Breakthrough

Anika Completes Enrollment in Hyalofast® U.S. Pivotal Phase III Study Achieving Key Milestone

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Tuesday, May 30, 2023
Debridement, Surgeon, File, Elective surgery, Lead, Hyaluronic acid, Cartilage, Pain, PMA, BMAC, Patient, FDA, Therapy, Breakthrough, Medical device, Dentistry, Pharmaceutical industry

BEDFORD, Mass., May 30, 2023 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company focused on early intervention orthopedics, today announced that it has completed enrollment of the pivotal Phase III clinical study for Hyalofast (Hyalofast 15-01) on its path to achieving FDA approval in the United States.

Key Points: 
  • We believe that Hyalofast will drive significant market expansion and further accelerate our company’s growth in the coming years.
  • FDA has granted Anika Breakthrough Device Designation for the Hyalofast plus autologous bone marrow aspirate concentrate (BMAC) combination product.
  • This allows Anika to file product and manufacturing information while continuing to collect and analyze clinical data, making the regulatory review process more efficient.
  • While widely used to treat insufficiency fractures, it is also indicated for use with the augmentation of hardware, such as suture anchors.

BNBuilders breaks ground on Office to Lab Conversion in Boulder, Colorado

Retrieved on: 
Wednesday, May 31, 2023
3D, CO, Breakthrough, 3D printing

BOULDER, Colo., May 31, 2023 /PRNewswire/ -- BNBuilders has begun construction on a 35,000 sf property for Breakthrough Properties in Boulder, CO.

Key Points: 
  • BOULDER, Colo., May 31, 2023 /PRNewswire/ -- BNBuilders has begun construction on a 35,000 sf property for Breakthrough Properties in Boulder, CO.
  • Known for their contributions to the life science market in Southern California, Breakthrough's expansion to Boulder is indicative of the growing life science sector in Colorado.
  • Collaborative scheduling and coordination are crucial to the project as the building will stay occupied by several current tenants throughout construction.
  • BNBuilders broke ground in April 2023 with completion expected by the end of 2023.

Pulse Medical receives FDA Breakthrough Device Designation for its μFR® system

Retrieved on: 
Friday, May 26, 2023
Pressure, Classification, Physiology, MACE, FFR, PCI, Therapy, Patient, Physician, Risk, Diagnosis, FDA, Cardiovascular disease, Death, Breakthrough, Medical device, Medical imaging

SHANGHAI, May 26, 2023 /PRNewswire/ -- Pulse Medical Technology, Inc. (Pulse Medical) 4th generation μFR® system has received an FDA Breakthrough Device designation.

Key Points: 
  • SHANGHAI, May 26, 2023 /PRNewswire/ -- Pulse Medical Technology, Inc. (Pulse Medical) 4th generation μFR® system has received an FDA Breakthrough Device designation.
  • Pulse Medical, founded in 2015, located in Shanghai, China, is dedicated to developing innovative technology for precise diagnosis and optimal treatment of patients with pan-vascular disease.
  • Pulse Medical has been pioneering and invented the key algorithm of μFR®, the fast computation methodology of fractional flow reserve (FFR) from multiple imaging data.
  • The classification enables a coordinated and expedited review process with FDA, accelerating the commercialization of Pulse Medical.

Pulse Medical receives FDA Breakthrough Device Designation for its μFR® system

Retrieved on: 
Friday, May 26, 2023
Pressure, Classification, Physiology, MACE, FFR, PCI, Therapy, Patient, Physician, Risk, Diagnosis, FDA, Cardiovascular disease, Death, Breakthrough, Medical device, Medical imaging

SHANGHAI, May 26, 2023 /PRNewswire/ -- Pulse Medical Technology, Inc. (Pulse Medical) 4th generation μFR® system has received an FDA Breakthrough Device designation.

Key Points: 
  • SHANGHAI, May 26, 2023 /PRNewswire/ -- Pulse Medical Technology, Inc. (Pulse Medical) 4th generation μFR® system has received an FDA Breakthrough Device designation.
  • Pulse Medical, founded in 2015, located in Shanghai, China, is dedicated to developing innovative technology for precise diagnosis and optimal treatment of patients with pan-vascular disease.
  • Pulse Medical has been pioneering and invented the key algorithm of μFR®, the fast computation methodology of fractional flow reserve (FFR) from multiple imaging data.
  • The classification enables a coordinated and expedited review process with FDA, accelerating the commercialization of Pulse Medical.

