About Us

Biocompatibility Innovation is a pioneer in the development of biostealth technology for medical devices and life support equipment.

BCI’s biostealth technology is precision engineered to increase the biocompatibility of medical devices, prolonging their lifespan and increasing their durability, all while maintaining full device functionality.

Founded by a team of scientists and biotech industry executives, BCI partners with medical device manufacturers to bring its disruptive technology to market.

Our Certifications

We are certified to ISO 9001, ISO 55001, and ISO 13485 standards, demonstrating our commitment to quality management, asset integrity, and medical device safety across all operations.

Our Roadmap

2025
First patents extending BCI technology to consumer goods
2024

Selected as one of the top 15 Italian Medtech SMEs for the Innovit accelerator program in San Francisco by the Italian Ministry of Foreign Affairs

2024

Patent #8
on Facta technology

Patent #9
D-Fendor technology introduced for dental applications

2024

Patent #6
Firmo technology is added​

Patent #7
on Protego technology for metal based and ceramic medical devices

2023

Protego introduced with
Patent #5
opening new markets in polymeric medical devices

2021

Patent #4
on Facta technology

2020

Winner of Brevetti+ grant by Invitalia

2019

Patent #3
on Facta technology

Named Best Italian North-East start-up at Innovabiomed Verona

Recipient of a grant from EU Horizon 2020

2018

Facta key effects verified with preclinical studies

Seal of Excellence award under the EU Horizon 2020 Framework

Finalist at Tech Tour 2018 Italian Healthcare Venture Forum

2016

Patent #2
on Facta technology

2015

Patent #1
Facta technology introduced, focusing on cardiovascular applications

2014
BCI founded in Padova, Italy

Our Mission

To transform the biomedical industry by seamlessly integrating technology that increases the biocompatibility and durability of medical devices, eliminating their leading causes of failure and extending their lifespan. 

We pledge to improve clinical outcomes, broaden access to life-enhancing medical solutions, and equip the healthcare system with reliable, safe, and sustainable technology.

Leadership

EXECUTIVE TEAM

Alessandro Gandaglia, PhD MBA

Chief Executive Officer

Filippo Naso

Chief Technology and Innovation Officer

Ugo Stefanelli, MD

Chairman

Shuki Porath, MBA

Biomedical Division

Susan Alpert, PhD MD

Regulatory Affairs

Jane Oberwager, MBA

Business Development Officer and General Affairs Textiles, Apparel and Consumer Goods

Giulio Sturaro, PhD

Quality Assurance Specialist

Raffaele Scalcione, JD LLM SJD

General Counsel
Strategic board
Clinical board

Strategic Board

Marcello Conviti

Robert J. Melder

Ivan Vesely, PhD

Clinical Board

Isaac George, MD

Chief Medical Officer

Andrea Colli, MD

Luca De Stavola, DMD

Alessandro Gandaglia, PhD MBA

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Chief Executive Officer

Biologist

Alessandro began his career in 2003 as a research fellow at Children’s Hospital Los Angeles. Alessandro obtained his PhD in Molecular and Cell Biology and Pathology and subsequently was appointed as senior research scientist charged with establishing the scientific international laboratory of Regenerative Medicine, Cardiac Surgery at the University Hospital of Padova. In 2011, upon completing his MBA, Alessandro began his corporate experience in the biomedical industry working for both large companies, such as Zoppas Industries, and medium enterprises in a variety of sales, marketing, and business development roles. Alessandro’s experience spans various fields within biotech, from telemedicine to the production of active pharmaceutical ingredients.

Education: MSc in Biology, University of Padova. PhD in Molecular Biology and Cellular Pathology from the University of Southern California (USC) and University of Padova. MBA, MIB Trieste School of Management.

Filippo Naso

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Chief Technology and Innovation Officer

Biotechnologist

Filippo has over 20 years of experience as a scientific researcher and laboratory coordinator in tissue engineering and regenerative medicine at the Experimental Cardiac Surgery Laboratory of the University Hospital of Padova. He has been awarded European research grants and awards, serves on the editorial boards of several indexed journals in the biomaterials and cardiovascular fields, has authored over 50 scientific publications, and holds a dozen international patents. Before BCI, Filippo held the role of research director in Italian biotechnology companies for about 3 years.

At BCI, Filippo focuses on innovation, anticipating the future needs of medical professionals in the market and developing next-generation technical and scientific solutions. He manages research and development, intellectual property, and know-how, while also coordinating the company’s Clinical Advisory Board and overseeing the dissemination of technical and scientific knowledge externally.​

Education: BSc in Biotechnology, University of Padova. Certified Medical Laboratory Technician. Business Strategy & Development Accelerator Program from the Golinelli Foundation in Bologna, Italy.

