De novo | Jotup

Notable Labs Presents the Design Plan for the PPMP-Enabled Phase 2 Trial with Volasertib for Relapsed/Refractory AML at AACR 2024

Retrieved on:

Tuesday, April 9, 2024

Toxicity, Flow cytometry, Labs, Bone marrow, AML, Patient, Cytarabine, Acute myeloid leukemia, PLK1, AACR, BSA, De novo, Poster, Pharmaceutical industry

“We are very pleased to share more data regarding our clinical program and proprietary platform with the oncology community at AACR 2024.

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“We are very pleased to share more data regarding our clinical program and proprietary platform with the oncology community at AACR 2024.
Our clinical program will incorporate the co-development of a companion diagnostic test,” said Thomas Bock, M.D., Chief Executive Officer of Notable.
Notable Labs provided an updated plan for the design of an open label Phase 2 study, including a dose optimization plan aimed at reducing toxicity while maintaining efficacy and an overview of study objectives and endpoints.
These preliminary metrics predict that 32-33% of de novo patients and 25% of R/R AML patients would be predicted to be responders if they were treated with volasertib.

Three-year Phase 1 Follow-Up Data for mRNA-based Individualized Immunotherapy Candidate Show Persistence of Immune Response and Delayed Tumor Recurrence in Some Patients with Resected Pancreatic Cancer

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Sunday, April 7, 2024

BNTX, Survival, Entrepreneurship, Genentech, Disease, BioNTech, Patient, Neoplasm, Tissue, Messenger, PDAC, Roche, Uridine, Safety, Cancer, De novo, Recurrence, Blood, Vaccine

The data show that in 8 out of 16 patients autogene cevumeran elicited an immune response up to three years post administration measured by activated T cells.

Key Points:

The data show that in 8 out of 16 patients autogene cevumeran elicited an immune response up to three years post administration measured by activated T cells.
The persistence of T cels was associated with a longer median recurrence-free survival in cancer vaccine responders.
“These new data are an early signal for the potential of our individualized mRNA cancer vaccine approach in this indication with an unmet medical need.
Over 80% of the vaccine-induced neoantigen-specific T cells could still be detected up to three years post administration in patients with an immune response.

Climate First Bank Initiates Next Phase of Growth with Capital Raise Season

Retrieved on:

Tuesday, April 2, 2024

Online, Health, HR, Growth, Letter, FDIC, Education, Bank, Climate, Cooperative, De novo

ORLANDO, Fla., April 02, 2024 (GLOBE NEWSWIRE) -- Climate First Bank , the world’s first FDIC-insured community bank founded to combat the climate crisis, today announces, through its holding company Climate First Bancorp, its latest round of capital raise to boost values-based banking efforts and initiatives across the nation supporting the company’s growth plans.

Key Points:

ORLANDO, Fla., April 02, 2024 (GLOBE NEWSWIRE) -- Climate First Bank , the world’s first FDIC-insured community bank founded to combat the climate crisis, today announces, through its holding company Climate First Bancorp, its latest round of capital raise to boost values-based banking efforts and initiatives across the nation supporting the company’s growth plans.
The Bank is headed into its third year of operation and is poised to exit de novo status in June 2024, allowing it to fully scale services outside Florida.
Climate First Bancorp will run the capital raise campaign through September 2024 and funds are anticipated to be put toward initiatives like mission-driven technology, climate-focused loan solutions, values-aligned products and future acquisitions to accelerate the growth of subsidiaries Climate First Bank and fintech OneEthos.
For more information on Climate First Bank, please visit https://www.climatefirstbank.com .

ONWARD® Medical Submits De Novo Application to FDA for its ARC-EX® System

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Tuesday, April 2, 2024

De novo, DPT, BCI, Arm, Paralysis, Evaluation, Doctor of Philosophy, Quality of life, Euronext, BDD, Annual report, Craig Hospital, Spinal cord, Safety, ARC, Food, Marketing, FDA, SCI, NCS, Movement, Hand, Medical device

EINDHOVEN, the Netherlands, April 02, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to improve or restore movement, function, and independence in people with spinal cord injury (SCI), today announces it has submitted its De Novo application to the US Food and Drug Administration (FDA) to allow marketing of its breakthrough ARC-EX System to restore function of the upper extremities after SCI.

