Shannon, Ireland, February 12th 2024: Irish medical device company Biomimetic Innovations Ltd, an affiliate of PBC Biomed, announced ‘Breakthrough Device’ designation from the Food and Drug Administration FDA in January, for the development of a groundbreaking new bio-adhesive bone void filler technology called OsStic®.  PBC Biomed leads a consortium for this development project, which is comprised of Biodesign Europe and SFI Research Centre for Advanced Manufacturing (I-Form) at Dublin City University, and Dolmen Design & Innovation, a Dublin-based product design company. The project (2021 – 2024) is funded under the Disruptive Technologies Innovation Fund (DTIF), which is a €500 million fund established under the National Development Plan (NDP) in 2018 and led by the Department of Enterprise, Trade and Employment, and administered by Enterprise Ireland. The aim of the fund is to drive collaboration between Ireland’s world-class research base and industry, as well as facilitating enterprises to compete directly for funding in support of the development and adoption of these technologies.  Welcoming the announcement, Dr Imelda Lambkin, Disruptive Technologies and Innovation Department Manager, Enterprise Ireland commented; “This announcement is a great success for PBC Biomed and is testament to the capability and talent, vibrancy and international competitiveness of the Irish innovation and research system. In line with Enterprise Ireland’s strategy, this success will support the company to build on their existing capabilities, scale and create jobs. “The collaboration between Dublin City University, Dolmen Design & Innovation, Biomimetic Innovations, and PBC Biomed exemplifies the power of interdisciplinary efforts in research and development. The ‘Breakthrough Device’ designation by the FDA validates the promising trajectory of OsStic®, showcasing Ireland’s capability to lead in cutting-edge medical technologies. This achievement not only highlights the success of the project but also emphasizes the importance of sustained investment in disruptive technologies to foster innovation and elevate Ireland’s global standing in the medical device industry.” Professor Nicholas Dunne, Founding Executive Director of Biodesign Europe, Dublin City University and Funded Investigator in the SFI Research Centre for Advanced Manufacturing and SFI Centre for Advanced Materials and BioEngineering Research. “This announcement marks a major milestone in the evolution of calcium-based biomaterials. The proposed indication will be unique and for the first time will address all surgeon needs when dealing with complex fractures and allow for faster recovery times and greatly improved results for patients.” Gerard Insley, Chief Science Officer BMI. Learn more about DTIF here: https://lnkd.in/dHQ3_2vF About BMI Biomimetic Innovations Ltd, is an affiliate of PBC Biomed; a medical device company involved in design, development and manufacturing headquartered in Shannon, Ireland and with offices in Memphis, Tennessee and Chamonix, France.  

Shannon, Ireland, 19th January, 2024: Biomimetic Innovations Ltd today announced that OsStic® has been granted ‘Breakthrough Device’ designation by the FDA. The proposed indication statement for this novel new technology is; ” OsStic®Synthetic Injectable Bone Void Filler is a structural, mechanically enhanced bioadhesive for reduction, provisional fixation, or void filling of peri-articular fractures or defects to enhance structural stability where standard fixation alone cannot provide sufficient support for functional mobilization.” This Breakthrough Designation of our disruptive technology fuels our passion for earlier mobilization of trauma patients. Paul Burke, Director BMI. The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. [source] The program is intended to provide patients and health care providers with timely access to medical devices, by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. [source] OsStic® pioneers the evolution of structural orthobiologics, to the point where surgeons can now use this material as an aid for the reduction, provisional fixation and void filling of peri-articular fractures. This is the first calcium phosphate that meets all these clinical requirements. Dr Thomas A Russell, CMO BMI. About BMI Biomimetic Innovations Ltd, is an affiliate of PBC Biomed; a medical device company involved in design, development and manufacturing headquartered in Shannon, Ireland and with offices in Memphis, Tennessee and Chamonix, France.   Contact Details Bronagh O’Doherty, Global Product Manager, PBC Biomed. Email: [email protected] Reference (Image) Lundin TPO, Pujari-Palmer M, Svensson G, Höglund OV. Canine ex vivo tarsal arthrodesis: fixation by using a new bone tissue glue. Front Vet Sci. 2023 Sep 20;10:1250147. doi: 10.3389/fvets.2023.1250147. PMID: 37799403; PMCID: PMC10548131. Link: https://www.frontiersin.org/articles/10.3389/fvets.2023.1250147/full

