What Caldera Medical does

Caldera Medical is a privately held women's health medical device company that develops, manufactures, and markets minimally invasive surgical products and devices for three core pelvic health conditions: Stress Urinary Incontinence (SUI), Pelvic Organ Prolapse (POP), and hysteroscopic tissue removal for uterine polyps and fibroids. The company's product portfolio includes the Desara family of mid-urethral slings (including Desara Blue SS and Desara TVez), the Vertessa line of POP implants with reusable introducers, the Benesta hysteroscopic tissue removal system, the LUMINELLE hysteroscopy and cystoscopy platform (acquired via UVision360 in October 2024), the INNOVO non-invasive pelvic floor strengthening device (acquired via Atlantic Therapeutics in September 2023), and the GYNECARE TVT family of products (acquired from Ethicon/Johnson & Johnson). Underlying technologies span surgical implant design, battery-powered hysteroscopic tissue morcellation with integrated visualization and tissue differentiation, high-resolution hysteroscopy optics, and electrical muscle stimulation for non-invasive pelvic floor therapy.

Caldera Medical generates revenue through hardware sales of medical devices to healthcare providers, primarily gynecologic surgeons and hospitals, using a multi-channel go-to-market model that combines direct field sales targeting specialist physicians, a global distributor network (Find Your Local Distributor program), and institutional access via group purchasing organizations, notably a national agreement with Premier Inc. covering approximately 4,350 U.S. hospitals. The company also operates the largest humanitarian program in women's health, which has treated over 400,000 women across 56 countries since 2016, serving both as a brand-building engine and as a channel for surgeon training and product adoption. With 51-100 employees and headquarters in Westlake Village, California (plus a European headquarters and innovation center in Galway, Ireland), the company is led by CEO and founder Bryon Merade and CFO John Pitstick, and pursues an active acquisition strategy to consolidate product lines and geographic reach in the women's pelvic health device market.

Name

Caldera Medical

Legal name

Caldera Medical, Inc

Website

https://calderamedical.com

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

51–100 employees

Short description

Caldera Medical is a privately held women's health medical device company developing and marketing minimally invasive surgical and non-invasive devices for stress urinary incontinence, pelvic organ prolapse, and hysteroscopic tissue removal, sold to gynecologic surgeons, hospitals, and distributors globally.

Ownership category

akta.pro rank

Product category

Women's Health 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)

akta.pro primary industry

Open & Minimally Invasive Surgical Instruments (Handheld, Laparoscopic, MIS) (HLAHADAA)

akta.pro secondary industries

Urogynecology & Pelvic Reconstructive Surgery (Female Pelvic Medicine) (HLAKAJAE), Minimally Invasive Gynecologic Surgery (Laparoscopy/Hysteroscopy) (HLAKAJAF)

Keywords

• Women's pelvic health
• Stress urinary incontinence devices
• Pelvic organ prolapse implants
• Hysteroscopic tissue removal
• Surgical medical devices

Headquarters

HQ city

Agoura Hills

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Caldera Medical develops, manufactures, and markets surgical products for treating Stress Urinary Incontinence, Pelvic Organ Prolapse, polyps, and fibroids. Revenue is generated through direct sales to healthcare providers and distribution partnerships.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

Caldera Medical develops, manufactures, and markets minimally invasive medical devices for women's pelvic health, including surgical slings and implants for Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP), hysteroscopic tissue removal systems for uterine polyps and fibroids, and a non-invasive pelvic floor strengthening device. Products are sold to gynecologic surgeons and healthcare institutions through direct field sales, a national group purchasing agreement with Premier Inc., and a global distributor network.

Product overview

Caldera Medical offers a portfolio of women's health medical devices focused on three main treatment areas: Stress Urinary Incontinence (SUI), Pelvic Organ Prolapse (POP), and hysteroscopic tissue removal for polyps and fibroids. The SUI portfolio includes the Desara family of slings (Desara Blue SS, Desara TVez), the GyneCare TVT family, and the non-invasive Innovo device acquired from Atlantic Therapeutics. The POP treatment solutions include Vertessa implants. For hysteroscopy, the company offers the Benesta tissue removal system and the LUMINELLE system acquired from UVision360. The products range from minimally invasive surgical implants to non-invasive devices, serving both office-based and surgical environments.