Ugo Stefanelli, MD

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Chairman

Physician and Entrepreneur

A lifelong entrepreneur with a passion for innovation, Ugo is the Chairman of BCI. Ugo has spent his entire medical career as a pediatrician and general practitioner in Padova, Italy. It is as a pediatrician that he observed the dramatic consequences of the rapid degeneration of bioprostheses on the lives of patients, especially children, who are forced to undergo multiple replacement surgeries from a young age. Prior to his work as a physician, Ugo was a professional basketball player in the Italian Serie A1.

Education: MD, University of Padova. Certified pediatrician since 1979. Specialist in thermal (medical spa) medicine from the University of Pavia.

Shuki Porath, MBA

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Biomedical Division

A seasoned executive with over 27 years of managerial experience in the medical device industry. Shuki served as CEO of Valcare Medical, a leading start-up in the structural heart field. He was CEO of Keystone Heart, focusing on embolic protection. Formerly served, for over 10 years, as a senior executive in Johnson & Johnson, holding various positions in the areas of product management, business development, and clinical applications.

Education: BS, MS, and MBA, Technion – Israel Institute of Technology. Executive Program, M&A, The Wharton School, University of Pennsylvania.

Susan Alpert, PhD MD

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Regulatory Affairs

Susan Alpert, PhD, MD advises BCI on regulatory compliance and the product approval process, ensuring that our technologies meet all necessary regulatory requirements.

She is a former Corporate Senior Vice President for Global Regulatory at Medtronic, Inc. and prior to that VP Regulatory Science at C.R. Bard, Inc. She previously worked at the US FDA where she held a variety of management positions in the Centers dealing with drugs, devices and radiological health, and foods. Susan is a microbiologist and pediatrician with a specialty in infectious diseases.

Susan is the principle of SFA Regulatory, LLC, a consulting firm focused on the strategies needed to place medical devices and other medical products into the global market.

Education: BS, Barnard College, Columbia University. MS and PhD in Biomedical Sciences, New York University. MD, University of Miami.

Jane Oberwager, MBA

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Business Development Officer and General Affairs
Textiles, Apparel and Consumer Goods

Business Development and Marketing

Jane brings experience in business development, enhancing corporate performance and international visibility through strategic analysis, marketing management, and partnerships. A dual US-Italian citizen, Jane has relevant experience in both countries. After obtaining her MBA, Jane worked for Lilly Pulitzer, an iconic clothing brand, where she managed their licensees and was responsible for market research and planning. She has also worked extensively with non-profits and social enterprises helping them find new revenue streams. Jane joined BCI in 2024.

Education: BA, Georgetown University. MBA, The Wharton School, University of Pennsylvania.

Giulio Sturaro, PhD

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Quality Assurance Specialist

Scientist

Giulio is a scientist with a strong background in regenerative medicine, anticancer research, photobiology, and tissue engineering. He started his career as a pharmacist working in the Veneto region. Since 2022 he has worked in BCI as Quality Assurance Manager, overseeing laboratory operations and developing new research initiatives in the field of cardiovascular tissue engineering and regenerative medicine.

Education: MSc in Pharmacy and PhD in Regenerative Medicine from the University of Padova.

Raffaele Scalcione, JD LLM SJD

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General Counsel

Admitted to the Italian and NY bar

A licensed attorney in Italy and in the U.S. for the state of New York, Raffaele has worked on a wide variety of matters involving corporate transactions, commercial and civil litigation, and securities regulation. He has held positions as in-house counsel and has practiced law in association with firms both in Italy and in the United States. Raffaele previously has served in-house as the Senior Attorney and Head of Regulatory Compliance and the Head of Listed Companies Regulation at Borsa Italiana Spa (the Italian stock exchange), as well as the Head of Italian Public Affairs for the London Stock Exchange in the United Kingdom. Additionally, he has worked as Legal Counsel for Assosim, the Italian Association of Financial Intermediaries representing the majority of financial intermediaries acting in the Italian markets.

Raffaele is the author of numerous law articles, published in law reviews and in law books, and of The Derivatives Revolution: A Trapped Innovation and a Blueprint for Regulatory Reform, Wolker Kluwer, 2011, a study regarding risks and benefits of derivative instruments, including significant recommendations for regulatory reform in this important area of the financial markets.

Education: JD, University of Siena (Italy). Master of Laws (LLM) and Doctorate of Judicial Science (SJD), University of Pennsylvania Carey Law School.

Marcello Conviti

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Senior executive with extensive experience in top management positions in the biomedical sector. He debuted as an engineer at IBM and then switched to FIAT in 1978 where he remained for two years. He then switched to the biomedical sector through the SORIN Group serving as Marketing Vice President until 1992. He was Europe Vice President of Baxter for the cardiovascular area and then he moved to Edwards Lifesciences, the leading manufacturer of heart valves, in the role of Global Senior Vice President New Business Development. In 2009 he became CEO of Carmat (a subsidiary of Airbus), which was the first company in the world manufacturing a totally artificial heart. He currently works as a consultant for biomedical companies and as an advisor to investment funds.

