Kaneka Medical America (KMA) - LIPOSORBER

What Kaneka Medical America (KMA) - LIPOSORBER does

Kaneka Medical America LLC is a wholly-owned US subsidiary of Japan's Kaneka Corporation that markets the LIPOSORBER LA-15 System, an FDA-approved extracorporeal apheresis platform first cleared in June 1996 and headquartered in New York. The device selectively removes Low-Density Lipoprotein Cholesterol (LDL-C) and Lipoprotein(a) [Lp(a)] directly from the bloodstream via an automated continuous-flow circuit, and is indicated for patients with familial hypercholesterolemia (FH), elevated Lp(a) with documented cardiovascular disease, and steroid-resistant primary focal segmental glomerulosclerosis (FSGS) — populations in which diet and maximum tolerated pharmacotherapy have failed or are not tolerated. The platform is the company's sole product line and addresses two rare-disease therapeutic areas: cardiovascular (FH/Lp(a)) and renal (FSGS), serving both adult and pediatric patients.

The business is built around a distributed clinical infrastructure of more than 50 LIPOSORBER treatment locations across the United States, comprising hospital outpatient departments, physician office-based centers, and specialty lipid/nephrology clinics. Revenue is generated through hardware sales of the apheresis console plus recurring consumables consumed per treatment session, with reimbursement handled through Medicare and most commercial insurers. Kaneka Medical America runs a direct enterprise field-sales model staffed by sales account representatives and medical affairs representatives who deliver clinical training, a nurse hotline, technical service, reimbursement consultation, and continuing medical education. Pricing is not publicly disclosed; commercial inquiries are routed through a single 800-number sales line.

Strategic activity is concentrated on label expansion and ecosystem development rather than portfolio diversification. The most consequential recent move was the FDA's January 2025 approval of a PMA 180-day supplement extending LIPOSORBER's FH indications to Groups C and D (patients with documented cardiovascular disease). The company also maintains supporting-tier partnerships with the American Heart Association, the Family Heart Foundation, the National Kidney Foundation, and NephCure to drive disease awareness, earlier detection, and patient referrals into its treatment center network.

Name

Kaneka Medical America (KMA) - LIPOSORBER

Legal name

Kaneka Medical America LLC

Website

https://liposorber.com

Company type

Private

Founded year

1996

Operating status

Operating

Headcount range

11–50 employees

Short description

Kaneka Medical America markets the FDA-approved LIPOSORBER LA-15 extracorporeal apheresis system in the United States for adult and pediatric patients with familial hypercholesterolemia, elevated lipoprotein(a), and steroid-resistant FSGS who have failed drug therapy.

Ownership category

akta.pro rank

Product category

Lipid Apheresis Medical Devices

SIC

Services-Health Services (8000)

akta.pro primary industry

Preventive Cardiology & Lipidology (HLAKABAF)

Keywords

• Lipid apheresis systems
• Extracorporeal cholesterol therapy
• Familial hypercholesterolemia treatment
• FSGS therapeutic apheresis
• Medical apheresis devices

Headquarters

HQ city

New York

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. LIPOSORBER Medical Device Sales: Sale and service of the LIPOSORBER LA-15 System to hospitals and physician office-based treatment centers. The system generates recurring revenue through device sales, consumables used in each treatment session, and ongoing technical support contracts. Insurance coverage by Medicare and most commercial insurers supports patient access and provider reimbursement.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Kaneka Medical America develops, markets, and supports the LIPOSORBER LA-15 System, an FDA-approved extracorporeal apheresis device that directly removes LDL-C and Lp(a) from the blood of patients with familial hypercholesterolemia and elevated lipoprotein(a), and that is also indicated for steroid-resistant primary focal segmental glomerulosclerosis (FSGS). The company sells the system and its per-treatment consumables to hospital outpatient departments and physician office-based treatment centers, and provides clinical training, technical support, a nurse hotline, and reimbursement consultation to the treating facilities.

Product overview

Kaneka Medical America offers the LIPOSORBER LA-15 System, an FDA-approved extracorporeal (outside the body) therapy device designed to remove harmful cholesterol—specifically LDL-C and Lipoprotein(a) [Lp(a)]—directly from the patient's blood. The therapy serves as a clinical alternative for patients who have failed or cannot tolerate maximum drug therapies. The single unified product targets two distinct therapeutic areas: cardiovascular disease (Familial Hypercholesterolemia) and kidney disease (FSGS).

