Tricuspid Flow Optimizer, FDA Approved, 6 months follow up of the First-in-Man Implantation in Rome, Italy
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 10/29/2024
Innoventric Secures $28.5M and Unveils Groundbreaking Tricuspid Regurgitation Treatment to Help Patients, Many of Whom Were Previously UntreatableReduces Treatment Risk By Eliminating the Need for Surgical Valve Replacement and General Anesthesia – Which Ensures Shorter OperationsNew York, NY — Innoventric, a leader in transcatheter tricuspid regurgitation (TR) treatment, today announced a $28.5 million Series B funding round to advance its revolutionary cross-caval technology, bringing the total funds raised since inception to $41 million. Innoventric has already successfully completed a first-in-human clinical trial in Europe, and performed many additional implantations — treating over 40 participants so far. Recently, the company received FDA clearance for an Early Feasibility Study (EFS) in the US, and patient enrollment is actively ongoing with the first US patients already treated. The funds raised will be used to advance clinical trials and expand regulatory approvals in the US and Europe.Innoventric’s device addresses tricuspid regurgitation, a severe condition that impairs the cardiac blood flow, by replacing the native valve’s function through a heterotopic, cross-caval approach. With Innoventric, a prosthetic valve is anchored to the vena cava instead of the beating heart, so a complete seal is achieved without the risk of leakage or detachment. This method simplifies the implantation process and overcomes the anatomical complexities associated with traditional treatments. Positioned at the forefront of the $10 billion annual transcatheter heart valve replacement market, Innoventric’s technology is poised to transform tricuspid valve treatment.The Innoventric device offers significant advantages:Broad Patient Applicability: Designed for various anatomies, it extends treatment options to patients who are typically ineligible for tricuspid procedures.Innovative Anchoring Technique: It anchors securely to the tubular superior vena cava (SVC) and inferior vena cava (IVC), instead of the moving heart, minimizing risks such as leakage or detachment.Streamlined Procedure: The device can be implanted rapidly without the use of echocardiography or general anesthesia, significantly improving success rates and reducing patient recovery time.The round was led by RA Capital Management, with new investment from the European Investment Committee (EIC). Returning investors BRM Group, JG Private Equity, and Mivtach Shamir Holdings also participated, reinforcing their confidence in Innoventric’s path-breaking technology.Amir Danino, CEO of Innoventric, stated: “Our mission is to revolutionize tricuspid regurgitation care with minimally invasive therapies that significantly improve patient outcomes. The strong backing from our investors, coupled with the progress we’ve achieved, underscores the need and huge potential of our approach to treat TR.”Anurag Kondapalli, Principal at RA Capital, said: “We are excited to support Innoventric as it looks to transform the approach to TR treatment. The strong outcomes from their European first-in-human trial demonstrate the immense potential of their anatomy-agnostic device to treat a broader range of patients who have lacked viable options. We have been very impressed with Innoventric’s technology and leadership, and believe their solution has the potential to reshape the future of TR care.”To learn more about Innoventric and its world leading approach, visit https://innoventric.com/.About InnoventricSince its foundation in 2017, Innoventric has been committed to addressing the complexities of tricuspid regurgitation with its innovative transcatheter TR solutions. As leaders in cross-caval technologies, Innoventric is dedicated to the ongoing development of advanced devices to extend the reach of TR treatment. Innoventric’s approach is rigorously data-driven, with its roots grounded deep in clinical research, and its treatments are designed to benefit a broad spectrum of patients, with the aim of making high-quality care more accessible and improving health outcomes. Visit https://innoventric.com/ to learn more.
SOURCE
From: Brook Terran <brook@evergreenandoak.com>
Reply-To: Brook Terran <brook@evergreenandoak.com>
Date: Tuesday, October 29, 2024 at 11:39 AM
To: Aviva Lev-Ari <avivalev-ari@alum.berkeley.edu>
Subject: $28.5M Funding Round Solves Cardiac Issue
Tricuspid Flow Optimizer graphic courtesy of Triflo Cardiovascular.
TR – Tricuspid Regorgitation
the Tricuspid Flow Optimizer, was developed by Triflo Cardiovascular, a U.S.-based biomedical company founded in 2017 by a team of structural heart specialists.
After using CT and transesophageal echocardiography (TEE) scans to confirm the procedure was feasible, the care team implanted the device. It includes three anchors that are positioned at the tricuspid valve’s commissures. A 37 French steerable catheter was positioned in the patient’s right atrium for the implant, and the device’s positioning was “optimized” before being released. A second TEE scan confirmed the device had been successfully implanted. The patient was discharged after four days of recovery, and a permanent pacemaker was required after three weeks due to slow-rate AFib.
Six months later, the authors reported, reserve remodeling of the right ventricle and a clear improvement in TR were evident, moderate tricuspid regurgitation.
“The minimal interaction with the right cardiac chamber resulted in an easy implantation of the pacemaker; the polymer leaflets and the minimal footprint demonstrated an optimal adaptation to the native anatomy and stability through six months’ follow-up.”
SOURCES
Original Study:
2012pharmaceutical
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