ABOUT

Tensive is a biomedical startup established in 2012 to develop innovative scaffolds aiming to offer a natural breast reconstruction or augmentation.

Tensive prostheses are based on biodegradable synthetic biomaterials and fabricated with an internal micro-architecture.

REGENERA is not yet commercially available and is undergoing clinical investigation pursuant to regulations for investigational medical devices.


Tensive
recently completed a First-in-Human study of REGENERA, conducted in Italy in patients diagnosed with benign breast lesion and treated with lumpectomy.

OUR MISSION

The loss of a breast can psychologically impact the life of a breast cancer patient.
Tensive’s long-term mission is to restore a natural breast to patients who experienced reconstructive surgery after mastectomy or lumpectomy, to improve their quality of life and avoiding recurrent and expensive surgical operations.

MANAGEMENT

Sanjay Kakkar

Sanjay Kakkar

Sanjay Kakkar, MD, MSc, MPH (Chief Executive Officer) is a biotech and medtech entrepreneur with 30 years of experience in multinational, early-stage and high growth enterprises. He has a track record of building innovative companies in the life sciences industries in Europe, Asia and the US and advancing novel technologies for the improvement of human health. Prior to joining Tensive, he served as CEO at Tranquis, Peptilogics, Armetheon, and Trigen (which he also co-founded), and was the founder and chairman of Jai Medica. Before becoming a serial entrepreneur, he held R&D roles at Pharmacia (now Pfizer) and Novartis. Sanjay received his medical degree from King’s College, University of London, holds a Master’s degree in healthcare management from Harvard University and a Master’s degree in preventive cardiology from Imperial College.

Federico Martello

Federico Martello

Federico Martello, Ph.D. (co-founder; Chief Industrial Officer), has served as Operation Director from the company’s foundation. In the team, Federico’s role comprises relations with investors, client seeking, and general administration. Federico has been also Team Leader of the Advanced Biomaterials platform at Fondazione Filarete for 4 years, where he managed the platform activities and development from 2009 to 2012, bringing the platform to economical sustainability. Before his collaboration with Fondazione Filarete, Federico obtained a PhD in Industrial Chemistry from the University of Milan and the University of Twente (Enschede, The Netherlands). He received his Master of Science in Industrial Chemistry and Management from the University of Milan. Currently, he is involved in an H2020 SME Instrument project as a coordinator. Federico is also the author of ten peer-reviewed articles and is a co-inventor of five international patents.

Alessandro Tocchio

Alessandro Tocchio

Alessandro Tocchio, Ph.D. (co-founder and Chief Strategy Officer), graduated with a Bachelor and Master of Science in Physics Engineering from the Politecnico of Milan. Dr. Tocchio holds a Ph.D. in Medical Nanotechnology from the European School of Molecular Medicine and the University of Milan, and completed his training in nanotechnology and tissue engineering with a postdoc at Stanford University.

Alessandro co-authored 18 peer-reviewed papers and is co-inventor of five patents. Alessandro also co-founded the non-profit organization Organ Preservation Alliance.

Valentina Morigi

Valentina Morigi

Valentina Morigi, MSc (co-founder and CFO) has experience in financial and operational due diligence (buy and sell side) and M&A. She graduated with a bachelor’s in economics from the University of Bologna (incl. 2 semesters in Biology) and a Master in Finance from the Catholic University of Milan. During her Master, she joined the nanomedicine team of the Houston Methodist Research Institute to lead an economic study on the US nanomedicine market. In 2018, Valentina completed the leadership and entrepreneurship Ignite Program at Stanford University, Graduate School of Business.

Previously, Valentina was an Executive at PwC, in the M&A and strategy divisions. She co-founded the Organ Preservation Alliance, a Silicon Valley-based non-profit incubated at NASA - Ames Research Park, where she served as an Executive Director of the Organ Banking Summit.

Valentina was awarded Gifted Citizen and created the Innovation in Biotech and Healthcare blog.

Irini Gerges

Irini Gerges

Irini Gerges, Ph.D. (co-founder, Chief Technology Officer and R&D Director). She received her Bachelor in Chemistry from Ain Shams University (Egypt); M.Sc in Chemistry from the University of Milan (Italy) and a Ph.D. in biomaterials from the University of Pisa (Italy) Biomolecuar Sciences (BIOS) doctorate school.

She worked as a senior researcher and project coordinator at the Advanced Biomaterials platform of Fondazione Filarete, where she was a key player for the development of biomaterials for implantable medical devices. She was awarded the first prize “women in research” for her research project: biodegradable matrices for soft tissue regeneration. Irini is author of 21 peer-reviewed research articles, 2 academic book chapters and co-inventor of 6 international patents. Her current h-index is 9. Over the past 15 years, Irini gained specific skills in production process customization, synthesis upscaling and intellectual property management. She is coordinating a plurality of research projects with the aim to expand Tensive’s products portfolio.

