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
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