Biomedical Braille

What Biomedical Braille does

Braile Biomédica (legal name: Braile Biomédica Indústria Comércio e Representações Ltda., CNPJ 52.828.936/0001-09) is a privately held Brazilian medical device manufacturer founded in 1977 by Dr. Domingo Braile in São José do Rio Preto, São Paulo. The company develops, manufactures, and sells cardiac, vascular, and oncological surgery equipment organized into four product lines: Structural Line (including the INOVARE SAFESYNC transcatheter aortic valve replacement system), Perfusion Line (including the Solis Prime ECMO system, OxyPrime membrane oxygenators, Safira Centriflux centrifugal pumps, and BRCoating-coated tubing sets), Vascular Line (endoprostheses and the Aureus expandable introducer), and Valve Line (biological heart valves with over 50 years of development from a single pericardium). A central technology differentiator is BRCoating®, a proprietary biocompatible coating based on recombinant human albumin applied to blood-contact surfaces across multiple product lines.

The company's revenue model is based on direct hardware sales of medical devices to hospitals and cardiac surgery centers, primarily through a sales-led GTM with dedicated sales teams and institutional procurement/bidding processes. Braile holds ISO 13485, NBR IEC 60601-1, and CE certifications and operates internationally, supplying products to more than 50 countries with multilingual commercial presence in Portuguese, English, and Spanish. The firm employs more than 400 direct people at its São José do Rio Preto headquarters and manufacturing facility, and is positioned as the first manufacturer of a fully Brazilian-developed ECMO system and the first Brazilian-made TAVR device. No institutional investor ownership, funding rounds, M&A activity, or revenue figures are disclosed in the available data.

Name

Biomedical Braille

Legal name

Braile Biomédica Indústria Comércio e Representações Ltda.

Website

https://braile.com.br

Company type

Private

Founded year

1977

Operating status

Operating

Headcount range

101–250 employees

Short description

Braile Biomédica is a Brazilian medical device manufacturer founded in 1977 that produces heart valves, ECMO systems, oxygenators, TAVR devices, and vascular products for hospitals and cardiac surgery centers in more than 50 countries.

Ownership category

akta.pro rank

Product category

Cardiac Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Structural Heart Valves (TAVR/SAVR) & Valve Repair (HLAHAFAB)

Keywords

• Cardiac surgery devices
• Extracorporeal circulation equipment
• Heart valve prosthetics
• ECMO systems
• Perfusion medical devices

Headquarters

HQ city

São José do Rio Prêto

HQ country

Brazil

HQ region

Latin America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Braile Biomédica generates revenue through the sale of medical devices for cardiac surgery including heart valves, oxygenators, ECMO systems, cannulas, tubing sets, and cardiopulmonary bypass equipment. Products are sold directly to hospitals and healthcare facilities in Brazil and internationally.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Biomedical Braille (Braile Biomédica) is a Brazilian medical device manufacturer specializing in cardiac, vascular, and oncological surgical equipment. The company designs and manufactures heart valves, ECMO systems, membrane oxygenators, centrifugal pumps, cardiopulmonary bypass machines, cannulas, tubing sets, and transcatheter aortic valve replacement (TAVR) devices. Its products are organized into four lines (Structural, Perfusion, Vascular, Valve) and incorporate a proprietary BRCoating biocompatible coating based on recombinant human albumin.

Product overview

Braile Biomédica is a Brazilian medical device manufacturer specializing in cardiac, vascular, and oncological surgery equipment. Founded in 1977, the company produces a comprehensive portfolio organized into four product lines: Structural Line (transcatheter valve systems including Safesync TAVR), Perfusion Line (ECMO systems including Solis Prime, OxyPrime oxygenators, centrifugal pumps, tubing sets), Vascular Line (stent-grafts, expandable introducers), and Valve Line (biological heart valves with 50+ years of development). Key products include the Solis Prime ECMO system (first 100% Brazilian-developed ECMO), the INOVARE SAFESYNC transcatheter aortic valve, and various cannulas, tubing sets, and surgical accessories. The company holds ISO 13485, NBR IEC 60601-1, and CE certifications, with presence in over 50 countries and 400+ employees.