Updated Data from Part A of Verastem Oncology's RAMP 201 Trial Show an Objective Response Rate of 45% in Patients with Recurrent Low-Grade Serous Ovarian Cancer Treated with Avutometinib and Defactinib

Retrieved on: 
Thursday, May 25, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, KRAS, Bevacizumab, FRCP, Verastem Oncology, MBBS, Avutometinib, Diarrhea, Xeroderma, Ovarian cancer, Safety, Survival, Cancer, PO, Woman, Royal Marsden Hospital, The Institute, FRAME, MEK, CPK, Rash, EMA, ORR, Vomiting, Peripheral edema, RAMP, Patient, Blood, Memorial Sloan Kettering Cancer Center, NHS foundation trust, MA, Nausea, Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Breakthrough, Food, Fatigue, Pharmaceutical industry, Medical device, Part

In the RAMP 201 study, treatment with the combination of avutometinib and defactinib resulted in an objective response rate (ORR) of 45% (13/29) and tumor shrinkage in 86% (25/29) of evaluable patients.

Key Points: 
  • In the RAMP 201 study, treatment with the combination of avutometinib and defactinib resulted in an objective response rate (ORR) of 45% (13/29) and tumor shrinkage in 86% (25/29) of evaluable patients.
  • RAMP 201 is an international registration-directed Phase 2 study evaluating the safety and efficacy of avutometinib (VS-6766) alone and in combination with defactinib among patients with recurrent LGSOC.
  • The discontinuation rate, due to ≥ 1 adverse event, was 12% in the trial overall to date (4.9% due to elevated blood CPK).
  • These results indicate that the combination of avutometinib and defactinib shows promise as a tolerable treatment with impressive response rates for women with recurrent LGSOC.

Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging System

Retrieved on: 
Monday, May 22, 2023
Diagnosis, Breakthrough, LOS, FDA, Moles, Melanoma, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Physician, Food, Biopsy, Pharmaceutical industry, Medical imaging

LOS GATOS, Calif., May 22, 2023 /PRNewswire/ -- Orlucent, Inc., a company focused on clinical assessment of suspicious moles, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's Orlucent® Skin Fluorescence Imaging System.

Key Points: 
  • LOS GATOS, Calif., May 22, 2023 /PRNewswire/ -- Orlucent, Inc., a company focused on clinical assessment of suspicious moles, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's Orlucent® Skin Fluorescence Imaging System.
  • The Orlucent system is a handheld point-of-care molecular-based imaging system designed to noninvasively identify and clinically assess the presence of biological tissue remodeling activity associated with the development of atypical moles in adults.
  • The designation allows a collaborative and streamlined review pathway with FDA so the Orlucent technology can get to the market faster.
  • "We are excited the FDA has recognized the Orlucent system as a Breakthrough Device," said Catherine Shachaf, Ph.D., president of Orlucent.

EQS-News: Innolux to Showcase High-Value, Cross-Domain, Sustainable Products and Technologies at SID Display Week 2023

Retrieved on: 
Monday, May 22, 2023
Paper, Digital photo frame, Marketing, Presence (album), Royal College of Emergency Medicine, SID, TFT-LCD, Pioneer, Digital technology, Module, WTSR, Integration, LID, Breakthrough, AR, Television, Professional corporation

MIAOLI, TAIWAN - Media OutReach - 22 May 2023 - Innolux is set to attend the SID Display Week 2023 (Booth# 313) in Los Angeles from May 23 to 25, 2023.

