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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.

Five-Year Data Demonstrate InterStim Therapy Offers Sustained Long-Term Efficacy and Quality of Life Improvements for Overactive Bladder Patients

Medtronic plc today announced that the InterStim system, which provides sacral neuromodulation therapy, offers sustained long-term efficacy and quality of life improvements for overactive bladder (OAB) at five years.1 Results of the InSite study, which were published online in the Journal of Urology,1 found that 82 percent of patients had therapeutic success (defined as a greater than 50 percent improvement in symptoms) at five years and sustained quality of life improvements.

Steven Siegel, M.D., primary investigator and director, Metro Urology Centers for Female Urology and Continence Care, Minneapolis, Minn. “Effective long-term bladder control is critical because OAB is a chronic condition that significantly impacts all aspects of a person’s quality of life, including confidence, activities and intimacy,” said “Many struggle to find long-term relief and these results, which show the InterStim system offers sustained long-term efficacy, meaningful symptom reduction and quality of life improvements, offer new hope for those who suffer.”

The prospective InSite study evaluated the efficacy and safety of the InterStim system at five-years in patients with bothersome OAB symptoms, who had failed or could not tolerate more conservative treatments, including urinary urge incontinence (UI) and/or urgency-frequency (UF). The five-year results include:1

  • The overall therapeutic success rate was 82 percent using the completers analysis (subjects with data at baseline and each follow-up) and 67 percent using the modified completers analysis (subjects who either had a baseline and follow-up evaluation or withdrew early due to device-related reasons and are considered failures)
  • Forty-five percent of patients with UI had complete continence
  • UI patients had an average reduction of 2 leaks per day (p<0.0001) and UF patients had a mean reduction of 5.4 voids per day (p<0.0001)

In addition, patients experienced sustained quality of life improvements measured using the ICIQ-OABqol questionnaire (p<0.0001) that were three times greater than what is considered clinically significant

The InSite study demonstrated that the InterStim system was a safe option for OAB sufferers. The most common device-related adverse events were undesirable change in stimulation, implant site pain and ineffectiveness.1 The study reported only one serious device-related adverse event associated with the InterStim system.1 Implanting an InterStim system has risks similar to any surgical procedure.

Linnea Burman, vice president and general manager of the Pelvic Health & Gastric Therapies business, part of the Restorative Therapies Group at Medtronic added, “The InterStim system has been an important treatment option for 20 years and is the only sacral neuromodulation treatment with five-year clinical data demonstrating sustained, long-term efficacy for the treatment of both OAB and fecal incontinence.”  Burman concluded, “These data should give physicians and patients confidence that relief and restored quality of life are possible and we hope this will help encourage the many still suffering from bothersome OAB symptoms to seek help.”

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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

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

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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...