Degenerative disease

ZKR Orthopedics announces FDA Breakthrough Device designation for the LIFT Implant Technology

Retrieved on: 
Monday, October 9, 2023
Osteoarthritis, Incidence, Pain, Cartilage, Food, Hope, Obesity, Knee, Prevalence, Mutation, Stair climbing, FDA, Swelling, PEEK, IDE, Orthopedic surgery, Exercise, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, Degenerative disease, Pharmaceutical industry, Medical device

KENTFIELD, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, today announced that its LIFT implant technology has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • KENTFIELD, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, today announced that its LIFT implant technology has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
  • The LIFT implant is designed to decrease pain, improve function, and delay or eliminate the need for knee replacement.
  • The LIFT system includes trial spacers, a PEEK implant, titanium bone screws, K-wires, and a proprietary positioning instrument.
  • Under the program, ZKR Orthopedics will receive prioritized review and accelerated interaction with the FDA throughout the premarket review phase.

SwanBio Advances to Higher-Dose Cohort in First-in-Human Study of Gene Therapy for Adrenomyeloneuropathy

Retrieved on: 
Wednesday, October 4, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, AMN, DSMB, Adrenoleukodystrophy, Clinical trial, Mutation, CTA, AAV, Trial of the century, Data monitoring committee, Degenerative disease, ABCD1, Patient, Central committee, Therapy, PROPEL, Safety, Pharmaceutical industry

SwanBio Therapeutics , a gene therapy company developing AAV-based therapies for the treatment of devastating, inherited neurological conditions, today announced it has begun the second dose-escalation cohort of its first interventional clinical study, PROPEL.

Key Points: 
  • SwanBio Therapeutics , a gene therapy company developing AAV-based therapies for the treatment of devastating, inherited neurological conditions, today announced it has begun the second dose-escalation cohort of its first interventional clinical study, PROPEL.
  • PROPEL is a Phase 1/2 first-in-human clinical trial assessing the safety and efficacy of SBT101, an investigational gene therapy designed to compensate for the ABCD1 mutation that causes adrenomyeloneuropathy (AMN).
  • An independent Data Safety Monitoring Board (DSMB) recommended progressing the study to the higher-dose cohort following the review of the initial safety data readout in August.
  • No serious adverse events related to the procedure, nor the gene therapy product, have been reported to date.

Voiceitt Announces CEO Transition

Retrieved on: 
Thursday, September 14, 2023
DSM-IV codes, Heart, Business development, Partnership, Alyson, Letter board, Disability, API, Human, Pace, Science, Degenerative disease, TEL, Cisco Webex, Brain, Algorithm, Growth, Entrepreneurship, AI, Management, Cisco, Collaboration

TEL AVIV, Israel and STAMFORD, Conn., Sept. 14, 2023 /PRNewswire/ -- Voiceitt, a leading provider of speech recognition for non-standard speech, announced that its Board of Directors has appointed Alyson Pace, formerly Director at Cisco, as Chief Executive Officer, effective immediately. Alyson Pace succeeds Danny Weissberg, Co-Founder, who has stepped down as CEO. Mr. Weissberg will remain involved to ensure a smooth transition, and serve as a strategic advisor and Director of the company.

Key Points: 
  • Mr. Weissberg will remain involved to ensure a smooth transition, and serve as a strategic advisor and Director of the company.
  • Alyson joins Voiceitt from Cisco, where she served as Director of Strategy, Business Development and Partnerships in the Collaboration business.
  • "Co-Founder and CEO Danny Weissberg has done a remarkable job building the technological foundation of Voiceitt.
  • On behalf of the Investors and the Board of Directors of Voiceitt, we are thrilled that Alyson will bring her leadership skills, business acumen and industry relationships to bear as our new CEO.

Enlivex Announces Reprioritization Plan and Second Quarter 2023 Financial Results

Retrieved on: 
Monday, September 11, 2023
Workforce, Heart, Insurance, Osteoarthritis, Maintenance, Drug development, Shoulder, Synovial fluid, Hospital, Drainage, Clinical trial, Absorption, Inflammation, Immunotherapy, Sepsis, Shoulder joint, Pain, Degenerative disease, Malignancy, Patient, Physician, Joint, Research, FDA, Therapy, Phase, Knee, Safety, Disease, Pharmaceutical industry

Results demonstrated acceptable tolerability and safety, allowing the program to proceed to assess the efficacy of AllocetraTM in solid tumor indications in combination with other therapies and at higher doses.

