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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.

Gynesonics Announces Publication of CHOICES

June 30, 2020

Gynesonics announced the peer-reviewed publication of CHOICES, a comparative, case-matched healthcare economic study.

Gynesonics notes the study compared the short-term resource utilization, facility costs, and perioperative patient outcomes for transcervical fibroid ablation (TFA) using the Sonata® system compared to myomectomy. CHOICES demonstrated that TFA using the Sonata system has a significantly shorter operating room time and length of stay than myomectomy for the treatment of symptomatic uterine fibroids. All procedure, anesthesia, laboratory, pathology, and pharmacy costs were significantly higher for myomectomy as compared to TFA with Sonata. TFA was also associated with significantly lower facility procedure-related costs compared to myomectomy, including inpatient, abdominal, or laparoscopic myomectomy.

The significant clinical advantages demonstrated by Sonata in the CHOICES comparator study compared to myomectomy, along with the long-term symptom relief and high patient satisfaction as reported in the FAST-EU and SONATA clinical trials, clearly shows that Sonata should be the standard-care when considering options for women with symptomatic fibroids,” said David Forstein, DO, FACOOG, Dean, Harlem Campus, Touro College of Osteopathic Medicine, New York City. “The considerable, robust and consistent data reported in multiple peer-reviewed publications to date, is compelling and supports Sonata as being a key component in the algorithm for treating uterine fibroids.”

“The impressive durable patient outcomes already published on Sonata, out to more than 5 years, has established the clinical importance of our technology,” commented Gynesonics President and CEO, Christopher Owens. “CHOICES, an essential head-to-head comparator study, now demonstrates the procedural cost and early patient outcome advantages provided by Sonata over myomectomy. Peer-reviewed published clinical data for Sonata, continues to demonstrate significant advantages for the patient, facility, payers and the physician.”

CHOICES (Brooks E, Singer A, Delvadia D et al. ClinicoEconomics and Outcomes Research. 2020:12 299-306) is a multi-center, case matched comparator 30-day outcomes and facility cost analysis study. A total of 88 patients at 4 centers were enrolled, equally divided between the two cohorts. The design controlled for potential biases such as prior procedural experience, internal facility procedures and protocols, facility billing practices and patient demographic differences. The outcomes included:

  • Sonata TFA had a significantly lower mean operating room duration (90 minutes) and length of stay (5.2 hours) than myomectomy (143 minutes and 45.8 hours respectively).
  • The average total mean facility costs for myomectomy ($11,425) were 51% higher than for Sonata TFA ($7,563, p=0.002).
  • Sonata TFA facility costs were significantly lower than that associated with inpatient, abdominal, or laparoscopic myomectomy (all p<0.001).

Elizabeth Brooks, Ph.D., healthcare economist and lead author on CHOICES said, “This case-matched comparator study identified important cost and operative patient outcome advantages provided by Sonata compared to a surgical standard of care – myomectomy. These data provide essential insights to payers and facilities in the evaluation of a breakthrough technology in addressing a significant clinical need.”

CHOICES is the third recently published study providing analysis of facility and payer costs for Sonata compared to surgical treatments for fibroids, hysterectomy and myomectomy. The previous publications are the INSPIRE and COMPARE studies. This base of healthcare economic evidence consistently demonstrates the cost benefits to both facilities and payers provided by Sonata in relation to hysterectomy and myomectomy. This is important data that complements the significant base of published clinical outcomes data demonstrating the impressive and durable benefits of the Sonata treatment for patients – out to more than 5 years.

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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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