Latest news with #ISO13485


Business Wire
10 hours ago
- Business
- Business Wire
3DBioFibR Raises $3M to Advance Next-Gen Biopolymer Fiber Manufacturing Platform
HALIFAX, Nova Scotia--(BUSINESS WIRE)--3DBioFibR Inc., a leading manufacturer of advanced biopolymer fibers, today announced the successful close of a $3 million equity financing round. The raise follows a string of recently signed paid partnerships and collaborations across key sectors—including tissue engineering, medical devices, defense, cosmetics, and apparel, with several multinational corporations. The round drew participation from both new and existing investors, including AoA Innovation Fund, Build Ventures, Invest Nova Scotia, and Concrete Ventures. 3DBioFibR Secures $3M to Scale Game-Changing Biopolymer Fiber Platform—New funding powers ISO 13485 certification, clean room expansion, and manufacturing scale-up to meet soaring global demand for next-gen medical and performance biomaterials. This financing represents an important milestone for 3DBioFibR as it improves operational scale and deepens its role as a critical supplier of next-generation biomaterials. The funds will support increased manufacturing capacity, operational growth, and implementation of ISO 13485 certification, including the construction of a clean room manufacturing facility—essential for producing medical-grade materials. 'This investment fuels the next phase of our growth,' said Kevin Sullivan, CEO of 3DBioFibR. 'It enables us to meet growing demand from our commercial partners and to become a qualified supplier for regulated medical and therapeutic applications. ISO 13485 certification is a key step in delivering clinical-grade fibers at the scale and consistency our partners require. We're excited to expand our impact across industries that urgently need stronger, more sustainable biomaterials.' Over the past two years, 3DBioFibR has secured paid development agreements with a growing roster of global and regional companies developing products in tissue engineering, medical devices, defense, cosmetics, and apparel. These partnerships focus on integrating 3DBioFibR's best-in-class fibers into existing and developing product pipelines. The new capital ensures the company can continue to deliver high-performance materials at commercial scale, while laying the groundwork for expanded clinical partnerships. '3DBioFibR has accomplished something rare, translating cutting-edge biomaterials science into real commercial traction,' said Patrick Keefe, General Partner at Build Ventures. 'They've partnered with serious players in global industries and built a manufacturing platform that can deliver fibers at a scale and quality the market hasn't seen before. This team is setting the benchmark in biopolymer fiber manufacturing, and we're proud to support their journey.' 'As an early investor in 3DBioFibR, Invest Nova Scotia has been active with the company throughout its growth into a unique business that offers novel and unparalleled manufacturing potential for biopolymer applications, representing multibillion-dollar market opportunities,' said Lidija Marušić, Invest Nova Scotia. 'With this latest investment, Invest Nova Scotia looks forward to seeing 3DBioFibR achieve their objectives.' 3DBioFibR's proprietary dry-spinning platform enables the production of fibers from a wide range of biopolymers, currently over six, with performance metrics that meet or exceed natural tissue strength by two to three times. Compared to conventional techniques like wet spinning and electrospinning, 3DBioFibR's process delivers material at over 3,600 times the scale, with vastly improved uniformity and cost-efficiency. These properties position the company's fibers for use in applications where strength, biocompatibility, or scale have previously been limiting factors. About 3DBioFibR Inc. 3DBioFibR is driving the adoption of biomaterials in regenerative medicine, medical devices, defense, cosmetics, and sustainable textiles. It's patented dry-spinning technology enables scalable, high-precision manufacturing of advanced biopolymer fibers—delivering superior performance at industrial scales. By collaborating with industry leaders, 3DBioFibR is unlocking transformative applications for strong, lightweight, and biocompatible materials across some of the world's most demanding sectors.
