Deformity

SI-BONE Expands Portfolio with the Launch of New Offering for the iFuse Bedrock Granite Implant System and Completes Inaugural Surgical Procedures

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火曜日, 5月 7, 2024
FDA, University, Henry Ford Health, Sacrum, Food, DSM-IV codes, Surgeon, S1, Columbia University, Workflow, Motion, Anatomy, Joint, Spine, Patient, Silicon, Medicare, Deformity, Dentistry

When placed across the SI joint, the Granite implant provides sacroiliac fusion and spinopelvic fixation as a foundational element for multi-segment spinal fusion.

Key Points: 
  • When placed across the SI joint, the Granite implant provides sacroiliac fusion and spinopelvic fixation as a foundational element for multi-segment spinal fusion.
  • The iFuse Bedrock Granite Implant System was awarded a Breakthrough Device Designation by the Food & Drug Administration and a New Technology Add-on Payment by the Centers for Medicare and Medicaid Services.
  • More importantly, even with complex reconstructions, as in my experience for my first Granite 9.5 case, the implant did not change my surgical workflow.
  • The S1 Granite 9.5 implants were a welcome addition to the 10.5 mm Granite implants I use for sacroalar-iliac fixation in my constructs.

OrthoPediatrics Corp. Reports First Quarter 2024 Financial Results and Increases Full Year 2024 Revenue Guidance

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月曜日, 5月 6, 2024
Total, International, Investment, Research, Elective surgery, Growth, Webcast, Event, Pega, Marketing, Orthopediatrics, OPSB, Deformity, Scoliosis

U.S. revenue for the first quarter of 2024 was $34.3 million, a 44% increase compared to $23.8 million for the same period last year, representing 77% of total revenue.

Key Points: 
  • U.S. revenue for the first quarter of 2024 was $34.3 million, a 44% increase compared to $23.8 million for the same period last year, representing 77% of total revenue.
  • International revenue for the first quarter of 2024 was $10.4 million, a 33% increase compared to $7.8 million for the same period last year, representing 23% of total revenue.
  • Trauma and Deformity revenue for the first quarter of 2024 was $33.3 million, a 42% increase compared to $23.4 million for the same period last year.
  • Scoliosis revenue was $10.2 million, a 44% increase compared to $7.1 million for the first quarter of 2023.

SI-BONE, Inc. Reports Financial Results for the First Quarter 2024

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月曜日, 5月 6, 2024
International, Person, Investment, Publication, Depreciation, DSM-IV codes, Surgeon, Security (finance), Research, Webcast, Anatomy, Risk, Patient, Worldwide, All rights reserved, Physician, Form 10-K, Bank statement, Deformity, ASP, GAAP, Growth, Bookkeeping

Gross margin was ~79% for the first quarter 2024, as compared to ~82% in the corresponding period in 2023.

Key Points: 
  • Gross margin was ~79% for the first quarter 2024, as compared to ~82% in the corresponding period in 2023.
  • Gross margin in the first quarter 2024 was impacted by procedure and product mix.
  • Operating expenses increased ~10% to $41.9 million in the first quarter 2024, as compared to $38.1 million in the corresponding period in 2023.
  • SI-BONE will host a conference call to discuss the first quarter 2024 financial results after market close on Monday, November 6, 2023 at 4:30 P.M. Eastern Time.

Orthofix Announces FDA 510(k) Clearance for the Rodeo Telescopic Nail

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木曜日, 5月 9, 2024
Health, FDA, Medical Devices, Consumer, Surgery, Genetics, Children, Food, Osteogenesis imperfecta, Fracture, Rodeo, Food and Drug Administration, Deformity, Patient, OI, Child, Multimedia, Prevalence, Dentistry

(NASDAQ:OFIX), a leading global spine and orthopedics company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo™ Telescopic Nail.

