Bioteque

What Bioteque does

Bioteque America Inc. is a privately held medical device manufacturer and distributor founded in 1992, headquartered in Richardson, Texas, with wholly-owned regional entities in Taiwan, the Philippines, and Ireland. The company designs, develops, and distributes OB/GYN and urological medical devices for healthcare providers, primarily targeting OB/GYN specialists, urologists, and women's health clinics that treat pelvic floor disorders such as pelvic organ prolapse, cystocele, rectocele, and stress urinary incontinence. Its product portfolio spans pessaries (17+ types including Ring, Cube, Gellhorn, Donut, Hodge, and the proprietary FlexiShelf), HSG and sonohysterography catheters, uterine manipulators/injectors, endometrial sampling devices (Pipelle, curettes), biopsy punches, speculums, dilators, and forceps, all built on a 100% medical-grade silicone platform with no latex content and certified to FDA, CE Mark, and ISO 13485 standards.

The underlying product technology is rooted in medical-grade silicone manufacturing for reusable (autoclavable) and disposable devices, with proprietary features such as the FlexiShelf pessary's dual-layer curved-base design and a 4.5mm uterine manipulator/injector with built-in injector. The business model is B2B, quote-based, and prescription-mediated: healthcare providers fit patients using Bioteque fitting sets, prescribe the appropriate device, and Bioteque fulfills orders through its direct e-commerce platform (bioteque.com), its medical representative force, distributor network, and private-labeling partners after payment and prescription verification. There is no public pricing; revenue is generated through one-time device sales rather than subscriptions or licensing. The company is founder-/privately-held with no disclosed venture capital, private equity, or public-market involvement, and operates at a small 11-50 employee scale with documented operations spanning the US, APAC, and Europe.

Evidence supporting demand includes a broad SKU catalog, multi-decade operating history, and same-day shipping capability, though the absence of publicly disclosed revenue, named key customers, or recent capital events limits visibility into commercial momentum.

Name

Bioteque

Legal name

Bioteque America Inc.

Website

https://bioteque.com

Company type

Private

Founded year

1992

Operating status

Operating

Headcount range

11–50 employees

Short description

Bioteque America Inc., founded in 1992 and headquartered in Richardson, Texas, designs, develops, and distributes OB/GYN and urological medical devices — including pessaries, HSG catheters, and uterine manipulators — to OB/GYN specialists, urologists, and women's health clinics worldwide.

Ownership category

akta.pro rank

Product category

OB/GYN Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391)

SIC

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

akta.pro primary industry

Single-Use Medical Disposables & Procedure Kits (Drapes, Tubing, Catheters, Syringes, Custom Packs) (HLAHANAG)

akta.pro secondary industries

Endoscopic Therapeutic & Access Devices (Trocars, dilators, biopsy/ablation tools) (HLAHADAN), Incontinence & Urological Supplies (Catheters, Briefs, Ostomy Supplies) (HSABAKAH)

Keywords

• OB/GYN medical devices
• Pessary supplies
• Gynecological instruments
• Urological medical devices
• Medical-grade silicone devices

Headquarters

HQ city

Richardson

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Bioteque generates revenue through one-time product sales of OB/GYN and urological medical devices including pessaries, catheters, surgical instruments, and related accessories. Products are sold to healthcare providers through their e-commerce platform and distributor network. The ordering process involves prescription verification where doctors fit patients using Bioteque's fitting sets, prescribe the appropriate device, and Bioteque ships directly after payment verification.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels3 records

Core offering

Bioteque designs, develops, and distributes OB/GYN and urological medical devices, with a primary focus on pessaries (vaginal support devices for prolapse and incontinence) and complementary gynecological instruments such as uterine manipulators, HSG catheters, endometrial sampling devices, dilators, speculums, and biopsy punches. All products are manufactured from 100% medical-grade silicone and sold to healthcare providers worldwide through direct e-commerce, medical representatives, and distributor networks.

Product overview

Bioteque America Inc. designs, develops, and distributes OB/GYN and urological medical devices. The product portfolio is organized into three main categories: Pessaries (vaginal support devices for prolapse and incontinence treatment including Cube, Cup, Dish, Donut, Ring, Gellhorn, Hodge, Gehrung, Marland, Shaatz, Oval, FlexiShelf, and Incontinence Ring varieties with corresponding fitting sets and accessories); OB-GYN Products (diagnostic and sampling devices including HSG Catheters, Bellota Sonohysterography Catheters, Uterine Manipulator/Injectors, Uterine Sounds, Vaginal and Cervical Dilators, Curettes, Pipelle, Loop Electrodes, and Bartholin Catheters); and OB-GYN Instruments (surgical tools including Biopsy Punches, Curettes, Dilators, Forceps, LLETZ Products, Speculums, and Vaginal Retractors). The company also offers comprehensive fitting sets for proper pessary sizing. All products are made from 100% Medical Grade Silicone with no latex content, and are compliant with FDA, CE Mark, and ISO 13485 standards.

