller/ Distributor · 10 November 2025NeXtGen Biologics partnered with Lovell Government Services to provide its FDA-cleared NeoMatriX advanced wound care technology to federal healthcare systems. Lovell serves as the federal vendor, facilitating distribution through government contracting channels to the Veterans Health Administration (VHA), the Military Health System (MHS), and the Indian Health Service (IHS). The partnership targets federal healthcare procurement for wound management of veterans and military patients using the axolotl-derived collagen wound matrix.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Organogenesis: Organogenesis is a leading regenerative medicine company selling Apligraf and Dermagraft, two of the most well-known skin substitute/wound matrix products for chronic wounds including diabetic foot ulcers. It is the most direct competitor to NeXtGen's NeoMatriX in the wound matrix category.
• MiMedx Group: MiMedx markets EpiFix and AmnioFix, dehydrated amniotic membrane allografts used for chronic wound care and surgical applications. It is a leading direct competitor in the skin substitute and wound matrix space.
• MTF Biologics: MTF Biologics distributes allograft-based wound care matrices such as AmnioBand and AlloPatch, used for chronic wounds and surgical applications. It is a direct peer in the wound matrix/skin substitute category.
• Cook Biotech: Cook Biotech manufactures ECM-based wound care and surgical repair products (e.g., OASIS Wound Matrix) derived from porcine small intestinal submucosa. It is a direct competitor in the ECM-based wound matrix category.

Broad incumbents

• Integra LifeSciences: Integra LifeSciences offers a broad portfolio of wound matrices (e.g., Integra Dermal Regeneration Template, PriMatrix) and is a major established player in regenerative wound care and surgical reconstruction, competing broadly with NeXtGen in hospital wound care.
• Coloplast: Coloplast has a substantial wound and skin care portfolio including Biatain and other advanced wound care products, serving hospitals and home health for chronic wounds. It is a broad incumbent competing in the same wound management category.
• Smith+Nephew: Smith+Nephew's Advanced Wound Management division offers a comprehensive portfolio of skin substitutes, collagens, and wound matrices. As a large global medtech incumbent, it competes broadly with NeXtGen in hospital and outpatient wound care.
• ConvaTec: ConvaTec is a global medical products company with a substantial Advanced Wound Care portfolio (e.g., AQUACEL) serving hospitals, wound clinics, and home health. It is a broad incumbent competing in the overall wound care category where NeXtGen operates.

Emerging players

• Aroa Biosurgery: Aroa Biosurgery develops ECM-based products derived from ovine forestomach for wound healing and soft tissue reconstruction. It is an emerging player using a novel (non-mammalian) ECM source, comparable to NeXtGen's regenerative ECM approach.

Others

• AxoGen: AxoGen is a peripheral nerve repair company co-founded by NeXtGen co-founder Jamie Grooms. It shares ECM-based regenerative medicine technology roots and was led to IPO by Grooms, making it a thematically related peer and a precedent for the founders' execution capability.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/NeXtGen_Bio
• LinkedInlinkedin.com/company/nextgen-biologics

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds7 records

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 NeXtGen Biologics