Key Points: 
  • Results demonstrated acceptable tolerability and safety, allowing the program to proceed to assess the efficacy of AllocetraTM in solid tumor indications in combination with other therapies and at higher doses.
  • Nes-Ziona, Israel, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company announced today a strategic reprioritization plan and its financial results for the second quarter ended June 30, 2023.
  • "Patient well-being and advancing medical science have always been at the heart of our mission," said Oren Hershkovitz, Ph.D., CEO of Enlivex.
  • As of June 30, 2023, Enlivex had cash and cash equivalents, short term bank deposits and long term interest-bearing bank deposits of approximately $36 million.

Phase 3 Trial Results for Stempeutics Cell Therapy in Knee Osteoarthritis Published in American Journal of Sports Medicine (AJSM)

Retrieved on: 
Wednesday, August 23, 2023
Communications, Health, Clinical Trials, Publishing, Pharmaceutical, Biotechnology, Osteoarthritis, Medicine, American Journal of Sports Medicine, Disease, Sports medicine, Stiffness, Quality of life, VAS, Cartilage, AJSM, TSP-2, Kellgren, Microsoft Exchange Server, MS, Degenerative disease, MRI, Kasturba Medical College, American Journal, Patient, WOMAC, Regulatory affairs, Rush University Medical Center, American Orthopaedic Society for Sports Medicine, Conference, Inflammation, Pharmaceutical industry, Medical imaging, Knee

Stempeutics, a leader in allogeneic cellular medicines for inflammatory diseases, announced the publication of the Knee OA Phase 3 trial results in the premier journal, the American Journal of Sports Medicine (AJSM).

Key Points: 
  • Stempeutics, a leader in allogeneic cellular medicines for inflammatory diseases, announced the publication of the Knee OA Phase 3 trial results in the premier journal, the American Journal of Sports Medicine (AJSM).
  • Stempeutics has analysed the potency of Stempeucel-OA by their ability to secrete pro-chondrogenic factors such as TSP-2.
  • Dr Pawan Gupta, President, Medical & Regulatory Affairs, Stempeutics, said, "The Stempeucel-OA product is developed from Stempeucel® Technology, i.e.
  • We have administered Stempeucel-OA using ultrasound guidance and used T2 mapping MRI techniques to assess the quality of articular cartilage.

Sarepta Therapeutics Announces FDA Approval of ELEVIDYS, the First Gene Therapy to Treat Duchenne Muscular Dystrophy

Retrieved on: 
Thursday, June 22, 2023
Research, FDA, Neurology, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Duchenne muscular dystrophy, Gene, SRPT, Food and Drug Administration, Sarepta, Myocarditis, Mutation, B cell, Multimedia, Interest, Vomiting, Degenerative disease, PIN, DMD, Patient, Physician, Nausea, Rare, Therapy, Fever, Nationwide, Safety, BLA, Thrombocytopenia, Food, Pharmaceutical industry, Nursing, Duchenne

This indication is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin observed in patients treated with ELEVIDYS.

Key Points: 
  • This indication is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin observed in patients treated with ELEVIDYS.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene.
  • View the full release here: https://www.businesswire.com/news/home/20230622454844/en/
    ELEVIDYS is the first FDA approved gene therapy to treat Duchenne muscular dystrophy.

Positive Preclinical Data of ORY-4001 for the Treatment of Charcot-Marie-Tooth (CMT) Disease Presented at the 2023 Peripheral Nerve Society (PNS) Annual Meeting

Retrieved on: 
Wednesday, June 21, 2023
Genomics, HDAC, Charcot–Marie–Tooth disease, Diabetic neuropathy, DSM-IV codes, ALS, CMT, Sciatic nerve, Hemotoxin, Sympathetic nervous system, HDAC6, Degenerative disease, ORY, Animal, ISIN, IND, Pharmacology, Pharmaceutical industry

ORY-4001 treatment was able to reverse disease progression symptoms in a Charcot-Marie-Tooth (CMT) mice model.

