BioSintex

What BioSintex does

BioSintex (legal entity BIOSINTEX SRL) is a privately held Romanian medical device manufacturer founded in 2002 and headquartered in Snagov, Ilfov County, Romania. The company manufactures surgical sutures across two product families—absorbable sutures (poly glycolic acid variants sold as DACRIL 910, DACRIL, DACRIL RAPID; polydioxanone PDO'x; and poliglecaprone 25 MONO'x) and non-absorbable sutures (polyester BIOPRO and BIOSTER, silk BIOSILK, and nylon BIONIL MULTI'x and BIONIL MONO'x)—marketed to hospitals, surgical centers, military medical facilities, dental practices, and medical training institutions. Its secondary product line distributes home care medical devices including SYSMED oxygen concentrators, CMS 50DL pulse oximeters, wheelchairs, Actreen/Curan/Urimed catheters, ostomy systems (flanges, bags, accessories), and OMRON C28 Plus nebulizers.

The company operates two product verticals—manufactured surgical sutures and distributed home care devices—under a quality management system certified to ISO 9001:2015 and EN ISO 13485, with all medical devices CE-marked under Notified Body 2460 (DNV-GL Presafe) per European Directive MDD 93/42/EEC. Revenue is generated through B2B hardware sales via an international distributor network covering at least five countries (Romania, Italy, Bulgaria, Ukraine, Argentina), supplemented by direct sales to institutional customers such as the Central Military University Emergency Hospital Dr. Carol Davila and the Romanian Students' Society of Surgery. Go-to-market combines distributor-led channel sales with direct inquiry handling (Monday–Friday 8am–5pm customer service), social media presence (Instagram, Facebook, LinkedIn), an email newsletter, downloadable product brochures and suture manuals, and selective international trade show participation such as Medica Dusseldorf 2018. Pricing is not publicly disclosed and follows a B2B distributor model with multi-year contract cadence.

Management is founder-led and privately owned, with Alin Iosif identified as the company representative in a 2018 scientific research grant announcement. No venture capital, private equity, institutional investors, parent company, or subsidiary structure is disclosed, and the only known external R&D engagement is a February 2018 scientific research grant competition. The company shows no history of M&A, restructuring, leadership turnover, or public capital markets activity, and remains an independent regulated medical device manufacturer primarily serving Eastern European and select LATAM healthcare markets through channel partners.

Name

BioSintex

Legal name

BIOSINTEX SRL

Website

https://biosintex.com

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

51–100 employees

Short description

BioSintex (BIOSINTEX SRL) is a privately held Romanian medical device manufacturer founded in 2002, producing CE-marked, ISO 9001:2015 certified absorbable and non-absorbable surgical sutures and distributing home care devices, selling to hospitals, surgical centers, and dental/educational institutions via international distributors across Romania, Italy, Bulgaria, Ukraine, and Argentina.

Ownership category

akta.pro rank

Product category

Surgical Sutures and Medical Devices

NAICS

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

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Wound Care, Bandaging & Consumables (Dressings, Sutures, Staplers) (HLAMAFAF)

akta.pro secondary industries

Wound Healing & Skin Regeneration (advanced dressings, skin substitutes) (HLAAAGAG), Biodegradable Medical & Hygiene Materials (absorbables, disposables substrates) (IMAEAOAL)

Keywords

• Surgical sutures
• Absorbable sutures
• Medical devices
• Home care devices
• Wound closure products

Headquarters

HQ city

Snagov

HQ country

Romania

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Surgical Sutures: Manufacturing and sale of surgical sutures including absorbable and non-absorbable types. Revenue generated through direct sales and distributor networks.
2. Home Care Medical Devices: Distribution of home care devices including oxygen concentrators, catheters, ostomy products, and aerosol devices.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

BioSintex manufactures and sells surgical sutures (both absorbable and non-absorbable) under the BIOSTER, BIOSILK, BIONIL, DACRIL, BIOPRO, MONO'x, and PDO'x brands for hospital and clinical wound closure. The company also distributes home care medical devices including oxygen concentrators, pulse oximeters, catheters, ostomy systems, wheelchairs, nebulizers, and oxygen therapy accessories.

Product overview

BioSintex is a Romanian medical device manufacturer specializing in surgical sutures and home care devices. The company operates two primary product lines: (1) Surgical Sutures portfolio comprising absorbable sutures (DACRIL 910, DACRIL, DACRIL RAPID, PDO'x, MONO'x) and non-absorbable sutures (BIOPRO, BIOSTER, BIOSILK, BIONIL MULTI'x, BIONIL MONO'x) for various surgical applications; and (2) Home Care Devices including oxygen concentrators (SYSMED M50, S50, OC-E100), pulse oximeters, wheelchairs, catheters, ostomy products (flanges, bags, accessories), and aerosol therapy devices (OMRON C28 Plus). Both product lines serve healthcare professionals and patients in Romania and international markets through distribution partnerships.

