Visual analogue scale

BioRestorative Therapies Announces Filing of 2023 Annual Report on Form 10-K

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Monday, April 1, 2024
Administration, Annual report, B cell, Obesity, Development, Cell, Patent, Library, Visual analogue scale, Patient, DSM-IV codes, Data monitoring committee, Form 10-K, Security (finance), Functional, Adipocyte, Type 2 diabetes, Small business, Investment, Research and development, NOA, European Patent Convention, Safety, Infrared spectroscopy correlation table, Orthopaedic Research Society, Annual general meeting, Pharmaceutical industry

MELVILLE, N.Y., April 01, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ: BRTX ), a clinical stage company focused on stem cell-based therapies, announced today the filing of its Form 10-K annual report with the Securities and Exchange Commission ("SEC") for the year ended December 31, 2023.

Key Points: 
  • MELVILLE, N.Y., April 01, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ: BRTX ), a clinical stage company focused on stem cell-based therapies, announced today the filing of its Form 10-K annual report with the Securities and Exchange Commission ("SEC") for the year ended December 31, 2023.
  • The annual report can be accessed on the SEC's website at www.sec.gov , and on the Company's website at www.biorestorative.com under "SEC Filing" in the Investors and Media section.
  • A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States.
  • At December 31, 2023, BioRestorative had cash, cash equivalents and investments in marketable securities of $11.07 million.

Zevra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates

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Thursday, March 28, 2024
Narcolepsy, Exercise, Somnolence, New Drug Application, Patient, Visual analogue scale, Sale, NDA, G&A, Arimoclomol, Nature, IND, Bank statement, Microsoft Access, Investment, Therapy, Priority review, Corporation, Audit committee, Research, Niemann–Pick disease, Medical science liaison, Sleep disorder, Brain, Trial of the century, Safety, Interim, Food, Sleep, QuickStart, Disease, FY, Acquisition, Emetine, UCD, COL3A1, Celiprolol, Syndrome, FDA, Marketing, Conference call, Conference, EAP, SDX, NPC, Epworth Sleepiness Scale, Idiopathic hypersomnia, Physician, PDUFA, Pharmaceutical industry

CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023. 

Key Points: 
  • ET
    CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023.
  • “We made solid progress on our key priorities in 2023,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra.
  • Overview of Q4 2023 and FY 2023 Financial Results:
    Net revenue for Q4 2023 was $13.2 million, compared to prior year Q4 net revenue of $2.2 million.
  • ET, to discuss its corporate and financial results for Q4 and FY 2023.

Zevra Therapeutics Announces Top-Line Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia

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Tuesday, March 26, 2024
Brain, Disease, Somnolence, Appetite, Partnership, Headache, Visual analogue scale, Patient, Insomnia, EDS, Anxiety, SDX, Doctor of Philosophy, Epworth Sleepiness Scale, Nausea, Clinical trial, Therapy, Safety, Narcolepsy, ESS, IHSS, Idiopathic hypersomnia, Clouding of consciousness, BFS, Food, Pharmaceutical industry

CELEBRATION, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial (NCT05668754) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate, or SDX) in patients with idiopathic hypersomnia (IH). This proof-of-concept study was not powered to demonstrate statistical significance.   The data gathered for several secondary and exploratory endpoints, including the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS) and Sleep Inertia Visual Analog Scale (SIVAS) will inform the Phase 3 study design.

Key Points: 
  • CELEBRATION, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial ( NCT05668754 ) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate, or SDX) in patients with idiopathic hypersomnia (IH).
  • The data gathered for several secondary and exploratory endpoints, including the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS) and Sleep Inertia Visual Analog Scale (SIVAS) will inform the Phase 3 study design.
  • The results from the completed Phase 2 trial provide key information for the design of a potentially pivotal Phase 3 trial of KP1077 in patients with IH.
  • The Company plans to request an end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration to seek guidance on the Phase 3 clinical trial design.

Endonovo’s SofPulse® to Be Featured at Innovative Pain Management Solutions

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Monday, March 4, 2024
Surgeon, PEMF, Pain, Department of Defence, Chronic pain, Electromagnetic field, Organization, SDVOSB, OTC, Army, Edema, Length of stay, Veteran, Service-Disabled Veteran-Owned Small Business, Baylor University, Distribution, Opioid, Traumatic brain injury, Use, FSS, Conference, Safety, Morphine, Acquisition, Inflammation, FDA, Visual analogue scale, DAPA, Baylor College of Medicine, Nursing

Los Angeles, CA, March 04, 2024 (GLOBE NEWSWIRE) -- SofPulse Inc. -- a subsidiary of Endonovo (OTC PINK: ENDV) and a proposed spin-off company -- announced today the participation of its SofPulse® Pulsed Electro-Magnetic Field (PEMF) FDA-cleared medical device in the United States Army Medical Research and Development Command (USAMRDC) May 2024 Vendor Day.

