Shaping the Future

of Mitral Valve Replacement

Our Technology

THE TIOGA TMVR SYSTEM

  • Unique valve and anchor design
  • Designed to minimize patient exclusions and treat more patients with MR

The Tioga TMVR System is for Investigational Use only and is not for sale in the U.S. or outside the U.S.

  • Large atrial brim designed to reduce 
paravalvular leak risk
  • Reduced valve height designed to reduce risk 
of left ventricular outflow tract obstruction
  • Atrial brim accommodates both small and large native mitral valve sizes
  • Gently encircles and captures chordae to bring mitral valve leaflets together
  • Can be repositioned and redeployed, as needed, prior to release
  • Fits waist of valve as it expands
Valve
  • Large atrial brim designed to reduce 
paravalvular leak risk
  • Reduced valve height designed to reduce risk 
of left ventricular outflow tract obstruction
  • Atrial brim accommodates both small and large native mitral valve sizes
Anchor
  • Gently encircles and captures chordae to bring mitral valve leaflets together
  • Can be repositioned and redeployed, as needed, prior to release
  • Fits waist of valve as it expands

LOW-PROFILE DELIVERY SYSTEMS Intended FOR PROCEDURAL EASE

Anchor Delivery System

28 French delivery system with deflectable/ steerable catheters

Valve Delivery System

28 French over-the-wire delivery system with steerability and depth control

See How It Works

Clinical Need

Mitral Regurgitation (or MR) is the most common heart valve condition, impacting more than 6.6 million people.1 MR occurs when the leaflets of the mitral valve do not close properly, which results in blood flowing backward or “leaking” from the left ventricle into the left atrium.

For patients with MR, the heart compensates and works harder to ensure that enough blood flows properly to the body.

Over time, as MR becomes more severe, the increased workload can lead to cardiac symptoms and complications, such as:

  • Stroke
  • Heart failure
  • Pulmonary hypertension
  • Death

1. Adams DH, Rosenhek R, Falk V. Degenerative mitral valve regurgitation: best practice revolution. Eur Heart J. 2010;31(16):1958-1966.; US Census Data

1. Adams DH, Rosenhek R, Falk V. Degenerative mitral valve regurgitation: best practice revolution. Eur Heart J. 2010;31(16):1958-1966.; US Census Data

Mitral Regurgitation (or MR) is the most common heart valve condition, impacting more than 6.6 million people.1 MR occurs when the leaflets of the mitral valve do not close properly, which results in blood flowing backward or “leaking” from the left ventricle into the left atrium.

For patients with MR, the heart compensates and works harder to ensure that enough blood flows properly to the body.

Over time, as MR becomes more severe, the increased workload can lead to cardiac symptoms and complications, such as:

  • Stroke
  • Heart failure
  • Pulmonary hypertension
  • Death

1. Adams DH, Rosenhek R, Falk V. Degenerative mitral valve regurgitation: best practice revolution. Eur Heart J. 2010;31(16):1958-1966.; US Census Data

1. Adams DH, Rosenhek R, Falk V. Degenerative mitral valve regurgitation: best practice revolution. Eur Heart J. 2010;31(16):1958-1966.; US Census Data

Medical

Medical treatment targeted at preservation / improvement of heart muscle function

Surgical

Surgery to repair or replace the mitral valve

  • Repair: primarily mitral annuloplasty
  • Replacement: done infrequently because of invasiveness and fragile nature of patients

Transcatheter

  • Transcatheter edge-to-edge (TEER) repair is the only commercially-available therapy but not every patient is a candidate for TEER
  • TMVR options are in early stages of clinical evaluation and investigation

Mayo Clinic, Mitral Valve Regurgitation Overview. September 2023.

About Us

Tioga Cardiovascular, a Shifamed portfolio company, is focused on providing elegant valve replacement solutions for mitral applications that are procedurally simpler and use a less invasive, transcatheter approach.

Mike Dineen

President & CEO

Mike brings more than 30 years of leadership and MedTech experience with a focus on medical device startups.  As executive in residence (EIR) at Shifamed, he was one of Tioga’s co-founders.  Previously, he was CEO of Kalila Medical, another Shifamed portfolio company, where he led the company from early prototype through regulatory approvals and successful product launch. He also led Kalila’s successful acquisition by Abbott Laboratories and FTC-mandated divestiture to Terumo Medical. Before Kalila, he was VP of Business Development for Maya Medical, another Shifamed company that was acquired by Covidien (now Medtronic), VP of Marketing for Aragon Surgical (acquired by Aesculap), and VP of Marketing for Concentric Medical (acquired by Stryker). Earlier, he was a cofounder, board member and VP of marketing, business development, clinical and regulatory affairs at Aspire Medical, a minimally invasive implant for obstructive sleep apnea (acquired by Philips/ Respironics). He also held marketing or sales roles at Radiant Medical, Target Therapeutics (acquired by Boston Scientific, now Stryker), Devices for Vascular Intervention/Guidant and The Upjohn Company (now Pfizer). He is a named inventor on more than 65 issued US patents and holds a BS in Biology and an MBA from Santa Clara University.

