Tricuspid Valve Insufficiency

PLEASANTON, Calif.--(BUSINESS WIRE)-- ConKay Medical Systems, a medtech start-up company developing a unique device for treating patients suffering from valvular regurgitation, has closed an oversubscribed $1.8M seed round. Multiple investment funds participated in the round including Unorthodox Ventures, SCP Ventures, WS Investment Company, and individual angel investors. “ConKay’s innovative technology addresses a significant unmet need experienced by tens of millions of patients,” said Unorthodox Ventures Founder Carey Smith. “We're pleased to support the company as it heads toward first-in-human clinical trial.” With the company first focusing on the Tricuspid Valve, the funding will support the company growth and development of its one-size fits all annular repair catheter system. Albert Yuan, Founder and CEO of ConKay Medical, shared, "Millions of Tricuspid Regurgitation patients worldwide are currently left with no medical options and at ConKay, our mission is to help patients live longer lives with their loved ones. We are grateful to our investors for their trust and support in helping us achieve this goal.” There are more than 70 million people worldwide with Tricuspid Regurgitation. Current devices, including those in trials, have major limitations preventing patients with severe Tricuspid regurgitation from receiving treatment. ConKay’s unique catheter is completely adjustable and tackles all the current limitations, including avoiding pacemaker leads. Without the need to open a patient’s chest, the device mimics open heart surgery by leaving a minimal implant around the annulus of the valve. Dr. Jamie McCabe, Section Chief of Interventional Cardiology at the University of Washington, Seattle, said, “Despite recent advances in the treatment of tricuspid regurgitation, it's clear that none of the current technologies are capable of addressing even a fraction of all patients with TR. ConKay Medical has developed some really exciting technology to implement tricuspid annuloplasty. Their independent arms and novel anchor concepts are really exciting. Additionally, the range of annulus sizes their technology should be able to treat will open up therapy for almost everyone with TR, which would be a huge advance.” The company anticipates raising its next round of financing in the 2nd quarter of 2024 to support First-in-Human testing. About ConKay Medical Systems, Inc. ConKay Medical Systems is an early-stage medical device company advancing solutions to treat valvular regurgitation in patients with progressive heart failure. , LinkedIn View source version on businesswire.com: Contacts Albert Yuan, Founder & CEO Telephone: (530) 902-6066 Email: albert.yuan@ConKayMedical.com Source: ConKay Medical Systems, Inc. View this news release online at:

Tucson Medical Center Implants First Patient with Novel Investigational Device MINNEAPOLIS, Feb. 26, 2024 /PRNewswire/ -- Minnesota based Laplace Interventional announced the successful completion of its first-in-human (FIH) procedure with its Laplace Transcatheter Tricuspid Valve Replacement (TTVR) system by Dr. Thomas Waggoner and Dr. George Makdisi from US Heart and Vascular Institute at Tucson Medical Center (TMC). In addition, Dr. Pradeep Yadav from Piedmont Heart Institute, Atlanta was also present during the case as a clinical proctor. The procedure was conducted under an Early Feasibility Study (EFS) clinical protocol approved by the U.S. FDA intended to understand the safety and technical feasibility of the Laplace TTVR System. The patient was discharged from the hospital and is recovering. Laplace Interventional's device is intended to replace the leaky native tricuspid valve to reduce or eliminate Tricuspid Regurgitation (TR). Laplace Interventional's TTVR system is designed for procedural simplicity and is delivered through the patient's vasculature without requiring a high risk open-heart surgery. "TMC is focused on providing leading-edge cardiac care to our patients by bringing advanced minimally-invasive technologies to our patients. We are proud to be the first medical center in the world to successfully implant a patient with Laplace Interventional's cutting-edge new technology to treat tricuspid regurgitation. Thanks to the FDA's dedication to the EFS Program, we are able to offer our patients new options for TTVR as early as possible through studies such as this." commented Dr. Waggoner. "The team at Laplace Interventional has developed an incredibly easy to use TTVR system. I can see this procedure to be readily learnt by physicians and Laplace's technology to be routinely adopted across the world potentially improving the lives of several million patients who need a treatment." commented Dr. Yadav. "In Tucson Medical Center's 80th year serving Southern Arizona, we're incredibly proud of partnerships like this, that allow us to pursue innovation for our patients," said Mimi Coomler, CEO of Tucson Medical Center. "Continued research and the pursuit of new medical technology allows us to continue our mission of providing exceptional health care with compassion." Laplace Interventional Founder and CEO, Ramji Iyer, PhD said " On behalf of the Laplace team, I would like to congratulate Dr. Waggoner, Dr. Makdisi and the entire team at TMC, especially the TMC Cardiovascular Research team, on this incredible achievement and sincerely thank them for their dedication towards outstanding patient care. I am also very thankful to Dr. Yadav for his participation in the procedure as a clinical proctor. The successful completion of the FIH procedure in the US EFS study marks a significant milestone for Laplace's technology and in understanding its potential to benefit a significant number of patients with tricuspid regurgitation." Caution: Laplace Interventional's TTVR System is approved for investigational use in the United States and limited by Federal (or United States) law to investigational use only. Note: Laplace Interventional's TTVR System is intended to be used for reduction of TR in adults who have severe or more symptomatic TR despite medical therapy and who have been determined to be appropriate for transcatheter tricuspid valve replacement. For more information, contact: Laplace Interventional, Inc. [email protected] SOURCE Laplace Interventional