Differentiator

Problem solved

Functional benefit

Brands

• LIPOSORBER LA-15 System: FDA-approved extracorporeal therapy device that removes Low-Density Lipoprotein Cholesterol (LDL-C) and Lipoprotein(a) [Lp(a)] directly from the blood for treatment of familial hypercholesterolemia and FSGS.

Products and services

• LIPOSORBER LA-15 System FDA-approved extracorporeal therapy system that removes Low-Density Lipoprotein Cholesterol (LDL-C) and Lipoprotein(a) [Lp(a)] directly from the blood via an automated continuous-flow apheresis circuit. Indicated for adult and pediatric patients with Familial Hypercholesterolemia (FH) and elevated Lp(a) with documented cardiovascular disease, and for steroid-resistant primary focal segmental glomerulosclerosis (FSGS). Sold to hospital outpatient departments and physician office-based treatment centers for use by cardiologists, nephrologists, and lipid specialists.

Quantifiable outcome

• 72% reduction in coronary events for Familial Hypercholesterolemia patients
• +3 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered supporting.

• Family Heart FoundationsupportingOthersPatient advocacy organization supporting families affected by familial hypercholesterolemia (FH) and elevated Lipoprotein(a). The Family Heart Foundation's mission is to save generations of families from heart disease through timely identification and improved care of FH and elevated Lp(a). Through research, advocacy, and education they drive change and empower families to navigate their own health.
• American Heart AssociationsupportingOthersLeading cardiovascular organization with nearly 100 years of fighting heart disease and stroke. The AHA has released updated U.S. dyslipidemia guidelines in 2026 emphasizing earlier detection, greater awareness of genetic risk, and more intensive treatment for patients at risk. Provides Lp(a) Toolkit for Health Care Professionals.
• NephCuresupportingOthersOrganization empowering people with rare, protein-spilling kidney disease (such as FSGS) to take charge of their health while leading the revolution in research, new treatments, and care.
• National Kidney FoundationsupportingOthersLifeline for all people affected by kidney disease, focusing on the whole patient through the lens of kidney health. Provides education and support for kidney disease patients including those with FSGS.

Scale indicators5 records

Recent moves3 records

Expansion highlights4 records

Emerging players

• Travere Therapeutics: Develops therapies targeting rare kidney diseases including FSGS, directly competing with LIPOSORBER's steroid-resistant FSGS indication if its pipeline agents reach approval.

Direct peers

• Asahi Kasei Medical: Manufactures plasma fractionation and therapeutic apheresis devices, including LDL apheresis systems, directly competing with LIPOSORBER in the lipid apheresis equipment market.
• Fresenius Medical Care: Global leader in dialysis and extracorporeal blood therapies, with apheresis product lines that overlap directly with LIPOSORBER's therapeutic apheresis device category in hospital and outpatient settings.
• Terumo BCT: Major provider of apheresis and blood component collection devices used in therapeutic and donor applications, competing head-to-head with LIPOSORBER in the extracorporeal therapy device class.
• Haemonetics: Blood and apheresis device manufacturer with therapeutic apheresis offerings overlapping with LIPOSORBER's extracorporeal technology platform and clinical use cases.
• B. Braun: Medical device company whose H.E.L.P. LDL apheresis system directly competes with LIPOSORBER as an alternative extracorporeal therapy for severe lipid disorders.

Broad incumbents

• Novartis (Leqvio): Markets Leqvio, a long-acting siRNA therapy for LDL-C reduction that competes with LIPOSORBER for FH patients seeking less invasive lipid-lowering options.
• Esperion Therapeutics: Markets oral LDL-C lowering therapies (Nexletol, Nexlizet) for ASCVD and FH patients, positioning as a step-edit competitor to more invasive therapies like LIPOSORBER.
• Amgen (Repatha): Markets Repatha, a leading PCSK9 inhibitor for LDL-C lowering in FH patients, providing a pharmacologic alternative to LIPOSORBER within the same Familial Hypercholesterolemia treatment pathway.
• Regeneron Pharmaceuticals (Praluent): Co-markets Praluent, a PCSK9 inhibitor for FH and ASCVD patients, representing a pharmacological alternative to LIPOSORBER's extracorporeal lipid apheresis.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/liposorberKMA
• Facebookfacebook.com/LIPOSORBER
• LinkedInlinkedin.com/company/kaneka-liposorber

Compliance1 record

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 Kaneka Medical America (KMA) - LIPOSORBER