Margherita Tamplenizza

Margherita Tamplenizza

Margherita Tamplenizza, Ph.D. (co-founder; Chief Regulatory Officer) founded the biological section at the Advanced Biomaterial platform of Fondazione Filarete and she has launched several innovation projects in the field of Life Sciences and Silver Economy for companies associated to Assolombarda, the largest territorial association of the entire entrepreneurial system in Italy. Previously, Margherita has worked in The Interdisciplinary Centre for Nanostructured Materials and Interfaces (CIMaINa) at the University of Milan where she depth her experience on cell-material interaction. She obtained her Ph.D. in Molecular and Cellular Physiology at the University of Milan and the Paracelsus Medical University of Salzburg (Austria) and she also worked at the University of Innsbruck (Austria) and the Italian Institute for Auxology for biomedicine projects. She trained on Manufacturing of Advanced Therapy Medicinal Product and she obtained her Master degree as Qualified Person of Pharmaceutical Laboratories in 2014. Margherita is an author of 15 peer- reviewed articles and a co-inventor of 4 patents.

Alberto Cantaluppi

Alberto Cantaluppi

Alberto Cantaluppi, MD (Chief Medical Officer) is a senior executive with strong background in Medicine, Pharmaceuticals, Medical Devices, Renal Therapy, Diagnostics, Bioscience, Cardiovascular Medicine, and Healthcare Services.
Alberto had full P&L responsibility and holds expertise in Sales and Marketing, Merger and Acquisition Integration, Governmental Affairs and Public Policies, Negotiation, Strategy and Organizational Design, Turnaround, Divestiture, Restructuring, Legal Split, Commissionaire and Toll Manufacturing Model, and Team Dynamics.

ADVISORS

Scott Guelcher, Ph.D.

Scott Guelcher, Ph.D.

Associate Professor of Chemical and Biomolecular Engineering at Vanderbilt University School of Engineering (TN, USA). After completing his B.S. degree in Chemical Engineering at Virginia Tech, Dr. Guelcher worked in the Research Division of Eastman chemical Company in Kingsport, TN on a number of projects in chemical and nutraceutical processing. He subsequently completed his Ph.D. with Professor John Anderson in Chemical Engineering at Carnegie Mellon University, where his dissertation work focused on investigating the electric field-induced motion of colloidal particles deposited near an electrode. Prior to his appointment at Vanderbilt, Dr. Guelcher was a Senior Associate Scientist in the Polyurethanes Division at Bayer Corporation and an NIH NRSA Fellow in the Department of Biomedical Engineering at Carnegie Mellon University where he worked with Professor Jeffrey Hollinger in bone tissue engineering. Professor Guelcher joined Vanderbilt University in 2005, and opened the Biomaterials and Tissue Engineering Laboratory in January 2006. He is author of more than 160 peer-reviewed scientific papers and inventor of 26 patents. Dr. Guelcher is a renown expert in the design, synthesis, and characterization of polymeric biomaterials for bone tissue engineering (with synthetic scaffolds)

Mario Rietjens, MD

Mario Rietjens, MD

Plastic Surgeon: Director of the Division of Reconstructive Surgery at the European Institute of Oncology (IEO). He graduated in Medicine and Surgery at the University do Estado de Sao Paulo (Unesp) of Botucatu (Brazil) and specialized in general oncology surgery at the Pio XII Foundation of Barretos (Brazil). He also graduated and specialized in plastic surgery at the University of Milan. At IEO he performs clinical researches in the field of Plastic Reconstruction Surgery, mainly in the development of new techniques, such as lipofilling, mammal repairing after a reconstructive surgery following removal caused by neoplasy. He is the referent of a clinical study aimed at evaluating the time of degeneration of silicone-gel mammal prostheses according to the time of implant. He participates in a new European study for the development of the use of the stem cells of adipose origin for the mammal repairing after quadrantectomy or mastectomy.

Andrea Buscaglia

Andrea Buscaglia

Ex-investment banker and Life Sciences corporate finance executive.

After completing his degree in Business Administration at Bocconi University in Milan, he worked with Arthur Andersen between 1988 and 1991.

In 1992 he transitioned to investment banking and worked for eight years in London and Milan with the corporate finance divisions of S.G.Warburg & Co. (now UBS), Morgan Grenfell (Deutsche Bank) and Salomon Smith Barney (Citigroup), with a focus on the origination and execution of IPOs, public tender offers, rights issues, equity offerings, and M&A transactions.