Differentiator

Problem solved

Functional benefit

Products and services

• Cube Pessary Vaginal pessary available with or without drains, used to relieve symptoms of cystocele, rectocele, and second or third-degree uterine prolapse. Made from 100% medical-grade silicone.
• Cup Pessary Vaginal pessary available with or without supporting membrane, used for first, second, or third degree uterine prolapse, cystocele, or stress urinary incontinence.
• Dish Pessary Vaginal pessary available with or without supporting membrane, used to relieve first, second, and third degree uterine prolapse, cystocele, or stress urinary incontinence.
• Marland Pessary Vaginal pessary with elevated platform used to relieve symptoms of first, second, and third degree uterine prolapse, cystocele, and stress urinary incontinence.
• Gellhorn Pessary Vaginal pessary with drains used to relieve symptoms of cystocele as well as second or third-degree uterine prolapse. Features stem with knob for easy insertion and removal.
• Hodge Pessary Malleable vaginal pessary commonly used for first or second degree uterine prolapse, stress urinary incontinence, or retro displacement. Designed for reproductive-aged women.
• Ring Pessary Vaginal pessary available with or without supporting membrane, primarily used for first or second degree uterine prolapse or cystocele.
• Ring with Knob Pessary Knobbed vaginal pessary available with or without supporting membrane, primarily used for first or second degree uterine prolapse, cystocele, or stress incontinence.
• Incontinence Ring Vaginal pessary primarily used for stress urinary incontinence.
• Oval Pessary Vaginal pessary commonly used for first or second degree uterine prolapse or cystocele. Oval shape inhibits rotation in women with history of vaginal surgery.
• Shaatz Pessary Vaginal pessary that can relieve symptoms of first, second, or third degree uterine prolapse. Features convex shape for snug fit and drainage holes for easy removal.
• Gehrung Pessary Malleable vaginal pessary with supporting membrane, primarily used for significant cystocele or rectocele and can also provide relief for second or third-degree uterine prolapse.
• FlexiShelf Pessary Exclusive Bioteque vaginal pessary with unique thin curved-base design, rigid inner layer and soft outer layer, and curved cone-shaped handle for easy removal. Used for second or third-degree uterine prolapse. Autoclavable and resterilizable up to 100 times. Available in 4 sizes (57mm, 64mm, 70mm, 76mm).
• Inflatable Donut Pessary Inflatable vaginal pessary used to relieve stress of second or third-degree uterine prolapse, cystocele, or rectocele. Easily compressed for insertion and removal.
• Pessary Fitting Sets Comprehensive fitting sets including Ring, Cube, Dish, Oval, Gellhorn, Ring with Support, Ring with Knob, Marland, Cup, and FlexiShelf fitting sets. Designed for physicians to determine proper size and type of pessary before prescription.
• Uterine Manipulator/Injector 4.5mm Small diameter (4.5mm) disposable sterile uterine manipulator with curved shaft for easy insertion. Built-in injector eliminates need for second instrument; ideal for laparoscopy and minilaparotomy.
• Silicone Balloon-Tipped HSG Catheter Set Latex-free silicone balloon-tipped hysterosalpingography (HSG) catheter sets available in 5Fr and 7Fr sizes, including SureFlex variants. Used for evaluating abnormal bleeding, menstrual disorders, recurrent miscarriage, and infertility.
• Bellota Sonohysterography Catheter Latex-free silicone sonohysterography catheter with cervical cone, used for evaluating causes of abnormal bleeding, menstrual disorders, recurrent miscarriage, and unexpected infertility.
• Uterine Sounds Latex-free, malleable, disposable uterine sounds used for dilating and measuring the cervix. Graduated in centimeters with markings at 3cm, 5cm, 7cm, 9cm, and 11cm.
• Cervical Dilators Disposable cervical dilators including OS Finder Type I, Canal Finder Type II, and Fundus Dilator Type III. Used for locating and dilating external OS, cervical canal, and internal OS, particularly valuable for post-menopausal patients with cervical stenosis.
• Pipelle Endometrial Sampler Sterile uterine sampling device, 245mm length, 3mm outside diameter, used for endometrial tissue sampling.
• Ensula Curette Endometrial tissue sampling device with twist-and-lock syringe and Randall cutting edge, used for histological study.
• Speculums Vaginal speculums in multiple configurations including Graves (small, medium, large, XXL), Moore Graves, Snowman, Pederson (XS to XXL), Weisman Graves, and View-More variants. Integrated light-source models also available.
• Biopsy Punches Biopsy punches including Tischler (standard, baby, rotating), Kevorkian, Sullivan Sur-Lok, Oval (Burke), Baggish Sur-Lok, and Keyes variants in various sizes for cervical tissue sampling.
• Loop Electrodes and LLETZ Products LEEP loop electrodes in various sizes (3mm ball, 5mm to 25mm loops) and configurations, plus complete LLETZ procedure kits including Graves speculums, Pederson speculums, View-More speculums, Kogan speculums, and thumb dress forceps.
• Vaginal Dilators Silicone vaginal dilator sets available in small, medium, and large sizes, used for progressive vaginal dilation.
• Word Bartholin Catheter Silicone catheter for Bartholin gland procedures, available with syringe and scalpel for treating Bartholin gland cysts/abscesses.
• Surgical Forceps Surgical forceps including I.U.D. removal forceps, Foerster sponge forceps, and tenaculum forceps (Schroeder, Braun) for OB/GYN procedures.
• Vaginal Retractors Sims retractors (single-ended, double-ended, with grip), R.W. retractors, and lateral vaginal retractors for surgical access in gynecological procedures.
• Curettes Endometrial and uterine curettes including Randall and Novak suction curettes, Kevorkian (with/without basket), Townsen, and Sims uterine curettes for tissue sampling and removal.
• Surgical Dilators Surgical dilators including Mini, Cervical, Hegar, Hank (double-ended and sets), Pratt uterine, and Denniston sets for cervical and uterine dilation procedures.
• Pessary Remover Instrument designed for safe removal of vaginal pessaries, used by healthcare providers during patient follow-up.
• P.O.P.s Ruler Clinical tool to identify severity of pelvic organ prolapses and anatomical success or failure of prolapse surgery. Ink-free disposable plastic sticks.
• Cytology Brush Cytology brush used for specimen collection in gynecological diagnostic procedures.