Differentiator

Problem solved

Functional benefit

Brands

• Solis Prime: Complete ECMO solution - the first ECMO system developed and manufactured entirely in Brazil
• Safesync
• Safira Centriflux
• OxyPrime ECMO
• BRCoating
• Aureus

Products and services

• Solis Prime ECMO System Complete ECMO (Extracorporeal Membrane Oxygenation) solution integrating centrifugal pump, heating system, and integrated battery in a single equipment. Designed for hospitals and cardiac centers performing extracorporeal membrane oxygenation procedures.
• INOVARE SAFESYNC Bioprosthetic Valve (TAVR) Bioprosthetic valve for transcatheter aortic valve replacement (TAVR) with chromium-cobalt alloy structure, bovine pericardium leaflets, minimal foreshortening, and outer PET skirt. Indicated for symptomatic patients with severe aortic stenosis at intermediate predicted mortality risk for conventional surgery.
• OxyPrime ECMO Membrane Oxygenator with BRCoating Dual-chamber membrane oxygenator with polymethylpentene (PMP) capillary membrane for gas exchange and thermoplastic polymer capillaries for heat exchange, coated with BRCoating. Designed for long-duration ECMO procedures with high gas transfer performance.
• Hemoconcentrator Cylindrical device with hydrophobic polyethersulfone fiber bundle forming a porous hollow fiber filtering membrane that removes water and electrolytes through transmembrane pressure while retaining blood cells and proteins during cardiopulmonary bypass.
• Extracorporeal Circulation Machine (BEC) Heart-lung machine with four pump modules (peristaltic pumps with double rollers and unidirectional flow), two rechargeable batteries, and water circulator for heating and cooling, used in extracorporeal circulation.
• Armored Venous Cannula Wire-reinforced venous cannula made of PVC, 304 stainless steel, polycarbonate, EVA, and polyethylene. Available with proximal tip in straight or angled configurations with 1-3 stages for extracorporeal circulation.
• Armored Arterial Cannula Arterial cannula made of non-toxic PVC with tip, body, and distal end; tip available in straight and curved forms with or without flange; body contains stainless steel reinforcement to prevent kinking.
• Kit Cânulas CEC (Extracorporeal Circulation Cannula Kit) Set of cannulas made of extruded transparent flexible PVC arranged in a plastic case, including connectors, tips, forceps protectors, drainage cannulas, and accessories for cardiac surgery.
• Tubing Set BPM (Extracorporeal Circulation Tubing) Tubing sets for adult, infant, and newborn extracorporeal circulation circuits, compatible with major electromedical equipment and coated with BRCoating biocompatible coating based on recombinant human albumin.
• ECMO Tubing Set with BRCoating Tubing set for ECMO systems with BRCoating biocompatible coating, including arterial, venous, centrifugal, oxygen, serum, MF extender, and accessories lines.
• Safira Centriflux Centrifugal Pump with BRCoating Centrifugal pump with magnetically coupled rotor that generates centrifugal force to propel blood; components in contact with blood are made of injected polycarbonate and feature reduced hemolytic trauma, with N48 bipolar magnet and exclusive BRCoating formulation.
• Suction Drain Suction tip attached to flexible extension with vacuum adapter, connecting to a vacuum source for fluid aspiration and drainage during surgical procedures.
• Temperature Sensor Five-way male connector with gold-plated pins, 3-meter shielded cable, and temperature sensing chip used with Digital Clinical Thermometer model AG-2000.
• Recirculation Filter PMMA plastic housing with 5µm porosity PVDF filter membrane that removes particles and microbubbles from blood during recirculation.
• Arterial Blood Filter Polycarbonate body with 40µm porosity pleated polyester filter membrane and attached PVC bypass line, retaining particles and microbubbles and allowing removal of large air bubbles during extracorporeal circulation.
• Autotransfusion Set Polymethylmethacrylate reservoir with 1000ml capacity, 105µm particle filter, and bubble-breaking system, including two PVC tubes for blood collection and reinfusion during autotransfusion procedures.
• Membrane Oxygenator Microporous membrane oxygenation chamber with integrated heat exchanger made of impermeable capillaries, used for extracorporeal circulation procedures up to 6 hours.
• Mediastinal Drainage System Graduated PVC reservoir (2000, 1000, 500, or 200ml) with drainage line, vacuum line, and multi-perforated catheter for draining air and fluids by gravity or vacuum.
• OxyPrime Duo Membrane Oxygenator Dual-chamber membrane oxygenator for extracorporeal circulation (up to 6 hours) with integrated 41µm polyester arterial filter and bubble trap geometry.
• Cardioplegia System High-performance heat exchanger with polyester fibers for thermal conditioning of cardioplegic solution, plus PVC tubing set for myocardial protection during cardiac surgery.
• Antegrade Cardioplegia Cannula PVC tube with vent line and flow regulator, metallic introducer needle, and tip with lateral hole and suture ring, connecting to the cardioplegia system via luer lock adapter.
• Digital Clinical Thermometer Electronic circuit-based thermometer with display and battery that linearizes measurements from 20 to 42°C, compatible with remote and rectal temperature sensors.
• Agile Femoral Venous Cannula with BRCoating Wire-reinforced femoral venous cannula with BRCoating biocompatible coating (recombinant albumin and PEG 300), compatible with 0.038 inch guide wire for percutaneous introduction.
• Agile Femoral Arterial Cannula with BRCoating PVC femoral arterial cannula with stainless steel wire spring, PVC introducer for 0.038 inch guide wire, polycarbonate connector, and BRCoating biocompatible coating.
• Venous Blood Reservoir Polycarbonate venous reservoir with rotating cap, safety valve, volumetric scale, and polyurethane filter with polyester screen, providing bubble-breaking and blood filtration capability with vacuum drainage. Available in 500, 2000, and 4000ml capacities.
• Wired Venous Cannula (Multiple Configurations) Wire-reinforced venous cannulas available in double-stage, single-stage (curved/straight/90-degree tips), and triple-stage configurations. PVC body with 304 stainless steel reinforcement.
• Structural Line (Product Line) Product line including transcatheter aortic valve systems and structural heart devices for cardiac interventions, headlined by the INOVARE SAFESYNC TAVR system.
• Perfusion Line (Product Line) Product line including oxygenators, ECMO systems, centrifugal pumps, tubing sets, and perfusion equipment for extracorporeal circulation, including the Solis Prime ECMO system.
• Vascular Line (Product Line)

