Cosmesis

Accuray CyberKnife® and TomoTherapy® Platforms Featured in More Than 55 Abstracts Presented at ESTRO 2023, Reinforcing Systems' Versatility, Efficiency and Effectiveness

Retrieved on: 
Wednesday, May 17, 2023
Pancreatic cancer, Cyberknife, SBRT, Abstract, CE, Deep inspiration breath-hold, SRS, Radiation, Health care, DIBH, Prostate cancer, Metastasis, Cosmesis, Cancer, Quality of life, Lung cancer, Toxicity, MBA, Brain, Prostate, Sale, Movement, Synchrony, Radiation therapy, Motion, LINAC, Patient, Tomotherapy, Breast, Ultra, Accuracy and precision, Neoplasm, European Society for Medical Oncology, Congress, Health, Recurrence, Melphalan, Safety, Pharmaceutical industry, Medical imaging, Medical device, Dairy, Accuray

SUNNYVALE, Calif., May 17, 2023 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that new data presented at the European Society for Radiotherapy and Oncology (ESTRO) meeting reinforces the benefits of the company's CyberKnife® and TomoTherapy® platforms, including the latest generation Radixact® System. More than 55 abstracts highlighting Accuray technologies were presented at the 2023 ESTRO annual congress held in Vienna, Austria, from May 12 to May 16, 2023, building on existing clinical evidence and supporting the systems' use to deliver (ultra) hypofractionated radiation treatments for the precise and personalized treatment of a wide range of cancers.

Key Points: 
  • During the meeting, Accuray hosted a symposium titled " Advances in Hypofractionation for Breast and Prostate Cancer " featuring clinical experts who discussed the most recent – and promising – clinical studies.
  • "The information sharing that takes place at meetings such as ESTRO is focused on the same critical goal – improving patient care.
  • Delivering ablative doses to target spinal metastases, ensuring good local control and low rates of toxicity while protecting critical organs5.
  • It is not CE marked and availability is subject to regulatory clearance or approval in some markets.

MOLLI Surgical Launches Breakthrough Products to Simplify Breast Cancer Surgery and Deliver a Better Patient Experience

Retrieved on: 
Tuesday, April 4, 2023
Cosmesis, Surgeon, Radiology, Patient, Physician, Medical imaging

DEERFIELD, Ill., April 4, 2023 /PRNewswire-PRWeb/ -- MOLLI Surgical, the company that is pushing the boundaries of precision surgery, today announced the launch of two new products, MOLLI 2® and MOLLI re.markable™. The latest products, including the industry's first tool that ensures lesions are accurately marked, are paving the way for the next generation of healthcare. They deliver on the company's commitment to elevate the patient experience, refine precision surgery, and boost physicians' confidence.

Key Points: 
  • DEERFIELD, Ill., April 4, 2023 /PRNewswire-PRWeb/ -- MOLLI Surgical , the company that is pushing the boundaries of precision surgery, today announced the launch of two new products, MOLLI 2® and MOLLI re.markable™.
  • They deliver on the company's commitment to elevate the patient experience, refine precision surgery, and boost physicians' confidence.
  • The MOLLI Marker is the smallest on the market and precisely marks where lesions are located before breast cancer surgery.
  • The launch of MOLLI 2 and MOLLI re.markable will improve the patient experience by creating the simplest possible process for accurate breast surgery."

MediWound Announces FDA Approval of NexoBrid® for the Treatment of Severe Thermal Burns in Adults

Retrieved on: 
Thursday, December 29, 2022
Vericel, Office of Inspector General, U.S. Department of Health and Human Services, NEXT, TBSA, Administration, Cosmesis, Food, Burn, MD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ASPR, BLA, SOC, Regeneration, MCM, Trial of the century, Patient, Development, Eschar, HHS, Safety, Bromelain (pharmacology), FDA, Body surface area, Union, Incidence, Debridement, BARDA, Pharmaceutical industry

YAVNE, Israel, Dec. 29, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

Key Points: 
  • “We are pleased and excited that the FDA has approved NexoBrid, an innovative, non-surgical alternative for the treatment of severe burn injuries,” said Ofer Gonen, Chief Executive Officer of MediWound.
  • We also thank our partner, BARDA, for their unwavering support since 2015, and our commercial partner, Vericel, who will launch NexoBrid in the U.S.
  • This U.S. FDA approval of NexoBrid validates our enzymatic technology platform.
  • MediWound will receive a $7.5 million milestone payment from Vericel Corporation, triggered by the FDA approval of NexoBrid.