Key Points: 
  • The command unit has a key role in identifying innovative pain management solutions for Veterans Administration (VA) and Department of Defense (DoD) patients and uses.
  • SofPulse®, along with its VA reseller, Academy Medical Inc., is planning to showcase SofPulse® and its non-evasive, drug-free pain management solution to the VA and military attendees.
  • SofPulse® featured by Academy Medical at USAMRDC Vendor Day, offers extended exposure for the opportunity to present and demonstrate its innovative pain management solutions to multiple organizations at one time.
  • Integrating SofPulse® into its post-operative pain management protocols, the VA can improve the quality of care and enhance the well-being of veterans nationwide.

IceCure's ProSense® a Promising Alternative Treatment for Extra-Pelvis Endometriosis: Independent Study Presented at ECR 2024

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Monday, March 4, 2024
Woman, PAIN, Neoplasm, Teaching hospital, Patient satisfaction, Abdominal wall, Endometriosis, Freezing, Visual analogue scale, Safety, Patient, MRI, Medical imaging

Five doctors participated in the study, including interventional radiologist and ProSense® user Prof. Julien Frandon, who has previously led hands-on training sessions with ProSense® at multiple medical conferences.

Key Points: 
  • Five doctors participated in the study, including interventional radiologist and ProSense® user Prof. Julien Frandon, who has previously led hands-on training sessions with ProSense® at multiple medical conferences.
  • The investigator-initiated single-site study enrolled 7 women, ages 30-45 years, with endometriosis in the abdominal wall and para-diaphragmatic areas.
  • One month following treatment, assessment by MRI revealed hemorrhagic signal had disappeared and necrotic changes developed.
  • We are very pleased that all patients treated in this study were relieved of their endometriosis condition and pain within as little as a month following treatment," stated IceCure CEO Eyal Shamir.

ZKR Orthopedics Receives IDE Approval for Clinical Trial

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Wednesday, February 14, 2024
SAN, Incidence, Degenerative disease, Stair climbing, Orthopedic surgery, FDA, Obesity, Pain, Mutation, Swelling, Exercise, IDE, Visual analogue scale, Conference, Prevalence, Safety, Elective surgery, Canaccord Genuity, Patient, Knee, Cadaver, Investigational device exemption, AAOS, American Academy, Pharmaceutical industry

SAN FRANCISCO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial.

Key Points: 
  • SAN FRANCISCO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial.
  • We expect the data collected by this trial will establish a strong foundation of compelling clinical evidence for the LIFT implant approval for clinical use," commented David Cash, CEO of ZKR Orthopedics.
  • The IDE approval announcement was made as part of the ZKR Orthopedics activities at the 2024 American Academy of Orthopedic Surgeons annual meeting in San Francisco.
  • In addition to reporting IDE trial approval, the Company participated in the Canaccord Genuity Musculoskeletal Conference earlier this week.

BioRestorative Therapies Presents Preliminary Clinical Data from Phase 2 Study of BRTX-100 in Chronic Lumbar Disc Disease

Retrieved on: 
Monday, February 5, 2024
Poster, International, Functional, Patient, Safety, Pain, FDA, Food, Injection, Visual analogue scale, Annual general meeting, BLA, Orthopaedic Research Society, Pharmaceutical industry

MELVILLE, N.Y., Feb. 05, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced the public availability of a poster, presented yesterday at the Orthopaedic Research Society (ORS) 2024 Annual Meeting, which describes preliminary 26 and 52 week blinded data from the ongoing Phase 2 clinical trial of the Company’s lead clinical candidate, BRTX-100, in subjects with chronic lumbar disc disease (“cLDD”).

Key Points: 
  • The presented poster, titled “Autologous Stem Cell Therapy for Chronic Lumbar Disc Disease; Initial Phase 2 Clinical Safety and Feasibility Data of Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells” can be accessed on the Company’s website at www.biorestorative.com under “Scientific Publications” in the Product Candidate section.
  • During a webcasted conference call scheduled for 8:30am EST today, BioRestorative management will be available to discuss data from the presentation as well as provide a clinical update.
  • Previous clinical studies have demonstrated that the harsh microenvironment of the disc could impact cell dose viability and result in a non-efficacious or the worsening of clinical outcomes.
  • The preliminary clinical data shows meaningful signals in patients enrolled in the study and, importantly, no notable safety signals,” said Lance Alstodt, Chief Executive Officer of BioRestorative.

