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.

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.

05-08-2025
  • Has more than 30 years of experience bringing innovations to market, including one of the world’s first drug-eluting coronary stents at Angiotech Pharma
  • Appointment adds world-class capabilities to Tensive as the company approaches pivotal clinical trial milestones
  • Pivotal trial may enable European and U.S. commercialization of Tensive’s innovative bioresorbable REGENERA and SOFTAG devices for breast reconstruction and tissue marking
  • Tensive published positive first impressions from pivotal trial in April, and from first-in-human trial in 2023

Milan, Italy – August 5, 2025 – Tensive S.r.l, a clinical-stage advanced biomaterials medical device company, and the developer of REGENERA and SOFTAG bioresorbable scaffolds for breast reconstruction and tissue marking, has appointed Bill Hunter, MD, as Chairman of its Board of Directors. Dr. Hunter brings more than 30 years of leadership in the medical technology and life sciences sectors. His appointment reflects Tensive’s focus on strengthening its governance and expanding its global network as it accelerates toward pivotal clinical milestones and commercialization in the U.S. and Europe.
Dr. Hunter is the founder and CEO of Canary Medical, a medical data company developing implantable sensor technology. Previously, he founded Angiotech Pharmaceuticals, where he led the development of one of the world’s first drug-eluting coronary stents, a multi-billion-dollar innovation that transformed interventional cardiology.

    “It’s a great honor and validation of the medical potential of Tensive’s advanced biomaterials that Bill has accepted to lead our board of directors. His track record of successfully guiding pioneering technologies from concept to commercialization is unmatched,” said Sanjay Kakkar, Chief Executive Officer of Tensive. “Bill’s strategic insights and industry perspectives will be crucial advantages as we complete registrational studies and advance our first device into regulatory processes for marketing approval and commercialization in the U.S. and Europe.”

    Tensive’s innovative polymeric bioresorbable scaffolds allow a natural, non-invasive, permanent and safe solution for breast reconstruction during lumpectomy. In addition, they enable precision tissue marking, demarcating the affected area to direct more targeted radiotherapy and improve imaging accuracy during surveillance and follow-up.

    “I am truly excited to join Tensive at such a pivotal moment in its journey,” said Bill Hunter, MD, Chairman of the Tensive Board of Directors. “In addition to being impressed by the leadership, I became convinced that this was an exceptional opportunity after reviewing the recently published interim data from the ongoing pivotal study of REGENERA, as well as the excellent long-term follow-up data from the first-in-human clinical trial. The enthusiasm expressed by the key opinion leaders involved with the clinical studies further confirmed my impression of the data. I look forward to supporting Sanjay and his
    experienced team at Tensive as they bring REGENERA and SOFTAG to the market.” REGENERA / SOFTAG advanced biomaterial is a bioresorbable implant designed to be placed during lumpectomy surgery. The bioresorbable medical device is gradually absorbed by the body and enables the patient’s own tissue to regrow in the area it fills. The result is breast restoration composed of natural tissue that preserves the patient’s original breast shape and feel, yet is clearly differentiated from surrounding tissues on imaging, supporting more targeted delivery of radiotherapy and more accurate monitoring for
    potential recurrence. The biomaterial used in REGENERA and SOFTAG resembles a sponge with a fine scaffold matrix; its placement during the lumpectomy surgery is a one-step, minimally invasive, rapid and easy-to-adopt procedure.

    Currently, patients undergoing benign and malignant lumpectomy do not typically receive cosmetic intervention to prevent breast disfigurement, which can be psychologically devastating. Of the 2.1 million lumpectomies performed worldwide each year, 1.9 million are not reconstructed, constituting a sizeable unmet clinical need [1]. Despite the psychological impact of breast disfigurement following lumpectomy, more common cosmetic surgery options are rarely used, because they entail invasive and complex procedures that often fail to achieve the desired outcome.
    Preliminary data from the first 16 patients in Tensive’s ongoing multi-center pivotal trial in 94 patients undergoing malignant lumpectomy were published in Updates in Surgery in April 2025, with investigators writing: “In conclusion, we are convinced that REGENERA could represent a great innovation in breast oncological surgery, representing a possible alternative to volume replacement with faster operative time, faster recovery, less morbidity, and good patient satisfaction [2].”

    These results followed the publication in Breast Cancer in 2023 of six-month follow-up data from five patients in a first-in-human trial that demonstrated positive outcomes in terms of both safety and performance, leading the clinical investigators who authored the paper to conclude that the data were “paving the way to an innovative approach with a potential remarkable impact on clinical application of tissue engineering [3].”

