ATRIAL SEPTAL DEFECT (ASD)

Commonly described as a “hole in the heart”

An ASD allows oxygen rich blood to flow into the oxygen-poor chamber, which would not otherwise occur.

This can increase blood flow to the lungs.

Patients may experience shortness of breath, fatigue, and palpitations.
Over time, the increased blood flow may lead to high blood pressure, arrhythmia, heart failure or an increased risk of stroke.¹

SCOTT WILSON / VP REGULATORY

Scott is a veteran regulatory affairs executive with a proven track record in successful global regulatory strategies.

Scott leads the atHeart Medical regulatory affairs team with over two decades of regulatory affairs leadership experience. His expertise includes developing and implementing global regulatory strategies including CE Marking, IDE, 510(k), PMA and de novo clearances. He has provided regulatory leadership for large-scale clinical studies and managed teams in executing international regulatory strategy expansions. Previously, he held senior regulatory roles with Cala Health, Twelve (MDT), Ardian (MDT), Radiant Medical and Edwards Lifesciences. Scott holds a Bachelor of Arts in Political Science and German from UC Berkeley and a PhD in Political Science from UC Santa Barbara.

ALEXANDER GOEHRING / VP OPERATIONS

Alex’s broad range of expertise in operations and operations quality results from 30 years in the cardiac and cardiovascular medtech industry.

Alexander is Vice-President of Operations at atHeart Medical since May 2022. He has been with the company in a consulting role since it began operations in 2020.

With a drive for accomplishments and a strong compliance attitude, Alex has a remarkable experience spanning from manufacturing to clinical project management, from sales and business development to quality assurance.

Alex previously worked in-house at major corporations, such as Abbott and Guidant, and at start-up companies such as Xeltis. More recently, he also worked in the medtech industry as a consultant.

Alexander holds a biomedical engineering degree from Technical University Ulm, Germany.

Maureen’s expertise is setting up quality systems for successful start-up organizations.

Maureen is Vice-President of Quality for atHeart Medical since April 2022. She joined the company, bringing over twenty years of distinguished quality experience in multiple, prominent cardiovascular medical device start-ups such as Twelve and Ardian.

She has previously worked both in-house and as a consultant for a number of medical device companies that have been acquired by major medical device corporations, including Medtronic.

A biomedical engineer graduate from Marquette University in Milwaukee, WI, Maureen contributed to the development of intellectual property for systems and methods related to prosthetic heart valve devices.

In her spare time, she is also a Court Appointed Special Advocate (CASA) – volunteering to enrich the lives of kids in foster care.

AJIT MALLIK / MD, PhD, HEAD OF EU REGULATORY

Ajit’s physician background provides a unique perspective bringing meaningful medical device technologies to market.

Ajit leads the atHeart Medical European regulatory team and brings a decade of experience in medical device regulatory leadership. He has extensive expertise in developing and executing complex global regulatory strategies and has worked with products in various stages of the development life cycle and across all medical device classifications, spearheading submissions that initiated clinical trials and successfully brought much needed innovations to market. Ajit is co-author on several peer reviewed publications and has numerous regulatory certifications in the U.S. and Europe. He holds an MD from SCB Medical College in India, a Master’s in Medical Science and Technology from the Indian Institute of Technology, and an MD PhD from the University of Zurich, Switzerland.

KUNO LIMACHER / VP R&D

Kuno led the development of the reSept ASD Occluder with his expertise in engineering and cardiovascular device design.

Kuno leads the atHeart Medical product development team with twenty years of medical device engineering experience. His efforts and leadership have been instrumental in the development of the reSept ASD Occluder since the inception of the device in 2007. Kuno is co-author on several peer-reviewed publications and co-inventor on seven published patents. He holds a Bachelor of Science in Mechanical Engineering and a Master of Science in Industrial Management and Manufacturing, with a specialization in biocompatible materials and product management, from ETH Zurich, Switzerland.

BRANDI SADOWSKI / VP CLINICAL AFFAIRS

Brandi is a seasoned clinical affairs leader with extensive experience building and executing successful clinical programs.

Brandi leads the atHeart Medical clinical affairs team with over twenty years of clinical affairs leadership experience. Her expertise includes overseeing global large-scale, multicenter randomized clinical trials, including both Investigational Device Exemption (IDE) and post-market studies. In addition to creating and implementing robust clinical programs, Brandi has played a key role in numerous regulatory submissions, strategic development, diligence, and fundraising efforts. Previously, she has held clinical leadership positions with innovative medical device companies such as EBR Systems, Cotera, Ivantis and Ardian. Brandi holds a Bachelor of Science in Genetics from the University of Wisconsin in Madison, WI.

LAURENT GRANDIDIER / CEO

Laurent is a global medtech executive with talent for turning research projects into commercially viable companies.

Laurent leads the atHeart Medical team with over fifteen years of experience in medical device development and commercial leadership. He is a veteran in innovative cardiovascular devices and brings a solid track record of successfully building and leading diverse, cross functional teams for both start-ups and Fortune 500 companies, including Xeltis, Endosense, Boston Scientific, Guidant, and Procter and Gamble. Laurent holds several independent board positions and has received numerous professional awards including the 2018 Outstanding Executive at the Global Business Excellence Awards and the Best European CEO in Medical Devices by European CEO Magazine in 2015. He holds a Master of Science in Computer Science from the National Institute for Applied Sciences in Lyon, France, and an MBA from INSEAD, France-Singapore.