He transitioned to Life Sciences in 2000, when he joined Geneva-based biotech group Serono as VP Corporate Development to coordinate its NYSE listing and $2bn equity offering, lead M&A and support Investor Relations.

In 2007 he became CFO of VC-backed Nitec Pharma, which he contributed to refinance and merging into Horizon Therapeutics (now Amgen). In 2009 he became CFO of VC-backed MedTech company Endosense (acquired by St Jude Medical, now Abbott), which he contributed to refinance.

Between 2012 and 2022 he was CFO of Medicines for Malaria Venture, a non-profit organization, financed by the Bill & Melinda Gates Foundation and various governments. He has been VP Corporate Development at Mundipharma since 2023.

Alexei S. Mlodinow, MD, MBA 

Alexei S. Mlodinow, MD, MBA 

Alexei is a surgeon and serial entrepreneur with two successful exits thus far. In his most notable role as founding CEO of SIA, he led the company through FDA-clearancecommercializationNIH grant funding for a “first-and-only” indication in a new market, and pivotal trial initiation to achieve that indication. SIA achieved all this in less than four years and with only $6.3M in equity capital, while maintaining a developmental pipeline. After kicking off a $15M Series B fundraise that would later be oversubscribed and expanded, Alexei began his training in plastic surgery at Northwestern McGaw Medical Center. He remained active as an executive board member during his first 18 months of surgical residency, leading the process that culminated in SIA being acquired by Integra LifeSciences (Nasdaq: IART) in December of 2022. Following the completion of three years of surgical residency, he is now taking a sabbatical as he considers his next step.

In addition to his work at SIA, in 2020, Alexei simultaneously co-founded RapidRona, a shared-economy platform that connects clinical laboratories directly to consumers, and one of the first companies to bring a home PCR test to market. They were acquired by DMH in 2021. He has authored over 20 peer-reviewed publications and book chapters, and lectures on science and entrepreneurship at national and international meetings. He is listed as inventor on multiple patents and serves as an investor and board advisor to early-stage companies focused on nanotechnology, tissue engineering, radiofrequency ablation, and transseptal puncture. Alexei was also named one of Forbes’ “30 under 30” in 2018 and Crain’s “20 in their 20s” in 2019. 

Andrew G. Tymkiw 

Andrew G. Tymkiw 

Andrew Tymkiw is a distinguished senior executive with a 35 year career  in varied life science markets including cardiovascular, structural heart, neuro-interventional and aesthetics sectors. A seasoned leader in global strategy and execution, his expertise spans multinational markets including the U.S., Europe, Latin America, and Asia in support of commercializing transformational technologies and scalable operations for major brands like Edwards’ Transcatheter Aortic Valve Therapy..  Since founding Lifescience Business Solutions in 2017, Andrew has focused on strategic development in regulated environments, helping innovation-driven clients and private equity partners mobilize resources, tackle complex clinical challenges, and build sustainable growth. Known for his results-driven approach, he is a valued partner for organizations navigating competitive markets.  Previously, Andrew held senior executive roles at Edwards Lifesciences,  Mentor/J&J, and  Marquest/GE Healthcare, with earlier management positions at Becton Dickinson and Meadox/Boston Scientific. A strong advocate for STEM and healthcare advancement, he also serves as on the Board of Directors for Special Olympics. Andrew holds an advanced education in Engineering and Finance from the New Jersey Institute of Technology and the Wharton School.

Sam Gilbert, VMD

Sam Gilbert, VMD

Owner and Principal Consultant at Metro Preclinical Consulting, LLC. Dr. Gilbert received both his BSE in Mechanical Engineering and Applied Mechanics as well as his Doctor of Veterinary Medicine (VMD) degree from the University of Pennsylvania. He pursued specialty training in veterinary surgery prior to moving into industry where he has developed expertise in preclinical research and generating safety and effectiveness data to support product development and regulatory approval of a diverse range of medical technologies. He has held roles in startups and corporations spanning the medtech and pharmaceutical industries. Dr. Gilbert has particular interests in animal and surgical model development and is a strong advocate for the judicious use of animals in preclinical research.

NEWS & ACHIEVEMENTS

Tensive team received numerous awards from different institutions such as the Chamber of Commerce of Milan, StartCup Milano-Lombardia, ItaliaCamp, Startup dell’Anno, the French Embassy in Italy, Premio Gaetano Marzotto, Intel Global Challenge, Veneto Nanotech, 360 Capital Partners, Unicredit Start Lab Italian Venture Forum and the Italian Education Ministry. Tensive has been also featured on several media channels, including Wired and Forbes. Team members also attended outstanding international programs such as Singularity University, SeedLab, Mind the Bridge School and Startup Revolutionary Road.