Key Points:

The submission marks an historic milestone for the Company in its mission to restore mobility and function for people with SCI.
Once cleared by the FDA, ARC-EX will be the first-ever spinal cord stimulation therapy to restore hand and arm function after SCI and the first commercial product for ONWARD Medical.
“We are delighted to be one step closer to bringing our breakthrough ARC-EX System to people living with SCI after submitting this De Novo application for regulatory clearance in the United States,” said ONWARD Medical CEO Dave Marver.
The ARC-EX System was previously awarded FDA Breakthrough Device Designation (BDD) for upper limb function, which provided prioritized FDA review, the opportunity to interact with FDA experts, and the potential for additional reimbursement.

Spectral AI Announces 2023 Fourth Quarter and Full Year Financial Results

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Wednesday, March 27, 2024

DALLAS, March 27, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the fourth quarter (“Q4 2023”) and full year (“FY 2023”) ended December 31, 2023 and provided an update on its ongoing business activities.

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DALLAS, March 27, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the fourth quarter (“Q4 2023”) and full year (“FY 2023”) ended December 31, 2023 and provided an update on its ongoing business activities.
“Spectral AI achieved much in 2023, and our progress along multiple fronts has continued into 2024,” said Peter M. Carlson, Chief Executive Officer.
“
In September 2023, we were awarded the largest contract in our history from the US Government valued at up to $150.0 million.
All comparisons to Q4 2023 and FY 2023 are to the comparable periods ended December 31, 2022, unless otherwise stated.

Transgene anticipates significant progress from immunotherapy pipeline in 2024 and extends financial visibility until Q4 2025

Retrieved on:

Wednesday, March 27, 2024

Extended financial visibility secured until Q4 2025 through a revised credit facility provided by the major shareholder Institut Mérieux.

Key Points:

Extended financial visibility secured until Q4 2025 through a revised credit facility provided by the major shareholder Institut Mérieux.
“During 2023 Transgene continued to make significant progress, delivering compelling data that confirm the value of our approach to treating cancer using our novel immunotherapies” commented Dr. Alessandro Riva, MD, Chairman and CEO of Transgene.
As announced on May 5, 2023, AstraZeneca terminated its oncolytic virus research and development collaboration with Transgene following a strategic review of its pipeline.
In 2024, Transgene expects to communicate progress and significant results and readout on all of its clinical stage assets.

Orthobond Secures De Novo Classification Grant for First-in-Class Antibacterial Surface Treatment Applied to a Spinal Device

Retrieved on:

Monday, April 8, 2024

Medical Supplies, Medical Devices, FDA, Health, Dental, Biotechnology, De novo, Textile, Patient, Corporation, Sterilization, Bacteria, Operating, Infection, Pain, Physician, Food, Sports medicine

Orthobond Corporation , a leader in covalently-bound antibacterial surface technologies with broad applications in the medical device industry, announced today that the U.S. Food and Drug Administration (FDA) granted its De Novo marketing request for the use of Ostaguard™, its proprietary antibacterial surface treatment, on a permanent medical device.

Key Points:

Orthobond Corporation , a leader in covalently-bound antibacterial surface technologies with broad applications in the medical device industry, announced today that the U.S. Food and Drug Administration (FDA) granted its De Novo marketing request for the use of Ostaguard™, its proprietary antibacterial surface treatment, on a permanent medical device.
Numerous studies have shown between 70-100% of explanted hardware from failed joint implants have some level of contamination from different sources.
Orthobond pioneered a method to covalently-bond its antibacterial molecule to the surface of implants.
The proprietary surface technology is applied during the manufacturing process prior to packaging and sterilization.

Onkos Surgical Announces First FDA De Novo Approval of an Antibacterial Coating for Tumor and Revision Orthopaedic Implants

Retrieved on:

Monday, April 8, 2024

Failure, De novo, Health, Prevalence, Infection, Arthroplasty, Patient, Trauma, Mortality, Bacteria, Osteoporosis, Food and Drug Administration, Neoplasm, Amputation, FDA, Onko, Pharmaceutical industry

PARSIPPANY, N.J., April 8, 2024 /PRNewswire/ -- Onkos Surgical, an orthopaedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that the U.S. Food & Drug Administration (FDA) granted the company a De Novo approval for its novel antibacterial coated implants. Bacterial contamination of a permanent implant may have devastating effects, particularly in orthopedic oncology and revision arthroplasty applications where the patient population is highly vulnerable.