Differentiator

Problem solved

Functional benefit

Products and services

• DACRIL (DACRIL 910) Absorbable Surgical Sutures Absorbable polyglycolic acid (PGA) sutures used for soft tissue approximation and ligation across general surgical procedures. Sold to hospitals, surgical centers, and medical device distributors.
• DACRIL RAPID Absorbable Surgical Suture Fast-absorbing polyglycolic acid suture for superficial soft tissue approximation where shorter absorption is required. Sold to hospitals and surgical centers through distributors.
• PDO'x Polydioxanone Absorbable Suture Absorbable monofilament polydioxanone suture for soft tissue approximation, particularly indicated for pediatric and contaminated wound surgery.
• MONO'x Poliglecaprone 25 Absorbable Monofilament Absorbable monofilament suture made from poliglecaprone 25 for soft tissue approximation with handling characteristics suited to general surgery.
• BIOPRO Polyester Non-Absorbable Suture Non-absorbable polyester suture designed for soft tissue approximation where long-term tensile strength is required.
• BIOSTER Polybutylate-Coated Polyester Suture Non-absorbable polybutylate-coated polyester suture for cardiovascular and ophthalmic surgical applications requiring long-term tissue support.
• BIOSILK Silk Non-Absorbable Suture Non-absorbable natural silk suture traditionally used for ligation and soft tissue approximation in surgery.
• BIONIL MULTI'x Multifilament Nylon Suture Non-absorbable multifilament nylon suture for general soft tissue approximation and ligation.
• BIONIL MONO'x Monofilament Nylon Suture Non-absorbable monofilament nylon suture offering minimal tissue reactivity and high tensile strength for soft tissue closure.
• SYSMED Oxygen Concentrators (M50, S50, OC-E100) Home care oxygen concentrators including the SYSMED M50, S50, and OC-E100 10L model, providing supplemental oxygen therapy for patients with respiratory conditions. Distributed to home care providers and patients.
• CMS 50DL Pulse Oximeter Fingertip pulse oximeter that measures blood oxygen saturation (SpO2) and pulse rate for home patient monitoring.
• Manual Wheelchair Manual wheelchair for mobility assistance of patients with limited mobility, supplied as part of the BioSintex home care range.
• Urinary Catheter Range (Actreen Lite, Curan Lady/Mann, Urimed Vision, Silicone Foley) Urinary catheter products including the Actreen Lite intermittent catheter, Curan Lady/Mann catheters in Tiemann and Nelaton tip configurations, Urimed Vision external condom catheter, and Silicone Foley indwelling catheters for home bladder management.
• Ostomy Care Products (Flanges, Bags, Accessories) Ostomy care products including Little Ones flexible pediatric flanges, Combihesive 2S Stomahesive flanges in rigid, flexible, and convex configurations, colostomy/ileostomy/urostomy bags in one- and two-piece systems, urine collection bags, and stoma care accessories such as adhesive removers, barrier creams, protective powders, and odor neutralizers.
• OMRON C28 Plus Compressor Nebulizer Compressor nebulizer for aerosol therapy used in the treatment of respiratory conditions such as asthma and COPD.
• Oxygen Therapy Accessories (Nasal Cannula and Masks) Oxygen therapy accessories including nasal cannulas, masks, and humidifiers distributed alongside BioSintex home oxygen concentrators.

Quantifiable outcome

• Positive customer feedback from healthcare professionals across 4+ countries

Named customers8 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Medica - World Forum for MedicinecoreGTM or Marketing Partner · 12 November 2018Biosintex participated at Medica Dusseldorf 2018, one of the world's largest medical trade fairs. The company exhibited at Booth 70C01/Hall 7.0 to showcase products and connect with international distributors and customers.
• DNV-GL Presafe (Notified Body 2460)coreOthers · 1 November 2018DNV-GL Presafe serves as the Notified Body for Biosintex's CE mark certification of medical devices under European Directive MDD 93/42/EEC. This is a critical regulatory partnership for market access in the European Union.
• DNV-GL Business AssurancecoreOthers · 12 October 2018DNV-GL Business Assurance provides ISO 9001:2015 quality management system certification for Biosintex, upgrading from ISO 9001:2008 to demonstrate compliance with current regulatory requirements.
• Alin Iosif (Scientific Research Grant)minorStrategic or Co-development Partner · 14 February 2018BIOSINTEX SRL, represented by Alin Iosif, launched a scientific research grant competition during February 2018, supporting innovation in medical device research and development.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Ethicon (Johnson & Johnson): The dominant global suture manufacturer (Vicryl, Monocryl, PDS, Prolene, Ethibond) and the benchmark competitor BioSintex references as an international benchmark; both compete on absorbable/non-absorbable surgical sutures.
• Medtronic: Owns the former Covidien suture franchise (Polysorb, Biosyn, MonoPlus, V-Loc) and is a direct head-to-head competitor across the full suture portfolio BioSintex markets.
• B. Braun: Manufactures and globally distributes a comparable absorbable/non-absorbable suture portfolio (Safil, Monosyn, Premilene, Dafilon) with strong European presence — BioSintex's direct competing supplier in EU tenders.
• Becton Dickinson (BD): Major global manufacturer/distributor of surgical sutures, surgical instruments, and home-care devices (catheters, oxygen delivery); broad overlap with BioSintex's combined sutures + home-care portfolio.
• Smith & Nephew: Global medical device company with a smaller but established suture and wound closure portfolio (such as Ethicon-alternative brands) competing for the same European and international hospital customers.
• Teleflex: Broader surgical and specialty device manufacturer (Surgislk, Deklene, Tevdek sutures); competes with BioSintex across absorbable sutures while also distributing competing catheters and ostomy consumables.

Direct peers

• Coloplast: World leader in ostomy and continence care — directly comparable to BioSintex's ostomy bags, flanges, and catheter product lines distributed in the same hospital and home-care channels.
• Sutures India: An India-based manufacturer of absorbable and non-absorbable surgical sutures exporting globally — closest direct comparator by scale, manufacturing-only model, and cost-competitive positioning against major incumbents.
• Demetech: Niche suture manufacturer focused on absorbable PGA/PDO products with international distributor model very similar to BioSintex, competing for the same cost-sensitive hospital tender segment.

Emerging players

• Meril Life Sciences: Indian surgical consumables manufacturer (MerilEndo, suture lines) expanding globally with EU regulatory approvals — emerging peer competing for the same cost-tier European and emerging-market hospital contracts as BioSintex.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/biosintex
• LinkedInlinkedin.com/company/biosintex

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 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 BioSintex