Conformal Medical
Conformal Medical is a pre-commercial medical device company developing the CLAAS AcuFORM System, a proprietary foam-based left atrial appendage occlusion device designed to reduce stroke risk in patients with non-valvular atrial fibrillation. The company was acquired by W. L. Gore & Associates in January 2026.
- Company typePrivate
- Founded2016
- HeadquartersNashua, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Conformal Medical does
Conformal Medical is a privately held medical device company developing left atrial appendage occlusion (LAAO) devices for stroke prevention in patients with non-valvular atrial fibrillation. The company is targeting the more than 6 million people in the U.S. with atrial fibrillation (a population projected to exceed 12 million cases by 2030) who are at increased risk of stroke. End users of the device are interventional cardiologists and cardiac electrophysiologists performing LAAO procedures in hospital cardiac centers. Founded in 2016 and headquartered in Nashua, New Hampshire, Conformal Medical was acquired by W. L. Gore & Associates in January 2026 and now operates as part of Gore's endovascular franchise.
The company's core product is the CLAAS AcuFORM System, a next-generation LAAO device featuring a proprietary conformable foam matrix implant combined with a nitinol endoskeleton. It is the first and only LAAO device to use foam technology to seal the left atrial appendage. The device is produced in only two sizes (versus the multiple sizes required by incumbent devices such as WATCHMAN and Amulet), enabling simplified sizing, off-axis positioning, seal testing with angiography, and procedures under conscious sedation without transesophageal echocardiography (TEE). These features are intended to support same-day outpatient procedures without general anesthesia. The portfolio also includes the original CLAAS System, and clinical evidence is being generated through the CONFORM Pivotal Trial (randomized vs. WATCHMAN and Amulet in ~1,600 patients), the GLACE Study, the Conformal Early Feasibility Study, and the Conformal Prague Study. The leadership team controls a substantial patent estate, with Chairman/CMO Aaron Kaplan holding 65 U.S. patents (National Academy of Inventors, Class of 2015) and CSO Carol Devellian an inventor on 30+ issued U.S. patents.
Conformal Medical is pre-commercial and has not generated product revenue. Its go-to-market is centered on clinical trial enrollment at hospital sites in the U.S. (CONFORM Pivotal Trial, EFS) and Europe (GLACE Study, Prague Study, EU arm of CONFORM), with investigational devices supplied only to participating centers. Upon FDA pre-market approval, the documented plan is to monetize via direct sales of hardware to hospitals and physicians performing LAAO procedures, supported by clinical-site relationships built during the trial program. The company raised approximately $161 million across four rounds, including an $85 million Series C in 2020, a $35 million Series D in 2023 led by SPRIG Equity, and a $32 million Series D extension in August 2025. The January 2026 acquisition by W. L. Gore & Associates shifts commercialization to Gore's established global endovascular distribution network.
Conformal Medical firmographics
Firmographics- Name
- Conformal Medical
- Legal name
- Conformal Medical, Inc.
- Website
- https://conformalmedical.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Acquired
- Headcount range
- 11–50 employees
- Short description
- Conformal Medical is a pre-commercial medical device company developing the CLAAS AcuFORM System, a proprietary foam-based left atrial appendage occlusion device designed to reduce stroke risk in patients with non-valvular atrial fibrillation. The company was acquired by W. L. Gore & Associates in January 2026.
- Ownership category
- akta.pro rank
Conformal Medical industry classification
Industry- Product category
- Cardiac Medical Devices
- NAICS
- Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (3391)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)
- akta.pro primary industry
- Cardiac Surgery Devices (Cannulas, Clamps, Closure, Grafts) (HLAHAFAH)
- akta.pro secondary industry
- Vascular Access & Closure Devices (Sheaths, Guidewires, Closure Systems) (HLAHAFAK)
Keywords
Where Conformal Medical is headquartered
LocationHeadquarters
- HQ city
- Nashua
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Conformal Medical business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Others, Marketing or Sales
Revenue model
- Medical Device Sales (Planned): Conformal Medical is developing its CLAAS AcuFORM System for left atrial appendage occlusion. Once FDA pre-market approval is obtained, the company plans to generate revenue through direct sales of the LAAO device to hospitals and physicians performing stroke prevention procedures in atrial fibrillation patients.