Key Points: 
  • (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo™ Telescopic Nail.
  • View the full release here: https://www.businesswire.com/news/home/20240509384510/en/
    The Rodeo Telescopic Nail by Orthofix is an innovative device to surgically treat deformities or fractures in patients suffering from osteogenesis imperfecta.
  • (Photo: Business Wire)
    The Rodeo Telescopic Nail is an innovative device indicated to surgically treat deformities or fractures in patients suffering from osteogenesis imperfecta (OI).
  • The Rodeo system is designed to address many of the biomechanical and procedural challenges associated with current OI telescopic rod systems.

OrthoPediatrics Corp. Receives “Breakthrough Device” Designation from FDA for eLLi™ Growing Rod System for Pediatric Patients with Scoliosis

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木曜日, 5月 2, 2024
EOS, FDA, Public, Safety, Food, De novo, Surgeon, Elective surgery, Pathology, Breakthrough, Spine, Patient, Diagnosis, Deformity, Elli, Scoliosis

eLLi aims to provide a non-invasive means of extending the growing rods that provides increased force, enhanced mechanical reliability, and superior distraction precision, while also addressing safety concerns associated with current technology.

Key Points: 
  • eLLi aims to provide a non-invasive means of extending the growing rods that provides increased force, enhanced mechanical reliability, and superior distraction precision, while also addressing safety concerns associated with current technology.
  • eLLi will allow surgeons a new alternative to address deformity of the growing spine with an advanced technology that will complement our efforts to build a platform of EOS technologies.
  • We are proud to have an expert design team comprised of surgeons who have dedicated their careers to treating these unique patients.
  • David Bailey, OrthoPediatrics’ President & CEO, commented, “Receiving the Breakthrough Device designation from the FDA is a great achievement for our team.

Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene Treatment of epidermolysis bullosa, 12/10/2017 Withdrawn

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木曜日, 4月 18, 2024
Eurostat, Diagnosis, Civil service commission, Gene, Mutation, Epidermolysis bullosa, Skin cancer, Patient, Committee, Knowledge, Regulation, Keratin, EMA, IRIS, Protein, Life expectancy, Deformity, Blister, European, Skin, Collagen, COMP, Infection, Sponsor, European Commission, Safety, Unit, Marketing, COL7A1, Medicine, Pharmaceutical industry

Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene Treatment of epidermolysis bullosa, 12/10/2017 Withdrawn

Key Points: 


Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene Treatment of epidermolysis bullosa, 12/10/2017 Withdrawn

Orphan designation: Diacerein Treatment of epidermolysis bullosa, 20/02/2014 Positive

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木曜日, 4月 18, 2024
Eurostat, Diagnosis, Civil service commission, Gene, Anthraquinones, Skin cancer, Epidermolysis bullosa, Disease, Inflammation, Patient, Committee, Knowledge, Regulation, Keratin, EMA, IRIS, Joint, Protein, Life expectancy, Deformity, Blister, Interleukin-1 family, Mouth, European, Skin, Collagen, COMP, Infection, Safety, European Commission, Pain, Osteoarthritis, Marketing, Swelling, FGK, Medicine, Pharmaceutical industry

Orphan designation: Diacerein Treatment of epidermolysis bullosa, 20/02/2014 Positive

Key Points: 


Orphan designation: Diacerein Treatment of epidermolysis bullosa, 20/02/2014 Positive

Protein ice cream company wins 2024 Rice Business Plan Competition

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月曜日, 4月 8, 2024
Friends, Ulcer, University, Obstructive sleep apnea, Rice University, Entrepreneurship, Bacteria, Deformity, Love, Harvard University, Chevron Corporation, RWTH Aachen University, Chemical engineering, Reiss, Podiatry, University of Houston, Greater Houston, Foot, TiE, Mentorship, Northwestern University, Rice, University of California, Berkeley, WRX, Carnegie Mellon University, Yale University, University of Kansas, EY, Tulane University, Ice cream, Michigan State University, Johns Hopkins University, Heart, Intuitive Machines

HOUSTON, April 8, 2024 /PRNewswire/ -- Ice cream company Protein Pints took home the grand prize at the 2024 Rice Business Plan Competition (RBPC) April 6 as the best student ventures from top universities across the world competed for prizes in front of nearly 350 angel, venture capital and corporate investors and members of the business community.