Panel of independent experts reviewed data from the TRILUMINATE™ pivotal trial demonstrating safety, effectiveness and quality-of-life benefits of the TriClip system An investigational device in the U.S., TriClip is approved in more than 50 countries and has treated more than 10,000 people with tricuspid regurgitation worldwide ABBOTT PARK, Ill., Feb. 13, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the U.S. Food and Drug Administration (FDA) confirmed 13 to 1, with 0 abstention that the benefits of Abbott's TriClip™ transcatheter edge-to-edge repair (TEER) system outweighed the risks for the treatment of people with tricuspid regurgitation (TR). The panel's decision was based on clinical data from the TRILUMINATE™ pivotal trial, as well as expert testimony. The panel's vote will be considered by the FDA when making a decision regarding the approval of TriClip, a first-of-its-kind minimally invasive device specifically designed to treat the difficult-to-access tricuspid valve. "Tricuspid regurgitation can put added strain on the heart and lead to other cardiovascular issues, which can significantly worsen a person's quality of life, but historically there have been few treatment options," said Lars Søndergaard, M.D., chief medical officer and divisional vice president of medical affairs of Abbott's structural heart business. "Abbott recognized the unmet need for people with this condition and explored the use of our proven clip-based technology to find a truly life-changing intervention. TriClip offers an urgently needed alternative that is safe and effective for people who require tricuspid valve repair but are not able to withstand surgery." The tricuspid valve controls blood as it flows from the heart's right atrium to the right ventricle. TR occurs when the valve doesn't close properly, causing a leak and allowing blood to flow backward in the heart. For those who continue to have symptoms or persistent TR despite treatment with medical therapy and are not considered good candidates for surgery, TriClip represents a potentially new option that can improve a person's quality of life. Delivered through a vein in the leg, TriClip's TEER technology works by clipping together a portion of the leaflets – or flaps of tissue – to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery. After reviewing data from Abbott's TRILUMINATE pivotal trial and listening to testimony, the panel voted on the device's safety, effectiveness and risk/benefit profile as a treatment for TR. On the question of whether there is enough data to support the safety of the device, the vote was 14 to 0 in favor. On the separate question of whether there is reasonable assurance that the device is effective, the vote was 12 to 2 in favor. On the final question of the benefit of TriClip versus the risk, the vote was 13 to 1 in favor. "Tricuspid regurgitation can cause fatigue, shortness of breath, irregular heart rhythms, swelling and organ dysfunction. As the disease progresses, it is often debilitating and impacts a person's ability to live the life they want," said David Adams, M.D., chairman of the department of cardiovascular surgery at the Icahn School of Medicine at Mount Sinai and cardiac surgeon-in-chief of the Mount Sinai Health System, who served as co-principal investigator of the TRILUMINATE pivotal trial. "In the TRILUMINATE pivotal trial, we found that 90% of people who received tricuspid valve repair with the TriClip implant experienced a marked improvement in the severity of their TR with unprecedented procedural safety, and their improvement in quality of life was sustained at one year. The TriClip system ushers in a new era of structural therapy for patients suffering from severe tricuspid valve disease." Abbott submitted its pre-market approval (PMA) application for the TriClip device in March 2023 to the FDA, which lead to today's advisory committee panel for expert advice on the device's clinical safety, effectiveness, risk and benefit. The FDA routinely seeks input from advisory committees, especially for first-of-a-kind medical devices. The FDA's decision on Abbott's TriClip is expected in 2024. TriClip is approved for use in more than 50 countries, including in Europe and Canada, and has already been used to treat more than 10,000 people with TR. It is an investigational device in the United States. Abbott offers the industry's most comprehensive portfolio of structural heart solutions. In addition to TriClip, the company's innovative, minimally invasive therapies include first-of-its-kind technologies MitraClip™ (to treat leaky valves in people with mitral regurgitation) and Amplatzer Piccolo™ Occluder (to close a hole in the heart of babies), as well as the Navitor™ transcatheter aortic valve implantation system (to treat aortic stenosis). Abbott continues to focus on addressing the unmet needs of patients with structural heart disease and advancing standards of care so people can live their fullest possible lives. For U.S. important safety information on MitraClip, visit . For U.S. important safety information on the Amplatzer Piccolo Occluder, visit . For U.S. important safety information on Navitor, visit . About the Abbott TRILUMINATE Pivotal Trial The TRILUMINATE pivotal trial is the world's first randomized, controlled clinical trial evaluating the safety and effectiveness of transcatheter repair with the TriClip system compared to medical therapy in people with symptomatic severe TR who are at intermediate or greater risk for open-heart surgery. Data presented at the 35th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in October 2023 for all randomized patients (N=572) and those enrolled in the concurrent single-arm group (patients with more complex tricuspid valve anatomy) illustrated the device's safety, effectiveness and benefits. About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at and on LinkedIn, Facebook, Instagram, X and YouTube. SOURCE Abbott