- Clinical Trial Services: The company conducts clinical trials (CONFORM Pivotal Trial, GLACE Study) at hospital sites, generating revenue through clinical site management and device supply for investigational use.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels4 records
Conformal Medical product offering
Product offeringCore offering
Conformal Medical develops the CLAAS AcuFORM System, a next-generation left atrial appendage occlusion (LAAO) implant for stroke prevention in patients with non-valvular atrial fibrillation. The device combines a proprietary conformable foam matrix with a nitinol endoskeleton and is offered in only two sizes, eliminating the need for transesophageal echocardiography, general anesthesia, and overnight hospitalization. The product is currently investigational and is being evaluated in the CONFORM Pivotal Trial and GLACE Study to support FDA pre-market approval.
Product overview
Conformal Medical is a privately held medical device company developing left atrial appendage occlusion (LAAO) technology for stroke prevention in atrial fibrillation patients. The core portfolio includes the CLAAS System (first foam-based LAAO device) and its next-generation iteration, the CLAAS AcuFORM System featuring a proprietary foam matrix with nitinol endoskeleton that requires only two sizes. Both devices are designed to seal the LAA without requiring anticoagulants and enable same-day procedures without general anesthesia or TEE. The company is actively conducting multiple clinical trials including the CONFORM Pivotal Trial and GLACE Study. Conformal Medical was acquired by W.L. Gore & Associates in early 2026.
Differentiator
Problem solved
Functional benefit
Brands
- CLAAS: The first & only LAAO device to use conformable foam to seal the left atrial appendage. Designed to reduce the risk of stroke without the need for anticoagulants.
- CLAAS AcuFORM
Products and services
- CLAAS AcuFORM System Next-generation left atrial appendage occlusion (LAAO) device featuring a proprietary foam matrix implant with nitinol endoskeleton designed to conform to patient anatomy. Offered in only two sizes, enabling simplified same-day procedures without general anesthesia or transesophageal echocardiography (TEE). Intended for stroke prevention in patients with non-valvular atrial fibrillation as an alternative to long-term oral anticoagulation. Currently investigational and limited to clinical trial use.
Quantifiable outcome
- Same-day LAAO procedures without general anesthesia or overnight hospitalization
- +2 more outcomes
Companies that use Conformal Medical
Customer profileSegments3 records
Ideal customer profiles2 records
Conformal Medical technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Conformal Medical partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- W. L. Gore & AssociatescoreW.L. Gore & Associates entered into a definitive agreement to acquire Conformal Medical in January 2026 for an undisclosed amount. The acquisition expands Gore's endovascular portfolio and adds the CLAAS AcuFORM next-generation LAAO technology to Gore's cardiac product line. Transaction expected to close in early 2026 pending regulatory approval. Gore generates approximately $5.3 billion in annual revenues.
Scale indicators7 records
Recent moves6 records
Expansion highlights6 records
Conformal Medical competitors and assessment
Company assessmentDirect peers
- Boston Scientific: Boston Scientific markets the WATCHMAN family of left atrial appendage closure devices, the leading LAAO product against which CLAAS AcuFORM is directly being compared in the CONFORM Pivotal Trial. Both companies target interventional cardiologists and electrophysiologists performing LAAO procedures for stroke prevention in non-valvular AFib patients.
- Abbott: Abbott markets the Amplatzer Amulet LAA Occluder, the second major percutaneous LAAO device competing in the same clinical indication as Conformal's CLAAS AcuFORM. Both compete head-to-head in the CONFORM Pivotal Trial and target the same AFib stroke prevention patient population.
