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SmartCella and Catalent sign nonexclusive license agreementfor GMP iPSCs

Tullinge, Sweden, and Tampa, FL, US - SmartCella Holding AB (“SmartCella”), a global biopharma company developing and manufacturing cutting-edge cell therapy approaches for difficult-to-treat diseases, and Catalent, Inc., the leader in enabling the development and supply of better treatments for patients worldwide, today announced a nonexclusive license agreement for SmartCella to use Catalent’s proprietary off-the-shelf GMP compliant induced pluripotent stem cells (iPSCs) for research, development and clinical translation of novel allogeneic stem cell-based regenerative therapies. The

SmartCella appoints Professor Jan Lundberg to Scientific Advisory Board

SmartCella Holding AB (“SmartCella”) today announces the appointment of Professor Jan Lundberg former Global Head of R&D at Eli Lilly and AstraZeneca, to its Scientific Advisory Board (“SAB”). The appointment coincides with an SAB meeting focused on identifying priority disease areas and mRNA-encoded payloads most relevant for the company's induced MSC (iMSC) and Extroducer® delivery platforms.SmartCella’s SAB consists of global scientific and clinical key opinion leaders and discusses innovation, efficiency, healthcare economics, sustainability, and most importantly, improved patient

First patient dosed in XyloCor Therapeutics’ Phase IIb trial using SmartCella’s Extroducer delivery platform

SmartCella Holding AB (“SmartCella”) today shares an update from XyloCor Therapeutics (”XyloCor”). XyloCor recently announced that the first patient has been dosed in their Phase IIb EXACT-2 trial, evaluating their XC001 therapy for patients with refractory angina using SmartCella’s Extroducer as the investigational delivery platform.SmartCella is a global biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. SmartCella combines novel delivery platforms, such as the Extroducer®, with state-of-the-art development and

SmartCella forms Scientific Advisory Board with leading global scientific experts

SmartCella Holding AB (“SmartCella”) has established a Scientific Advisory Board (SAB), chaired by Professor Anna Martling who also serves on the Board of Directors of SmartCella. The purpose of the SAB is to provide scientific and clinical insights and support the strategic direction of SmartCella and its research programs.SmartCella is a global biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. SmartCella combines novel delivery platforms, such as the Extroducer®, an endovascular delivery device that enables direct

Procella obtains regulatory approval to widen the scope of cell therapy manufacturing for clinical stages

ProCella, a unit within the SmartCella Regenerative Medicines business segment, has received updated approval by the Swedish Medicinal Product Agency for manufacturing and quality control testing of sterile biological medicinal products for cell therapy.SmartCella is pleased to announce that Procella has successfully completed another routine authority inspection. The Swedish Medicinal Product Agency (MPA) has granted the updated manufacturing authorization as well as the GMP certification (Good Manufacturing Practice). The approval signifies the certification and quality control of

SmartCella publishes its 2024 Annual Report

Following yesterday’s invitation to the Annual General Meeting, SmartCella Holding AB (“SmartCella”) today publishes its inaugural formal Annual Report. The English version is an extended, unaudited translation of the official 2024 Annual Report in Swedish. Both reports are available at www.smartcella.com/shareholders.SmartCella has made significant commercialization and scientific progress in 2024. In parallel, the company has focused on strengthening its infrastructure in key areas to enable scaling for continued growth and development. In his statement, Christian Kinch, founder and

SmartCella enters agreement to advance Professor Johan Ericson’s research on cell replacement therapies for Parkinson’s disease

SmartCella Holding AB (“SmartCella”) today announces entering an agreement with Professor Johan Ericson from the Department of Cell and Molecular Biology at Karolinska Institutet on his research around cell replacement therapies for Parkinson’s disease. Under the terms of the agreement, SmartCella acquires exclusive rights to advance this research into clinical development and commercialization.Parkinson's disease (PD) is a chronic, progressive neurodegenerative movement disorder affecting over ten million people worldwide. PD is caused by the selective degeneration and death of nerve cell

SmartCella granted new European patent for the Extroducer delivery platform

SmartCella Holding AB (“SmartCella”) today announces that the European Patent Office (EPO) has granted a new European patent for the Extroducer® endovascular delivery platform.SmartCella is a global innovative biotechnology company that combines novel delivery platforms, such as the Extroducer, with cutting-edge cell and mRNA therapies. The Extroducer is a first-in-class endovascular delivery device that enables direct-to-tissue drug delivery. It addresses a significant unmet clinical need for a wide range of indications, enabling targeted delivery of various modalities to solid tumors and

