NEWTOWN, Pa., May 27, 2021 /PRNewswire/ — Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA™-T Percutaneous Tricuspid Annuloplasty System. The MIA-T system treats moderate-severe tricuspid regurgitation (TR) via a 12F catheter-based system.
MID develops proprietary Transcatheter Cardiac Repair (TCR) technologies addressing unmet needs in the treatment of structural heart disease. The company’s products are designed to achieve surgical efficacy with percutaneous safety.
The safety and performance of MIA-T has been demonstrated in the STTAR, Study of Transcatheter Tricuspid Annular Repair, conducted at 6 European clinical sites. The encouraging 12-month follow up data was submitted for CE Mark approval in December 2020. The company anticipates receiving both CE Mark approval and IDE approval to initiate the STTAR-US pivotal study by the end of 2021. Publication of the STTAR data is also pending.
“Significant two and three grade reductions in tricuspid regurgitation (TR) have been achieved acutely and maintained at 12-month follow-up with no reported incidence of device or procedure-related mortality, stroke or myocardial infarction,” stated Michael Whitman, President and CEO of MID. “The reductions in TR achieved have significantly improved the quality of life for these patients, resulting in an average improvement of 36% from baseline on the Minnesota Living with Heart Failure Questionnaire.”
Breakthrough device designation will allow MID to have more frequent and timely interactions with FDA, including “sprint discussions,” support on data development plans, and regular status updates via teleconferences and face-to-face meetings to expedite the clinical trial process as the company shifts its focus towards a US-based clinical trial.
“There is growing interest in the percutaneous treatment of tricuspid regurgitation as early clinical data for catheter-based technologies show promise for improving the quality of life in patients with severe TR,” stated Mathew Williams, MD, Chief, Division of Adult Cardiac Surgery and Director, CVI Structural Heart Disease Program at NYU Langone Medical Center. “MIA-T appears to have advantages in treating a broad range of patients and in overall ease of use. I am encouraged by the results of the European STTAR study and am excited for the US IDE approval.”
“The relative simplicity, safety and security of the MIA-T system will help many patients suffering from moderate-severe tricuspid regurgitation in the United States,” Michael Whitman, continued. “Over 1.6 million people in the US alone suffer from TR and only 8,000 receive surgical treatment today.* We expect that breakthrough device designation will speed the process to commercialization so patients, physicians and the healthcare system can benefit from this technology.”
*Data on File
About Micro Interventional Devices, Inc. (MID):
MID is a leader in Transcatheter Cardiac Repair (TCR) utilizing its proprietary percutaneous compliant fixation technology that emulates open surgical procedures addressing structural diseases of the heart.
MIA-T utilizes proprietary, compliant PolyCor™ anchors, the world’s first low mass polymeric implant designed to comply with normal physiological valvular function. The MIA-T implant is engineered to plicate and comply with cardiac tissue once deployed.
MID is a privately held medical device company developing minimally invasive solutions for structural heart disease. MID’s primary focus is repairing the tricuspid and mitral valves while the heart is beating, eliminating the need for cardiopulmonary bypass surgery.
WILMINGTON, Del., Aug. 5, 2020 /PRNewswire/ — Katabat, a leading global provider of debt management software solutions for lenders, fintechs, and collection agencies, announced today a strategic growth investment from Tritium Partners, a growth-focused private equity firm with extensive experience investing in fintech and financial services companies, and Terminus Capital, an enterprise software private equity firm. The investment provides Katabat with significant resources to expand and enhance its industry-leading suite of debt collection products. The transaction also represents an exit for Katabat’s venture backers, including Camden Partners, Osage Venture Partners and Activate Venture Partners. Terms of the transaction were not disclosed.
Katabat is a recognized global leader in cloud-based debt collection managed service software products. Founded by consumer lending experts, the Katabat platform has been built from the ground up to provide unparalleled ease and flexibility. The software synchronizes customer offers, implements customer workflows, and builds integrated content and treatments across all customer channels. Powered by machine learning, Katabat’s products are easily deployed to enable speed to ROI for its clients, and its products ensure full compliance with policy and regulatory guidance.
“We were made for this moment. Having begun operations during the 2008 financial crisis, we are battle-tested and ready to support our clients, both today, as they grapple with the economic effects of Covid-19, and in the future,” said Ray Peloso, President and CEO of Katabat. “We recognize the criticality of product functionality, flexibility, speed and auditability as our clients require unprecedented speed to react to today’s rapidly shifting credit environment.” Mr. Peloso added, “We are thrilled to have Tritium and Terminus as our partners as we enter the company’s next phase of growth.”
Chris Steiner, Principal at Tritium Partners, commented, “Katabat has created a world-class platform that delivers a clear and compelling return on investment to its clients, making it the debt collections software solution of choice for credit and collection professionals. We see significant potential for Katabat as a leader in a market that is increasingly seeking out intelligent, compliance-minded, and data-driven work-flow management capabilities that enable a true omni-channel experience for consumer customers throughout the entire credit lifecycle. No other platform can duplicate the unique capability that Katabat offers to its clients.”
Alex Western, Managing Director at Terminus, added, “We are focused on ensuring a quality customer experience and creating a transparent, positive presence in the sector. We are investing to expand Katabat’s go-to-market team and further enhance its product differentiation to meet the demand from clients who seek technology to improve operational success and better serve consumers.” Mr. Western also commented, “We are thrilled to be partnering with Ray Peloso, CEO, and Ye Zhang, Co-Founder and Head of Product Strategy, and we are confident that the company is well-positioned to dominate the market for debt collection software.”
With more than a decade of experience delivering debt collection solutions to global banks and debt collection agencies, Katabat combines collections and machine learning expertise to help clients engage with customers and increase collections. Katabat partners with lenders and collectors across multiple industries to stay at the cutting edge of debt management, machine learning, automation, regulatory compliance, and data security. To learn more about our full range of debt management products, contact Katabat at email@example.com.
About Tritium Partners
Founded in 2013, Tritium is a private equity firm focused on companies with exceptional growth potential. For over 17 years, both at Tritium and prior vehicles, Tritium’s founders have deployed over $850 million of equity capital while partnering with talented founders and executives to build market-leading companies. Tritium’s approach emphasizes creating long-term value through strategic growth initiatives and acquisitions, with a focus on internet and information services, financial and business services, and supply chain and logistics.
About Terminus Capital
Terminus Capital Partners is a private equity firm focused on business software companies, founded in 2017 and based in Atlanta, GA. Differentiated by its industry expertise, sourcing engine, operations playbook, and buy-and-build methodology, Terminus strives to be the premier partner for capital providers, bankers, and management teams in the enterprise software sector.
Lambert & Co.
Lambert & Co.