Medical Device Information
1st SurgiConcept (第一外科概念) - French Aesthetic Thread and Medical Device Specialist

1st SurgiConcept (第一外科概念) - French Aesthetic Thread and Medical Device Specialist

admin132026-04-15 18:59:58
2025 China Market Entry:
On July 31, 2025, 1st SurgiConcept's Spring Thread® received NMPA Class III medical device approval (Registration No.: 国械注进20253130328), becoming the second imported facial thread approved in china after Korea's MINT®Lift (2024). The company appointed Nanjing Ouyi Medical Device Co., Ltd. as registration agent and Nanjing Heng'aorong Medical Device Co., Ltd. as exclusive sales distributor, with a strategic cooperation agreement signed in June 2025 to drive localized commercial operations.

Company Overview (Updated April 2026)

1st SurgiConcept (第一外科概念公司) is a French medical device manufacturer headquartered in Tourcoing, Hauts-de-France, France. Established on May 15, 2007, the company operates as a Société à responsabilité limitée (SARL) specializing in the design, manufacturing, and trade of medical-surgical devices. With 3-5 employees, 1st SurgiConcept has established itself as a niche player in the global aesthetic medicine market through its proprietary elastic thread technology.

Global Reach: Spring Thread® is 100% manufactured in France and has been sold in over 40 countries worldwide, with distribution networks across Europe, Russia, Asia, and now China.

History & Development

Key Milestones:

- 2007: Company founded on May 15 in Marcq-en-Barœul, France; began development of Spring Thread® technology

- 2007-2023: Established global distribution network in 40+ countries; built clinical track record for facial rejuvenation applications

- January 2023: Spring Thread® received Class C medical device approval from Singapore HSA (Health Sciences Authority)

- March 2025: Presented at IMCAS World Congress 2025, demonstrating neck ptosis improvement techniques with Spring Thread®

- June 2025: Signed strategic cooperation agreement with Nanjing Ouyi Medical and Nanjing Heng'aorong Medical for China market entry

- July 31, 2025: Received NMPA approval (国械注进20253130328) for facial implantation threads in China, indicating use for correction of moderate nasolabial fold wrinkles

China Market Strategy (2025-2026)

Regulatory Approval Details

- Registration Number: 国械注进20253130328

- Product Name: 面部埋植线 (Facial Implantation Thread)

- Indication: Implantation in facial superficial musculoaponeurotic system (SMAS) and superficial tissues for correction of moderate nasolabial fold wrinkles (中度鼻唇沟皱纹)

- Target Demographics: Patients aged 35-75 with mild to moderate skin ptosis

Commercial Partnership Structure

- Registration Agent: 南京欧益医疗器械有限公司 (Nanjing Ouyi Medical Device Co., Ltd.)

- Exclusive Distributor: 南京恒奥荣医疗器械有限公司 (Nanjing Heng'aorong Medical Device Co., Ltd.)

- Strategy: Three-party collaboration to drive localized commercial operations, leveraging domestic partners' regulatory expertise and distribution networks

Core Technology & Products

Spring Thread® Elastic Suture System (Flagship Product)

Product Composition:

- Core Material: Multifilament polyethylene terephthalate (PET) providing structural strength and elasticity

- Outer Coating: Medical-grade polydimethylsiloxane (silicone) with integrated cogs (barbs) for tissue fixation

- Design: Non-absorbable, elastic suture with multiple uncolored barbs arranged along the thread length

- Manufacturing: 100% French-made with ethylene oxide (EO) sterilization (SAL 10⁻⁶)

- Shelf Life: 5 years

Product Variants & Specifications

- Spring Thread® Face Thread (FL 6-300): Standard facial thread for mild to moderate ptosis

- Spring Thread® Face Thread with Needle (FA 6-300): Pre-attached needle configuration for easier implantation

- Technical Properties: High elasticity, excellent tensile strength, optimal barb load capacity, biocompatible coating

Clinical Applications

Indications:

- Correction of mild to moderate facial ptosis (sagging)

- Treatment of moderate nasolabial folds (鼻唇沟皱纹)

- Facial rejuvenation through implantation in superficial musculoaponeurotic system (SMAS) layer

- Localized tissue lifting and volume restoration for patients aged 35-75

Regulatory Compliance & Quality

International Approvals

- Singapore (HSA): Class C medical device approval (January 12, 2023)

- China (NMPA): Class III medical device approval (July 31, 2025) - Registration No. 国械注进20253130328

- European Union: CE marking for medical device distribution in EU markets

- Russia: Active export market with established trade relationships

Biocompatibility & Safety Testing

Comprehensive biocompatibility evaluation conducted according to ISO 10993 and GB/T 16886 standards, including:

