Stedical Scientific

What Stedical Scientific does

Stedical Scientific (Shanghai) Co., Ltd and its U.S. subsidiary Stedical Scientific, Inc. (Carlsbad/San Diego, CA) is a privately-held medical device company founded in 2019 to acquire and commercialize healthcare technologies addressing large unmet needs. The company acquired PermeaDerm, Inc. in August 2019 and now commercializes the PermeaDerm® biosynthetic wound matrix (BSM) platform — a two-layer matrix combining a silicone-membrane epidermal analogue with a 3D micro-scaffold dermal analogue, configurable via variable porosity for wound-specific customization. The product family consists of PermeaDerm B (acute wounds and partial-thickness burns), PermeaDerm C (chronic wounds including diabetic, venous, and pressure ulcers), and PermeaDerm G (a glove for debrided partial-thickness hand burns); all three are FDA-cleared 510(k) devices and PermeaDerm holds ISO 13485 certification (since 2018).

The company's core technology, developed by Chief Scientific Officer Dr. Aubrey Woodroof (the inventor of Biobrane), operates on a proprietary R.A.S.E. four-stage healing mechanism (Reconstruction, Primary Adherence within 5 hours, Secondary Adherence within 72 hours, and Epithelialization) and is covered by multiple granted patents including Biobrane, AWOD, AWOD Plus, and PermeaDerm. The stated clinical benefit is single-application healing of deep second-degree burns in approximately 9 days, compared to the 3–7 week standard of care.

Stedical generates revenue from one-time device sales of PermeaDerm B/C/G, sold through a hybrid go-to-market model: top-tier distribution partners in the wound care, infection control, and burn markets handle U.S. commercialization while the company retains direct enterprise field sales and clinical-evidencing relationships with leading burn centers and KOLs. The company operates a dual-headquarters structure (Shanghai parent, U.S. subsidiary) and is actively expanding in the U.S., Europe, and Greater China, with stated plans for the Middle East, Southeast Asia, Africa, and Latin America. In China, a 184-subject multi-center clinical trial across four authoritative burn centers is ongoing under the leadership of Academician Dr. Zhaofan Xia, supporting an eventual China commercial launch.

Name

Stedical Scientific

Legal name

Stedical Scientific, Inc.

Website

https://stedical.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

Stedical Scientific acquires and commercializes FDA-cleared PermeaDerm biosynthetic wound matrix products (B, C, G) for burn, chronic, and surgical wound care, sold through top-tier distribution partners in the U.S. and Europe with active clinical-trial-driven expansion into the China market.

Ownership category

akta.pro rank

Product category

Wound Care Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112), 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)

akta.pro secondary industries

Wound Healing & Skin Regeneration (advanced dressings, skin substitutes) (HLAAAGAG), Wound Care & Ulcer Management (HLAKACAN)

Keywords

• Wound care products
• Biosynthetic skin substitutes
• Burn care devices
• Medical device manufacturing
• Chronic wound treatment

Headquarters

HQ city

Carlsbad

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. PermeaDerm Product Sales: Stedical Scientific generates revenue from the sale of its FDA-cleared PermeaDerm medical device products (PermeaDerm-B, -C, -G). These are sold as one-time or repeat purchase medical devices through distribution partnerships in the wound care, burn, and infection control markets across the U.S., Europe, and China.
2. Global Marketing and Distribution Rights: The company commercializes its proprietary FDA-cleared products through global marketing and distribution in the U.S., Europe, and Greater China, leveraging partnerships with top-tier commercialization partners and its own distribution infrastructure.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels5 records

Core offering

Stedical Scientific develops, manufactures, and commercializes FDA-cleared PermeaDerm biosynthetic wound matrix medical devices for burn and chronic wound care. Its portfolio includes PermeaDerm-B for acute wounds, PermeaDerm-C for chronic wounds, and PermeaDerm-G for hand burns, sold through distribution partners and direct enterprise sales across the U.S., Europe, and China.