21-10-2024

Milan, Italy – 21 October 2024 - Tensive S.r.l. is excited to announce the launch of a groundbreaking multicenter clinical trial aimed at assessing the safety and performance of REGENERA in patients undergoing reconstructive surgery after lumpectomy for malignant breast lesions. This trial represents a significant advance in the post-lumpectomy breast reconstruction field.

Led by Prof. Manuela Roncella, Santa Chiara Hospital Breast Unit Director, the following 9 centers across Italy and Spain are participating this pivotal study: Santa Chiara Hospital - Pisa, Italy (Prof. Manuela Roncella), Complexo Hospitalario Universitario A Coruña - Coruña, Spain (Prof. Benigno Acea Nebril), IEO Istituto Europeo di Oncologia - Milano, Italy (Prof. Mario Rietjens), IRCCS Humanitas Research Hospital - Milano, Italy (Prof. Corrado Tinterri),  IRCCS Ospedale San Raffaele - Milano, Italy (Prof. Oreste Davide Gentilini), Policlinico Universitario Agostino Gemelli IRCCS - Roma, Italy (Prof. Gianluca Franceschini), Istituto Oncologico di Candiolo FPO-IRCCS - Torino, Italy (Prof. Antonio Toesca), ICS Maugeri IRCCS - Pavia,  Italy (Prof. Fabio Corsi), IRCCS Humanitas Istituto Clinico Catanese - Catania,  Italy (Prof. Francesco Caruso).

This clinical trial will investigate the safety and performance of REGENERA in 92 female adult subjects aged 40-70 years undergoing reconstructive surgery after excision of a malignant tumor by lumpectomy.

“REGENERA has already demonstrated in a First in Human Study in 15 patients with non-malignant breast lesions to be a safe, easy-to-use, effective, & practical implant to treat breast disease following lumpectomy providing a natural breast shape & feeling in a single-step, minimally invasive, easy-to-adopt, & potentially cost-saving procedure. All the participating centers are excited to participate in this Pivotal clinical trial aiming to solve an unmet need in the treatment of breast lesions with lumpectomy” said Prof Roncella, PI of the study.

In conjunction with this month’s Breast Reconstruction Awareness (BRA) campaign, IEO (The European Institute of Oncology in Milan) has announced its participation in the study: Istituto Europeo di Oncologia (ieo.it). As part of his summary on developments in the field of breast reconstruction, Prof Rietjens from IEO states (translated), “In the future, implants may even no longer exist. For some years, in fact, several companies, including in Italy, have been working on the idea of replacing silicone with entirely biodegradable structures, as if they were scaffolding, which can be reabsorbed and slowly replaced by the patient's soft tissue, giving the woman back a breast as natural as possible. These will be definitive solutions, which do not require replacement over time and, hopefully, without side effects. The first multicenter clinical trial is already underway with the aim of validating the use of the REGENERA resorbable implant and the IEO is excited to participate together with some of the best Italian breast centers. We are the first to have joined, together with the Santa Chiara Hospital in Pisa, and we have already recruited the first 20 patients.”

Tensive is an innovative biomedical company on a mission to offer breast cancer survivors the option for a natural breast reconstruction, Tensive’s first product, REGENERA, utilizes the company’s innovative polymeric scaffolds applied as a bio-absorbable breast implant.  It is designed to restore the natural aspect of the breast and preserve the femininity of lumpectomy patients in one single surgery.

This study holds great promise for improving the quality of life of breast lumpectomy patients and represents a step forward towards the commercialization of Tensive’s highly innovative device, REGENERA.

REGENERA is not yet commercially available and is undergoing clinical investigation pursuant to regulations for investigational medical devices. 

To learn more about the trial and eligibility criteria, visit the study page on ClinicalTrials.gov.

For more information about the trial, please contact: media@tensivemed.com

If you want to learn more about Tensive's previous First in Human study of REGENERA implant in patients diagnosed with localized non-malignant breast lesions treated by excision or lumpectomy, you can read our paper on the first interim analysis published in Breast Cancer here.

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About Tensive S.r.l.

Tensive S.r.l. was founded in 2012 with the mission to offer breast cancer survivors the option for natural breast reconstruction after lumpectomy, and breast augmentation patients a superior aesthetic outcome through an innovative bio-absorbable implant.

