Neurosurgery

Sosei Group Announces Marketing Approval for PIVLAZ™ (clazosentan sodium) 150 mg in South Korea

Retrieved on: 
Thursday, December 7, 2023

Tokyo, Japan, Seoul, South Korea, and Cambridge, UK, 7 December 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) today announces that PIVLAZ™ (clazosentan sodium) 150 mg has received marketing approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing.

Key Points: 
  • Tokyo, Japan, Seoul, South Korea, and Cambridge, UK, 7 December 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) today announces that PIVLAZ™ (clazosentan sodium) 150 mg has received marketing approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing.
  • The MFDS approval is based on scientific and clinical data from an extensive Japanese Phase 3 program submitted by Idorsia Pharmaceuticals Korea (“IPK”), a Sosei Group company.
  • In South Korea, the Marketing Authorization of PIVLAZ™ is held by IPK and will become commercially available to patients in early 2025.
  • PIVLAZ™ received marketing approval in Japan in January 2022 and was launched in April 2022 by Idorsia Pharmaceuticals Japan ("IPJ”), also a Sosei Group company.

Aurora Spine Corporation Announces Newly Published Paper on First 6-month Clinical Evaluation of its ZIP™ Fusion Implant

Retrieved on: 
Monday, December 4, 2023

This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the ZIP interspinous fusion device.

Key Points: 
  • This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the ZIP interspinous fusion device.
  • Dr. Sebastian Koga, a neurosurgeon from Covington, LA emphasized, “Our study demonstrates that the ZIP device provides a stable platform for posterior fusion.
  • I am happy to contribute objective clinical evidence to this area of spine surgery.
  • A previously published retrospective study has also demonstrated the ZIP device’s safety and effectiveness in the hands of interventional pain physicians.

NurExone Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, November 24, 2023

TORONTO and HAIFA, Israel, Nov. 24, 2023 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V) (the “Company” or “NurExone”), a pioneering biotechnology company, released a corporate update and reported financial results for the quarter ended September 30, 2023.

Key Points: 
  • TORONTO and HAIFA, Israel, Nov. 24, 2023 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V) (the “Company” or “NurExone”), a pioneering biotechnology company, released a corporate update and reported financial results for the quarter ended September 30, 2023.
  • Research and development expenses were US$0.40 million in the third quarter of 2023, compared to US$0.42 million in the same quarter in 2022.
  • Financial (income) expenses were (US$0.01) million in the third quarter of 2023, compared to US$0.02 million in the same period in 2022.
  • Net loss was US$1.16 million in the third quarter of 2023, compared to a net loss of US$1.04 million in the same quarter in 2022.

IEEE EMBS Executive Committee Appoints Dr. Erika Ross Ellison as President-Elect, Along With Two New Vice Presidents

Retrieved on: 
Tuesday, December 19, 2023

Beena Ahmed and Natalie Mrachacz-Kersting were elected vice president of Conferences and vice president of Member and Student Activities, respectively.

Key Points: 
  • Beena Ahmed and Natalie Mrachacz-Kersting were elected vice president of Conferences and vice president of Member and Student Activities, respectively.
  • “My top objective will be to establish IEEE EMBS as the largest global forum for biomedical engineers, clinicians and scientists,” said Dr. Ross Ellison.
  • She is the technical representative on the IEEE EMBS administrative committee, and served as program co-chair of EMBC 2023.
  • She is an IEEE EMBS practitioner representative, and is active on the IEEE Brain steering committee.

Kelyniam Global Releases 3rd Quarter 2023 Financials

Retrieved on: 
Thursday, December 21, 2023

CANTON, Conn., Dec. 21, 2023 /PRNewswire/ -- Kelyniam Global (OTC:KLYG), a maker of custom cranial implants, today announced results for its third quarter ended September 30, 2023.

Key Points: 
  • CANTON, Conn., Dec. 21, 2023 /PRNewswire/ -- Kelyniam Global (OTC:KLYG), a maker of custom cranial implants, today announced results for its third quarter ended September 30, 2023.
  • The company also added new sales representatives in the last two quarters and expect to see results from these efforts in the fourth quarter."
  • Kelyniam is recognized as the leader in the ability to rapidly design and manufacture complex cranial implants overnight.
  • Kelyniam Inc., specializes in the rapid production of custom prosthetics utilizing computer aided design and computer aided manufacturing of advanced medical grade polymers.

