Bistool

What Bistool does

Bistool (BISTOOL INC., 주식회사비스툴) is a South Korean medical device manufacturer founded in 2005 and headquartered in Seoul, specializing in facial aesthetic implants and aesthetic thread lifts. The company designs and manufactures three core product lines: SOFTXiL, a facial silicone implant made of medical-grade silicone with double-hardness technology (hard silicone for bone-contact surfaces, soft silicone for tissue-contact surfaces); SOFIT, a premium 3D-customized facial implant produced from patient-specific CT scan data with approximately one-week lead time; and VXIL, a PDO (Polydioxanone) and PCL (Polycaprolactone) thread for lifting procedures, manufactured using a proprietary Press Sculpting molding method that produces 180-degree bidirectional barbs with higher tensile strength than conventional cut threads. All products are manufactured in the company's Seoul production facility under ISO Class 7 (Class 10,000) cleanroom conditions using Nusil Technology's FDA-approved long-term implantable silicone as raw material, with EO sterilization and a four-stage inspection process.

Bistool's regulatory positioning is unusually strong for a company of its size: SOFTXiL is the first facial silicone implant in Asia to hold simultaneous US FDA registration and European CE Mark certification, complemented by KFDA (MFDS) approval, ISO 13485 quality certification, and KGMP compliance. The company holds registered patents on lightweight silicone implants and nasal implants, four utility model registrations, and 25 industrial design registrations covering plastic surgery implants.

The business model is a hybrid direct B2B and distributor-channel hardware sale: in Korea, Bistool sells exclusively to registered hospital/clinic operators through a free membership portal, with SOFIT customized orders placed individually and billed per contract. The company maintains a domestic distributor network covering Seoul/Gyeonggi, Daejeon/Chungcheong, Jeonju/Jeolla, Daegu/Gyeongbuk, and Busan/Gyeongnam, with 71+ clinic clients concentrated in the Gangnam/Apgujeong aesthetic surgery district. International distribution is handled through authorized partners in Taiwan, Japan, Thailand, Vietnam, Malaysia, Indonesia, Iran, Mongolia, and Argentina, with the option of direct purchase from Bistool HQ where no local distributor exists. Bistool supports adoption through the BISTOOL Academy medical training program, participation in conferences such as the Korean Society of Aesthetic and Plastic Surgery, and multilingual digital resources (Korean, English, Japanese). As of October 2024 the company secured a 700 million KRW pre-Series A round from The Invention Lab to accelerate SOFIT and Southeast Asian expansion.

Name

Bistool

Legal name

주식회사 비스툴 (BISTOOL INC.,)

Website

https://bistool.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

Bistool is a Seoul-based medical device manufacturer founded in 2005 that designs and produces facial silicone implants (SOFTXiL), 3D CT-customized implants (SOFIT), and PDO/PCL lifting threads (VXIL), selling directly to plastic surgery clinics in Korea and through distributors across nine international markets.

Ownership category

akta.pro rank

Product category

Aesthetic Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

3D-Printed & Patient-Specific Implants (Custom Ortho/Spine/Cranial) (HLAHAEAJ)

Keywords

• Facial silicone implants
• Aesthetic medical devices
• PDO thread lifts
• Customized facial implants
• Plastic surgery supplies

Headquarters

HQ city

Seoul

HQ country

South Korea

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Facial Implant Product Sales (SOFTXiL, SOFIT): Direct B2B sales of facial silicone implants to registered hospital/clinic customers. SOFIT is a customized 3D CT-based implant ordered through the member portal, with costs billed after production begins per individual contracts. SOFTXiL is a pre-formed implant sold directly. Revenue is generated per unit/order as a one-time hardware sale with potential for repeat orders from clinic customers.
2. VXIL PDO/PCL Thread Sales: Sales of PDO and PCL thread products (VXIL) for aesthetic lifting procedures. PDO threads have a 6-month biodegradation period; PCL threads last approximately 2 years. PCL is currently only available overseas.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Bistool designs, manufactures, and sells facial silicone implants (SOFTXiL, SOFIT) and PDO/PCL thread lift products (VXIL) used by plastic and aesthetic surgery clinics and hospitals. The company produces pre-formed and 3D CT-scan-customized facial implants for nasal, chin, malar, and paranasal augmentation, plus biodegradable PDO/PCL suture threads for aesthetic lifting procedures. All products are manufactured in ISO Class 7 cleanroom facilities in Seoul, South Korea, and sold exclusively through a B2B membership model to registered hospital and clinic operators.

Product overview

Bistool is a South Korean medical device company specializing in facial aesthetic implants and thread lifts. The product portfolio centers on three main offerings: SOFTXiL (standard facial silicone implants with dual-hardness technology), SOFIT (premium customized 3D implants based on patient CT data built on SOFTXiL technology), and VXIL (PDO/PCL thread lifts using innovative Press Sculpting molding). All products are manufactured in Seoul, Korea under strict ISO 13485 and GMP quality standards, with FDA and CE certifications for global market access.