Differentiator

Problem solved

Functional benefit

Brands

• Desara: Line of surgical slings for stress urinary incontinence treatment, including Desara Blue SS, Desara TVez, and other sling products.
• Vertessa
• Benesta
• LUMINELLE
• Innovo

Products and services

• Desara Blue SS Sling Short suture mid-urethral sling for surgical treatment of Stress Urinary Incontinence, designed for transobturator (TOT) outside-in and suprapubic approaches. Features a reduced suture loop for easier tip attachment, unique blue mesh for enhanced intraoperative visibility, and compatibility with Suprapubic and TOT Outside-In introducers. Used by gynecologic surgeons for sling-based SUI repair.
• Desara TVez Sling System FDA-cleared mid-urethral sling system for surgical treatment of Stress Urinary Incontinence with design improvements developed through physician collaboration to enhance ease of use and patient safety.
• Vertessa Pelvic Organ Prolapse Implants Implant products for surgical treatment of pelvic organ prolapse (POP), featuring reusable introducers designed to reduce medical waste and lower SKU counts by at least 33%, delivering durable support for patients.
• Benesta Hysteroscopic Tissue Removal Family Flagship hysteroscopic tissue removal device for uterine polyp and fibroid removal. Features push-button hand activation, enlarged cutting window, built-in tissue differentiation technology for safety, state-of-the-art optics and illumination, and universal compatibility with all scopes and fluid management systems. Used by gynecologic surgeons for minimally invasive intrauterine procedures.
• LUMINELLE Hysteroscopy System High-resolution hysteroscopy and cystoscopy system for diagnostic and therapeutic procedures, with simplified workflow and novel LUMINELLE Bx on-demand biopsy technology featuring integrated visualization. Acquired via UVision360 in October 2024.
• INNOVO Pelvic Floor Strengthening System FDA-cleared non-invasive pelvic floor strengthening and nerve stimulating device for first-line therapy treatment of Stress Urinary Incontinence. Uses electrical muscle stimulation in a wearable 'smart shorts' format to deliver 180 perfect Kegels in 30 minutes. Acquired from Atlantic Therapeutics in September 2023.
• GyneCare TVT Family Mid-urethral sling products for surgical treatment of Stress Urinary Incontinence, acquired from Ethicon (J&J) and integrated into Caldera Medical's expanded SUI surgical portfolio.

Quantifiable outcome

• 87% of women were defined as dry after 12 weeks using INNOVO device
• +4 more outcomes

Named customers2 records

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• Atlantic TherapeuticscoreStrategic or Co-development Partner · 6 September 2023Acquired Atlantic Therapeutics, an Ireland-based provider of non-invasive pelvic floor strengthening and nerve stimulating solutions for women. The acquisition adds the commercial leading non-invasive, FDA-cleared INNOVO product family as a first-line therapy for women with stress urinary incontinence. Caldera Medical maintains European headquarters and innovation center in Galway, Ireland.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Minerva Surgical: Minerva Surgical directly competes with Caldera's Benesta hysteroscopic tissue removal device in the treatment of uterine polyps and fibroids with a similar office- and OR-based tissue removal platform.
• Axonics: Axonics offers sacral neuromodulation for urinary incontinence as a non-mesh alternative to Caldera's sling portfolio; both target the same SUI patient population but via different mechanisms, making Axonics a relevant competitor for first-line therapy decisions.
• ConvaTec: ConvaTec operates a continence care portfolio that competes with Caldera's INNOVO non-invasive SUI device and shares the same women with stress urinary incontinence patient population.
• Boston Scientific: Boston Scientific competes directly with Caldera in pelvic floor repair (mesh and biologic implants) and surgical SUI solutions through its Women's Health portfolio, and operates at meaningfully larger scale.
• Coloplast: Coloplast is a direct competitor in surgical SUI and pelvic organ prolapse treatment through its AttaSeal and Altis sling systems, as well as a leading continence care portfolio that overlaps with Caldera's INNOVO non-invasive therapy.
• Hologic: Hologic's MyoSure hysteroscopic tissue removal system is a direct competitor to Caldera's Benesta family for polyp and fibroid removal, and Hologic is a major player in women's health minimally invasive gynecology.
• Laborie Medical Technologies: Laborie is a private medical device company focused on urology and pelvic health diagnostics and therapeutics, with products including urodynamic systems and incontinence therapies that overlap with Caldera's pelvic health focus.
• CooperSurgical: CooperSurgical operates broadly in women's health including hysteroscopy systems and pelvic floor products that compete with multiple Caldera lines, including hysteroscopy and surgical SUI/POP solutions.

Emerging players

• Renovia: Renovia is an emerging digital therapeutics company developing connected pelvic floor training devices for female SUI, providing partial overlap with Caldera's INNOVO non-invasive first-line therapy positioning.

Broad incumbents

• Medtronic: Medtronic's InterStim sacral neuromodulation system is a major non-mesh alternative for SUI and overactive bladder, making Medtronic a broad incumbent competitor for incontinence patient treatment decisions even though it does not specialize in women's pelvic health.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/calderamedical
• LinkedInlinkedin.com/company/caldera-medical
• Facebookfacebook.com/CalderaMedicalOfficial

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Caldera Medical