Neuros Medical Receives FDA Breakthrough Device Designation for its Novel Altius® High-Frequency Nerve Block System
On June 29, 2021, the US Food and Drug Administration (FDA) granted Neuros Medical, Inc. Breakthrough Device Designation for the use of their unique Altius High-Frequency Nerve Block device in the management of chronic intractable pain of the lower limb in adult amputees.
By the fall of 2021, Neuros expects completion of enrollment in its pivotal QUEST (High-FreQUEncy Nerve Block for PoST-Amputation Pain) study. QUEST is a 180-subject, randomized, double-blinded, active sham-controlled clinical trial that is being conducted under an investigational device exemption (IDE). QUEST is designed to assess the safety and effectiveness of the company’s Altius High-Frequency Nerve Block system to treat intractable chronic post-amputation pain.
William Patterson Ph.D., Chief Technology Officer said, “The Altius System – as a designated Breakthrough Device – is the result of outstanding multi-disciplinary teamwork, and we look forward to the completion of QUEST enrollment this Fall as another key milestone in our effort to develop this important therapy option for patients who suffer from chronic post-amputation pain.”
Seegene announces partnership with Bio-Rad to develop diagnostic testing products for the US Market
On July 01, 2021, Seegene Inc., a leading South Korean biotechnology company, inked a partnership agreement with Bio-Rad Laboratories, Inc. for the clinical development and commercialization of infectious disease molecular diagnostic products.
Under the terms of the agreement, Seegene will provide diagnostic tests for use on Bio-Rad’s CFX96™ Dx Real-Time PCR System for the US market, pending clinical development and approval from the US Food and Drug Administration (FDA).
“To expand our business in the US market, it is important to work closely with a global company like Bio-Rad that has a comprehensive network in the region. Together with Seegene’s advanced technology and Bio-Rad’s solid client base, the two will be able to take the lead in the US market,” said Ho Yi, Chief Sales and Marketing Officer of Seegene. He further added that “The deal is expected to serve as the steppingstone for Seegene to secure its foothold in the US market. And it will also help increase the company’s revenue and expand the business into other countries going forward.”
This includes an intent to clear Seegene’s ‘AllplexTM SARS-CoV-2/FluA/FluB/RSV Assay’, a multiplex real-time PCR assay. The AllplexTM SARS-CoV-2/FluA/FluB/RSV Assay can simultaneously detect and differentiate a total of five viruses including Flu A, Flu B, RSV A/B, and three target genes of COVID-19 (N gene, S gene, and RdRP gene) in a single test. It is also suitable for mass testing and capable of targeting more genes than its competitors’ products.
CytoSorbents Receives FDA Approval of Investigational Device Exemption (IDE) for US STAR-T Trial on Ticagrelor Removal During Cardiothoracic Surgery
On July 06, 2021, CytoSorbents received FDA regulatory approval for its investigational device exemption (IDE) application to conduct the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) double-blind, randomized, controlled trial (RCT) in the United States.
The FDA granted CytoSorbents Breakthrough Device Designation in April 2020 for the removal of ticagrelor during cardiothoracic surgery, recognizing a large unmet medical need. STAR-T study is designed to support regulatory clearance of the newly designated DrugSorb-ATR™ Antithrombotic Removal system for intraoperative ticagrelor removal during cardiothoracic surgery.
Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents said, “We are pleased to announce the FDA has granted full IDE approval for the randomized, controlled, double-blind STAR-T trial, which will enroll up to 120 patients across 20 US clinical sites and is expected to begin enrollment this summer. The primary endpoint of the study will evaluate whether the use of DrugSorb-ATR with the standard of care in patients on ticagrelor undergoing cardiothoracic surgery reduces the risk of perioperative bleeding complications compared to standard of care alone. The trial will also evaluate reductions in ticagrelor blood levels and several additional outcomes to capture the full potential clinical and cost-economic benefits of DrugSorb-ATR. We believe the study can be completed in 2022 based on the high level of excitement and engagement we are seeing from participating sites. Finally, we will continue to collaborate closely with the FDA to leverage the priority review associated with our ticagrelor removal application in the spirit of the granted Breakthrough Designation.”
First Alpha DaRT™ Patient Treated in the US as Part of Pilot Multicenter Skin Cancer Trial
On July 06, 2021, Alpha Tau Medical, the company behind the groundbreaking α-radiation cancer therapy Alpha DaRT™, announced that the first patient in its US skin cancer pilot trial was treated with Alpha DaRT at University Cancer Center in Houston, Texas. This location is part of an expanded multicenter investigation that originated as a single-center trial at Memorial Sloan Kettering Cancer Center (MSK) in New York City and is led by radiation oncologist, Dr. Mark A. D’Andrea.
Alpha Tau CEO, Uzi Sofer said, “We are so excited to have treated our first patient in the critical US market, after expanding our MSK trial to new sites including University Cancer Center in Houston. As we had hoped, following the Breakthrough Device Designation, our clinical studies are starting to progress rapidly, and we anticipate treating patients at additional US sites in the near future, which we believe will confirm the promising results we have observed so far in our other trials around the world.”
The company expects to bring results as the international clinical study program is already progressing in Israel, Japan, Italy, and Russia.
Smith+Nephew launches the FAST-FIX™ FLEX Meniscal Repair System
On July 07, 2021, Smith+Nephew launched the FAST-FIX FLEX Meniscal Repair System, the only device with a surgeon-guided, bending needle and shaft providing access to all zones of the meniscus, in the US and select countries across the globe. This benefits the patients in the long run as improving access increases the chances of repairing the meniscus rather than removing it.
“FAST-FIX FLEX is a patient and surgeon friendly device that simplifies the all-inside approach. The ability to personalize the degree of curvature to the patient’s tear pattern eliminates the need to change portals or utilize multiple techniques while preserving meniscal tissue during repair,” said Dr. Jeffrey Klauser, Connecticut Orthopaedics.
“The launch of FAST-FIX FLEX represents a new milestone in meniscal repair, and we are truly delighted to provide this technology to surgeons across the globe,” commented Christie Van Geffen, Vice President Global Marketing, Joint Repair, Smith+Nephew. “Its addition to our All Tears, All Repairs Meniscal Repair Solutions portfolio will accelerate our goal to change the standard of care away from meniscectomy and toward meniscal repair.”
Hyalex Orthopaedics receives FDA Breakthrough Device Designation for novel HYALEX® Cartilage System
On July 07, 2021, Hyalex Orthopaedics, Inc received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its HYALEX® Cartilage System. The HYALEX Cartilage System is designed to restore function and treat cartilage abnormalities in patients who have lost articular cartilage and bone in their knees and require surgery.
The system is currently in the preclinical stage of research, with outstanding findings so far, and is preparing for its first-in-human clinical trial. HYALEX® