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Attune Medical Major Milestones: Including ensoETM in Cardiac Ablation Procedures Published Study and $4 Mil Convertible Note Closing

Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation.

Signia Introduces World’s First ‘Face Mask Mode’ for Hearing Devices: Improves Audibility for Those Communicating with Someone Wearing a Face Covering & No More Lip Reading

“The hearing challenges presented by face masks became obvious pretty quickly into the pandemic, so Signia developed the first-of-its-kind Face Mask Mode to help those with hearing loss better communicate in this new reality,” said Tish Ramirez, Au.D. of Signia. “When this setting is activated, the hearing aids optimally capture the sound of the speech signals, enabling the words to sound clearer and reducing any background noise to help the wearer understand what is being said.” 

Modulim Announces CE Mark of Clarifi Imaging System for Microvascular Assessment

Modulim can now expand its marketing and distribution throughout Europe and apply for registration in other international markets that recognize the CE Mark.

Genius AI Detection Receives FDA Clearance

Hologic notes the new technology which the company has now made commercially available represents a pivotal milestone in the early detection of breast cancer, as studies showed Genius AI Detection software aids in the identification and early detection of breast cancer when used with the Genius 3D Mammography exam.

TomoTherapy Platform: New Data Reinforces Benefits

Accuray Incorporated announced today that studies continue to demonstrate the unmatched flexibility of the cutting-edge TomoTherapy® System to treat, with precision and efficiency, a wide variety of indications of all complexities.

More than 50 studies were presented during the poster and oral sessions at the 36th Annual European Society for Radiotherapy & Oncology (ESTRO) Meeting in Vienna, Austria, May 5 – 9, 2017.

Study highlights include:

Breast

  • A study evaluated hypofractionated intensity-modulated radiation therapy (IMRT) using TomoHelical™ in 121 postmastectomy patients with implant-based immediate breast reconstruction (IBR). Results demonstrated the TomoTherapy Treatment Planning System produced high-quality treatment plans providing optimal coverage of both the chest wall and supraclavicular region and sparing of all organs at risk. An additional analysis showed that the superior dosimetric outcomes provided treatment benefits. The side effect profile following treatment was favorable, with no patient experiencing greater than grade 2 acute toxicity.  Rates of toxicity remained low in 85 patients with a median follow-up of 14.2 months. Clinicians at the European Institute of Oncology in Milan, Italy, conducted these two studies.

Lung

  • A study of 68 patients with medically inoperable lung tumors found that image-guided stereotactic body radiation therapy (SBRT) delivered using TomoHelical provides an effective treatment option with minimal toxicity. The study was conducted at three Italian hospitals.

Prostate

  • A retrospective study evaluated the safety and efficacy of preoperative TomoHelical in combination with chemotherapy in patients with locally advanced rectal cancer (LARC). The three-year local control rate was 96.9% and treatment was well-tolerated. Clinicians at two Swiss hospitals conducted the research, which included the largest of this patient population to date.
  • Toxicity and survival outcomes were reported for patients with high-risk prostate cancer enrolled in a phase 1-2 study evaluating hypofractionated TomoTherapy® and routine irradiation of pelvic lymph nodes. Five- and seven-year biochemical relapse-free survival (bRFS) was 87% and 80%, respectively; cancer-specific survival was 98% and 96%. Treatment was well-tolerated. Clinicians at the San Raffaele Scientific Institute in Milano, Italy conducted the study.
  • Researchers at three European centers assessed the feasibility of boosting radiation dose to the dominant intraprostatic lesion (DIL) using the TomoTherapy System and found it to be a viable treatment option. Additionally, based on a dosimetric comparison of treatment plans, the system performed better than volumetric modulated arc radiotherapy (VMAT) in terms of achievable boost doses, target coverage and organ at risk sparing, and was similar in several aspects to intensity-modulated proton therapy (IMPT).

“The data presented at the ESTRO 36 meeting continue to show that the benefits of the TomoTherapy® System’s ring gantry platform and daily 3D  image guidance in the treatment of a range of clinical indications,” said Fabienne Hirigoyenberry, VP Global Medical and Scientific Affairs of Accuray Inc. “The Radixact™ System, the latest generation TomoTherapy platform, provides the same unrivaled delivery capabilities while giving clinicians the versatility to treat the broad spectrum of patients and disease types with the highest level of precision and increased speed and efficiency.”

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Fusion Antibodies and Queen’s University Belfast Awarded a £453,000 Grant from Invest Northern Ireland

The two organisations will use the funds to accelerate the discovery of novel therapeutic and diagnostic antibodies with validated anti-infective properties against COVID-19. Building on strong scientific knowhow, a new antibody development platform will be created that will help realise the vision of producing a breakthrough therapeutic that directly targets SARS-CoV-2.

Attune Medical Major Milestones: Including ensoETM in Cardiac Ablation Procedures Published Study and $4 Mil Convertible Note Closing

Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation.

Signia Introduces World’s First ‘Face Mask Mode’ for Hearing Devices: Improves Audibility for Those Communicating with Someone Wearing a Face Covering & No More Lip Reading

“The hearing challenges presented by face masks became obvious pretty quickly into the pandemic, so Signia developed the first-of-its-kind Face Mask Mode to help those with hearing loss better communicate in this new reality,” said Tish Ramirez, Au.D. of Signia. “When this setting is activated, the hearing aids optimally capture the sound of the speech signals, enabling the words to sound clearer and reducing any background noise to help the wearer understand what is being said.” 

Kayentis, a global provider of digital data capture systems for clinical trials, today announces it has raised €7M (approx. $8.3M) in growth capital.

Kayentis is active in the global electronic Clinical Outcome Assessment (eCOA) market, which is expected to reach $2.6 billion by 2027. Market growth in eCOA – a method of capturing outcomes data electronically in clinical trials – is driven by the clinical trials industry.

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New England Biolabs® Introduces NEBNext® Custom RNA Depletion Design Tool and RNA Depletion Core Reagent Set for Customizable RNA Depletion

This technology has been superb for eliminating the ribosomal RNA for a range of custom projects, including tracking novel viruses in mosquitoes, longitudinal profiling for astronauts, and host-pathogen interactions in COVID samples.

INTERCEPT Blood System for Cryoprecipitation Receives FDA Approval States Cerus Corporation

"FDA approval of the INTERCEPT Blood System for Cryoprecipitation is an important step forward in our mission to establish pathogen reduction as the standard of care for transfused blood components globally," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer.

Research Paper Showing ProtoKinetix AAGP® Enhanced Stem Cell Derived Retina Precursor Cells Restoration of Vision

ProtoKinetix notes the research paper has been submitted to a prestigious journal specializing in tissue regeneration for peer review and editing.

OrganaBio to Expand Its cGMP Cell and Gene Therapy Manufacturing Facility: 19,000 Sq. Ft. Slated to Commence Operations In Q3 2021

OrganBio, a Miami-based cGMP facility, will include process development space, ISO 7 cleanrooms, state-of-the-art scientific equipment, analytics and QC laboratories, and a suite of support services to enable OrganaBio and its partners to rapidly and economically self-manufacture clinical materials. 

Stoke Therapeutics Announces Proposed Public Offering

November 18, 2020 Stoke Therapeutics, Inc., a biotechnology company pioneering a new way to treat the underlying cause of genetic diseases by precisely upregulating protein...