Lumbar spinal stenosis

Vertos Medical, Inc. Ranked Number 370 Fastest-Growing Company in North America on the 2023 Deloitte Technology Fast 500™

Retrieved on: 
Wednesday, November 8, 2023
Vertos Medical, Fintech, Quality of life, Deloitte Technology Fast 500, Growth, Lumbar spinal stenosis, Patient, Telecommunications, Pharmaceutical industry

ALISO VIEJO, Calif., Nov. 8, 2023 /PRNewswire/ -- Vertos Medical today announced it ranked 370 on the Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America, now in its 29th year. Vertos Medical grew 343% between 2019 and 2022.

Key Points: 
  • Attributes the company's remarkable 343% revenue growth to its innovation and unwavering commitment to enhancing the quality of patients' lives.
  • ALISO VIEJO, Calif., Nov. 8, 2023 /PRNewswire/ -- Vertos Medical today announced it ranked 370 on the Deloitte Technology Fast 500 ™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America, now in its 29th year.
  • Wichems said, "We're honored to receive recognition for a second year in a row as one of North America's fastest-growing companies.
  • Vertos Medical previously ranked 384 as a Technology Fast 500 award winner for 2022.

Premia Spine Announces New Technology Add-On Payment for TOP™ System

Retrieved on: 
Monday, October 2, 2023
CMS, NTAP, Centers for Medicare & Medicaid Services, Policy, Long-term care, Quality of life, Spine, Multimedia, Stenosis, Spondylolisthesis, Medicare, QOL, Journal, PMA, MD, Patient, Lumbar spinal stenosis, DRG, Neurosurgery, IDE, Neuro, FDA, Treatment, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Spinal stenosis, Safety, Health care, Pharmaceutical industry

NORWALK, Conn., Oct. 2, 2023 /PRNewswire-PRWeb/ -- Premia Spine, an innovator in spine medical devices, announced the initiation of the Centers for Medicare & Medicaid Services (CMS) New Technology Add-on Payment (NTAP) Program for the TOPS™ System. The payment, of up to an additional $11,375 beyond the standard DRG payment for the procedure, is available to all facilities who provide inpatient care to patients with spinal stenosis and spondylolisthesis. This is only the third time that CMS has granted an incentive payment to facilities for the use of any spinal implant.

Key Points: 
  • NORWALK, Conn., Oct. 2, 2023 /PRNewswire-PRWeb/ -- Premia Spine, an innovator in spine medical devices, announced the initiation of the Centers for Medicare & Medicaid Services (CMS) New Technology Add-on Payment (NTAP) Program for the TOPS™ System.
  • This is only the third time that CMS has granted an incentive payment to facilities for the use of any spinal implant.
  • TOPS has proven its ability to provide both clinical excellence and healthcare economic advantage to patients, providers, and payers," says Ron Sacher, CEO of Premia Spine.
  • Ron Sacher , CEO of Premia Spine commented, "We are honored by the recognition of CMS.

Sino Biopharmaceutical (1177.HK) Announces 2023 Interim Results

Retrieved on: 
Friday, August 25, 2023
Neutropenia, Hepatitis, NASH, Marketing, Sino Biopharmaceutical Limited, Liver disease, Clinical trial, Cancer, Breakthrough therapy, Respiratory system, Research, COVID, YOY, Tablet, Patient, ROCK2, CDE, Growth, HK2, Development, Center for Drug Evaluation and Research, NMPA, Idiopathic pulmonary fibrosis, Lumbar spinal stenosis, Safety, Flurbiprofen, Pharmaceutical industry, Generic drug, Fine chemical, Q2, PRC

HONG KONG, Aug 25, 2023 - (ACN Newswire) - Sino Biopharmaceutical Limited ("Sino Biopharmaceutical" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited interim results for the six months ended 30 June 2023 (the "Period").

Key Points: 
  • HONG KONG, Aug 25, 2023 - (ACN Newswire) - Sino Biopharmaceutical Limited ("Sino Biopharmaceutical" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited interim results for the six months ended 30 June 2023 (the "Period").
  • In the first half of 2023, two innovative products were launched to market and two biosimilar drugs received marketing approval.
  • -- Annike (Penpulimab monoclonal antibody) injection was approved in January 2023 for treating, in combination with chemotherapy, first-line locally advanced or metastatic squamous non-small cell lung cancer.
  • -- Yilishu (Efbemalenograstim alpha) injection was approved in May 2023 for the prevention and treatment of neutropenia in cancer patients taking chemotherapy drugs.