    [1] Analysis based on estimates from the International Society of Aesthetic Plastic Surgery
    (ISAPS), Breast Cancer Research Foundation (BCRF), the American College of Surgeons (ACS),
    the World Health Organization (WHO) and Global Market Insights.
    [2] A.V.E. Lisa et al. Updates in Surgery Apr 2025. https://doi.org/10.1007/s13304-025-02212-2
    [3] Mariniello et al. Breast Cancer 2023. https://doi.org/10.1007/s12282-023-01446-5

    Tensive S.r.l. (www.tensive.com) is a clinical-stage advanced biomaterials medical device company developing bioresorbable polymeric scaffolds for breast reconstruction and tissue marking. Its patented REGENERA biomimetic scaffold is designed to allow regeneration of a patient’s own breast tissue to create natural, safe, and lasting reconstruction for patients recovering from lumpectomy or undergoing cosmetic procedures, while its SOFTAG precision tissue marking device enables more targeted delivery of radiotherapy and increases the accuracy of surveillance and follow-up. Tensive’s mission is to improve clinical outcomes and the quality of life for women worldwide through accessible, innovative, and sustainable solutions.

    For more information please contact:
    Tensive Srl
    media@tensivemed.com
    info@tensivemed.com

    Cohesion Bureau
    Italian and international media & investors
    Giovanni Ca’ Zorzi
    tensive@cohesionbureau.com
    +337 8467 0727

    30-01-2025

    Platform based on innovative polymeric scaffolds applied as bio-absorbable implants

    Initially being developed in breast cancer reconstruction and breast augmentation settings. Pivotal study for first indications recently announced involving leading breast cancer surgery centers in Italy and Spain.

    Milan, Italy – January 30, 2025- Tensive S.r.l., an innovative biomedical company on a mission to offer breast cancer survivors a natural breast reconstruction and breast augmentation patients a superior clinical and aesthetic outcome has closed a €14,000,000 Series A financing led by Panakès Partners SGR. with participation from the EIC Fund, along with other institutional and angel investors. In conjunction with this investment Sanjay Kakkar, MD, MSc, MPH has joined the company as CEO.

    “We are delighted to welcome Panakès as the lead investor along with the EIC, CDP, Recomec and other investors, and we appreciate the trust they have demonstrated in our vision and capabilities. The addition of Sanjay Kakkar to the team is a significant step forward as he brings a wealth of experience in the development of life sciences companies which will be instrumental in propelling Tensive toward its goals,” said Alberto Cantaluppi, MD, Chief Medical Officer, and co-Founder.

    "We are excited to lead this Series A funding round for Tensive, whose innovation and vision are transforming the landscape of women's health. Its groundbreaking technology has the power to make a profound difference in the lives of breast cancer survivors worldwide. It is a real privilege to support solutions that create lasting, meaningful impact for patients while also offering the potential for significant financial returns for investors. We look forward to collaborating closely with Tensive’s team as we embark on this journey of development, growth, and global expansion,” stated Diana Saraceni, Founder and Managing Partner at Panakès Partners.

    "This financing round is a critical milestone towards realizing the potential of Tensive’s groundbreaking technology. The Series A funds will enable the company to complete a pivotal clinical trial evaluating the safety and performance of the company’s lead product, REGENERA, in patients undergoing reconstructive surgery after lumpectomy for malignant breast lesions,” stated Alessandro Tocchio, PhD, Chief Strategy Officer, and co-Founder. The company recently announced the initiation of the REGENERA pivotal study involving leading breast cancer surgery centers across Italy and Spain: Tensive S.r.l. Announces Multi-Center Pivotal Clinical Trial for REGENERA Implant in Post-Lumpectomy Breast Reconstruction | Tensive

    “This capital injection and valuable addition to the leadership team bring important resources and expertise that will be pivotal for Tensive’s growth. This vote of confidence from our existing and new investors is crucial for us to continue working towards our mission of improving the quality of life for breast cancer survivors by restoring their natural breast,” said Valentina Morigi, Chief Financial Officer, and co-Founder.

    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 (where he continues as Chairman), Peptilogics, Armetheon, and Trigen (which he also co-founded), and was the founder and chairman of Jai Medica. Before becoming a serial life sciences 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. Sanjay was born and raised in the UK and has worked in the UK, Italy, Germany, India and the US.

    “The unique properties of REGENERA hold incredible promise to bring forward a new class of bio-absorbable implants that potentially offer an easy-to-use, effective and practical option to manage breast disease following lumpectomy ultimately providing a natural breast shape and feel in a single-step, minimally invasive and potentially cost-saving procedure,” said Sanjay Kakkar, CEO. “I am genuinely excited to work closely with a group of groundbreaking innovators and leading investors to leverage this powerful technology to provide breast cancer survivors and healthcare practitioners an important new medical device to address a tremendous unmet clinical need.”

    Tensive was advised by EY Advisory S.p.A. and Pavia e Ansaldo.

    --

    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 the development of proprietary, innovative bio-absorbable implants.

    --

    About Panakès Partners SGR 

    Panakès Partners is a Venture Capital firm, based in Milan, that invests in the most ambitious companies and teams developing revolutionary technologies and products in the field of life sciences with the aim of improving the lives of people around the world. Panakès, founded in 2016 by Fabrizio Landi, Alessio Beverina and Diana Saraceni, has €250 million under management.

    --

    About EIC Accelerator Program

    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.

    --

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

    Media Relations: media@tensivemed.com

    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.

    --

    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.

    --

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

    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