Named customers1 record

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• PolyVascular Inc.minorStrategic or Co-development Partner · 1 August 2023PolyVascular Inc. partnered with nonprofit CobiCure to develop non-surgical heart valve repair methods for children with congenital heart defects. This partnership is mentioned in industry context regarding pediatric heart valve market developments but relationship to Braile is not explicitly stated.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Edwards Lifesciences: Global leader in transcatheter aortic valves (SAPIEN platform) and structural heart, plus surgical heart valves. Directly comparable as Braile's primary TAVR and surgical-valve competitor.
• Getinge (Maquet cardiopulmonary): Major manufacturer of heart-lung machines, oxygenators, and ECMO systems under the Maquet/Cardiohelp brand. Closest global peer to Braile's perfusion line, including Solis Prime.
• Terumo: Japanese medtech with a strong perfusion and oxygenator/ECMO franchise (Terumo Cardiovascular). Direct peer for Braile's perfusion line and consumables.
• LivaNova: Manufacturer of heart valves (including tissue and mechanical) and cardiopulmonary bypass systems. Directly comparable to Braile's valve and perfusion product lines.
• Eurosets: Italian specialist in ECMO, oxygenators, and cardiopulmonary bypass equipment. Closest mid-sized competitor to Braile's Solis Prime ECMO and OxyPrime oxygenator family.
• Artivion (formerly CryoLife): Focused cardiovascular device company in heart valves (On-X mechanical, CryoValve tissue) and aortic repair. Comparable niche pure-play to Braile's structural heart and valve line.
• Xenios (Fresenius Medical Care): Xenios develops ECMO and cardiopulmonary support systems now operating within Fresenius Medical Care. Directly comparable to Braile's Solis Prime ECMO offering.

Broad incumbents

• Medtronic: Multi-billion-dollar incumbent with the Evolut TAVR franchise plus broad cardiovascular and cardiac surgery portfolios. Competes with Braile across structural heart, perfusion, and vascular lines.
• Abbott: Diversified medtech incumbent with structural heart (Portico/Navitor), ECMO (Cardiohelp), and perfusion adjacencies. Direct competitor across multiple Braile product lines.

Emerging players

• Meril Life Sciences: Indian manufacturer of structural heart and cardiovascular devices including the Myval TAVR. Emerging competitor with a value-priced TAVR proposition similar in positioning to Braile's Safesync.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

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 Biomedical Braille