Surgical mesh

TELA Bio Announces U.S. Commercial Launch of LIQUIFIX™ – the Only FDA-Approved Liquid Adhesive for Internal Use in Hernia Surgery

Retrieved on: 
Thursday, March 21, 2024
Vein, Consultant, Risk, Anatomy, Surgical mesh, Trauma, Chronic pain, Artery, Surgeon, AMS, FDA, Inguinal hernia, Suture

(NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced the U.S. launch of LIQUIFIX FIX8™ Laparoscopic and LIQUIFIX Precision™ Open Hernia Mesh Fixation Devices.

Key Points: 
  • (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced the U.S. launch of LIQUIFIX FIX8™ Laparoscopic and LIQUIFIX Precision™ Open Hernia Mesh Fixation Devices.
  • LIQUIFIX FIX8 is indicated for minimally invasive femoral and inguinal hernia repairs; and LIQUIFIX Precision is indicated for open femoral and inguinal hernia repairs.
  • The LIQUIFIX devices are the only FDA-approved devices that affix mesh and approximate peritoneal tissue with liquid anchors.
  • LIQUIFIX hernia mesh fixation devices eliminate the need for penetrating mechanical tacks, sutures, or staples by delivering a liquid adhesive that allows for precise and controlled mesh fixation.

Global Bioplastics & Biopolymers Market Report 2022-2023 & 2027 - Opportunities in the Development of Newer Applications and High Potential in Emerging Economies

Retrieved on: 
Saturday, February 11, 2023
PBAT, Final good, Biopolymer, Government, Bioplastic, PHA, Food packaging, Agriculture, Region, Horticulture, PBS, Coating, Polymer, BASF SE, Food, Petroleum, USD, Automotive industry, Toray Industries, Transport, BASF, Plastic, Farmer, Biodegradation, Surgical mesh, Soil, NatureWorks, Recycling, Flour, Cassava, Textile

The global market size of bioplastics & biopolymers was USD 11.5 billion in 2022 and is projected to reach USD 27.3 billion by 2027, at a CAGR of 18.9%, during the same period.

Key Points: 
  • The global market size of bioplastics & biopolymers was USD 11.5 billion in 2022 and is projected to reach USD 27.3 billion by 2027, at a CAGR of 18.9%, during the same period.
  • The key drivers of the bioplastics & biopolymers market are the increased use of bioplastics in the packaging end-use industry, increased focus of government on green procurement policies and regulations.
  • North America is the second-largest bioplastics & biopolymers market in terms of value, in 2021.
  • The countries in the region have already started implementing new regulations that promote the wide use of bioplastic materials.

Correcting & Replacing -- Celularity Receives Preliminary Assessment of Product Classification and Jurisdiction for Its Investigational Celularity Tendon Wrap (CTW) to be Regulated as a Device Within U.S. Food and Drug Administration (FDA) Center for Dev

Retrieved on: 
Thursday, February 2, 2023
CDRH, Fibrosis, Placenta, Food, Surgical mesh, CELU, Classification, FDA Center for Devices and Radiological Health, Wound healing, Device, Cytokine, Degenerative disease, Chemokine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Scar, Instituto de Biologia Molecular e Celular, Cell, Research, CTW, Medical device

FLORHAM PARK, N.J., Feb. 02, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, announced today that, in response to its October 2022 Pre-Request for Designation (Pre-RFD) for its investigational Celularity Tendon Wrap (CTW), the U.S. Food and Drug Administration (FDA) has reviewed information provided by the Company and other relevant available information, and agreed with the Company’s recommendation that its investigational CTW product be regulated as a device by the FDA Center for Devices and Radiological Health (CDRH). The FDA feedback is preliminary and non-binding. Celularity intends to submit a 510(k) application for regulatory clearance to CDRH by the end of 2023.

Key Points: 
  • Celularity intends to submit a 510(k) application for regulatory clearance to CDRH by the end of 2023.
  • “We are delighted to receive this feedback from the FDA on preliminary CTW product classification and CDRH jurisdiction,” said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder.
  • “Our unique business model continues to generate innovative therapeutic products from the biomaterials and stem, progenitor and immune cells derived from the placenta.
  • In terms of regional breakdown, in 2021 North America accounted for the highest revenue share, $821.1 million or 45.2 percent.

Celularity Receives Preliminary Assessment of Product Classification and Jurisdiction for Its Investigational Celularity Tendon Wrap (CTW) to be Regulated as a Device Within U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Heal

Retrieved on: 
Wednesday, February 1, 2023
CDRH, Fibrosis, Placenta, Food, Surgical mesh, CELU, Classification, FDA Center for Devices and Radiological Health, Wound healing, Device, Cytokine, Degenerative disease, Chemokine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Scar, Instituto de Biologia Molecular e Celular, Cell, Research, CTW, Medical device

FLORHAM PARK, N.J., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, announced today that, in response to its October 2022 Pre-Request for Designation (Pre-RFD) for its investigational Celularity Tendon Wrap (CTW), the U.S. Food and Drug Administration (FDA) has reviewed information provided by the Company and other relevant available information, and agreed with the Company’s recommendation that its investigational CTW product be regulated as a device by the FDA Center for Devices and Radiological Health (CDRH). The FDA feedback is preliminary and non-binding. Celularity intends to submit a 510(k) application for regulatory clearance to CDRH by the end of 2023.

