SCIP

SpineX Closes Recruitment for SCONE™ Clinical Trial

Retrieved on: 
Monday, April 8, 2024
Children, Biotechnology, FDA, Health, Neurology, Health Technology, Medical Devices, Research, Consumer, Science, Clinical Trials, Cord, Brain, Cerebral palsy, Multiple sclerosis, SCIP, Patient, Stroke, Clinical trial, Urinary bladder, Trial of the century, Skin, Spinal cord, Heart, Urinary incontinence, Cauda equina syndrome, Neuromodulation, Pharmaceutical industry

SpineX Inc. has closed recruitment for its clinical trial of its proprietary SCONE™ device.

Key Points: 
  • SpineX Inc. has closed recruitment for its clinical trial of its proprietary SCONE™ device.
  • The clinical trial— Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE “CONTINENCE” Clinical Study — began in May 2022.
  • “SCONE has the power to transform the lives of millions of patients with neurogenic bladder,” says Parag Gad, SpineX co-founder & CEO.
  • SpineX anticipates beginning a multi-center pivotal trial for children with Cerebral Palsy in 2024.

Prime Medicine Reports Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Friday, March 1, 2024
Sequence, Composition, Liver, RHO, Immunotherapy, Investment, FDA, Research and development, HSC, Food, CGD, Patent, SCIP, Lung, Ataxia, Cystic Fibrosis Foundation, Hematology, Administration, Patient, Target, IND, AAV, CTA, Pharmaceutical industry

CAMBRIDGE, Mass., March 01, 2024 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results for the full year ended December 31, 2023 and provided a business update.

Key Points: 
  • “In 2024, we anticipate undergoing a significant transformation, maturing into a clinical-stage company and bringing the first-ever Prime Editing-based therapeutic candidate to patients.
  • This funding will allow Prime Medicine to progress two distinct strategies for applying Prime Editing to treat CF: hotspot editing and PASSIGE™ (Prime Assisted Site Specific Integrase Gene Editing).
  • Gross proceeds to Prime Medicine from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $161.0 million.
  • In January 2024, Prime Medicine announced the appointment of Allan Reine, M.D., as the Company’s Chief Financial Officer.

SpineX Announces Successful in-Human Results to Treat Adults with Cerebral Palsy

Retrieved on: 
Wednesday, January 3, 2024
Medical Devices, People with Disabilities, Neurology, Clinical Trials, Health Technology, Biotechnology, Physical Therapy, General Health, Consumer, Health, Clinical trial, SCIP, FDA, Walking, DRS, BDD, CP, Cerebral palsy, Doctor of Philosophy, DPT, Life

SpineX Inc. today announced groundbreaking results in its first in-human study treating an adult with Cerebral Palsy (CP).

Key Points: 
  • SpineX Inc. today announced groundbreaking results in its first in-human study treating an adult with Cerebral Palsy (CP).
  • View the full release here: https://www.businesswire.com/news/home/20240103634112/en/
    CP patient walking down stairs before vs after SCiP therapy.
  • Note the minimal hand support needed and the more confident steps taken by her after eight weeks of SCiP therapy.
  • “I am excited by the potential impact that SCiP could have on the CP population for both adults and children.”

SpineX close to full recruitment for SCONE™ clinical trial

Retrieved on: 
Wednesday, December 6, 2023
Medical Devices, Health, Clinical Trials, General Health, Cardiology, Biotechnology, Neuromodulation, Brain, Cerebral palsy, Clinical trial, FDA, Heart, Stroke, Urinary incontinence, Multiple sclerosis, Urinary bladder, Cord, Cauda equina syndrome, Skin, Trial of the century, SCIP, Spinal cord, Pharmaceutical industry, Pediatrics

SpineX Inc. is today announcing close to full recruitment -- over 80% -- of the patient cohort for its clinical trial of its proprietary SCONE™ device.

Key Points: 
  • SpineX Inc. is today announcing close to full recruitment -- over 80% -- of the patient cohort for its clinical trial of its proprietary SCONE™ device.
  • The clinical trial— Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE “CONTINENCE” Clinical Study — began in May 2022 and is expected to complete in early 2024.
  • SpineX scientists and researchers anticipate participants will experience a statistically significant improvement in symptoms of neurogenic bladder as assessed by the Neurogenic Bladder Symptom Score (NBSS).
  • SpineX anticipates beginning a multi-center pivotal trial for children with Cerebral Palsy in 2024.