Yahoo
2 days ago
- Business
- Yahoo
STEMCELL Technologies Announces Acquisition of Cellular Highways
VANCOUVER, British Columbia & CAMBRIDGE, England, June 02, 2025--(BUSINESS WIRE)--STEMCELL Technologies, Canada's largest biotechnology company, is pleased to announce the acquisition of Cellular Highways Ltd from TTP Group Ltd. Cellular Highways is a biotechnology company based near Cambridge, United Kingdom, that specializes in advanced cell sorting technologies with applications in cell and gene therapy, drug discovery, and general cell research, especially where cells are fragile. The acquisition includes the revolutionary Highway1 instrument, which uses Cellular Highways' proprietary VACS™ (Vortex-Actuated Cell Sorting) technology. VACS™ gently and precisely sorts cells and enables high-speed cell sorting in a closed, sterile system through microfluidic vortices. VACS™ uniquely avoids traditional non-sterile droplet-based and electrostatic sorting methods, which can degrade cell health and viability. Highway1 enables researchers and cell therapy developers to process cells more efficiently while maintaining high cell integrity for sensitive applications in research and therapeutic development. This significantly reduces the timelines and costs for research and development. "Since entering the market in 2024, Highway1 has proven to be the fastest GMP-ready cell sorter available and is designed and manufactured under ISO 13485 certification. We are pleased to welcome this powerful instrument, along with the entire Cellular Highways platform, to STEMCELL's portfolio of advanced cell processing instruments," said Dr. Allen Eaves, President and CEO, STEMCELL. "With this new complement to our existing cell isolation and culture product lines, we look forward to further supporting scientists with the tools they need to accelerate innovation in the development of life-changing cell and gene therapies." Current Highway1 customers will receive continued technical support from STEMCELL's dedicated team of Product and Scientific Support specialists. "Cellular Highways customers are in great hands with STEMCELL—a major player in the global biotechnology industry with a stellar reputation for its best-in-class products and customer service," said Dr. Alex Jones on behalf of Cellular Highways. "With STEMCELL's global reach, we are excited that this acquisition will help introduce Highway1 to even more labs around the world." "The acquisition is a testament to Cellular Highways' exceptional team and innovation. With STEMCELL's reputation and global reach, it is ideally positioned to thrive in the rapidly growing research and cell therapy manufacturing markets," said Dr. Sam Hyde, CEO of TTP. "For TTP Group, this demonstrates our unique ability to build and nurture businesses that deliver breakthrough technologies, transform them into market-leading products, and create significant value." "This acquisition aligns with STEMCELL's strategic growth in the cell therapy space," said Dr. Eaves. "With this enhanced ability to support cutting-edge research and biomanufacturing workflows, we will continue to help the scientific community advance research and make discoveries with greater speed and accuracy." About STEMCELL TechnologiesSTEMCELL Technologies supports life sciences research with more than 2,500 specialized reagents, tools, and services. STEMCELL offers high-quality cell culture media, cell separation technologies, instruments, accessory products, educational resources, and contract assay services that are used by scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research globally. About TTP GroupTTP Group is an independent technology company where scientists and engineers collaborate to invent, design, and engineer breakthrough technologies and products. Working across sectors including healthcare, life sciences, communications, and industrials, TTP combines deep technical expertise with commercial insight to deliver innovations that drive progress and create value. Founded in 1987, TTP Group develops technologies and products for clients worldwide and nurtures high-impact venture businesses. About Cellular HighwaysCellular Highways was founded to take fluorescence-based cell sorting into new therapy development and research applications, requiring fast, gentle, sterile, scalable cell sorting, using the unique potential of the VACS™ technology. Cellular Highways span out from TTP Group. View source version on Contacts Media Contact For more information and to arrange an interview, contact:Ryan-Sang LeeDirector, Corporate Communications, STEMCELL Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data


Business Wire
2 days ago
- Business
- Business Wire
STEMCELL Technologies Announces Acquisition of Cellular Highways
VANCOUVER, British Columbia & CAMBRIDGE, England--(BUSINESS WIRE)--STEMCELL Technologies, Canada's largest biotechnology company, is pleased to announce the acquisition of Cellular Highways Ltd from TTP Group Ltd. Cellular Highways is a biotechnology company based near Cambridge, United Kingdom, that specializes in advanced cell sorting technologies with applications in cell and gene therapy, drug discovery, and general cell research, especially where cells are fragile. The acquisition includes the revolutionary Highway1 instrument, which uses Cellular Highways' proprietary VACS™ (Vortex-Actuated Cell Sorting) technology. VACS™ gently and precisely sorts cells and enables high-speed cell sorting in a closed, sterile system through microfluidic vortices. VACS™ uniquely avoids traditional non-sterile droplet-based and electrostatic sorting methods, which can degrade cell health and viability. Highway1 enables researchers and cell therapy developers to process cells more efficiently while maintaining high cell integrity for sensitive applications in research and therapeutic development. This significantly reduces the timelines and costs for research and development. 'Since entering the market in 2024, Highway1 has proven to be the fastest GMP-ready cell sorter available and is designed and manufactured under ISO 13485 certification. We are pleased to welcome this powerful instrument, along with the entire Cellular Highways platform, to STEMCELL's portfolio of advanced cell processing instruments," said Dr. Allen Eaves, President and CEO, STEMCELL. 'With this new complement to our existing cell isolation and culture product lines, we look forward to further supporting scientists with the tools they need to accelerate innovation in the development of life-changing cell and gene therapies.' Current Highway1 customers will receive continued technical support from STEMCELL's dedicated team of Product and Scientific Support specialists. 'Cellular Highways customers are in great hands with STEMCELL—a major player in the global biotechnology industry with a stellar reputation for its best-in-class products and customer service,' said Dr. Alex Jones on behalf of Cellular Highways. 'With STEMCELL's global reach, we are excited that this acquisition will help introduce Highway1 to even more labs around the world.' 'The acquisition is a testament to Cellular Highways' exceptional team and innovation. With STEMCELL's reputation and global reach, it is ideally positioned to thrive in the rapidly growing research and cell therapy manufacturing markets,' said Dr. Sam Hyde, CEO of TTP. 'For TTP Group, this demonstrates our unique ability to build and nurture businesses that deliver breakthrough technologies, transform them into market-leading products, and create significant value.' 'This acquisition aligns with STEMCELL's strategic growth in the cell therapy space,' said Dr. Eaves. 'With this enhanced ability to support cutting-edge research and biomanufacturing workflows, we will continue to help the scientific community advance research and make discoveries with greater speed and accuracy.' About STEMCELL Technologies STEMCELL Technologies supports life sciences research with more than 2,500 specialized reagents, tools, and services. STEMCELL offers high-quality cell culture media, cell separation technologies, instruments, accessory products, educational resources, and contract assay services that are used by scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research globally. About TTP Group TTP Group is an independent technology company where scientists and engineers collaborate to invent, design, and engineer breakthrough technologies and products. Working across sectors including healthcare, life sciences, communications, and industrials, TTP combines deep technical expertise with commercial insight to deliver innovations that drive progress and create value. Founded in 1987, TTP Group develops technologies and products for clients worldwide and nurtures high-impact venture businesses. About Cellular Highways Cellular Highways was founded to take fluorescence-based cell sorting into new therapy development and research applications, requiring fast, gentle, sterile, scalable cell sorting, using the unique potential of the VACS™ technology. Cellular Highways span out from TTP Group.