- Cytotoxicity testing

- Skin sensitization

- Intradermal reaction

- Pyrogenicity

- Acute, subacute, and subchronic systemic toxicity

- Implantation local reaction tests

- Genotoxicity

- Hemocompatibility

- Chronic toxicity and carcinogenicity assessment

Market Position & Competition

Global Aesthetic Thread Market

- Market Size: US$ 121.4 million (2022) → projected US$ 203.0 million (2030)

- CAGR: 6.6% (2023-2030)

- Market Segment: Non-absorbable/elastic thread category (vs. PDO/PLLA absorbable threads)

- Key Competitors: Menarini Group, N-Finders Co. Ltd., River Aesthetics, Metro Korea Co. Ltd., Healux Corporation, Croma Pharma GmbH, Aptos International Ltd., Sinclair Pharma (Huadong Medicine), HansBiomed Corp. (MINT®Lift)

- Differentiation: Unique combination of PET strength + silicone elasticity; permanent (non-absorbable) solution vs. temporary PDO threads

China Market Context

As of August 2025, only 8 facial thread products hold NMPA approval:

- Imported (2): 1st SurgiConcept Spring Thread® (France), HansBiomed MINT®Lift (Korea)

- Domestic (5): Weidu Medical (Micro-Lift, Feiling), Imeik (Jinlian), Puliyan (Xinxiu), Suzhou Shangmei

- Hong Kong/Taiwan (1): Taiwan Crystal Drill Biomedical (METEORA®)

Corporate Information (2026)

Company Profile

Company Name: 1st SurgiConcept (1ST SURGICONCEPT)

Legal Form: Société à responsabilité limitée (SARL)

Founded: May 15, 2007

Headquarters: 96 Rue du Pont Rompu, 59200 Tourcoing, France

SIREN: 498 010 925

SIRET: 498 010 925 00036

VAT Number: FR84498010925

Share Capital: €40,000.00

Industry: Fabrication de matériel médico-chirurgical et dentaire (NAF Code 32.50A)

Employees: 3-5 employees (2021 INSEE data)

Company Size: PME (Small and Medium Enterprise)

Management

Current Manager (Gérant): Dominique MALARD (since February 7, 2013)

Quality & Regulatory Affairs Manager: Bertrand Proix

Former Manager: Jean FRISMAND (2007-2013)

Establishments

Headquarters: 96 Rue du Pont Rompu, 59200 Tourcoing (active since January 8, 2013)

Secondary Establishment: 278 Chaussée Fernand Forest, 59200 Tourcoing (March 1, 2008)

Former Address: 228 Boulevard Clemenceau, 59700 Marcq-en-Barœul (May 15, 2007 - October 31, 2010)

Financial Performance (Historical)

Fiscal Year 2012 (12 months ending September 30, 2012):

- Revenue: €574,000 (up 15.12% from 2011)

- Export Revenue: €506,000 (88% of total revenue)

- Net Profit: €56,900

- Operating Profit: €74,800 (13.28% margin)

2026 Outlook

Strategic Directions

- China Market Penetration: Leveraging Nanjing Ouyi/Heng'aorong partnerships to establish Spring Thread® in China's premium aesthetic clinic segment

- Asia-Pacific Expansion: Building on Singapore HSA and China NMPA approvals to target Japan, South Korea, and Southeast Asian markets

- Product Line Extension: Development of specialized thread configurations for neck, brow, and body applications

- Clinical Education: Training programs for practitioners on optimal implantation techniques, leveraging IMCAS congress participation

- Regulatory Diversification: Pursuing additional registrations (US FDA 510(k), Brazil ANVISA, Middle East)

Key Differentiators

- Elastic Technology: Unique combination of PET core and silicone coating provides both strength and flexibility, mimicking natural tissue elasticity; distinct from rigid PDO threads

- Permanent Solution: Non-absorbable design offers long-lasting results compared to absorbable alternatives (6-12 months for PDO)

- Niche Expertise: 18+ years specializing exclusively in elastic thread technology for facial rejuvenation

- High Export Ratio: Approximately 88% of revenue from international markets, demonstrating global competitiveness

- Regulatory Excellence: Successfully navigated stringent Class III medical device approvals in Singapore and China as a small SME

- Strategic Partnerships: Effective localization strategy through experienced Chinese distribution partners (Ouyi + Heng'aorong)

Keywords: 1st SurgiConcept,第一外科概念,Spring Thread,aesthetic thread,facial rejuvenation,medical device,France,Tourcoing,elastic suture,PET silicone,thread lift,plastic surgery,NMPA approval,国械注进20253130328,Nanjing Ouyi,Nanjing Heng'aorong,IMCAS 2025,Dominique Malard

文章下方广告位

猜你喜欢

网友评论