2024 OREF Clinical Research Award Celebrates Study of Local Gene Therapy to Treat Osteoarthritis

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Friday, February 2, 2024
University, Visual analogue scale, DSM-IV codes, Cell, Investigational New Drug, Mayo Clinic, Research, Liver, Knee, DNA, Disease, OA, Patient, Pain, Safety, University of Minnesota, Swelling, FDA, Rheumatoid arthritis, Osteoarthritis, Arthritis, Food, Risk, DRS, Biology, WOMAC, University of Florida, Doctor of Philosophy, Cancer, Joint, Molecular medicine, Pharmaceutical industry

ROSEMONT, Ill. , Feb. 2, 2024 /PRNewswire/ -- The 2024 Orthopaedic Research and Education Foundation (OREF) Clinical Research Award was presented to Christopher H. Evans, PhD (Mayo Clinic), Steven C. Ghivizzani, PhD (University of Florida), and Paul D. Robbins, PhD (University of Minnesota), for their research on local gene therapy for osteoarthritis (OA).

Key Points: 
  • ROSEMONT, Ill. , Feb. 2, 2024 /PRNewswire/ -- The 2024 Orthopaedic Research and Education Foundation (OREF) Clinical Research Award was presented to Christopher H. Evans, PhD (Mayo Clinic), Steven C. Ghivizzani, PhD (University of Florida), and Paul D. Robbins, PhD (University of Minnesota), for their research on local gene therapy for osteoarthritis (OA).
  • Together, the team spearheaded the research from a laboratory concept to human clinical trials over the course of 30 years.
  • The OREF Award recognizes outstanding clinical research related to musculoskeletal disease or injury.
  • Evans, Ghivizzani and Robbins co-founded an arthritis gene therapy startup company, Genascence Corporation, which will help fund future clinical trials.

Axogen, Inc. Announces Positive Topline Results from REPOSE, a Prospective, Randomized Clinical Trial of Axoguard Nerve Cap

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Thursday, January 18, 2024
Visual analogue scale, Axogen, Month, Nerve, Pain, Trial of the century, Neuroma

ALACHUA, Fla. and TAMPA, Fla., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced positive topline results from its REPOSE clinical study comparing standard-of-care neurectomy of symptomatic neuroma to neurectomy and protection of the terminated nerve end with Axoguard Nerve Cap. The post-marketing study met its primary endpoint for reduction in pain as measured by visual analog scale (p-value

Key Points: 
  • REPOSE® met its primary endpoint of non-inferiority between the pain visual analog scale outcomes for neurectomy with Axoguard Nerve Cap® vs. standard-of-care neurectomy at Month 12.
  • Axoguard Nerve Cap demonstrated statistical superiority vs. standard-of-care neurectomy in the reduction of total pain reported by participants over the course of follow-up.
  • ALACHUA, Fla. and TAMPA, Fla., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced positive topline results from its REPOSE clinical study comparing standard-of-care neurectomy of symptomatic neuroma to neurectomy and protection of the terminated nerve end with Axoguard Nerve Cap.
  • The post-marketing study met its primary endpoint for reduction in pain as measured by visual analog scale (p-value

Accelus Announces Renewed Focus on Pioneering Minimally Invasive Outpatient Procedures with Its Advanced Adaptive Geometry Technology

Retrieved on: 
Thursday, December 7, 2023
Subsidence, Pain, PALM, ODI, BEACH, ASC, Surgeon, Visual analogue scale, Lordosis, Innovation, Geometry, Abdominal ultrasonography, Spine, Human, Patient, Oswestry Disability Index, Hospital

"We’re excited about the ongoing shift toward minimally invasive, awake and outpatient spinal fusion surgeries, as it allows a broader spectrum of patients to experience the benefits of these less invasive, more patient-centric procedures,” said Kevin McGann, President & CEO of Accelus.

Key Points: 
  • "We’re excited about the ongoing shift toward minimally invasive, awake and outpatient spinal fusion surgeries, as it allows a broader spectrum of patients to experience the benefits of these less invasive, more patient-centric procedures,” said Kevin McGann, President & CEO of Accelus.
  • This controlled, in-situ, multiplanar expansion is designed to restore foraminal height, reestablish sagittal balance and reduce subsidence, a common concern in spinal fusion procedures.
  • The recent article, " Backbones of Innovation Signal What's Next in Spine Care ," published in BoneZone, highlights Accelus's role in this transformation.
  • No implant-related complications, cage subsidence, cage migration or need for revision surgery were reported at the one-year mark for this study.