Key Points: 
  • Celularity intends to submit a 510(k) application for regulatory clearance to CDRH by the end of 2023.
  • “We are delighted to receive this feedback from the FDA on preliminary CTW product classification and CDRH jurisdiction,” said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder.
  • “Our unique business model continues to generate innovative therapeutic products from the biomaterials and stem, progenitor and immune cells derived from the placenta.
  • In terms of regional breakdown, in 2021 North America accounted for the highest revenue share, $821.1 million or 45.2 percent.

TELA Bio Announces Publication of 24-Month BRAVO Study Results Demonstrating Benefits of OviTex® Reinforced Tissue Matrix in Hernia Repair

Retrieved on: 
Wednesday, October 26, 2022
Hernia, Company, 1S, Security (finance), CDC, U.S. Securities and Exchange Commission, Weakness, NASDAQ, Obesity, IceWall SSO, CEO, Recurrence, General surgery, Surgical mesh, Sheep, FACS, St. Francis Hospital, SSO, Annual report, Patient, Private Securities Litigation Reform Act, Risk, Quality of life, Research, GLOBE, Anatomy, Infection, Use, Coronary artery disease, Surgeon, BRAVO, COPD, Abdominal wall, Diabetes, Dentistry, Pharmaceutical industry, Medical device, Medical imaging, MD, Medicine

Our results provide evidence that OviTex 1S Permanent in ventral hernia repair results in a low rate of recurrence and improved quality of life for patients over a two-year period.

Key Points: 
  • Our results provide evidence that OviTex 1S Permanent in ventral hernia repair results in a low rate of recurrence and improved quality of life for patients over a two-year period.
  • We are very proud to share the full, final results of our BRAVO study, stated Antony Koblish, President and CEO of TELA Bio.
  • This commitment continues with our ongoing BRAVO II study which will evaluate the use of OviTex in robot-assisted ventral and inguinal hernia repairs.
  • OviTex Reinforced Tissue Matrix is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists.

The Plastic Surgery Foundation receives FDA approval to conduct multicenter study of ADM and surgical mesh used in breast reconstruction

Retrieved on: 
Thursday, October 13, 2022
Medicine, PMA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Bias, Volunteering, Patient, Society, Hospital, MBA, Research, MPH, Partnership, Surgical mesh, American Society of Plastic Surgeons, Food, Learning, ADMS, ADM, Safety, ASPS, Clinical trial, Observational study, Plastic, Investigational device exemption, FDA, IDE, Surgeon, PSF, Leadership, Medical device, MD

ARLINGTON HEIGHTS, Ill., Oct. 13, 2022 /PRNewswire-PRWeb/ -- The Plastic Surgery Foundation (PSF) received approval from the U.S. Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application and will now proceed as sponsor of a prospective, multicenter observational trial studying the impact of acellular dermal matrix (ADM) and surgical mesh in implant-based breast reconstruction.

Key Points: 
  • Surgical mesh devices whether synthetic, animal or human collagen-derived have not yet received FDA approval for any breast reconstruction indication.
  • Currently, surgeons, hospitals and other facilities may elect to use these devices in breast reconstruction or other breast surgery via "off-label" use.
  • "The PSF's partnership with FDA on this study will hopefully finally yield approval for these important devices in breast reconstruction surgery," Dr. Glasberg adds.
  • The Plastic Surgery Foundation (The PSF) supports the research and international activities of the American Society of Plastic Surgeons (ASPS) members.

TELA Bio Highlights Results from BRAVO and ReBAR Studies on the Benefits of OviTex® Reinforced Tissue Matrix in Hernia Repairs; Data to Be Presented at 2022 American Hernia Society (AHS) Meeting

Retrieved on: 
Thursday, August 4, 2022
Diabetes, Medicine, Coronary artery disease, BRAVO, Private Securities Litigation Reform Act, Security (finance), SSO, Annual report, Rebar, Hernia, Recurrence, Quality of life, COPD, Foreign Bodies, AHS, Anatomy, 1S, Risk, Use, Patient, Company, Obesity, U.S. Securities and Exchange Commission, Surgical mesh, Sheep, Journal, Research, Solution, Health, Weakness, GLOBE, CEO, CDC, Surgeon, Abdominal wall, Inguinal hernia surgery, IceWall SSO, NASDAQ, Pharmaceutical industry, Medical imaging

MALVERN, Pa., Aug. 04, 2022 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative technologies that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy, today announced that two studies examining clinical outcomes with use of its OviTex Reinforced Tissue Matrix will be presented at the 2022 American Hernia Society (AHS) Meeting.

