FIH

TransCode Therapeutics Reports 2022 Results; Provides Business Update

Retrieved on: 
Friday, March 31, 2023
Newton, Pancreatic cancer, IPO, Therapy, ODD, SBIR, Neoplasm, Survival, Clinical trial, Cancer, Transcoding, RNA, Antibody, Sale, Small RNA, RNA interference, Animal, Patent, Patient, Metastasis, FIH, Entrepreneurship, FDA, Recurrence, TTX, Disease, Pharmaceutical industry, Vaccine, Cryptocurrency

BOSTON, March 31, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to defeating cancer using RNA therapeutics, today reported financial results for 2022 and recent business progress.

Key Points: 
  • BOSTON, March 31, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to defeating cancer using RNA therapeutics, today reported financial results for 2022 and recent business progress.
  • “Despite the continued turbulence in the biotech sector, 2022 was extremely productive and, we believe, successful for TransCode.
  • “We achieved many important milestones, advancing our pipeline of therapeutic candidates enabled by our proprietary delivery platform.
  • We are looking forward to the upcoming FIH clinical trial that we hope will advance our potential to deliver RNA therapeutics to tumors and metastases in cancer patients”.

Cellusion Announces First Patient Transplanted iPSC-Derived Corneal Endothelial Cell Substitute (CLS001)

Retrieved on: 
Monday, March 27, 2023
Biotechnology, Health, Pharmaceutical, Surgery, Professional Services, Optical, Stem Cells, University, Research, Education, Start-Up, Hospitals, Science, Clinical Trials, Fujita Health University, Cornea, Human, Inc., Society, Safety, Efficacy, Visual impairment, Cataract, Keio University, Paratriathlon, Medicine, Regenerative medicine, Eye, Patient, Water, FIH, Corneal transplantation, Transplant, Visual acuity, IPS, Study, Conference, Endothelium, Disease, Pharmaceutical industry, Dentistry, Ophthalmology

Ph.D., "Cellusion") announced that our research collaborator, Dr. Shigeto Shimmura, Professor of Fujita Health University and Keio University presented at the 22nd Japanese Society for Regenerative Medicine Annual Conference (Kyoto, Japan, March 23-25, 2023) that iPS cell-derived corneal endothelial cell substitute ("CLS001") was transplanted to the first patient (First In Human*, "FIH Study").

Key Points: 
  • Ph.D., "Cellusion") announced that our research collaborator, Dr. Shigeto Shimmura, Professor of Fujita Health University and Keio University presented at the 22nd Japanese Society for Regenerative Medicine Annual Conference (Kyoto, Japan, March 23-25, 2023) that iPS cell-derived corneal endothelial cell substitute ("CLS001") was transplanted to the first patient (First In Human*, "FIH Study").
  • In addition, in terms of the efficacy, he also reported that the visual acuity, central corneal thickness, and minimal corneal thickness has tended to be improved so far.
  • Currently, the only treatment available for this disease is a corneal transplant that replaces normally functioning corneal endothelial cells.
  • Cellusion is developing CLS001, CECSi cells for Corneal Endothelial regeneration to cure Bullous Keratopathy which is applied to more than half of all cases of corneal transplantation.

Monopar Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Developments

Retrieved on: 
Thursday, March 23, 2023
Triple-negative breast cancer, Interim, Therapy, Life, BioMarin Pharmaceutical, Hair loss, National University of Singapore, Neoplasm, VOICE, LVEF, National university, Receptor (biochemistry), Cancer, Quality of life, Bone marrow, Clinical trial, G&A, PET, Patient, Investment, ASTS, Doxorubicin, FIH, Financial management, Pancreatic tumor, Actinium-225, Pharmaceutical industry, Medical imaging, Extrusion, Cryptocurrency, Fine chemical

WILMETTE, Ill., March 23, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced fourth quarter and full-year 2022 financial results and summarized recent developments.

Key Points: 
  • WILMETTE, Ill., March 23, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced fourth quarter and full-year 2022 financial results and summarized recent developments.
  • Results for the Fourth Quarter and Year Ended December 31, 2022, Compared to the Fourth Quarter and Year Ended December 31, 2021
    Cash, cash equivalents and short-term investments as of December 31, 2022, were $13.1 million.
  • R&D expenses for the fourth quarter of 2022 were $2.1 million compared to $2.0 million for the fourth quarter of 2021.
  • G&A expenses for the fourth quarter of 2022 were $0.8 million, compared to $0.7 million for the fourth quarter of 2021.