Key Points: 
  • ORY-4001 treatment was able to reverse disease progression symptoms in a Charcot-Marie-Tooth (CMT) mice model.
  • Notably, ORY-4001 was able to improve myelination and restore axon integrity in the sciatic nerve, and improved compound muscle action potential and nerve conduction in comparison with untreated animals.
  • We are exploring with the CMT community how we can expedite this program to the clinic.”
    CMT is a progressive, degenerative disease involving the peripheral nerves.
  • CMT1A is the most prevalent form, accounting for approximately half of all people with CMT.

ORYZON to Present Positive Preclinical Efficacy Data of ORY-4001 in Charcot-Marie-Tooth (CMT) Disease at the 2023 Peripheral Nerve Society (PNS) Annual Meeting

Retrieved on: 
Tuesday, May 30, 2023
Human, HDAC, Genomics, CMT, Sympathetic nervous system, Hemotoxin, PNS, HDAC6, Bella Center Copenhagen, Degenerative disease, ORY, CEST, Annual general meeting, ISIN, Peripheral neuropathy, Pharmacology, IND, Pharmaceutical industry

The scientific committee of the 2023 PNS Annual Meeting has selected “ORY-4001, a Novel Potent and Selective Oxadiazole-Based HDAC6 Inhibitor Shows Pre-Clinical Therapeutic Efficacy in CMT1A” for an oral presentation, which will take place on Tuesday, June 20, at 08:40 am CEST.

Key Points: 
  • The scientific committee of the 2023 PNS Annual Meeting has selected “ORY-4001, a Novel Potent and Selective Oxadiazole-Based HDAC6 Inhibitor Shows Pre-Clinical Therapeutic Efficacy in CMT1A” for an oral presentation, which will take place on Tuesday, June 20, at 08:40 am CEST.
  • Following positive preclinical results obtained under this collaboration, Oryzon selected a candidate for clinical development, ORY-4001.
  • The compound exhibits strong anti-inflammatory properties and positive in-vivo data in inflammatory models.
  • It is one of the most prevalent conditions among rare diseases and currently lacks effective treatments or cures.

Voiceitt and Webex by Cisco Make Video Meetings More Accessible for People with Disabilities

Retrieved on: 
Tuesday, May 16, 2023
Technology, Human Resources, Telecommunications, Professional Services, Software, Audio, Video, Other Health, General Health, Health, Artificial Intelligence, Product management, Database, DSM-IV codes, Communication, Partnership, Disability, API, Human, Cerebral palsy, Degenerative disease, Strategic partnership, Brain, Machine learning, Cisco, Algorithm, Mobile phone, Cisco Webex

The integration will be available on the Webex App Hub to be leveraged in Webex Meetings.

Key Points: 
  • The integration will be available on the Webex App Hub to be leveraged in Webex Meetings.
  • “Cisco's commitment to inclusive collaboration is aligned with Voiceitt's mission to make voice AI accessible to people with non-standard speech,” says Sara Smolley, Voiceitt co-founder and Vice President, Strategic Partnerships.
  • “The integration with Webex is game-changing because it creates more independence for users with disabilities, while increasing the potential for more collaborative, inclusive work environments.
  • Michael Cash , a Voiceitt employee with cerebral palsy, is a beta tester of the Webex integration.

DONATE TO IMPROVE THE QUALITY OF LIFE OF CHILDREN LIKE LEXIE AND JANESSA

Retrieved on: 
Monday, March 27, 2023
Sustainability, Kidney failure, QC, Quality of life, RONA, Degenerative disease, Bonneville, Hospital, Lowe's, Children's Miracle Network Hospitals, First Nations, Health, Sustainable development, Family, News, Social media, Disease, Dietary supplement

''It is truly an honour to help improve the health and quality of life of children across the country and to help hospitals provide advanced care.

Key Points: 
  • ''It is truly an honour to help improve the health and quality of life of children across the country and to help hospitals provide advanced care.
  • Today, her situation is stable and thanks to donor-funded support and innovation from her care team, Janessa can now get ongoing check-ups remotely.
  • By supporting children's hospitals, you're not just supporting children, you're helping entire families,'' explains her mother, Brenda.
  • To share this news on social media, please use @RONAcarrieres.careers (Facebook), @RONA (LinkedIn), and @RONAinc (Twitter).