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For more information about Tensive, visit www.tensivemed.com

19-12-2022

Milan, Italy - December 19th, 2022 - Tensive is awarded by the European Innovation Council Accelerator for its project REGENERA

Tensive S.r.l., the medical technology company pioneering innovative solutions for reconstructive surgery, announces that it is among the 78 winners of the prestigious EIC Accelerator program (October 2022 cut-off). Tensive was awarded blended finance consisting of a € 2.5 million grant and an additional € 6 million in equity investment.

"This award will be crucial to support Tensive in conducting the upcoming clinical trials towards commercialization to bring our revolutionary technology to patients in need", states Alessandro Tocchio, CSO of Tensive.

Tensive was founded in 2012 with the mission to offer breast cancer survivors the option for natural breast reconstruction after lumpectomy, and breast augmentation patients a superior aesthetic outcome through an innovative bio-absorbable implant supporting tissue self-regeneration.

"Our vision is to improve lumpectomy patients' quality of life and restore their femininity, avoiding recurrent, painful and expensive surgical operations", states Valentina Morigi, CFO of Tensive. 

The loss of a breast can cause a negative psychological impact on breast cancer patients beyond the frightening tumor diagnosis. Among other traumatizing consequences, they experience the loss of femininity and breast sensation. "By using a device designed to be gradually degraded in the body over time and safely replaced by the patient's soft tissue, breast cancer survivors will preserve a natural breast aspect", states Margherita Tamplenizza, CQA&RAO of Tensive. 

"Unlike silicone implants and fat grafting, our solution aims to offer a safe, single-surgery option for breast reconstruction with the goal to drastically reduce pain, costs and stress for patients and the healthcare system", states Irini Gerges, CTO of Tensive

"We'd like to thank our team, partners, and quota holders who supported us and worked relentlessly throughout the years towards our ambitious mission," states Alberto Cantaluppi, President of Tensive.

"The award of the EIC Accelerator program represents a further validation of Tensive's vision. We expect that this acknowledgment will enable us to attract additional private investors and venture capitalists to join our company, accelerate market entry, and commercialization", states Federico Martello, CEO of Tensive.

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The EIC Accelerator offers start-ups and SMEs grants of up to €2.5 million combined with equity investments through the EIC Fund ranging from €0.5 to €15 million. In addition to financial support, all projects benefit from a range of Business Acceleration Services that provide access to leading expertise, corporates, investors, and ecosystem actors.

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Links:

EIC announcement:  https://eic.ec.europa.eu/news/european-innovation-council-welcomes-78-high-potential-start-ups-and-smes-highly-competitive-2022-12-19_en

For more information about Tensive: https://www.tensivemed.com

Media Relations: media@tensivemed.com

29-07-2022

La Repubblica published an article citing Tensive's work in breast reconstructive surgery

PUBLICATIONS

Irini GergesMargherita TamplenizzaFederico MartelloStefano KomanGiulia Chincarini, Camilla Recordati, Mariacaterina Tamplenizza, Scott Guelcher, Maurizio Crestani & Alessandro Tocchio  “Conditioning the microenvironment for soft tissue regeneration in a cell free scaffold”. 

You can access the full-text of our paper here: https://rdcu.be/cncfX

I. Gerges, M. Tamplenizza, F. Martello, C. Recordati, C. Martelli, L. Ottobrini, M. Tamplenizza, S. A. Guelcher, A. Tocchio, C. Lenardi.  Exploring the potential of polyurethane-based soft foam as a cell-free scaffold for soft tissue regeneration. Acta Biomaterialia (2018)

E. Rossi*, I. Gerges*, A. Tocchio*, M. Tamplenizza, P. Aprile, C. Recordati, F. Martello, I. Martin, P. Milani, C. Lenardi. Biologically and mechanically driven design of an RGD-mimetic Macroporous Foam for Adipose Tissue Engineering Applications. Biomaterials (2016). (*Authors contributed equally)

C. Schulte; S. Rodighiero; M. A. Cappelluti; L. Puricelli; E. Maffioli; F. Borghi; A. Negri; E. Sogne; M. Galluzzi; C. Piazzoni; M. Tamplenizza; A. Podestà; G. Tedeschi; C. Lenardi; P. Milani. Conversion of nanoscale topographical information of cluster-assembled zirconia surfaces into mechanotransductive events promotes neuronal differentiation. J Nanobiotechnology (2016).

CONTACTS

Registered Office: Via Timavo, 34 20124 Milano (Italy)
Headquarters: Viale Ortles 22/4, 20139, Milano (Italy)
+39 (0) 2 5666 0265

General information: info@tensivemed.com
Careers: careers@tensivemed.com
Media Relations: media@tensivemed.com