KBI Biopharma, Inc. Releases Inaugural FIH Manufacturing Batch at Integrated Switzerland Facility Five Months After Opening

Retrieved on: 
Tuesday, March 21, 2023
Other Manufacturing, Mental Health, Clinical Trials, Health Technology, Manufacturing, Stem Cells, Biotechnology, Health, Pharmaceutical, Immortalised cell line, Good manufacturing practice, PROMIS, CLD, Clinical trial, Neuroscience, KBI, CDMO, CGMP, Patient, FIH, Fine chemical, Pharmaceutical industry

KBI Biopharma, Inc. (KBI), a JSR Life Sciences company, today announced that late in 2022, it successfully released its inaugural First In Human (FIH) manufacturing batch in compliance with current Good Manufacturing Practice (cGMP) standards in its recently expanded Geneva mammalian cell manufacturing facility.

Key Points: 
  • KBI Biopharma, Inc. (KBI), a JSR Life Sciences company, today announced that late in 2022, it successfully released its inaugural First In Human (FIH) manufacturing batch in compliance with current Good Manufacturing Practice (cGMP) standards in its recently expanded Geneva mammalian cell manufacturing facility.
  • The swift execution of this important milestone demonstrates the capabilities in cell line development (CLD) and biologics manufacturing of KBI and Selexis, allowing clients to accelerate clinical research timelines.
  • In July 2022, KBI and Selexis announced the completion of the fully integrated, 8,733 square-meter site combining Selexis’ Cell Line Development services and KBI’s development and manufacturing services.
  • The Geneva KBI and Selexis facility features integrated services including CLD services, analytical formulation services and clinical manufacturing, all under one roof.

Agilis Robotics has kickstarted its first trial in mainland China, taking a great leap forward in robotized endoscopic surgery in the country

Retrieved on: 
Monday, March 20, 2023
Learning curve, Endoscopy, USD, Physician, Robotics, Surgeon, FIH, ESD, FDA, System, NMPA, Safety, Medical device, Pharmaceutical industry

The company has developed the world's smallest flexible and dexterous endoscopic robot system, which is a breakthrough in the field of robotics surgery.

Key Points: 
  • The company has developed the world's smallest flexible and dexterous endoscopic robot system, which is a breakthrough in the field of robotics surgery.
  • The Agilis Robotics system is designed to make endoscopic and endoluminal surgery easier, faster, and more precise.
  • This is a great opportunity for investors to be part of a company that is revitalizing the landscape of endoscopic surgery.
  • The funds raised will be used to further develop the Agilis Robotics system for FDA and NMPA submission.

GLUCOTRACK PROVIDES SHAREHOLDER UPDATE

Retrieved on: 
Tuesday, March 14, 2023
Samsung Health, Research, Type 2 diabetes, Longevity, Electronics, Medtronic, Trust, Software, BGM, Android, Letter, Prediabetes, Smartphone, Patient, CGM, FDA, IOS, Growth, FIH, Doctor of Philosophy, Dexcom, Diabetes, Bluetooth, Second generation, Management, Medical device

Rutherford, NJ, March 14, 2023 (GLOBE NEWSWIRE) -- GlucoTrack, Inc. (Nasdaq: GCTK) (“GlucoTrack” or the “Company”), a medical device and digital health platform company focused on diabetes and prediabetes, announced today that Paul V. Goode, PhD, President and Chief Executive Officer has provided a shareholder update letter.

Key Points: 
  • Rutherford, NJ, March 14, 2023 (GLOBE NEWSWIRE) -- GlucoTrack, Inc. (Nasdaq: GCTK) (“GlucoTrack” or the “Company”), a medical device and digital health platform company focused on diabetes and prediabetes, announced today that Paul V. Goode, PhD, President and Chief Executive Officer has provided a shareholder update letter.
  • Our vision at Glucotrack is to become a leader in the diabetes market by providing a range of products and services addressing multiple verticals; those with Type 1 and Type 2, insulin dependent and non-insulin dependent, and prediabetes.
  • Our senior leadership hail from leading companies in the field, including Dexcom, Medtronic, Samsung Health, and Insulet.
  • We continue to make progress on our flagship Glucotrack non-invasive monitor.

Enthera Pharmaceuticals Initiates Phase 1 Clinical Trial with Lead Candidate Ent001

Retrieved on: 
Tuesday, March 7, 2023
Science, Stem Cells, Biotechnology, Research, Pharmaceutical, Health, Diabetes, Clinical Trials, Pancreas, Cell death, Clinical trial, TMEM219, Inflammatory bowel disease, FIH, T1D, Mab, SAD, Patient, Pharmacokinetics, Apoptosis, Volunteering, IBD, IGFBP3, Inflammation, Safety, Medication, Pharmaceutical industry

Enthera Pharmaceuticals (“Enthera”), a biotech company developing first-in-class biologics for selected autoimmune conditions, today announces the start of a Phase 1 first-in-human (FIH) clinical trial with its lead candidate Ent001.