Wenzel Spine Receives FDA Clearance Expanding Clinical Indications for primaLOK SP

Retrieved on: 
Tuesday, August 22, 2023
Biotechnology, Surgery, General Health, Health, FDA, Medical Devices, Health Technology, Other Health, Surgeon, National Center for Spinal Disorders, Multimedia, MD, Patient, Risk, Lumbar spinal stenosis, Pain, Rail freight transport, Dentistry, Medical imaging, Spine

With this clearance, Wenzel Spine continues its commitment to delivering high-quality products that enhance surgical outcomes and improve patient lives.

Key Points: 
  • With this clearance, Wenzel Spine continues its commitment to delivering high-quality products that enhance surgical outcomes and improve patient lives.
  • The new clinical indications from the FDA clearance allow for the primaLOK SP to be used at multiple levels and to treat patients with lumbar spinal stenosis.
  • “We are proud to receive FDA clearance to update the clinical indications for primaLOK SP.
  • For more information about the primaLOK SP System and other groundbreaking procedural solutions from Wenzel Spine, please visit their website at www.wenzelspine.com .

Vertos Medical Promotes Two Senior Leaders to Newly Created C-Suite Roles

Retrieved on: 
Tuesday, August 15, 2023
LSS, Deloitte Technology Fast 500, Spinal canal, Vertos Medical, Quality of life, CCO, Research and development, Development, Patient, R, Lumbar spinal stenosis, Management, Pharmaceutical industry, Research

ALISO VIEJO, Calif., Aug. 15, 2023 /PRNewswire/ -- Vertos Medical Inc., a leader in the development of innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), announced today that its Vice President of Sales, Stephen E. Paul, has been named chief commercial officer (CCO), and its Vice President of Research and Development, Mehrzad Khakpour, Ph.D., has been named chief technology officer (CTO) for the rapidly growing company. The promotions come on the heels of a recent Series C equity funding round of more than $26 million.

Key Points: 
  • The promotions come on the heels of a recent Series C equity funding round of more than $26 million.
  • Vertos Medical's proprietary technology, the mild® Procedure, has been shown in many studies to help restore mobility and decrease pain for LSS patients while greatly improving their quality of life.
  • Dr. Khakpour, previously Vertos' vice president of research and development, also boasts more than 20 years of experience in medical device research and innovation, with numerous notable past accomplishments.
  • In his newly created CTO position, he will oversee Vertos' upstream marketing, R&D, and clinical research teams to steer the company toward promising adjunctive innovations.

SWK Holdings Highlights Recent Achievements and Provides Portfolio Update

Retrieved on: 
Monday, July 17, 2023
LSS, Pressure, Software as a service, SWK, Pregnancy, First Horizon Bank, Partnership, STI, Polypharmacy, Marketing, Share repurchase, BIOL, LeMaitre Vascular, Risk management, Medicine, Carglumic acid, Sale, Homocystinuria, Pulmonary hypertension, Patient, ROP, Decompression, GPO, Rare, FDA, AGS, Lumbar spinal stenosis, Security (finance), Life insurance, Pharmaceutical industry, Medical device, Management, Nursing, Cofix, Algorithm, Growth

We view repurchasing shares at the current discount to book as a highly accretive use of capital that benefits shareholders."

Key Points: 
  • We view repurchasing shares at the current discount to book as a highly accretive use of capital that benefits shareholders."
  • SWK has received $1.5mm of proceeds from the sale and anticipates receiving approximately $0.5 million in additional proceeds from the estate.
  • SWK will provide an update on the Flowonix finance receivable in our second quarter earnings release.
  • Signed a partnership with LeMaitre Vascular to distribute Aziyo's cardiovascular repair portfolio within the U.S., increasing sales representative coverage five-fold.

Premia Spine TOPS™ System Achieves FDA Premarket Approval with Superiority-to-Fusion Label

Retrieved on: 
Tuesday, June 20, 2023
Injection, Spine, Journal, Failure, Stenosis, Arthroplasty, Index, Pain, Control, Back pain, Food and Drug Administration Amendments Act of 2007, Motion, PMA, Gold, Patient, Oswestry Disability Index, Lumbar spinal stenosis, Premia, Decompression, IDE, FDA, Treatment, Food, Spinal stenosis, Safety, Pharmaceutical industry, Lithium, Spondylolisthesis

NORWALK, Conn., June 20, 2023 /PRNewswire-PRWeb/ -- Premia Spine, a medical technology company revolutionizing the treatment of chronic leg and back pain, proudly announces the Food and Drug Administration (FDA) approval of its Total Posterior Spine (TOPS) facet joint replacement system. The TOPS System previously earned the FDA's Breakthrough Designation status and has now successfully completed its Premarket Approval (PMA) application. Premia Spine undertook rigorous testing to receive FDA approval, including an Investigational Device Exemption (IDE) study to confirm the safety and efficacy of the system. The company's pivotal FDA trial demonstrated that, at two years post-operation, the TOPS System outperformed fusion in treating grade 1 degenerative spondylolisthesis with stenosis. This accomplishment marks the TOPS System as the first lumbar spine implant to receive a superiority claim over lumbar fusion.