Product overview

Stedical Scientific offers a portfolio of PermeaDerm® biosynthetic wound matrix products acquired from PermeaDerm, Inc. The product line consists of PermeaDerm-B for acute wounds (burns, abrasions, lacerations), PermeaDerm-C for chronic wounds (diabetic ulcers, venous ulcers, pressure sores), and PermeaDerm-G specifically designed as gloves for hand burn treatment. All products are FDA-cleared 510k medical devices based on a biosynthetic matrix technology featuring a silicone membrane epidermal analogue and 3D micro-scaffold dermal analogue that provides a moist wound healing environment conducive to cell migration and proliferation. The company operates as both Stedical Scientific (Shanghai) Co., Ltd and its U.S. subsidiary Stedical Scientific, Inc.

Differentiator

Problem solved

Functional benefit

Brands

• PermeaDerm: Biosynthetic wound matrix product line including PermeaDerm-B for acute wounds, PermeaDerm-C for chronic wounds, and PermeaDerm-G gloves for hand burns treatment.

Products and services

• PermeaDerm-B FDA-cleared 510(k) medical device for acute wounds including partial thickness burns, donor sites, coverage of meshed autograft, abrasions, lacerations, skin tears, and draining wounds.
• PermeaDerm-C FDA-cleared 510(k) medical device for chronic wounds including pressure sores, venous ulcers, diabetic ulcers, vascular ulcers, post-Mohs surgery, post-laser surgery, podiatric wounds, and wound dehiscence.
• PermeaDerm-G (Gloves) FDA-cleared 510(k) medical device specifically designed as a glove for treatment of debrided partial thickness hand burns.

Quantifiable outcome

• Deep second-degree burn healed in 9 days with single PermeaDerm application, vs. standard healing time of 3-7 weeks
• +3 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Ten partnerships are on record, tiered core, minor and flagship.