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PARSIPPANY, N.J., April 8, 2024 /PRNewswire/ -- Onkos Surgical, an orthopaedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that the U.S. Food & Drug Administration (FDA) granted the company a De Novo approval for its novel antibacterial coated implants.
Bacterial contamination of a permanent implant may have devastating effects, particularly in orthopedic oncology and revision arthroplasty applications where the patient population is highly vulnerable.
"Implant contamination is a growing concern to the orthopaedic surgical community," said Steven Gitelis, MD, Onkos Surgical Chief Medical Officer, Rush Medical College, Endowed Professor of Orthopaedic Oncology and Director, Musculoskeletal Oncology at Rush Cancer Center.
The Onkos technology is a significant innovation and another option to help reduce local bacterial load on the implant."

UpHealth Provides Corporate Update and Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on:

Thursday, March 21, 2024

DELRAY BEACH, Fla., March 21, 2024 (GLOBE NEWSWIRE) -- UpHealth, Inc. (“we,” “UpHealth,” or the “Company”) (OTC: UPHL) today provided a corporate update and announced financial results for the fourth quarter and full year ended December 31, 2023.

Key Points:

“In short, 2023 was a challenging, yet transformative, year for UpHealth, as we continued to take steps to stabilize the business,” said Martin Beck, Chief Executive Officer.
Growth in proforma revenues in the fourth quarter of 2023 was driven by top line growth at TTC Healthcare and Cloudbreak and by certain non-recurring revenues associated with the cessation of operations at Thrasys;
Proforma fourth quarter 2023 gross margins were 62%, compared to 45% for the fourth quarter of 2022.
Proforma margin improvement in the fourth quarter was largely driven by an improved payor mix at TTC Healthcare;
Proforma fourth quarter 2023 Adjusted EBITDA was $11.1 million, compared with $1.9 million in the fourth quarter of 2022.
TTC Healthcare’s performance in 2023, and in particular the fourth quarter 2023, was driven by strong volumes and a significantly improved payor mix.

Sino Biological Announces Services Partnership with Rapid Novor

Retrieved on:

Thursday, March 14, 2024

ChiNext, Drug discovery, Partnership, Research, Protein, Antibody, De novo, Vaccine

BEIJING, China, March 14, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire — Sino Biological, Inc. (“Sino Biological” or the “Company”), a biotechnology company listed on the Shenzhen stock exchange subsidiary ChiNext (SZSE: 301047), which provides biological research reagents and related technical contract research services, is pleased to announce the formation of a services partnership with Toronto, Canada-based Rapid Novor, Inc. (“Rapid Novor”). Under the terms of this agreement, Sino Biological will market Rapid Novor’s proprietary de novo REmAb monoclonal antibody (mAb) sequencing service in combination with its custom mAb development and production services. Geographic areas covered under this partnership include China, Singapore, Thailand, Malaysia, Indonesia, Vietnam, Philippines, Japan and South Korea.

Key Points:

BEIJING, China, March 14, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire — Sino Biological, Inc. (“Sino Biological” or the “Company”), a biotechnology company listed on the Shenzhen stock exchange subsidiary ChiNext (SZSE: 301047), which provides biological research reagents and related technical contract research services , is pleased to announce the formation of a services partnership with Toronto, Canada-based Rapid Novor, Inc. (“Rapid Novor”).
Under the terms of this agreement, Sino Biological will market Rapid Novor’s proprietary de novo REmAb monoclonal antibody (mAb) sequencing service in combination with its custom mAb development and production services.
Headquartered in Beijing, China, Sino Biological is the world’s leading provider of mammalian cell-based recombinant proteins, antibodies, and related contract research services.
Rob Burgess, Sino Biological’s Chief Business Officer, stated, “Rapid Novor’s REmAb monoclonal antibody sequencing capabilities perfectly complement Sino Biological’s antibody development and manufacturing services.