XyloCor and SmartCella enter into license agreement for use of the Extroducer to administer novel gene therapy XC001 to the heart

· The Extroducer® Infusion Catheter System ® enables local delivery of XC001 to the heart without the need for surgery. · XC001 has achieved positive Phase 1/2 results in the EXACT Trial validating its transformative potential for treatment of refractory angina in patients who have exhausted available treatment options and have a debilitating quality-of-life.Wayne, PA, and Tullinge, Sweden July 10, 2024 —XyloCor Therapeutics, Inc. (“XyloCor”), a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, and SmartWise, a unit of SmartCella Holding

SmartCella raises EUR 50 million to accelerate growth and commercialization

SmartCella Holding AB (“SmartCella”) today announces a new share issue raising approximately EUR 50 million to accelerate growth and support commercialization of the Extroducer and the company’s cell and mRNA operations. The share issue was supported by existing large institutional investors such as Fjärde AP-fonden, AMF Pension and SEB-Stiftelsen, as well as a new long-term strategic investor, AstraZeneca (committing to approximately half of the share issue) and the new larger institutional investors Handelsbanken Fonder and RoosGruppen AB, at a pre-money valuation of approximately EUR 500

Senior life science and medical specialists join SmartCella’s Board of Directors

SmartCella Holding AB (“SmartCella”) held its 2024 Annual General Meeting on June 10. The company welcomed investors to its state-of-the art clinical GMP manufacturing facility in Stockholm to learn more about the progress of SmartCella during the last 12 months. In addition, the investors met and interacted with the new board members who all hold unique life science industry and medical expertise. The newly appointed Board of Directors will play a pivotal role as SmartCella embarks on its next strategic development phase.SmartCella is an innovative biotechnology company with a vision to

SmartCella strengthens team with Dr Ricardo Baptista as CTO

SmartCella Holding AB today announces that Dr Ricardo Baptista has been appointed Chief Technology Officer (CTO) and Head of Procella. Ricardo is an experienced Biochemical Engineer with almost 20-years of global experience in the medical biotechnology industry. He has a significant track record of leading technical teams at key cell and gene therapy companies, globally. Ricardo will be a member of SmartCella’s Executive Management Team and be based in Stockholm head office.SmartCella is an innovative biotechnology company developing stem cell and RNA-based therapies in combination with

SmartCella AB appoints Oskar Steneryd as new CFO

SmartCella Holding AB today announces that Oskar Steneryd has been appointed new Chief Financial Officer (CFO). Oskar Steneryd assumes the role on April 1, 2024, and most recently was Investment Director at Impilo, a Nordic-based investment company focused on the healthcare sector. Oskar will be a member of SmartCella’s Executive Management Team, based in the Stockholm head office.SmartCella is an innovative biotechnology company developing stem cell and RNA-based therapies in combination with novel delivery devices such as the FDA-cleared Extroducer. Oskar Steneryd’s recruitment adds

SmartCella obtains approval for GMP manufacturing and quality control testing of cell therapies

SmartCella, through its business unit ProCella, has been approved by the Swedish Medicinal Product Agency for manufacturing and quality control testing of sterile biological medicinal products for cell therapy.SmartCella is pleased to announce that ProCella has been granted manufacturing authorization as well as Good Manufacturing Practice (GMP) certification from the Swedish Medicinal Product Agency. The approvals signify the ability to start clinical production of cell-based therapies for clinical studies. The facility, located at SmartCella’s headquarters in Tullinge near Karolinska

SmartCella strengthens team by recruiting Dr. Nina Bauer as Chief Business Officer

SmartCella Holding AB today announces that Dr. Nina Bauer, MBA, has been appointed Chief Business Officer and Head of Smartwise. Nina Bauer joins in January 2024 from MilliporeSigma, where she most recently held the role of Global Head of Commercial, Viral Vector and Biologics CDMO. She will be a member of the SmartCella Exceutive Management Team, and based in Boston (MA, USA).SmartCella is an innovative biotech and medtech company that combines the development of future stem cell and RNA-based therapies and methods for administering such treatments via targeted delivery into organs and

Niklas Prager appointed new CEO of SmartCella

SmartCella Holding AB today announces that Niklas Prager has been appointed as the new CEO. SmartCella is an innovative biotech and medtech company that combines targeted delivery of medical substances to organs and tumors through a unique device, and the development of future stemcell and RNA-based treatments and methods for administering such treatments.Niklas Prager has extensive and solid experience from the global pharma industry and has held leadership positions in research-focused pharmaceutical companies such as Merck/MSD and Pfizer, with both Sweden and the USA as a base. He has

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