Assent Named a Leader in Product Compliance Solutions by Independent Research Firm Verdantix

Retrieved on: 
Thursday, November 9, 2023
Chemicals, Plastics, Environmental, Social and Governance (ESG), Retail, Data Management, Green Technology, Sustainability, Manufacturing, Technology, Professional Services, Supply Chain Management, Environment, Environmental Health, Transport, Other Manufacturing, Software, Logistics, REACH, Research, Data management, Multimedia, SCIP, Risk, PFAS, Electronics, Cryptocurrency, Audit, Cosmetics

"As new regulations continue to be released and existing regulations amended, firms require digital tools to gain clarity over their regulatory obligations and to manage risk to their business.” -- Verdantix, Smart Innovators: Product and Chemical Compliance Solutions, November 2023 (Graphic: Business Wire)

Key Points: 
  • Assent, Inc. announced today that independent research firm Verdantix recognized the company as a leader in the product compliance space in the recently released Smart Innovators: Product and Chemical Compliance Solutions report.
  • Key takeaways from the report include:
    Assent received the top scores in the product compliance sub-categories, confirming the platform’s position as a market leader in a field of 19 vendors.
  • Assent scored at least three out of four (defined as meeting the full Verdantix criteria for a comprehensive solution) in any product compliance category.
  • “This report validates Assent’s market leadership across the most critical aspects of product compliance that companies face today.

Micas Networks Releases Industry’s First 51.2T Co-Packaged Optics Network Switch System

Retrieved on: 
Tuesday, October 17, 2023
Engineering, Open Compute Project, TBPS, CPO, CMO, Marketing, SCIP, SAN, Software, Silicon, Video game, Package, Broadcom Inc.

SAN JOSE, Calif., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Micas Networks (Micas) today announced it has collaborated with Broadcom Inc. to introduce the industry’s first 51.2T co-packaged optics (CPO) switch and accelerate the adoption of CPO network switches for AI/ML cloud infrastructures.

Key Points: 
  • SAN JOSE, Calif., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Micas Networks (Micas) today announced it has collaborated with Broadcom Inc. to introduce the industry’s first 51.2T co-packaged optics (CPO) switch and accelerate the adoption of CPO network switches for AI/ML cloud infrastructures.
  • Micas defined the system architecture of the new switch, working closely with Broadcom, to develop hardware and software for field deployment of the 51.2 Tbps (51.2T) CPO switch system.
  • Micas also verified the design and will provide the fully tested CPO switch system.
  • “We strive to deliver fast time-to-market and to shrink development cycles down to nine months while working with leading technologies,” said Max Simmons, CMO of Micas Networks.

SpineX Receives NIH SBIR Phase II Award for SCiP Clinical Trial in Children With CP

Retrieved on: 
Tuesday, September 26, 2023
Research, Medical Devices, Children, Neurology, Clinical Trials, Health Technology, Biotechnology, Consumer, Health, Science, US Foods, SBIR, Spinal cord, SCIP, Clinical trial, CP, Multimedia, Brain, Bangladesh Technical Education Board, Small Business Innovation Research, Cerebral palsy, Breakthrough, Small business, Movement disorder, FDA, NIH, Food, Safety, Pharmaceutical industry

These funds will go towards completing a pivotal clinical trial to test the efficacy and safety of our proprietary SCiP™ device in children living with Cerebral Palsy (CP).

Key Points: 
  • These funds will go towards completing a pivotal clinical trial to test the efficacy and safety of our proprietary SCiP™ device in children living with Cerebral Palsy (CP).
  • In investigational studies, SCiP technology has demonstrated the ability to treat the root cause of CP through spinal cord neuromodulation.
  • “We are honored to receive Phase II funding through the SBIR program,” says Kara Allanach, Director of Product at SpineX.
  • SpineX plans to begin recruiting participants for the SCiP pivotal trial in the first half of 2024 and is aiming to launch SCiP therapy in the US market in 2026.