Key Points: 
  • Enthera Pharmaceuticals (“Enthera”), a biotech company developing first-in-class biologics for selected autoimmune conditions, today announces the start of a Phase 1 first-in-human (FIH) clinical trial with its lead candidate Ent001.
  • Ent001 is designed to bind to TMEM219 and prevent cell death and the inflammation underlying these disease states.
  • “The initiation of this trial is a major development milestone for Ent001 and transitions Enthera into a clinical stage company.
  • The Phase 1 trial will evaluate Ent001 in up to 30 healthy adult volunteers in a randomised, double-blind, placebo-controlled single ascending dose (SAD) study in the Netherlands.

Saranas Appoints Mike MacKinnon as CEO

Retrieved on: 
Monday, February 27, 2023
Biotechnology, Health, Surgery, Medical Devices, Aortic stenosis, Patient safety, Physician, FIH, Partner, Risk, Acquisition, MCS, Standard of care, FDA, EVAR, Patient, CT, Trial of the century, Atherectomy, Bleeding, Medtech, Growth, Innovation system, Hypertension, Private equity, Philips, Volcano, Early Bird, TAVR, Birth control, Multistrada Arah Sarana

Saranas® Inc., a medical device company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications, today announced the hiring of seasoned medtech executive, Mike MacKinnon, as Chief Executive Officer.

Key Points: 
  • Saranas® Inc., a medical device company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications, today announced the hiring of seasoned medtech executive, Mike MacKinnon, as Chief Executive Officer.
  • “We are delighted to have Mike join and lead Saranas as we continue our mission establishing early bleed detection and monitoring as the standard of care for patients undergoing endovascular procedures,” commented Dan Wolterman, Saranas Board Chairman.
  • He originally joined Volcano as part of the acquisition of AtheroMed in June 2014, which he led as CEO.
  • “I am excited to join Saranas at this important time as the company continues to build commercial momentum and clinical evidence for the Early Bird,” stated Mike MacKinnon, CEO of Saranas.

TransCode Therapeutics Reports Positive Preclinical Results with its Immunotherapy Candidate, TTX-RIGA, in Melanoma

Retrieved on: 
Tuesday, January 31, 2023
RNA, Breast cancer, Targeted therapy, Melanoma, Immunity, Tumor microenvironment, Immunotherapy, Pancreatic cancer, Cancer, RNA interference, Therapy, FIH, Animal, Immune system, Gene editing, Patient, MicroRNA, Neoplasm, Clinical trial, TTX, FDA, BioRxiv, PRR, Metastasis, CRISPR, Transcoding, RNA transfection, Toxicity, Doctor of Philosophy, Vaccine, Medical imaging

BOSTON, Jan. 31, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (Nasdaq: RNAZ), an RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today reported successful preclinical proof-of-mechanism studies with its immunotherapy candidate, TTX-RIGA, in melanoma.

Key Points: 
  • BOSTON, Jan. 31, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (Nasdaq: RNAZ), an RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today reported successful preclinical proof-of-mechanism studies with its immunotherapy candidate, TTX-RIGA, in melanoma.
  • This is expected to result in targeted activation of innate immunity in the tumor microenvironment.
  • TransCode believes that understanding how to recruit PRRs, such as RIG-I, in a tumor-selective manner is critical for its adoption in the clinic.
  • Similar immunotherapeutics of others have been shown to induce complete tumor regressions in animals and have triggered immunity against the tumor.

Microbot Medical Welcomes Distinguished Interventional Cardiologist and Early Adopter of Endovascular Robotics to its Next “Access-Ability Live by MBOT” Webinar Series

Retrieved on: 
Tuesday, January 31, 2023
Columbia University Irving Medical Center, NewYork-Presbyterian Hudson Valley Hospital, Safety, Navigation, Vision Guided Robotic Systems, Health, FIH, PCI, Web conferencing, Physician, Patient, Q&A, Public, Time-invariant system, Interventional cardiology, Clinical trial, Siemens Healthineers, Faculty, Cardiology, Corindus Vascular Robotics, Associate, Medical device, Medicine

HINGHAM, Mass., Jan. 31, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Robotic System, the first single-use endovascular robotic system, announced the next episode of its highly successful “Access-Ability Live by MBOT” webinar, which is intended for all stakeholders interested in the endovascular robotic space and will be held on Wednesday, February 8, 2023, at 1:00pm ET. It will be hosted by the Company’s Chief Medical Officer, Dr. Eyal Morag.

Key Points: 
  • It will be hosted by the Company’s Chief Medical Officer, Dr. Eyal Morag.
  • He is also a faculty member at the Cardiovascular Research Foundation in New York.
  • Dr. Weisz, who has a particular interest in current and innovative technologies in cardiovascular medicine, is an early adopter of robotic-enhanced coronary interventions, as well as navigation and positioning technologies.
  • The “Access-Ability Live by MBOT” webinar series focuses on key topics in the healthcare and endovascular space.