Kaneka Medical America develops the FDA-approved LIPOSORBER® LA-15 System, an extracorporeal apheresis device that selectively removes LDL-C and other Apo-B-containing lipoproteins from plasma. First approved for U.S. use in 1996, the system now supports patients with severe familial hypercholesterolemia, elevated Lp(a), and drug-resistant primary FSGS through a network of more than 70 treatment locations across the U.S. and Canada. The New York-based company also provides training and clinical support for treatment centers.
U.S. FDA approval for LIPOSORBER LDL-C apheresis
Compliance program
U.S. FDA Humanitarian Device Exemption for nephrotic syndrome associated with primary FSGS
Compliance program
ApolomedFounded in 2001, Shanghai-based Apolomed designs and manufactures professional medical aesthetic systems, with more than 135,000 square feet dedicated to manufacturing and research and development. Its platforms are used by distributors and clinics in more than 80 countries, while regional service centers in New York and Toronto extend factory-direct training and technical support. Apolomed operates under ISO 13485 and MDSAP quality certifications and holds market-specific clearances and registrations, including U.S. FDA 510(k) authorizations.BETHPAGE, NY
MedWell TechnologiesMedWell Technologies develops and distributes point-of-care systems for processing and delivering a patient’s own adipose tissue and platelet concentrates in regenerative medicine. Its patented Adinizer® uses sharp-blade mechanical processing to resize and concentrate lipoaspirate in a closed-loop workflow, giving physicians a consistent alternative to pressure-based fat processing. Based in Bethel Park, Pennsylvania, MedWell also supports physician-clients with practical education on autologous tissue therapies.BETHEL PARK, PA
Laminate Medical Technologies LtdFounded in 2012 by engineer Tammy Gilon and Dr. Eyal Orion, Laminate Medical Technologies develops medical devices aimed at making arteriovenous fistulas more usable for people receiving hemodialysis. Its flagship VasQ extravascular support device reinforces the fistula’s connection during maturation and is sold across the United States, Europe, Africa, Singapore and the United Kingdom. The company’s team spans Israel, Europe and the United States, with VasQ supported by CE marking and FDA clinical development.NEW YORK, NY
Nordson MEDICALWith more than 40 years of experience, Nordson MEDICAL is a U.S.-based medical-device manufacturer serving designers and providers in surgical and minimally invasive care. Its work includes specialized polymer-solution-cast cannulae and catheters, with products made in the United States for clinical applications ranging from cardiovascular support to fluid management.EASTON, PA