EMA Provides Regulatory Path for Pediatric Label Extension for NexoBrid

Retrieved on: 
Thursday, November 18, 2021
Patient, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Burn, Government, Trial of the century, Bleeding, Review, Safety, Regeneration, Phrase, Company, Debridement, European Directive on Traditional Herbal Medicinal Products, Committee, HHS, Eschar, Contract, Cosmesis, Annual report, BARDA, COVID-19, Bromelain (pharmacology), Office of Inspector General, U.S. Department of Health and Human Services, CHMP, Research, Form 20-F, GLOBE, Adult, Incidence, EMA, Vericel, Development, Union, FDA, SOC, Committee for Medicinal Products for Human Use, Assistant, ASPR, Growth, Standard of care, Biomedical Advanced Research and Development Authority, Pharmaceutical industry, Medical imaging

Based on the feedback, the Company anticipates submitting a pediatric label extension request in the first half of 2022.

Key Points: 
  • Based on the feedback, the Company anticipates submitting a pediatric label extension request in the first half of 2022.
  • We are very pleased to have received support and positive guidance from the CHMP on the regulatory pathway towards a pediatric label extension for NexoBrid, said Sharon Malka, Chief Executive Officer of MediWound.
  • NexoBrid growth in Europe has been strong, and with the potential pediatric label extension, our commercial team and distribution partners are looking forward to expanding the market and continuing to improve on the standard of care.
  • NexoBrid demonstrated a significant reduction in time to achieve complete eschar removal and significant reduction in wound area requiring surgical excision (surgical need) while demonstrating non-inferiority to SOC in quality of scars.

Hologic Debuts Documentary-Style Film Highlighting One Woman's Breast Cancer Journey Timed to Breast Reconstruction Awareness Day

Retrieved on: 
Wednesday, October 20, 2021
Film & Motion Pictures, Health, General Health, Women, Radiology, Online, Entertainment, Oncology, Medical Devices, Surgery, Consumer, Moonlight, Linda, Society, Awareness, Woman, Survivor, HOLX, Breast cancer, View, News, Parkview Health, Diagnosis, Poster, Deformity, Science, Radiation, CCO, Surgeon, Sale, Scar, Breast, Imaging, Nasdaq, Titanium, Patient, Partnership, Cancer, Breast Cancer Awareness Month, Cosmesis, Decision-making, Medical imaging, Public relations

Released on the Mediflix streaming platform timed to Breast Reconstruction Awareness Day (Oct. 20), Carolina follows a fictional patient through her cancer diagnosis and treatment, and features testimonials from real breast cancer survivors and clinicians about the physical and emotional experiences that women overcome throughout their breast cancer battle.

Key Points: 
  • Released on the Mediflix streaming platform timed to Breast Reconstruction Awareness Day (Oct. 20), Carolina follows a fictional patient through her cancer diagnosis and treatment, and features testimonials from real breast cancer survivors and clinicians about the physical and emotional experiences that women overcome throughout their breast cancer battle.
  • Women are faced with so many options and opinions when it comes to breast cancer treatment, which can be overwhelming and emotionally taxing.
  • This film helps educate women about their options for breast cancer surgery and breast reconstruction, reinforcing the fact that they dont need to sacrifice their confidence to live a healthy life.
  • Post-surgery appearance is one concern several survivors share in the film, as many associate breast cancer surgeries with scarring and indentations where the cancer was removed.

Vericel Announces Submission of Biologics License Application to the FDA for NexoBrid for the Treatment of Severe Thermal Burns

Retrieved on: 
Tuesday, June 30, 2020
Medicine, Clinical medicine, Health, Bromelain, Hydrolases, Wound, Debridement, Cosmesis, Thermal burn

Vericel holds an exclusive license for North American commercial rights to NexoBrid.

Key Points: 
  • Vericel holds an exclusive license for North American commercial rights to NexoBrid.
  • A key safety endpoint, non-inferiority in time to complete wound closure compared with patients treated with SOC, was also achieved.
  • Long-term follow-up data to assess cosmesis, function, and quality of life, including 12-month results from the DETECT study, were also included in the submission.
  • The company also holds an exclusive license for North American commercial rights to NexoBrid, a registration-stage biological orphan product for debridement of severe thermal burns.