Tom McNatt

Vice President
of R&D

Tom brings to Tioga more than 20 years of experience in R&D and Operations roles of increasing responsibility at Medtronic. His previous roles at Medtronic include VP of R&D for Structural Heart and Aortic, VP of R&D Aortic, Senior Director of R&D for CoreValve and Site Leader for facilities in California, Minneapolis, France, and Mexico. Before joining Medtronic, Tom was the General Manger of the Life & Analytical Sciences business unit of PerkinElmer with offices in the US, Wales, and Singapore. Earlier in his career, he was part of the Leadership Rotation Development Program at Johnson & Johnson where he gained experience in Quality, Business Development, Operations, Sales, and R&D. He is a named inventor on more than 50 issued patents. Tom holds BS degrees in Microbiology and Chemistry from California State University, Long Beach and an MBA from the University of California, Irvine.

Thomas Kelly

SVP Operations
& Quality

With more than 30 years of experience, Thomas brings a strong combination of management skills in both Operations and Quality and a focus on medical device startups. Before joining Tioga, Thomas was Vice President of Operations & Quality at AEGEA Medical, where he focused on advancing a new endometrial ablation technology through regulatory (PMA) approval and acquisition by CooperSurgical. Following the acquisition, Thomas became General Manager of the AEGEA site where he was responsible for commercial manufacturing and transfer of manufacturing to CooperSurgical.  Prior to AEGEA, he was Vice President of Operations & Quality at ForSight VISION4, a pre-commercial company developing an ocular implant for combination therapy which was ultimately commercialized by Genentech. Thomas also served as Vice President of Operations and Quality at Arstasis where he grew the Operations and Quality functions to support the company’s femoral access technology from early development to commercialization.  At Cierra, Thomas implemented and managed the Quality Assurance (QA) function as Director of Quality Assurance, obtaining CE Mark for a novel Patent Foramen Ovale closure technology.  Earlier in his career, Thomas spent ten years at Perclose with responsibilities in Quality, Manufacturing, and Product Development, contributing to the company’s growth from a small, pre-clinical femoral artery closure startup to a commercial, publicly-traded company, follow by acquisition into Abbott Laboratories. Thomas started his medical device career with Stryker Corporation’s Endoscopy division in Quality Assurance.  Thomas holds a BS in Manufacturing Engineering from Oregon State University.

Andrew Fu

Director, Regulatory and Clinical Affairs

Andrew brings a unique blend of industry and FDA experience in regulatory and clinical affairs. Previously, he was an FDA Commissioner’s Fellow and a reviewer with the Center for Devices and Radiological Health (CDRH) where he specialized in the reviews of early-stage novel technologies, including a first-of-its-kind Premarket Approval (PMA) that went to Advisory Panel. In addition, he was a member of CDRH’s Early Feasibility Study (EFS) Program Working Group and Payor Communication Task Force. Andrew then joined the Regulatory Affairs team for Boston Scientific’s structural heart program where he was responsible for securing an EFS Investigational Device Exemption (IDE) approval for the Millipede Transcatheter Mitral Valve Repair System. During his tenure at Boston Scientific, he was also a member of the ISO/AAMI technical committees that develop standards on cardiac valve prostheses and repair devices. Andrew holds a BS in Biomedical Engineering from The Johns Hopkins University and a PhD in Biomedical Engineering from Case Western Reserve University.

Louisa Wright

Director, Therapy Development

With more than 19 years of experience, Louisa is a multiple award-winning medical device therapy development expert and has extensive experience introducing novel interventional cardiology and structural heart therapies around the world. Louisa’s experience includes establishing strong relationships with KOLs, developing clinical training programs, and initiating clinical trials across the device development lifecycle, from early clinical experience (preclinical, early feasibility, and first-in-human studies) to pivotal trials for regulatory approvals. Prior to joining Tioga, Louisa worked as a Global Therapy Development Specialist at 4TECH Cardio, where she supported the initiation of the company’s early feasibility study (EFS) for tricuspid repair in Europe and the US. Before 4TECH, Louisa worked for 10 years at Boston Scientific in several roles of increasing responsibility including Clinical Specialist, Field Clinical Engineering and Therapy Development for Structural Heart, as well as commercial positions in both Interventional Cardiology and Structural Heart.

Join Our Team

Interested in working with a dynamic team to improve the lives of people with mitral regurgitation? See open positions with Tioga Cardiovascular and Shifamed’s other portfolio companies.

Note: Principals only. No third-party referrals will be accepted without prior approval by Shifamed. As a general practice, Shifamed does not accept unsolicited resumes or placement information from any individual or agency that supplies candidates for a fee.