Key Points: 
  • HOUSTON, April 8, 2024 /PRNewswire/ -- Ice cream company Protein Pints took home the grand prize at the 2024 Rice Business Plan Competition (RBPC) April 6 as the best student ventures from top universities across the world competed for prizes in front of nearly 350 angel, venture capital and corporate investors and members of the business community.
  • The best student ventures from top universities across the world competed in the 2024 Rice Business Plan Competition.
  • Hosted annually by the Rice Alliance for Technology and Entrepreneurship and Rice University's Jones Graduate School of Business , the RBPC is the world's largest and richest student startup competition.
  • Protein Pints is a high-protein, low-sugar, ice cream product designed for people who would benefit from having access to a functional ice cream and/or better tasting and more enjoyable protein options.

Dr. Mark Viktor Silver – Maintains Unique Double Board Certification

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月曜日, 3月 11, 2024
Health, Surgery, Neurology, Practice Management, Physical Therapy, General Health, University, Certification, McGill University, ABNS, Arm, Specialization, Surgeon, Column (periodical), Medical college, Patient, Neurosurgery, Human, General surgery, Neck, Deformity, Scoliosis, Spine, Physician, Royal college, School

Dr. Mark Viktor Silver , founder of the Silver Spine and Neurological Center , has maintained the unique distinction of being board-certified in neurosurgery by both the American Board of Neurological Surgery (ABNS) and the Royal College of Physicians and Surgeons of Canada.

Key Points: 
  • Dr. Mark Viktor Silver , founder of the Silver Spine and Neurological Center , has maintained the unique distinction of being board-certified in neurosurgery by both the American Board of Neurological Surgery (ABNS) and the Royal College of Physicians and Surgeons of Canada.
  • With more than 20 years of practice, Dr. Silver specializes in minimally invasive and complex neurosurgical procedures aimed at alleviating neck, back, arm, and leg pain.
  • “While not required for a medical license, the rigorous board certification process shows a physician’s commitment to his patients and profession,” said Dr. Silver.
  • With 21 years of professional practice, Dr Silver has worked in large academic and private institutions and has served as Chief of Neurosurgery at various prestigious hospitals.

Steps2Walk Announces the Impact of Q1 Surgical Mission and Orthopedic Training Programs

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木曜日, 4月 4, 2024
Walking, Partnership, Education, Patient, Foot, Child, Cadaver, Telehealth, Surgeon, Deformity, DRS, Nursing

DENVER, April 4, 2024 /PRNewswire-PRWeb/ -- Steps2Walk, a global humanitarian nonprofit organization providing surgical missions and surgeon training in under-served regions around the world, today announced the patient and educational impact of its first round of programs for 2024. In February and March, the organization conducted programs in Sri Lanka, Pakistan, and for the first time, Tanzania, treating 50 patients and providing surgical training and education to 120 local surgeons.

Key Points: 
  • Founded in 2000 by world-renowned orthopedic surgeon Dr. Mark Myerson , the organization addresses the surgical needs of those with severe foot and ankle deformities in regions where there is limited orthopedic care.
  • Each mission is organized in partnership with the Steps2Walk team, their international network of volunteer surgeons and the hosting medical institutions.
  • Steps2Walk has four upcoming programs scheduled for Q2:
    For more information on how to become a volunteer faculty member or trainee participant in one of the Steps2Walk Programs, visit https://steps2walk.org/faculty/ .
  • Steps2Walk also accepts donations , which can give the gift of walking to those most in need and help fund critical training and education for regional orthopedic surgeons.