Key Points: 
  • The conference, taking place from September 14-16, 2022, in Charlotte, North Carolina, will highlight the outcomes of two studies that underscore the efficacy of OviTex.
  • OviTex 1S Permanent demonstrated a 2.6% recurrence rate in ventral hernias repaired using open, laparoscopic, or robotic techniques at the 24-month time point.
  • These BRAVO 24-Month results follow the publication of the BRAVO 12-Month study, released in November 2021 in the Journal of Clinical Medicine .
  • OviTex Reinforced Tissue Matrix is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists.

Redesigning the Future of Aesthetic Medicine: Bellesoma® Welcomes Industry Leader, Vincent Wu, as New Chief Commercial Officer

Retrieved on: 
Monday, August 1, 2022
AI, Surgeon, Skin, Human, Business, Surgical mesh, Woman, CEO, Social media, Breast, Kelley School of Business, Technology, MBA, Reduction, Patient, Heart, Foreign Bodies, NP-hardness, Neck, IOT, Fudan University, Medical device, Management, Birth control, Mastopexy, Biotechnology

Wu is an industry disruptor, having already applied his marketing philosophies to multiple global businesses delivering results at a multibillion-dollar level.

Key Points: 
  • Wu is an industry disruptor, having already applied his marketing philosophies to multiple global businesses delivering results at a multibillion-dollar level.
  • "We're excited and lucky to have Vincent join our team," said Adam Cohen, CEO of Bellesoma.
  • "Startups are always a challenging business, and even the best of them can falter without a strong vision and a fantastic team.
  • Before joining Bellesoma, Vincent also helped create the first IOT home dialysis solution, along with new business models of hospital consultancy.

Medtronic announces FDA approval of spinal cord stimulation therapy for treating chronic pain resulting from diabetic peripheral neuropathy

Retrieved on: 
Monday, January 24, 2022
Disability, Neuromodulation, Patient, Diabetic neuropathy, Systematic review, LinkedIn, DPN, Peripheral neuropathy, Meta-analysis, SCS, Glucose, NYSE, Neuroscience, PDN, Spinal cord stimulator, Solution, Chronic pain, Hypoesthesia, Diabetes, U.S. Securities and Exchange Commission, Health, Surgical mesh, Pain, Hospital, Quality of life, American Diabetes Association, MRI, Food and Drug Administration, Risk, Food, Treatment, Twitter, Health care, Infection, Neurological disorder, Security (finance), Hyperreflexia, The Fear Is Excruciating, but Therein Lies the Answer, Pharmaceutical industry, Medical device, Dentistry, Medtronic

DUBLIN, Jan. 24, 2022 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration approval of its Intellis™ rechargeable neurostimulator and Vanta™ recharge-free neurostimulator for the treatment of chronic pain associated with diabetic peripheral neuropathy (DPN).

Key Points: 
  • Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomized clinical trial.
  • Spinal Cord Stimulation and Pain Relief in Painful Diabetic Peripheral Neuropathy: A Prospective Two-Center Randomized Controlled Trial.
  • Spinal cord stimulation for the management of painful diabetic neuropathy: a systematic review and meta-analysis of individual patient and aggregate data.
  • Severity of Neuropathy Is Associated With Long-term Spinal Cord Stimulation Outcome in Painful Diabetic Peripheral Neuropathy: Five-Year Follow-up of a Prospective Two-Center Clinical Trial.

Global Soft Tissue Repair Market Report 2021: Market is Expected to Reach $13.17 Billion in 2025 - Forecast to 2030 - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 2, 2021
Medical Devices, Health, Tissue, Sport, Asia, Safety, Surgical mesh, ACell, Acquisition, Hospital, Compliance, Prevalence, PMA, COVID-19, Electrode, Research, Extracellular matrix, Integra, Merck KGaA v. Integra Lifesciences I, Ltd., Injury, Organization, FDA, Connective tissue, Growth, Tissue paper

The soft tissue repair market consists of sales of soft tissue repair by entities (organizations, sole traders, and partnerships) that manufacture soft tissue repair products.

Key Points: 
  • The soft tissue repair market consists of sales of soft tissue repair by entities (organizations, sole traders, and partnerships) that manufacture soft tissue repair products.
  • The main types of soft tissue repair products include fixation devices, tissue patch or mesh, laparoscopic instruments.
  • The soft tissue repair is used in hernia repair, dural repair, skin repair, vaginal sling procedures, orthopedic repair, dental repair, breast reconstruction repair.
  • Major companies operating in the soft tissue repair sector are focused on developing a technologically advanced solution for soft tissues.