PBC BioMed, a medical device design and development company headquartered in Shannon, Ireland, today announced that it will open first U.S. office in Memphis, TN. The PBC BioMed Leadership team, Gerard Insley, Chief Science Officer, Dr. Thomas Russell, Chief Medical Officer, and Brittney Martinez, VP of Business Development and Marketing, were on-site this week for the official office opening at Epicenter, located at 150 Peabody Place. They were joined by Memphis Chamber President and CEO, Ted Townsend, and Jessica Taveau, the CEO of Epicenter.   PBC BioMed has an established track record of innovation since they first opened in Shannon in 2010. With a deep understanding of the regulatory, quality, clinical and commercial requirements facing innovators in Europe and the U.S., the PBC BioMed team are dedicated to accelerating medical innovation within the area of Biomaterials, through partnerships with healthcare professionals, academic institutions, and Medtech companies. Tennessee is an ideal first location for PBC BioMed in the U.S., as it is the second highest exporter of medical equipment, with Memphis specifically being home to a multitude of medical device companies. Memphis Chamber President and CEO, Ted Townsend was on site this week to welcome the PBC BioMed team and enthused,”Thanks to our central location, logistics prowess, and diverse workforce, Memphis has long been at the heart of medical technology innovation that is saving and improving lives across the world. Memphis is a natural fit for the first U.S. office of PBC BioMed, who are helping medical device companies develop their life-saving and life-changing products. This foreign direct investment in Memphis is also an investment in the future growth of our Medtech companies and startups.” Paul Burke, Managing Partner for PBC BioMed, said, ”PBC Biomed has a long legacy of collaboration in the U.S. and Memphis area, stretching back over 10 years. The office in Memphis is an inevitable expansion of our U.S. operations and we are excited to bring our innovation experience and unique skillset to the area, to collaborate with local innovators, academia and industry partners.” PBC BioMed’s Chief Medical Officer, Dr Toney Russell, commented: “It is exciting to welcome PBC BioMed to the Memphis area. This has been my home for almost 50 years and where I received my medical education and entry into the Medical Device Industry.  Numerous innovations and advancements in healthcare that have originated in this area, have healed many of the worlds’ sick and injured. We hope to contribute to this legacy with our world-wide team of physicians, scientists, academicians, engineers and specialists in medical commercialization, working in partnership with those with a passion for improving healthcare.” For more information on PBC BioMed or to submit a request for support, please visit the website at https://www.pbcBioMed.com/aim/ or reach out to a member of the team at [email protected]. About PBC BioMed Ltd – Accelerating Medical Innovation PBC BioMed was founded in 2010, with the mission of being the preferred partner for accelerating medical innovations from concept to commercialisation, to make a meaningful difference in patients’ lives. PBC BioMed delivers value to small, medium, and large MedTech ventures, through a wide array of services that include R&D, quality, regulatory, contract manufacturing, supply chain and commercialisation. With 3 global locations, PBC BioMed is the strategic partner for medical innovation from ideation to implantation.   

With an established track record of innovation, PBC BioMed has assembled a global team with a deep understanding of the regulatory, quality, clinical and commercial requirements facing innovators based in the EU or US, and wishing to enter new markets.

Shannon, Ireland, 8 June, 2021: PBC Biomed, an Irish-based Medical Device Company, have entered a partnership agreement with Curasan AG, a German-headquartered Medical Device company with global distribution, to develop innovative products in the field of musculoskeletal regeneration. This collaboration will bring together two pioneers in the advancement of biomimetic technologies to create an expanded offering of solutions for patients suffering from bone defects. Dirk Dembski, CEO of curasan AG, said “Curasan’s portfolio of products have been appreciated for decades by medical professionals around the globe. When it comes to regeneration of musculoskeletal defects, we are well known for quality, safety, and effectiveness. Partnering with PBC Biomed will support our efforts in further developing disruptive and innovative products. This collaboration significantly contributes to our mission of revolutionizing musculoskeletal healing.” PBC Biomed, a Shannon-based Medical Device company, with a US office in Memphis, Tennessee, USA, is focused on accelerating medical innovation in the areas of bone and tissue healing through partnerships with healthcare professionals, academic institutions and medtech companies worldwide. Paul Burke, Managing Partner at PBC Biomed, said “PBC Biomed is delighted to join forces with curasan AG to support their ongoing focus of improving patient healing. We look forward to working alongside curasan to develop and commercialise innovative biomaterials for the treatment of bone defects.“ About PBC Biomed Ltd – Accelerating Medical Innovation PBC Biomed was founded in 2010, with the mission of being the preferred partner for accelerating medical innovations from concept to commercialisation, to make a meaningful difference in patients’ lives. PBC Biomed delivers value to small, medium, and large medtech ventures through a wide array of services that include R&D, quality, regulatory, contract manufacturing, supply chain and commercialisation. Located in Shannon, Ireland, an international hub for the development and production of medical devices, biologics, and pharmaceuticals, PBC Biomed is the strategic partner for medical innovation from ideation to implantation. www.LinkedIn.com/company/pbc-biomed www.curasan.de