NYU Langone Health to adopt new Philips health technology solutions in multi-year partnership directed at patient safety, quality and outcomes

Retrieved on: 
Thursday, November 16, 2023

With the new technologies, NYU Langone clinicians can collaborate in real-time, whether sharing pathology, imaging studies or patient data to support diagnostic confidence and tailor individualized care plans.

Key Points: 
  • With the new technologies, NYU Langone clinicians can collaborate in real-time, whether sharing pathology, imaging studies or patient data to support diagnostic confidence and tailor individualized care plans.
  • Supported by Philips’ innovation and leadership in health technology, NYU Langone’s industry-leading knowledge of the patient journey and care pathways can help push the boundaries of personalized care.
  • With this new partnership, NYU Langone Health will be adopting Philips’ IntelliSite Pathology solution, enterprise informatics, and AI-enabled diagnostic imaging technologies such as the Philips Lumify Handheld Ultrasound.
  • [1] As an institution, NYU Langone consistently receives top-quality and safety accolades from independent arbiters of patient care.

Plus Therapeutics to Host Virtual KOL Event on New Phase 2 ReSPECT-GBM Data in Recurrent Glioblastoma Presented at the Society for NeuroOncology (SNO) Conference on Monday, November 20, 2023

Retrieved on: 
Wednesday, November 15, 2023

To register, click here.

Key Points: 
  • To register, click here.
  • The event will feature presentations from neuro-oncology expert and principal investigator Andrew Brenner, M.D., Ph.D. (Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio) and neurosurgeons Toral Patel, M.D.
  • Brain Institute) and John Floyd, M.D.
  • A live question and answer session will follow the formal presentations.

Lineage Announces Submission of OPC1 Investigational New Drug Amendment for Treatment of Chronic and Subacute Spinal Cord Injury

Retrieved on: 
Monday, December 18, 2023

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that the Company has submitted an Investigational New Drug amendment (INDa) to the U.S. Food and Drug Administration (FDA), for OPC1 , its 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 that the Company has submitted an Investigational New Drug amendment (INDa) to the U.S. Food and Drug Administration (FDA), for OPC1 , its investigational allogeneic oligodendrocyte progenitor cell transplant, for the treatment of spinal cord injury (SCI).
  • Receipt of FDA clearance of the INDa would enable the Company to initiate its DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study, to evaluate the safety and utility of a novel spinal cord delivery device in both subacute and chronic SCI patients.
  • “The submission of our IND amendment for OPC1 and its return to clinical testing represents a significant milestone for this program and a diligent effort by our team,” stated Brian M. Culley, Lineage CEO.
  • We are encouraged by the meaningful quality of life and safety results observed with OPC1 in previous trials, and we look forward to building on that promising work.

Imperative Care Announces First-In-Human Study of Novel Implant Designed to Enable Single Antiplatelet Therapy After Aneurysm Treatment

Retrieved on: 
Thursday, December 14, 2023

Imperative Care , a medical technology company developing connected innovations to elevate care for people affected by stroke and other ischemic diseases, today announced the initiation of a first-in-human clinical study for its novel stent system designed to only require single antiplatelet therapy for patients undergoing stent-assisted treatment of wide-neck intracranial aneurysms.

Key Points: 
  • Imperative Care , a medical technology company developing connected innovations to elevate care for people affected by stroke and other ischemic diseases, today announced the initiation of a first-in-human clinical study for its novel stent system designed to only require single antiplatelet therapy for patients undergoing stent-assisted treatment of wide-neck intracranial aneurysms.
  • “The ability for neurovascular implants to avoid dual antiplatelet drug therapy, which carries the risk of serious bleeding complications, will be an important step forward,” said Dr. Sakai.
  • The company intends to investigate versions of the stent for a wider scope of hemorrhagic and ischemic stroke-related conditions.
  • In addition to the neurovascular applications, we believe that a single antiplatelet stent could make an important contribution in other targets within the vascular system.”

SonALAsense Presents Preliminary Data From Clinical Study in Patients With Deadly Pediatric Brain Tumor

Retrieved on: 
Wednesday, December 13, 2023

These results were presented at the November 2023 Society for Neuro-Oncology (SNO) Annual Meeting in Vancouver, Canada.

Key Points: 
  • These results were presented at the November 2023 Society for Neuro-Oncology (SNO) Annual Meeting in Vancouver, Canada.
  • The preliminary data from Study SDT-201 shows signals of clinical activity and no safety concerns.
  • Study SDT-201 is a dose escalation and expansion study in patients with DIPG.
  • Six (6) patients have been treated to date and dose escalation is ongoing.