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Medical RepresentativescoreChannel Partner/ Reseller/ DistributorBioteque offers opportunities for medical representatives to represent their OB/GYN and urological medical device products. Representatives help distribute pessaries, catheters, and surgical instruments to healthcare providers and medical facilities.
• DistributorscoreChannel Partner/ Reseller/ DistributorBioteque partners with distributors to expand their global reach for OB/GYN and urological medical devices including pessaries, fitting sets, and related accessories.
• Private Labeling PartnersminorOEM/ Whitelabel/ Licensing PartnerBioteque offers private labeling opportunities for partners interested in marketing Bioteque's medical devices under their own brand name. Contact available at Richardson, TX headquarters.

Scale indicators2 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Sklar Instruments: Specialty manufacturer of surgical and OB/GYN instruments including speculums, biopsy punches, and curettes. Directly comparable product mix to Bioteque's surgical instrument category.
• MedGyn Products: Specialty OB/GYN medical device company offering diagnostic and procedure devices including endometrial samplers, HSG catheters, and biopsy instruments — directly overlapping with Bioteque's OB-GYN Products category.
• Coloplast: Global leader in urology and continence care with a portfolio of pessaries and urological devices. Directly comparable to Bioteque's pessary and incontinence product lines, with overlapping customer base in OB/GYN and urology.
• Utah Medical Products: Specialty women's health medical device maker focused on OB/GYN and neonatal products. Comparable niche-focus and product breadth to Bioteque, with overlapping categories in specialty disposables used by OB/GYNs.
• Besmed Health Business: Manufacturer and distributor of OB/GYN, urology, and ENT specialty medical devices including pessaries and procedure kits. Comparable scale and product mix to Bioteque.
• Panpac Medical: OB/GYN medical device company offering disposable procedural products including pessaries, catheters, and instruments. Closely comparable niche focus and B2B distribution model to Bioteque.

Broad incumbents

• CooperSurgical: A broad incumbent in women's health and OB/GYN medical devices offering pessaries, catheters, fertility, and surgical instruments. Directly comparable category to Bioteque across the OB/GYN workflow, but at much larger scale and broader portfolio.
• Cook Medical: Large diversified medical device company with meaningful women's health, urology, and reproductive medicine product lines including catheters and HSG devices. Overlaps with Bioteque's HSG catheter and specialty disposable offerings.
• Integra LifeSciences: Broad medical device incumbent with surgical instruments, disposables, and specialty products. Overlaps with Bioteque in OB/GYN and surgical instrument categories but operates at far greater scale across multiple specialties.

Emerging players

• Thomas Medical: Specialty OB/GYN device distributor with comparable B2B healthcare-provider sales motion and product focus areas such as catheters and procedural instruments. Comparable scale and distribution approach to Bioteque.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/bioteque-america-inc

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries3 records

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 Bioteque