• Shanghai Changhai Hospital (Burn Surgery / China National Engineering Academy)coreStrategic or Co-development Partner · 5 April 2022Academician Dr. Zhaofan Xia from Shanghai Changhai Hospital is the principal investigator of Stedical's multi-center clinical trial in China (184 subjects across 4 centers). Dr. Xia is a China National Engineering Academician and Director of Burn Surgery at Naval Medical University. He delivered the opening speech at Stedical's 2021 Clinical Trial Investigator Symposium and leads the China clinical development program.
• Affiliated Hospital of Jiangnan University / China Burn AssociationcoreStrategic or Co-development Partner · 5 April 2022Dr. Guozhong Lv, Chairman of the China Burn Association and Director of the Burn Trauma Treatment Center at the Affiliated Hospital of Jiangnan University, participated as a principal investigator in Stedical's China multi-center clinical trial. Dr. Lv is a key opinion leader supporting the clinical validation of PermeaDerm in China.
• Shanghai Ruijin Hospital / China Burn AssociationcoreStrategic or Co-development Partner · 5 April 2022Dr. Yan Liu, Vice Chairman of the China Burn Association and Director of the Burn Plastic Surgery Department at Ruijin Hospital affiliated with Shanghai Jiaotong University School of Medicine, participated as a clinical trial investigator for PermeaDerm in China. Dr. Liu and her team are evaluating the safety and efficacy of PermeaDerm across burn and wound care applications.
• Tongren Hospital, Wuhan UniversitycoreStrategic or Co-development Partner · 5 April 2022Dr. Weiguo Xie, Director of the Burn Department at Tongren Hospital affiliated with Wuhan University and past Vice President of the China Burn Association, participated as a principal investigator in Stedical's China multi-center clinical trial of PermeaDerm.
• Dr. David Herndon (UC San Diego / US National Academy of Medicine)coreStrategic or Co-development Partner · 12 January 2021Dr. David Herndon, member of the US National Academy of Medicine and Editor of Journal of Burn Care and Research, serves as Chairman of the Scientific Advisory Committee at Stedical Scientific in both China and the U.S. He joined the Clinical Trial Investigator Symposium via video conference, recapping the history of working with Dr. Woodroof since the 1980s on Biobrane, and expressed enthusiasm for bringing PermeaDerm's advancement to the world.
• Dr. Robert Bartlett (Father of ECMO)minorStrategic or Co-development Partner · 12 January 2021Dr. Robert Bartlett, known as the 'Father of ECMO,' was honored at Stedical's special event during the ABA annual meeting in April 2022. He shared the story of his friendship with Dr. Woodroof and the evolution of the biosynthetic skin substitute industry. Dr. Bartlett was the newly appointed director of UC Irvine Burn Center where he invented ECMO technology.
• PermeaDerm, Inc.flagshipStrategic or Co-development Partner · 8 August 2019Stedical Scientific completed the acquisition of PermeaDerm, Inc., a privately-held San Diego-based medical device manufacturer developing innovative wound healing products. PermeaDerm's FDA-cleared products (PermeaDerm B, C, G) became the core technology platform for Stedical's global commercialization strategy in burn and wound care markets.
• Jones DayminorImplementation/ SI/ Consulting Partner · 8 August 2019Jones Day acted as legal counsel to Stedical Scientific in the United States for the acquisition of PermeaDerm, Inc.
• King & Wood MallesonsminorImplementation/ SI/ Consulting Partner · 8 August 2019King & Wood Mallesons acted as legal counsel to Stedical Scientific in China for the acquisition of PermeaDerm, Inc.
• Objective Capital PartnersminorImplementation/ SI/ Consulting Partner · 8 August 2019Objective Capital Partners acted as the financial advisor for the transaction in which Stedical Scientific acquired PermeaDerm, Inc.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Integra LifeSciences: Diversified medical technology company with regenerative tissue technologies including Integra Dermal Regeneration Template and wound matrix products. Comparable to PermeaDerm as a competing skin substitute technology serving burn and reconstructive surgery customers.
• ConvaTec Group: Global medical products company with advanced wound care, ostomy, and continence franchises. Comparable to PermeaDerm in advanced wound dressings targeting chronic wounds (diabetic foot ulcers, pressure ulcers) that overlap with PermeaDerm-C.
• 3M Health Care (Solventum): Major medical products company (recently spun off as Solventum) with advanced wound care solutions and skin protectants. Comparable to PermeaDerm as a broad incumbent competing in hospital wound care channels.
• Smith+Nephew: Global medical device incumbent with a substantial advanced wound management portfolio (e.g., Allevyn, ACTICOAT). Comparable to Stedical as it sells into the same burn and chronic wound hospital channels, though as part of a much broader portfolio rather than specializing in biosynthetic matrices.
• Mölnlycke Health Care: Global wound care and surgical solutions company whose Mepilex and Mepitel product lines compete in advanced wound dressings and burn care. Comparable to PermeaDerm as an established wound care specialist serving burn centers and hospitals.
• Coloplast: Global medical device company specializing in wound care (Biatain, Conveen), ostomy, and continence care. Comparable to PermeaDerm in advanced wound care for chronic wounds, particularly diabetic foot and venous ulcers.

Direct peers

• Organogenesis Holdings: Specialist regenerative medicine company marketing Apligraf and Dermagraft, leading skin substitutes and living cell-based wound therapies for chronic wounds and burns. Directly comparable to PermeaDerm as a competing biologic/regenerative wound matrix.
• MiMedx Group: Commercial-stage wound care and surgical recovery company selling amniotic membrane-based products (EpiFix, AmnioFix) for chronic wounds, burns, and surgical applications. Directly comparable to Stedical in advanced wound healing biologics targeting similar burn and chronic wound end markets.

Emerging players

• PolyNovo: Specialty medical device company marketing NovoSorb BTM (biodegradable temporizing matrix) for burns and complex wounds. Comparable to PermeaDerm as a focused emerging player in biosynthetic dermal matrices for burn treatment.
• Vericel Corporation: Commercial-stage cell therapy company marketing Epicel (cultured epidermal autografts) for severe burns. Comparable to Stedical as a niche regenerative burn-care specialist, though using autologous cell therapy rather than biosynthetic matrices.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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 Stedical Scientific