 PBC Biomed_Our Why.mp4 SHANNON, Ireland, May 04, 2021 (GLOBE NEWSWIRE) — PBC Biomed, an Irish-based Medical Device Company, will lead a consortium comprised of Biodesign Europe and SFI Research Centre for Advanced Manufacturing (I-Form) at Dublin City University and Dolmen Design & Innovation, a Dublin-based product design company, in developing a bone adhesive for the treatment of osteoporotic fractures. This partnership was recently awarded €3.4M by the Irish Governments Disruptive Technologies Innovation Fund (DTIF), with an additional €2M investment from the industry partners associated with the project. PBC Biomed, located in Shannon with a US office in Memphis, Tennessee, is focused on accelerating medical innovation in the areas of bone and tissue healing through partnerships with healthcare professionals, academic institutions and medtech companies. The development of a bone adhesive that will significantly reduce operating times, risk of infection, and the need for hardware in complex fracture treatment has the potential to significantly disrupt the standard of care. The DTIF award will support the expansion of this technology into other clinical applications, such as tissue regeneration and repair. Dr. Gerard Insley, Chief Scientific Officer at PBC Biomed, highlighted, “Treating complex bone diseases using biomimetic biomaterials allows patients to quickly restore mobility and health. PBC Biomed has extensive experience in developing and commercialising solutions for unmet clinical needs, so we look forward to driving this project to completion to accelerate healing in osteoporotic patients.” Dolmen Design & Innovation’s role in this partnership is to develop an innovative delivery solution for the complex application of the bone adhesives in various anatomical settings, thus reducing the risk and complexity faced by surgeons in the operating rooms. Martin Bruggemann, Medical Design Director at Dolmen, said, “We are delighted to be part of this exciting consortia, where we will be bringing our expertise in dispense, deployment and delivery system innovation to the fore. We have patented award-winning solutions for clients around the world for the past 30 years and the opportunity to continue working with such visionaries as the PBC Biomed and DCU teams is what drives us to deliver solutions on a daily basis.” Biodesign Europe and I-Form at DCU will provide technical expertise associated with testing and validating the efficacy of the platform technology for use in treating osteoporotic bone fractures. They will also facilitate clinical adoption by utilising the OsStic platform technology at their world-class medical facilities. Prof. Nicholas Dunne said: “Biodesign Europe and I-Form are thrilled to be playing a pivotal role in this exciting challenge-based project. Our goal is to accelerate the development of the first mechanically-compliant bone adhesive with tissue regenerative properties. It’s application in orthopaedic surgery for the management and treatment of osteoporotic bone fractures has the potential to affect approximately 5 million people each year across the world. This interdisciplinary project truly epitomises the ground-breaking scientific discovery and MedTech innovation that is taking place in Ireland and has the potential to drastically alter the bone fracture orthopaedic market on a global scale.” Paul Burke, Managing Partner at PBC Biomed, said: “PBC Biomed is honoured to lead this collaboration in developing a technology that will truly disrupt the treatment of bone repair and enhance patient wellbeing. The investment by the Department of Enterprise, Trade and Employment and the DTIF Team allows partnerships such as these to not only improve healthcare, but also showcase Ireland’s world-class research and development capabilities. We thank them for funding this initiative.” About PBC Biomed Ltd PBC Biomed was founded in 2010, with the mission of being the preferred partner for accelerating medical innovations to launch in order to make a meaningful difference in patients’ lives. PBC Biomed delivers value through a wide array of services, including R&D, quality, regulatory, contract manufacturing, supply chain and commercialisation. Located in Ireland, an international hub for the development and production of medical devices, biologics and pharmaceuticals, PBC Biomed is the strategic partner for medical innovation from ideation to implantation.

We are delighted to announce the launch of Biomimetic Innovations , a collaboration between long time friends and colleagues, to further develop OsStic™ our biomimetic adhesive for tissue repair. Read More ..’In Vivo Safety Assessment of a Bio-Inspired Bone Adhesive’ J Mater Sci Mater Med 2020, 31(2):24

PBC Biomed is pleased to announce its role as Contract Manufacturer for Copper Hawk. Copper Hawk is an Irish company dedicated to improving animal health through the development of products made from natural sources. Eire Hide®, one such product, is a formulated, soothing ointment that is applied to animal skin. Please contact us for any information.