PMDA

NeuroStar TMS Receives Expanded Regulatory Approval in Japan

Retrieved on: 
Monday, December 4, 2023

The features covered in this approval include the NeuroStar 3.7 platform, MT Cap , D-Tect ™ MT Accessory, and the Dash treatment protocol.

Key Points: 
  • The features covered in this approval include the NeuroStar 3.7 platform, MT Cap , D-Tect ™ MT Accessory, and the Dash treatment protocol.
  • The Dash treatment protocol reduces the daily TMS treatment time from 38 minutes to under 19 minutes.
  • NeuroStar TMS Therapy aims to fill this unmet need through its exclusive distribution partnership with Teijin Pharma Limited.
  • NeuroStar is advancing its global strategy and strengthening its global presence with recent announcements of regulatory approval in South Korea , as well as EU-MDR and MDSAP certifications.

Alpha Tau Submits to Japanese PMDA for Pre-Market Approval of Alpha DaRT in Patients with Recurrent Head and Neck Cancer

Retrieved on: 
Monday, November 20, 2023

JERUSALEM, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, and HekaBio K.K.

Key Points: 
  • JERUSALEM, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, and HekaBio K.K.
  • (“HekaBio”) a Japan-based healthcare investment, development and commercialization platform which is partnered with Alpha Tau, announced today that Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) has accepted Alpha Tau’s submission requesting shonin pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer, following multiple pre-submission consultation meetings with the PMDA per common practice in Japan.
  • This submission is based upon Alpha DaRT’s clinical trial results in Japan which exceeded the target endpoints for safety and efficacy in patients with recurrent head and neck cancer.
  • The head and neck cancer indication includes all solid tumor cancer types after prior radiation treatment, including squamous cell carcinoma, basal cell carcinoma, and melanoma.

Alpha Tau Medical Announces Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 16, 2023

JERUSALEM, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, reported third quarter 2023 financial results and provided a corporate update.

Key Points: 
  • - Treated the first patient with advanced inoperable pancreatic cancer at Hadassah Medical Center in Israel in September, alongside safety and feasibility trial in similar indication currently underway in Montreal, Canada -
    JERUSALEM, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, reported third quarter 2023 financial results and provided a corporate update.
  • Planning treatment of the first patient in the Canadian liver metastases safety and feasibility trial in Q4 2023 or Q1 2024.
  • As of September 30, 2023, the Company had cash, restricted cash, deposits and restricted deposits in the amount of $90.1 million, compared to $105.4 million on December 31, 2022.
  • The Company expects that this cash balance will be sufficient to fund operations for at least two years.

Rapid Medical™ Announces Japanese Approval and Exclusive Partnership With Kaneka for TIGERTRIEVER–The World’s Only Adjustable Thrombectomy Device

Retrieved on: 
Wednesday, December 13, 2023

Rapid Medical™ , a leading developer of advanced neurovascular devices, announced Japanese approval for its TIGERTRIEVER revascularization device.

Key Points: 
  • Rapid Medical™ , a leading developer of advanced neurovascular devices, announced Japanese approval for its TIGERTRIEVER revascularization device.
  • With Pharmaceuticals and Medical Devices Agency (PMDA) approval, TIGERTRIEVER serves as the first device to offer individualized solutions for mechanical thrombectomy.
  • TIGERTRIEVER technology is inspired by advancements in aerospace engineering and transforms thrombectomy procedures from a passive to an active approach.
  • The device can be expanded and reduced on demand, activating clot integration and potentially reducing the risk of vessel perforation or damage during device retrieval.

Arcturus Therapeutics Announces Third Quarter 2023 Financial Update and Pipeline Progress

Retrieved on: 
Tuesday, November 14, 2023

“We had considerable progress this quarter expanding our next generation STARR® vaccine platform,” said Joseph Payne, President & CEO of Arcturus Therapeutics.

Key Points: 
  • “We had considerable progress this quarter expanding our next generation STARR® vaccine platform,” said Joseph Payne, President & CEO of Arcturus Therapeutics.
  • ARCALIS Inc., the Company’s manufacturing joint venture in Japan to support the production of mRNA vaccines and therapeutics, continues to make operational progress while also obtaining financial support from the Japanese government.
  • Arcturus achieved a milestone for $35 million and anticipates receipt from CSL in November 2023.
  • Arcturus expects the final database lock to occur in the fourth quarter of 2023.

One-Year Results from the AAA-SHAPE Early Feasibility Study to be Presented at VEITH 2023

Retrieved on: 
Monday, November 13, 2023

AAA-SHAPE is the Company’s prospective, multicenter, early feasibility study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).

Key Points: 
  • AAA-SHAPE is the Company’s prospective, multicenter, early feasibility study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).
  • Michel Reijnen, MD, PhD, vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands and principal investigator for AAA-SHAPE Netherlands will present the data.
  • “We are encouraged by the one-year results and how shape memory polymer technology may ultimately influence sac behavior,” stated Professor Reijnen.
  • In the United States, IMPEDE-FX RapidFill is an investigational device, limited by Federal (or United States) law to investigational use.