Robert J. Melder

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Robert has over 29 years of experience in biomedical research and development. He spent 7 years working as Assistant Professor of Radiation Oncology, MGH/Harvard Medical School. He spent 22 years in the Scientific Management at Human Genome Sciences (5 years) and Medtronic Cardiovascular (17 years) as a Senior Director R&D. Currently, he is a consultant at Mountain Hawk Consulting LLC.

Ivan Vesely, PhD

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Dr. Vesely is recognized internationally for his work in heart valves. Prior to founding ValveXchange, he was an Endowed Professor at the University of Southern California and prior to that, he founded the Cleveland Clinic’s heart valve laboratory and built it into the best-funded valve laboratory in the world. At ValveXchange, Dr. Vesely invented and developed the exchangeable heart valve and also serves as the company’s Chief Science and Technology Officer. Dr. Vesely previously founded Sonometrics, Inc. an ultrasound catheter guidance company, where he developed technology that was subsequently acquired by Cardiac Pathways (now Boston Scientific). Most recently, he was the Chief Technology Officer of CroiValve, where he led a team of engineers to develop a catheter based tricuspid valve therapy device. He is the author of 12 issued patents and over 85 publications.

Isaac George, MD

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Chief Medical Officer

Dr. Isaac George, MD joined New York Presbyterian/Columbia University Medical Center in the Department of Surgery in July of 2001 as a resident in general surgery following his graduation from Duke University School of Medicine. Prior to receiving his MD, Dr. George completed a B.S. in Mechanical Engineering at Massachusetts Institute of Technology in 1997. Dr. George also completed a fellowship program in cardiothoracic surgery in 2011 as well as a fellowship program in interventional cardiology in 2012. Dr. George is an Associate Professor of Surgery and Medicine, and the Surgical Director of Structural Heart Disease of the NYP health system.

Dr. George is board certified in thoracic (cardiac) surgery. He performs all types of open and reoperative adult cardiac surgery (aortic, mitral and tricuspid valve surgery, aortic aneurysm surgery, coronary bypass grafting, robotic surgery) with a particular interest in complex valvular disease. He specializes in minimally invasive mitral valve surgery with small incisions and repair of the mitral valve. He annually performs 150-200+ open heart surgeries a year and is the busiest heart surgeon by procedure volume in New York State. Dr. George is currently the Co-Director of the Structural Heart and Valve Center at Columbia University Medical Center. His surgical outcomes remain some of the best in the state despite taking on the highest risk cases

Dr. George is focused on integrating new technology and innovation into his clinical practice. He is one of the few physicians in the world trained in both cardiac surgery and interventional cardiology. He is an expert in the most current and cutting-edge procedures including Transcatheter Aortic Valve Replacement (TAVR), transcatheter valvular mitral valve repair (Mitraclip, Edge to Edge), transcatheter mitral and tricuspid valve replacement and surgical TAVR removal/explantation. As Primary Investigator of numerous national surgical and transcatheter trials, he also has extensive clinical research trial experience.

Andrea Colli, MD

After specializing in Cardiac Surgery at the University of Parma, Professor Colli trained professionally in Barcelona, Leipzig and at the Mount-Sinai Hospital in New York. Back in Italy, at the University Hospital in Padova, he was involved in transcatheter and micro-invasive beating heart mitral valve repair surgery, transcatheter tricuspid valve surgery, as well as in thoracic aorta surgery procedures and mechanical cardiovascular support in patients with heart failure.

Luca De Stavola, DMD

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Dr. Luca De Stavola graduated in dentistry from the University of Padova (Italy) in 2001. He completed a postgraduate program in oral surgery at Prof. Khoury’s Clinic in Olsberg, Germany, and earned a Master of Oral Medicine in implant dentistry from the University of Münster in 2007.

A recognized leader in implantology and digital surgery, Dr. De Stavola is the co-inventor of the SafeCut concept for computer-guided bone harvesting and co-developer of its patented digital workflow for implant dentistry. He maintains a private practice in Padova and Treviso, Italy.

Dr. De Stavola has been elected President of the Italian Academy of Osseointegration (IAO) for the 2027–2028 term. He is also a frequent invited speaker at major international congresses, including SEPA (2016, 2018, 2019, 2022), EAO (2017, 2019, 2022), and EuroPerio10 (2022). His research has been published in peer-reviewed journals such as The International Journal of Oral & Maxillofacial Implants (JOMI) and The Journal of Periodontics and Restorative Dentistry (PRD).

He currently serves as a Visiting Professor and Lecturer at the University of Padova and the Eastman Institute, University College London (UCL). Dr. De Stavola is also the co-founder of YOUR DENTAL FUTURE Academy, an advanced training center in Padova focused on bone augmentation and digital dentistry.