Key Points: 
  • NORWALK, Conn., June 20, 2023 /PRNewswire-PRWeb/ -- Premia Spine , a medical technology company revolutionizing the treatment of chronic leg and back pain, proudly announces the Food and Drug Administration (FDA) approval of its Total Posterior Spine (TOPS) facet joint replacement system.
  • The TOPS System previously earned the FDA's Breakthrough Designation status and has now successfully completed its Premarket Approval (PMA) application.
  • Premia Spine undertook rigorous testing to receive FDA approval, including an Investigational Device Exemption (IDE) study to confirm the safety and efficacy of the system.
  • This accomplishment marks the TOPS System as the first lumbar spine implant to receive a superiority claim over lumbar fusion.

Correction: Aurora Spine Corporation Announces Fourth Quarter and Fiscal 2022 Financial Results

Retrieved on: 
Monday, May 1, 2023
ASG, Patent, Surgeon, Use, Interest, Stenosis, Marketing, Silo, United States Patent and Trademark Office, 3D, Bone density, ZIP, TFX, Trial of the century, NASS, The Company, Patient, Physician, Motion, Pain management, Growth, DEXA, FDA, Earnings, MIS, Cadaver, Total, Lumbar spinal stenosis, Video game, Cryptocurrency, Pharmaceutical industry, Medical device, Depreciation

CARLSBAD, Calif. – May 1, 2023 -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced the financial results for fiscal 2022 ended December 31, 2022. All figures are in U.S. dollars.

Key Points: 
  • Mr. Trent Northcutt, President and Chief Executive Officer of Aurora Spine, stated, “Fiscal 2022 was an exceptional year for Aurora Spine.
  • Total operating expenses were $2.67 million for the fourth quarter of 2022, compared to $2.267 million in the fourth quarter of 2021.
  • Net loss was $(0.840) million for the fourth quarter of 2022, compared to the fourth quarter of 2021 with a loss of $(0.903) million.
  • Basic and diluted net (loss) income per share was $(0.01) per share in the fourth quarter of 2022 and $(0.01) per share for the fourth quarter of 2021.

Aurora Spine Corporation Announces Fourth Quarter and Fiscal 2022 Financial Results

Retrieved on: 
Monday, May 1, 2023
ASG, Patent, Surgeon, Use, Interest, Stenosis, Marketing, Silo, United States Patent and Trademark Office, 3D, Bone density, ZIP, TFX, Trial of the century, NASS, The Company, Patient, Physician, Motion, Pain management, Growth, DEXA, FDA, Earnings, MIS, Cadaver, Total, Lumbar spinal stenosis, Video game, Pharmaceutical industry, Medical device, Depreciation

CARLSBAD, Calif., May 01, 2023 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced the financial results for fiscal 2022 ended December 31, 2022. All figures are in U.S. dollars.

Key Points: 
  • Mr. Trent Northcutt, President and Chief Executive Officer of Aurora Spine, stated, “Fiscal 2022 was an exceptional year for Aurora Spine.
  • Total operating expenses were $2.67 million for the fourth quarter of 2022, compared to $2.267 million in the fourth quarter of 2021.
  • Net loss was $(0.840) million for the fourth quarter of 2022, compared to the fourth quarter of 2021 with a loss of $(0.903) million.
  • Basic and diluted net (loss) income per share was $(0.01) per share in the fourth quarter of 2022 and $(0.01) per share for the fourth quarter of 2021.

Premia Spine Completes FDA Site Inspections With No FDA Observations

Retrieved on: 
Thursday, April 13, 2023
Biotechnology, Surgery, General Health, Health, FDA, Medical Devices, Health Technology, Clinical Trials, Spine, Clinical trial, Index, Control, Back pain, Ćorić, Motion, PMA, Journal, Patient, Decompression, Cleveland, IDE, Spinal stenosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Treatment, Food, Lumbar spinal stenosis, Pharmaceutical industry, DRS, Spondylolisthesis

The inspections at two company facilities and two clinical trial sites in the U.S. resulted in no FDA Form 483s for objectionable observations.

Key Points: 
  • The inspections at two company facilities and two clinical trial sites in the U.S. resulted in no FDA Form 483s for objectionable observations.
  • “While a completely clean site inspection is what everyone strives for, it is a major accomplishment to receive no 483s across four separate sites,” said Ron Sacher, CEO, Premia Spine.
  • Coric, Steinmetz, their staff, and the other 35 clinical sites who diligently performed the IDE study to the highest standards,” responded Jeff Withrow, vice president, Clinical and Reimbursement, Premia Spine.
  • TOPS won Breakthrough Device Designation from the FDA in 2021.