Global regulators strengthen efforts to ensure continuous availability of safe and high-quality medicines

Retrieved on: 
Monday, December 18, 2023

The pilots focus on two essential parts of medicines evaluation: collaborative assessments of post-approval changes and hybrid inspections.

Key Points: 
  • The pilots focus on two essential parts of medicines evaluation: collaborative assessments of post-approval changes and hybrid inspections.
  • The collaborative assessment pilot aims to enable greater cross-regional access to high-quality, critical medicines through parallel assessments and approvals in different regions.
  • According to regulators, the pilot could indicate how regulators and industry could best work together to implement and promote innovative regulatory approaches and technologies.
  • Hybrid inspections allow multiple regulators to participate in an inspection either on-site or remotely and take one joint regulatory decision.

GMP cell CDMO I Peace, Inc. obtains accreditation as ISO 17025: 2017 compliant

Retrieved on: 
Wednesday, December 6, 2023

PALO ALTO, Calif., Dec. 6, 2023 /PRNewswire/ -- Leading GMP cell CDMO I Peace, Inc. (https://www.ipeace.com), specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that its Palo Alto quality control testing facility has been accredited as ISO 17025: 2017 compliant. The accreditation was certified by ANSI National Accreditation Board, one of the leading accreditation bodies in the world. The tests in the scope of accreditation center on the characterization of iPSCs and include cell count and viability per USP , detection of pluripotency marker expression by flow cytometry per USP , and also by immunofluorescence assay. I Peace has also been accredited for a quantitative real-time PCR method to detect residual Sendai virus vectors in the reprogrammed cells. The current ISO accreditation at the I Peace Palo Alto facility shows that our quality control testing is carried out at a high standard. I Peace cell manufacturing facility in Kyoto, Japan has been certified as compliant with US FDA cGMP 21 CFR 211 and 1271, and ICH Q7, and licensed by the Japanese government to manufacture specific cell products, suggesting that its quality management system meets the industry's highest standards both in manufacturing and quality control testing of the manufactured cell products.

Key Points: 
  • The accreditation was certified by ANSI National Accreditation Board, one of the leading accreditation bodies in the world.
  • The current ISO accreditation at the I Peace Palo Alto facility shows that our quality control testing is carried out at a high standard.
  • We support drug discovery and cell medicine development by providing our iPS cell and other cell products as high-quality cell products that meet PMDA and FDA standards to pharmaceutical companies and cell medicine development companies.
  • We aim for the earliest prevalence of regenerative medicine by establishing iPS cell banking services for individuals.

CMI Inc. and Life Molecular Imaging Announce the Reimbursement of the Amyloid-PET Diagnostic Neuraceq® (florbetaben 18F) in Japan

Retrieved on: 
Wednesday, November 22, 2023

TOKYO and BERLIN, Nov. 22, 2023 /PRNewswire/ -- CMI Inc. and Life Molecular Imaging (LMI) are pleased to announce that the amyloid-PET diagnostic  Neuraceq® (florbetaben 18F injection) has been approved from the Ministry of Health, Labor, and Welfare to be reimbursed by governmental health insurance. With this C2 path approval, Neuraceq®-PET is the first amyloid PET diagnostic tool currently reimbursed in Japan. Neuraceq® is available in Japan from the approved medical device 放射性医薬品自動合成装置Synthera+ (PMDA medical device license no. 30100BZX0016900) and is currently accessible at Keio University Hospital, Tokyo, Koseikai Takeda Hospital, Kyoto and Uozumi Clinic, Kumamoto. CMI Inc. plans to set up Neuraceq® production at further hospital radiopharmacy sites.

Key Points: 
  • With this C2 path approval, Neuraceq®-PET is the first amyloid PET diagnostic tool currently reimbursed in Japan.
  • Neuraceq® is available in Japan from the approved medical device 放射性医薬品自動合成装置Synthera+ (PMDA medical device license no.
  • 30100BZX0016900) and is currently accessible at Keio University Hospital, Tokyo, Koseikai Takeda Hospital, Kyoto and Uozumi Clinic, Kumamoto.
  • With the reimbursement of this diagnostic tool, Japanese physicians can use this state-of-the-art imaging technology to accurately evaluate their patients with cognitive decline.

BioCardia Reports Third Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Wednesday, November 8, 2023

The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.

Key Points: 
  • The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.
  • During the third quarter of 2023, BioCardia worked with the DSMB to unblind a small committee within the Company to review the closed session DSMB report of interim study results to better understand the rationale behind their recommendation.
  • The Company expects to complete the roll-in cohort of patients in the fourth quarter of 2023 and begin the randomized phase of the trial.
  • Third Quarter 2023 Financial Results:
    Revenues were approximately $357,000 for the three months ended September 2023, compared to approximately $212,000 for the three months ended September 2022.