Laminate Medical Technologies Ltd.

Laminate Medical Technologies Thanks Kidney Patients for Advocacy NEW YORK, Sept. 10, 2024 /PRNewswire/ -- Laminate Medical Technologies today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) granted their VasQ™ extravascular support device a Transitional Pass-Through (TPT) Payment under billing code C8000 (Support device, extravascular, for arteriovenous fistula (implantable). The code, effective starting October 1, 2024, will provide incremental Medicare reimbursement to medical providers for the creation of an extravascular supported fistula with VasQ in addition to the established payment rate for fistula creation. CMS developed the TPT program to facilitate more immediate access for patients to new and truly innovative devices, like devices in the U.S. Food and Drug Administration (FDA) Breakthrough Devices designation, in which VasQ falls, by allowing for adequate payment to providers while the necessary cost data is collected to incorporate them into the procedure Ambulatory Payment Category (APC) rate. The TPT Payment was granted by CMS, in part, due to the overwhelming grassroots national support from dialysis patients, caregivers and advocates organized by the American Association of Kidney Patients (AAKP), the nation's largest kidney patient organization. Since 2021, AAKP has worked closely with Laminate Medical to raise the unmet need for greater innovation in dialysis patient access and improved care outcomes by engaging thousands of patients throughout the FDA regulatory process and the CMS payment determination process related to VasQ. FDA granted De Novo status to VasQ in September of 2023 with strong AAKP support. Patients are excited for the potential of VasQ to increase the success rate of their fistulas without the need for additional surgical procedures, which has been consistently demonstrated over multiple studies.1-8 The hope is that VasQ supported fistula patients will be able to remove their central venous catheters (CVC) earlier to avoid the increased risk of hospitalization and death due to infection, including those caused by catheter related blood stream infections (CRBSIs). Additionally, the low aneurysmal rates reported by the VasQ U.S. Pivotal study provides hope that the fewer patients may suffer from the morbidity that can result from upper arm fistulas growing too large.1 Edward Hickey, III, president of AAKP and Chair of the Veterans Health Initiative stated, "AAKP believes the future of patient-centered kidney medicine, and reductions in patient mortality, is dependent upon more consistent alignments between FDA regulatory decisions and CMS payment determinations. We thank the FDA for carefully listening to dialysis patients and valuing their insights on an innovation that will contribute to safer dialysis access. AAKP is pleased with this CMS decision and remains fully engaged in the policy process to ensure all future regulatory and payment decisions are similarly aligned." Tammy Gilon, CEO of Laminate Medical Technologies, expressed her enthusiasm for the CMS decision: "The assignment of the Medicare billing code is a critical step forward in our mission and commitment to transcend status quo care for hemodialysis patients through timely innovations. We are deeply appreciative to the patients who raised their voices throughout this process via AAKP and to FDA and CMS for hearing them. With VasQ, we are offering a choice and a solution that has the potential to improve patient outcomes, reduce burdens on healthcare providers and prevent additional kidney care costs to taxpayers." The new Medicare billing code marks a significant milestone that will empower healthcare facilities to more easily integrate VasQ into their existing vascular access procedures, ensuring that more patients can benefit from this innovative technology. For more information about TPT and how to bring VasQ into your practice, contact [email protected]. About Laminate Medical Technologies Laminate Medical Technologies is a patient-centered company committed to advancing arteriovenous fistula (AVF) function for hemodialysis patients globally. Laminate's flagship product, VasQ™, is an external support device granted FDA De Novo to improve surgical fistula outcomes by providing permanent reinforcement to the artery-vein connection, promoting stability against wall tension, and decreasing turbulent flow. To see a demonstration video of VasQ, visit . Visit Laminate at . Dillavou et al. J Vasc Surg, July 30, 2023 Karydis et al. Am J Kidney Dis 2019; 75(1):45-53. Shahverdyan et al. J Vasc Access 2021; 22(2):166-172. Benedetto et al. J Vasc Access 2022; 23(4):524-531. Chemla et al. J Vasc Access 2016; 17(3):243-248. Shahverdyan et al. J Vasc Surg 2021 ;75(1):248-254. Leonardi G et al. J Vasc Access. 2021 Jul;22(4):658-665. Shahverdyan et al. Semin Dial. 2023 Mar;36(2):147-154. SOURCE Laminate Medical Technologies

