Spine

EQS-News: Biotest successfully meets primary endpoint in phase III trial with Fibrinogen concentrate

Retrieved on: 
Wednesday, February 14, 2024

Biotest announced today that the AdFIrst (Adjusted FIbrinogen replacement strategy) phase III trial met its primary endpoint, demonstrating that Fibrinogen concentrate is non-inferior to standard of care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency undergoing planned major spinal or abdominal surgery.

Key Points: 
  • Biotest announced today that the AdFIrst (Adjusted FIbrinogen replacement strategy) phase III trial met its primary endpoint, demonstrating that Fibrinogen concentrate is non-inferior to standard of care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency undergoing planned major spinal or abdominal surgery.
  • The AdFIrst trial was a prospective, randomised, active-controlled, multicentre phase III trial involving 222 patients undergoing elective spine or abdominal surgery.
  • This would be the first fibrinogen concentrate approved for an acquired fibrinogen deficiency indication in the US.
  • Compared with congenital fibrinogen deficiency, where efficacy has been demonstrated in an earlier trial, the market size for the treatment of acquired fibrinogen deficiency is many times larger.

Bone Solutions Receives 510(k) Clearance for Expanded Indications of Use for Mg OSTEOCRETE in Intervertebral Body Fusion Procedures

Retrieved on: 
Tuesday, February 13, 2024

Bone Solutions Inc. , an orthobiologics technology company located in Colleyville, Texas, announced today 510(k) clearance of Mg OSTEOCRETE from the U.S. Food and Drug Administration (FDA) for use in the intervertebral body disc space, including cervical, thoracic, and lumbar fusion procedures.

Key Points: 
  • Bone Solutions Inc. , an orthobiologics technology company located in Colleyville, Texas, announced today 510(k) clearance of Mg OSTEOCRETE from the U.S. Food and Drug Administration (FDA) for use in the intervertebral body disc space, including cervical, thoracic, and lumbar fusion procedures.
  • This expanded indication allows surgeons and patients to further benefit from the advantages of the Bone Solutions proprietary magnesium-based technology.
  • Mg OSTEOCRETE is a fast-setting bone substitute that remodels into bone over time through creeping substitution.
  • The magnesium component of Mg OSTEOCRETE is the significant differentiator from other bone substitutes on the market.

Jason E. Topolosky to join OsteoCentric Technologies as Chief Business Officer

Retrieved on: 
Tuesday, February 13, 2024

AUSTIN, Texas, Feb. 13, 2024 /PRNewswire/ -- OsteoCentric Technologies, inventor of UnifiMI, an implant-to-bone interface technology, capable of sustaining primary implant stability, is thrilled to announce that Jason E. Topolosky, MBA, MTM/MSE will be joining the company as Chief Business Officer. In this new role, Jason will oversee all corporate development activities including strategic development partnerships, licensing, and acquisitions.

Key Points: 
  • AUSTIN, Texas, Feb. 13, 2024 /PRNewswire/ -- OsteoCentric Technologies, inventor of UnifiMI, an implant-to-bone interface technology, capable of sustaining primary implant stability, is thrilled to announce that Jason E. Topolosky, MBA, MTM/MSE will be joining the company as Chief Business Officer.
  • In this new role, Jason will oversee all corporate development activities including strategic development partnerships, licensing, and acquisitions.
  • Jason is joining OsteoCentric Technologies from Olympus Corporation, a $7B leading endoscopic and therapeutic solutions provider, where he recently served as the global Vice President of Strategy & Portfolio Management.
  • "We are tremendously excited to welcome Jason to our team at OsteoCentric," said Eric Brown, Founder and Chief Executive Officer of OsteoCentric Technologies.

Nanox Receives FDA Clearance for HealthFLD, an Advanced AI-Based Software Empowering Clinicians in Assessment of Fatty Liver

Retrieved on: 
Tuesday, February 13, 2024

PETACH TIKVA, Israel, Feb. 13, 2024 (GLOBE NEWSWIRE) -- ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd., received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for HealthFLD, an artificial intelligence (AI) software that provides automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen CT scans in patients between the ages of 18 to 75. HealthFLD is intended to support clinicians in the detection of fatty liver, correlated with hepatic steatosis, an early sign of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD).

Key Points: 
  • HealthFLD is intended to support clinicians in the detection of fatty liver, correlated with hepatic steatosis, an early sign of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD).
  • MASLD is commonly asymptomatic until it progresses to advanced liver fibrosis, and the current gold standard for diagnosis is a liver biopsy, which is invasive and costly.
  • HealthFLD was designed to help clinicians in the assessment and analysis of fatty liver in the general population from routine CT scans.
  • It’s promising to have a liver solution available that may help evaluate early signs of illness from routine imaging.”
    The HealthFLD clearance is the third product across the Nanox AI suite of population health solutions to receive FDA clearance.

Phathom Pharmaceuticals Announces VOQUEZNA® (vonoprazan) Tablets for Erosive GERD and Associated Heartburn Added to Express Scripts National Formularies for Commercial Patients

Retrieved on: 
Tuesday, February 13, 2024

Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.