- AtriCure: AtriCure's AtriClip is a surgical left atrial appendage exclusion device used as an alternative to percutaneous LAAO for stroke prevention in AFib patients. Both companies target the same LAA closure clinical indication, though AtriCure is primarily used in surgical epicardial settings rather than transcatheter procedures.
Emerging players
- SentreHEART: SentreHEART developed the LARIAT suture-based LAA ligation system as an alternative approach to LAA closure. Both companies address the same underlying clinical need (LAA closure for AFib stroke prevention) using different mechanical approaches, and SentreHEART represents an emerging alternative modality.
- Occlutech: Occlutech offers an LAA Occluder as part of its broader structural heart occlusion portfolio. Both companies target the same LAAO clinical indication for AFib-related stroke prevention, and Occlutech represents an emerging player with primarily European commercial reach.
Regional players
- Lifetech Scientific: Lifetech Scientific (Shenzhen, China) markets the LAmbre LAA occluder, a transcatheter LAAO device competing in the same clinical indication as CLAAS AcuFORM. Lifetech is a regional player with primary commercial strength in Asia, while Conformal focuses on the US and EU markets.
Broad incumbents
- W. L. Gore & Associates: W.L. Gore & Associates acquired Conformal Medical in January 2026 to add the CLAAS AcuFORM System to its endovascular portfolio. Gore is a broad incumbent in medical devices with established cardiac, vascular, and structural heart product lines that provide infrastructure for Conformal's commercialization.
- Medtronic: Medtronic is a broad incumbent in cardiovascular devices with structural heart and cardiac surgery franchises. While Medtronic does not have a dedicated LAAO device competing head-to-head, its scale and hospital relationships make it a relevant comparable for the structural heart space Conformal operates in.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights7 records
Customer concentration
Conformal Medical social profiles
Digital presenceConformal Medical financial estimates
Financial estimateRevenue estimate
Valuation estimate
Conformal Medical leadership team
Management profileNumber of profiles
Profiles10 records
Conformal Medical funding detail
Funding detailFunding overview
Funding rounds4 records
Investors4 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Conformal Medical M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Conformal Medical
What does Conformal Medical do?
Conformal Medical develops the CLAAS AcuFORM System, a next-generation left atrial appendage occlusion (LAAO) implant for stroke prevention in patients with non-valvular atrial fibrillation. The device combines a proprietary conformable foam matrix with a nitinol endoskeleton and is offered in only two sizes, eliminating the need for transesophageal echocardiography, general anesthesia, and overnight hospitalization. The product is currently investigational and is being evaluated in the CONFORM Pivotal Trial and GLACE Study to support FDA pre-market approval.
Is Conformal Medical a public or private company?
Conformal Medical is a private company. It is classified as corporate owned and is currently acquired.
When was Conformal Medical founded?
Conformal Medical was founded in 2016. It employs 11 to 50 people.
Where is Conformal Medical based?
Conformal Medical is headquartered in Nashua, United States, in the North America region.
How does Conformal Medical make money?
Two revenue lines are on record. Medical Device Sales (Planned) is the primary driver. The others are clinical Trial Services.
Who are Conformal Medical's main competitors?
Direct peers on record are Boston Scientific, Abbott and AtriCure. Emerging players are SentreHEART and Occlutech. Lifetech Scientific is listed as a regional player. Broad incumbents are W. L. Gore & Associates and Medtronic.
Does Conformal Medical have an API?
No public API is recorded for Conformal Medical.
What industry is Conformal Medical in?
Conformal Medical's product category is Cardiac Medical Devices. Its primary akta.pro industry code is HLAHAFAH, Cardiac Surgery Devices (Cannulas, Clamps, Closure, Grafts), with a secondary code of HLAHAFAK, Vascular Access & Closure Devices (Sheaths, Guidewires, Closure Systems). Its NAICS code is 339112 and its SIC code is 3841.