SPARTANBURG, S.C., Jan. 16, 2024 /PRNewswire/ -- The first U.S. implantation of VasQ™ since FDA De Novo was granted was successfully performed by Dr. Ari Kramer, Director and principal surgeon of Vascular Access Surgery at Spartanburg Regional Hospital in Spartanburg, SC. Developed by Laminate Medical Technologies, this groundbreaking technology represents a pivotal advancement in vascular access procedures in the United States as it is the only approved product designed to assist surgical fistula success from the point of creation. Continue Reading Dr. Ari Kramer of Spartanburg Regional Hospital with Laminate's VasQ device after the successful inaugural U.S. implantation. Dr. Kramer expressed his enthusiasm for the transformative impact of VasQ on patient care, stating, "I am excited to revolutionize the standard of care for our fistula patients with VasQ. I firmly believe that this device offers my patients the optimal prospects for a sustained, well-functioning fistula with reduced complications and the need for additional procedures." VasQ is a nitinol-based external support device for the artery and vein anastomosis during the surgical creation of an arteriovenous fistula to promote maturation into a functional access for hemodialysis. The device was designed to provide structural reinforcement of the mobilized vessels and guides a more stable arterial flow profile as it transitions into the vein. The importance of this innovation has been underscored by the surge in use of central venous catheters (CVC) during the COVID-19 pandemic, leading to heightened risk of infection and mortality. Creating more functional fistulas with the assistance of a device like VasQ should help to reduce the CVC exposure for this patient population. Dr. Kramer expressed his enthusiasm for the transformative impact of VasQ on patient care, stating, "I am excited to revolutionize the standard of care for our fistula patients with VasQ. I firmly believe that this device offers my patients the optimal prospects for a sustained, well-functioning fistula with reduced complications and the need for additional procedures." In a statement, Laminate CEO, Tammy Gilon, hailed the successful completion of the inaugural VasQ case in the United States as a monumental achievement for Laminate Medical Technologies. Gilon remarked, "This accomplishment represents the culmination of 12 years of dedicated effort, and we are elated to introduce VasQ to the US population." About Laminate Medical Technologies Founded in 2012 by Tammy Gilon and Dr. Eyal Orion, Laminate Medical Technologies is committed to advancing arteriovenous fistula (AVF) function for hemodialysis patients. Building on the success of VasQ, the company is actively engaged in the development of additional devices designed to address the multifaceted challenges faced by AVF patients. To see a demonstration video of VasQ, visit . Visit Laminate at . SOURCE Laminate Medical Technologies

TEL AVIV, Israel, Sept. 27, 2023 /PRNewswire/ -- Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the FDA as a Breakthrough Technology, was cleared based on a De Novo review of the 144 patient VasQ U.S. Pivotal Study as well as a track record of safety and effectiveness of use in multiple studies from outside the U.S. As recently published in the Journal of Vascular Access,1 VasQ patients in the VasQ U.S. Pivotal Study met the primary end-point of improved primary patency (freedom from intervention plus adequate flow for hemodialysis) at 6-months. No serious adverse event associated with the device was reported over the 2-year study. Additional analysis comparing VasQ patients against claims data for traditional AVFs created by the same surgeons in the study reported statistically superior rates of functional success (confirmed use of the AVF for dialysis) and reduced need for additional procedures. The result was central venous catheters (CVC), the primary source of hospitalization due to infection in dialysis patients, were able to be removed in 80% of the patients within the first year as compared to 62% of unsupported fistulas as reported by the National Institute of Health's United States Renal Data System. Ellen Dillavou, Division Chief of Vascular Surgery at WakeMed Hospital Systems, stated, "I, along with other U.S. study investigators who have used the device, are excited that we can now offer VasQ to our fistula patients. We believe this will give our patients a better chance to receive a functioning fistula with fewer additional procedures and will allow earlier removal of central venous catheters before they lead to serious infections." VasQ is a nitinol-based device implanted around the artery and vein during the surgical creation of an arteriovenous fistula. The device was designed to provide structural reinforcement of the mobilized vessels now freed from its native supporting tissue as well as guides a more stable arterial flow profile as it transitions into the vein. MRI-based imaging as well as computational fluid dynamic models have supported the proposed mechanistic benefits of the VasQ design that have led to consistent beneficial clinical outcomes in multiple studies.2 "We are excited to finally bring VasQ to the U.S. dialysis patient population," said Laminate CEO Tammy Gilon. "We could not be more appreciative of our U.S. principal investigators as well as the global community of dialysis access physicians that saw the potential in VasQ and produced the wealth of data supporting the devices safety and effectiveness." About Laminate Medical Technologies Laminate Medical Technologies is dedicated to improving AVF function for hemodialysis patients. Founded in 2012 by Tammy Gilon and Dr. Eyal Orion, Laminate plans to build upon the success of VasQ with additional devices currently in development to address the challenges faced by AVF patients. Laminate Medical was founded in 2012 by Tammy Gilon and Dr. Eyal Orion to make fistulas better for dialysis patients. Laminate's flagship product, the VasQ™ External Support, has demonstrated success in reducing the high fistula failure rate and repeat procedures experienced by hemodialysis patients. To see a demonstration video of VasQ, go to . Visit Laminate at . 1 Dillavou E, Lucas JF, Woodside K, Burgess J, Farber A, Hentschel D, Ozaki CK. VasQ U.S. pivotal study demonstrates the safety and effectiveness of an external vascular support for arteriovenous fistula creation. J Vasc Surg. 2023 Jul 30:S0741-5214(23)01729-9. 2 Bozzetto M, Soliveri L, Poloni S, Brambilla P, Curtò D, Condemi GC, Cefalì P, Spina I, Villa A, Caroli A, Remuzzi A. Arteriovenous fistula creation with VasQTM device: A feasibility study to reveal hemodynamic implications. J Vasc Access. 2022 Apr 22:11297298221087160. SOURCE Laminate Medical Technologies