Differentiator

Problem solved

Functional benefit

Brands

• SOFTXiL (소프트씰): Facial silicone implant made of silicone with hardness similar to human tissue. First in Asia to receive both US FDA and European CE certification.
• SOFIT (쏘핏)
• VXIL (브이씰)

Products and services

• SOFTXiL Facial Silicone Implant (소프트씰) Pre-formed facial silicone implant made of medical-grade silicone with dual-hardness technology: hard silicone on bone-contacting surfaces and soft silicone on tissue-contacting surfaces to mimic human tissue hardness. Used by plastic and aesthetic surgeons for nasal, chin, malar, and paranasal augmentation. First facial silicone implant in Asia with simultaneous US FDA and European CE certification.
• SOFIT 3D Customized Facial Implant (쏘핏) Premium customized facial silicone implant manufactured from individual patient CT scan data, designed to fit each patient's unique bone structure and reflect the surgeon's surgical plan. Production takes approximately one week per implant. Ordered through the Bistool member portal by registered clinic/hospital operators with per-order contract pricing.
• VXIL PDO/PCL Thread Lift (브이씰) PDO (Polydioxanone) and PCL (Polycaprolactone) suture threads for aesthetic lifting procedures, manufactured using a proprietary Press Sculpting molding method that produces 180-degree bidirectional sturdy barbs (12 barbs per 1cm) without heating. PDO threads biodegrade in approximately 6 months; PCL threads last approximately 2 years. Available in 18G and 19G cannula types for no-incision procedures. PCL is currently only available overseas.

Quantifiable outcome

• 4-step quality inspection process across all products
• +2 more outcomes

Named customers4 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• KLS Martin Group: German-headquartered manufacturer of surgical implants and instruments, including a strong CMF (craniomaxillofacial) implant line used in facial reconstruction and aesthetic surgery. Overlaps with Bistool's implant category but as part of a much wider surgical products portfolio.
• AbbVie (Allergan Aesthetics): Allergan Aesthetics, owned by AbbVie, markets facial injectables and implant-adjacent aesthetics products to plastic surgeons globally. Competes for clinic shelf space and surgeon training time in the same aesthetic surgery channel as Bistool, though Allergan's portfolio centers on injectables rather than implantable silicone.
• Galderma: Global dermatology and aesthetics major (Nestlé-owned) with a broad portfolio spanning injectables, fillers, and aesthetic devices. While not a direct facial implant competitor, Galderma targets the same plastic surgery and dermatology clinics that Bistool serves and competes for the same patient procedure wallet.
• Stryker (Medpor): Medpor porous polyethylene facial implants, owned by Stryker, are widely used in craniofacial and reconstructive surgery globally. Stryker is a diversified medtech major; its Medpor line competes with Bistool in the facial implant category but represents only a small slice of its much broader portfolio.

Direct peers

• SurgiSil: US-headquartered company (with Korean distribution ties) that manufactures facial lip and silicone implants, including PermaLip and periorbital implant lines. Directly competes with Bistool's SOFTXiL facial implants and shares the same plastic surgery clinic channel and surgeon training approach.
• Aptos International: Producer of PDO/PLA thread lift products and methods for non-surgical facial lifting, with global distribution. Most directly comparable peer to Bistool's VXIL thread lift line in terms of product technology (barbed PDO threads) and customer base (aesthetic clinics offering lifting procedures).
• Hanson Medical: US manufacturer of facial implants (chin, cheek, jaw) and tissue expanders used in plastic and reconstructive surgery. Directly comparable product line to Bistool's SOFTXiL facial silicone implants, sold through the same plastic surgery clinic channel.
• Implantech Associates: US-based manufacturer specializing in facial contouring implants (cheek, chin, nasal) made of medical-grade silicone. Direct competitor to Bistool's SOFTXiL product line in the facial silicone implant category, serving the same plastic surgery clinic customer base with comparable surgical-grade implants.

Emerging players

• Sebbin: French manufacturer of long-term implantable silicone devices for aesthetic and reconstructive surgery, including breast, facial, and body implants. Comparable to Bistool in long-term implantable silicone expertise and CE-marked product positioning, though Sebbin is more focused on breast implants than facial.
• Xilloc: Dutch medical device company specializing in 3D-printed patient-specific implants for CMF and orthopedic indications. Most directly comparable to Bistool's SOFIT 3D CT-based customized facial implants in terms of patient-specific implant value proposition and technology positioning.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCEqLUdEYhr4PMAl7IF39Fjw
• Facebookfacebook.com/bistoolkorea
• Instagraminstagram.com/bistool_korea

Compliance11 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds2 records

Investors3 records

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 Bistool