Trade Arabia
7 days ago
- Health
- Trade Arabia
King Faisal Hospital gets ISO certification for 3D printing services
King Faisal Specialist Hospital & Research Centre (KFSHRC) has earned ISO 13485:2016 certification for its 3D Printing Services Department. This ISO certification represents the highest global standards for quality management systems in the design and manufacture of medical devices. It reflects the KFSHRC's strength in delivering innovative, custom-made solutions in complex clinical settings with rigorous quality control and assurance, said the Saudi facility in a statement. KFSHRC's 3D Printing Services Department has become a cornerstone of the hospital's precision healthcare ecosystem. The department uses advanced additive manufacturing to produce patient-specific anatomical models, surgical guides, prosthetics and implants to improve surgical planning, reduce intraoperative risks, and augment clinical outcomes, it stated. In 2023, the department produced over 1,100 physical models and more than 5,000 digital simulations, which shortened average surgery time by 30% and reduced complications by 85%, significantly improving patient satisfaction. KFSHRC's achievements in this field have also garnered international recognition. The hospital was ranked among the top 20 Saudi government entities in the Emerging Technology Adoption Readiness Index for 2025. The Global Project Management Forum (GPMF) awarded its 3D Printing Project the 2024 Global Excellence Award in Technology Project Management. "Our mission is to conduct cutting-edge, multidisciplinary research and integrate the innovative technologies into medical practice. Our expertise in 3D printing, artificial intelligence and robotics is combined to advance healthcare delivery. We are expanding our technology platforms and working towards our Kingdom's Vision 2030 to spin off a 3D printing medical technology company that would provide a broad healthtech and socioeconomic impact," he added. Notably, for the third consecutive year, KFSHRC has been ranked first in the Middle East and Africa and 15th globally in the list of the world's top 250 Academic Medical Centres. According to the 2025 Brand Finance rankings, it has been recognized as the most valuable healthcare brand in the Kingdom and the Middle East. Additionally, it was included in Newsweek magazine's World's Best Smart Hospitals list for 2025.


Zawya
27-05-2025
- Health
- Zawya
KFSHRC's 3D Medical Printing: Faster Surgeries, Fewer Complications
Riyadh: King Faisal Specialist Hospital & Research Centre (KFSHRC) has earned ISO 13485:2016 certification for its 3D Printing Services Department. This ISO certification represents the highest global standards for quality management systems in the design and manufacture of medical devices. It reflects the KFSHRC's strength in delivering innovative, custom-made solutions in complex clinical settings with rigorous quality control and assurance. KFSHRC's 3D Printing Services Department has become a cornerstone of the hospital's precision healthcare ecosystem. The department uses advanced additive manufacturing to produce patient-specific anatomical models, surgical guides, prosthetics and implants to improve surgical planning, reduce intraoperative risks, and augment clinical outcomes. In 2023, the department produced over 1,100 physical models and more than 5,000 digital simulations, which shortened average surgery time by 30% and reduced complications by 85%, significantly improving patient satisfaction. KFSHRC's achievements in this field have also garnered international recognition. The hospital was ranked among the top 20 Saudi government entities in the Emerging Technology Adoption Readiness Index for 2025. The Global Project Management Forum (GPMF) awarded its 3D Printing Project the 2024 Global Excellence Award in Technology Project Management. 'Our mission is to conduct cutting-edge, multidisciplinary research and integrate the innovative technologies into medical practice. Our expertise in 3D printing, artificial intelligence and robotics is combined to advance healthcare delivery. We are expanding our technology platforms and working towards our Kingdom's Vision 2030 to spin off a 3D printing medical technology company that would provide a broad healthtech and socioeconomic impact.' Notably, for the third consecutive year, KFSHRC has been ranked first in the Middle East and Africa and 15th globally in the list of the world's top 250 Academic Medical Centres. According to the 2025 Brand Finance rankings, it has been recognized as the most valuable healthcare brand in the Kingdom and the Middle East. Additionally, it was included in Newsweek magazine's World's Best Smart Hospitals list for 2025.