Key Points: 
  • Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.
  • doi:10.1136/ bmjgast-2022-000941
    VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated:
    for the healing of all grades of Erosive Esophagitis (Erosive Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn associated with Erosive GERD in adults.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.
  • Renal Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with severe renal impairment (eGFR

Lineage Announces FDA Clearance of IND Amendment for OPC1 Cell Transplant for the Treatment of Spinal Cord Injury

Retrieved on: 
Tuesday, February 13, 2024

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the clearance, by the U.S. Food and Drug Administration (FDA), of its Investigational New Drug amendment (INDa) for OPC1 , an investigational allogeneic oligodendrocyte progenitor cell transplant for the treatment of spinal cord injury (SCI).

Key Points: 
  • Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the clearance, by the U.S. Food and Drug Administration (FDA), of its Investigational New Drug amendment (INDa) for OPC1 , an investigational allogeneic oligodendrocyte progenitor cell transplant for the treatment of spinal cord injury (SCI).
  • The clearance of our INDa and the initiation of OPC1 clinical testing under our sponsorship represents a significant milestone for this program, and reflects our commitment to developing modern cell therapy product candidates,” stated Brian M. Culley, Lineage CEO.
  • We believe these improvements can lead to a safer surgical procedure for surgeons and patients.
  • The data from the Phase 1/2a clinical study of OPC1 in subacute cervical SCI is available here and the data from the Phase 1 clinical study of OPC1 in acute thoracic SCI is available here .

InventHelp Inventor Develops Specially Designed Pillow (LAX-1603)

Retrieved on: 
Monday, February 12, 2024

PITTSBURGH, Feb. 12, 2024 /PRNewswire/ -- "I wanted to create a specially designed pillow to provide optimum support for the head, neck, shoulders, arms, back, lower back, and hips," said an inventor, from Arcadia, Calif., "so I invented the WORLDS GREATEST PILLOW.

Key Points: 
  • PITTSBURGH, Feb. 12, 2024 /PRNewswire/ -- "I wanted to create a specially designed pillow to provide optimum support for the head, neck, shoulders, arms, back, lower back, and hips," said an inventor, from Arcadia, Calif., "so I invented the WORLDS GREATEST PILLOW.
  • I don't believe in one size fits all, so, it is a custom pillow made to fit each individual's size based on weights and heights."
  • The patent-pending creation provides an improved design for a pillow.
  • 22-LAX-1603, InventHelp, 100 Beecham Drive, Suite 110, Pittsburgh, PA 15205-9801, or call (412) 288-1300 ext.

HSS Research Evaluates Whether AI Chatbots Provide Reliable Medical Information

Retrieved on: 
Monday, February 12, 2024

"In the past 20 years, the Internet has been probably the number-one place that people go for medical information," says Sheeraz Qureshi, MD, MBA , co-chief of HSS Spine and co-author of the study.

Key Points: 
  • "In the past 20 years, the Internet has been probably the number-one place that people go for medical information," says Sheeraz Qureshi, MD, MBA , co-chief of HSS Spine and co-author of the study.
  • The same way that people use search engines to look for medical information now, we expect they will use chatbots in the future, including in their decision-making process."
  • "If a search takes you to the webpage for HSS or another well-established medical center, you can feel confident that the information has been vetted by experts."
  • Ultimately, their hope is to identify opportunities to ensure that when AI is responding to medical queries it is prioritizing the most reliable and credentialed information.

Accelus Strengthens Leadership with New Board Appointments

Retrieved on: 
Monday, February 12, 2024

This strategic enhancement to the board is aligned with Accelus’s mission to deliver innovative spinal solutions that elevate the surgical experience and improve patient outcomes.

Key Points: 
  • This strategic enhancement to the board is aligned with Accelus’s mission to deliver innovative spinal solutions that elevate the surgical experience and improve patient outcomes.
  • His journey with Accelus includes key roles as President and Chief Commercial Officer, showcasing his leadership and strategic vision.
  • Bernie Haffey, the founder of Haffey & Co., brings to the board a proven track record in executive management and leadership.
  • “I am delighted by the addition of Kevin McGann and Bernie Haffey to the Accelus Board of Directors," said Alex Lukianov, Chairman of the Board for Accelus.

OnPoint to participate in the 2024 Canaccord Genuity Musculoskeletal Conference

Retrieved on: 
Monday, February 12, 2024

BOSTON, Feb. 12, 2024 /PRNewswire/ -- OnPoint, a group of privately held augmented reality (AR) technology companies pioneering AR guidance for multiple verticals including spine, neurosurgical, and orthopedic surgical procedures, including robotic procedures, today announced that it will participate in the 2024 Canaccord Genuity Musculoskeletal Conference on Monday, February 12, 2024, at the Westin St. Francis Hotel, San Francisco, CA.

Key Points: 
  • BOSTON, Feb. 12, 2024 /PRNewswire/ -- OnPoint, a group of privately held augmented reality (AR) technology companies pioneering AR guidance for multiple verticals including spine, neurosurgical, and orthopedic surgical procedures, including robotic procedures, today announced that it will participate in the 2024 Canaccord Genuity Musculoskeletal Conference on Monday, February 12, 2024, at the Westin St. Francis Hotel, San Francisco, CA.
  • OnPoint Surgical is revolutionizing spinal procedures with the OnPoint AR Spine System which superimposes virtual surgical guides and virtual implants onto the surgeon's visual field using proprietary see-through optical head-mounted display technology.
  • The OnPoint AR Spine System platform technology is a cost-effective and highly accurate alternative to current robotic systems.
  • "OnPoint offers an attractive financial profile for hospitals and ASC's using its rapidly accretive, exceptionally accurate and cost-effective technology.