Key Points: 
  • MIAOLI, TAIWAN - Media OutReach - 22 May 2023 - Innolux is set to attend the SID Display Week 2023 (Booth# 313) in Los Angeles from May 23 to 25, 2023.
  • With the theme of "Make for Your Life," Innolux will exhibit a series of display technology applications in smart living.
  • Innolux's "Integrated automotive LID", the world's first-ever single-piece large curved display, is a front-seat display that maximizes information display.
  • Video featuring Innolux's SID products:
    Innolux SID 2023, Make For Your Life - Breakthrough Technologies:

Grünenthal's resiniferatoxin receives Breakthrough Therapy Designation from U.S. FDA for pain associated with osteoarthritis of the knee

Retrieved on: 
Monday, May 22, 2023
Osteoarthritis, Nobel Prize, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Transience, Shionogi, Marketing, Perception, Breakthrough therapy, TRPV1, Temperature, II, Pain, OA, Acquisition, Patient, European, Joint, Nobel Prize in Physiology or Medicine, System, FDA, Breakthrough, RTX, Food, Safety, Knee, Pharmaceutical industry, Medicine, Physiology

Knee osteoarthritis is a progressive condition affecting over 360 million people worldwide and may have severe symptoms, including pain.

Key Points: 
  • Knee osteoarthritis is a progressive condition affecting over 360 million people worldwide and may have severe symptoms, including pain.
  • Grünenthal is running a global Phase III programme to investigate the efficacy and safety of intra-articular injections of resiniferatoxin, a non-opioid therapy, in adults with pain associated with knee osteoarthritis.
  • AACHEN, Germany, May 22, 2023 /PRNewswire/ -- Grünenthal today announced that its investigational non-opioid medicine resiniferatoxin (RTX), currently undergoing clinical Phase III development, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for pain associated with osteoarthritis (OA) of the knee.
  • We are hopeful that the Breakthrough Therapy Designation will help us to bring this non-opioid therapy option more quickly to patients."

Grünenthal's resiniferatoxin receives Breakthrough Therapy Designation from U.S. FDA for pain associated with osteoarthritis of the knee

Retrieved on: 
Monday, May 22, 2023
Osteoarthritis, Nobel Prize, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Transience, Shionogi, Marketing, Perception, Breakthrough therapy, TRPV1, Temperature, II, Pain, OA, Acquisition, Patient, European, Joint, Nobel Prize in Physiology or Medicine, System, FDA, Breakthrough, RTX, Food, Safety, Knee, Pharmaceutical industry, Medicine, Physiology

Knee osteoarthritis is a progressive condition affecting over 360 million people worldwide and may have severe symptoms, including pain.

Key Points: 
  • Knee osteoarthritis is a progressive condition affecting over 360 million people worldwide and may have severe symptoms, including pain.
  • Grünenthal is running a global Phase III programme to investigate the efficacy and safety of intra-articular injections of resiniferatoxin, a non-opioid therapy, in adults with pain associated with knee osteoarthritis.
  • AACHEN, Germany, May 22, 2023 /PRNewswire/ -- Grünenthal today announced that its investigational non-opioid medicine resiniferatoxin (RTX), currently undergoing clinical Phase III development, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for pain associated with osteoarthritis (OA) of the knee.
  • We are hopeful that the Breakthrough Therapy Designation will help us to bring this non-opioid therapy option more quickly to patients."

The CorVista® Analysis provides a supervised machine-learned algorithm to IDENTIFY PH patients with New Onset Symptoms

Retrieved on: 
Sunday, May 21, 2023
Research, Professional Services, Data Management, Medical Devices, Technology, Artificial Intelligence, Health Technology, Data Analytics, Science, Cardiology, FDA, Health, Metadata, ATS, RHC, Cardiovascular disease, Multimedia, Federal, American Thoracic Society, Limited, TTE, Acquisition, PH, Diagnosis, Pulmonary hypertension, Breakthrough, Medical imaging, Pharmaceutical industry, Patient

This proof of concept showcases the effectiveness of a machine learned (ML) phase space electro-mechanical pulse wave analysis to identify pulmonary hypertension (PH) patients with new onset symptoms at the point-of-care.

Key Points: 
  • This proof of concept showcases the effectiveness of a machine learned (ML) phase space electro-mechanical pulse wave analysis to identify pulmonary hypertension (PH) patients with new onset symptoms at the point-of-care.
  • The measurements are used to identify PH patients with new onset symptoms.
  • The study enrolled consecutive patients across US-based healthcare centers who presented symptoms suggestive of PH.
  • “This advancement, when integrated into a point-of-care test, holds great promise for early PH detection within the clinical pathway.”
    Detailed results are available in the attached abstract from the ATS 2023 program: A Supervised Machine-learned Algorithm to IDENTIFY PH in Patients With New Onset Symptoms .