Prime Medicine Reports Second Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Monday, August 7, 2023
Myelodysplastic syndrome, Exercise, Chronic granulomatous disease, Partnership, Gene, SCIP, Eye, Immunotherapy, G&A, Toxicity, Research, Economics, CD34, Acute myeloid leukemia, Transplant, MDS, Health, AML, Investment, Patient, Cancer, Annual general meeting, Cell, CGD, American Society of Gene and Cell Therapy, Liver, Prime editing, HSC, R, Therapy, CD117, Society, DSM-IV codes, D, Medical device, Pharmaceutical industry, Vaccine, Video game, Cryptocurrency, IND

CAMBRIDGE, Mass., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results and provided business updates for the second quarter ended June 30, 2023.

Key Points: 
  • In May 2023, Prime Medicine presented new preclinical data at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting.
  • Prime Medicine expects the following activities and next steps to drive the Prime Editing platform forward:
    Initiate investigational new drug (IND)-enabling studies for PM359 in CGD in 2023.
  • Maximize Prime Editing’s broad therapeutic potential and create value through strategic business development that extends the reach and impact of Prime Editing to areas beyond Prime Medicine’s current areas of focus.
  • Second Quarter 2023 Financial Results:
    R&D Expenses: Research and development (R&D) expenses were $34.6 million for the three months ended June 30, 2023, as compared to $18.9 million for the three months ended June 30, 2022.

Leading MedTech Company SpineX Releases Groundbreaking Results of New Cerebral Palsy Therapies

Retrieved on: 
Thursday, July 27, 2023
Research, General Health, Pharmaceutical, Consumer, Medical Devices, Hospitals, Health Technology, Children, Science, Surgery, Biotechnology, Health, Life, SCIP, Parent, Spinal cord, Stroke, CP, Spine, Crutch, Multimedia, Rehabilitation, Brain, Multiple sclerosis, Movement, Cauda equina syndrome, US, Jess, Publication, Patient, Neuromodulation, Hearing, Child, Cerebral, Disease, Pharmaceutical industry, Frontiers

View the full release here: https://www.businesswire.com/news/home/20230727598285/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230727598285/en/
    SpineX technology has been proven to treat the root cause of CP through spinal cord neuromodulation.
  • (Graphic: Business Wire)
    Frontiers is a leading journal in its field, publishing rigorously peer-reviewed research in rehabilitation from biological, clinical, and socio-humanistic perspectives.
  • The company has been conducting clinical trials of its non-invasive therapy platforms which have the potential to dramatically improve the lives of children living with CP.
  • SpineX plans on conducting a multisite trial starting in 2024 following which it will approach the US FDA for regulatory approval.

Sapiens Strengthens Presence in DACH for Further Growth & Expansion Across the Region

Retrieved on: 
Friday, June 23, 2023
Insurance, Senior, Life, SCIP, Policy, Site manager, P&C, SPNS, Acquisition, TASE, Knowledge, Digital, Sapiens International Corporation, DACH, Sapiens, Reinsurance

HAMBURG, Germany and NEW YORK, June 23, 2023 /PRNewswire/ -- Sapiens International Corporation, (NASDAQ: SPNS) (TASE: SPNS), a leading global provider of software solutions for the insurance industry, has significantly strengthened its presence in DACH countries, as it furthers its strategy to expand business and provide more innovative technology to the region's insurance market. Sapiens has made significant investment in the region expanding its P&C and Digital products and increasing its sales and support team. Sapiens intends to continue developing its offering beyond P&C, Digital and Reinsurance, into life & annuities solutions in the future.

Key Points: 
  • Sapiens has made significant investment in the region expanding its P&C and Digital products and increasing its sales and support team.
  • Sapiens intends to continue developing its offering beyond P&C, Digital and Reinsurance, into life & annuities solutions in the future.
  • Sapiens already has significant operations in the DACH region following the acquisition of Germany-based sum.cumo in 2020.
  • sum.cumo is fully integrated into the Sapiens organization enabling the company to offer both its IDITSuite and SCIP solutions to DACH region insurers.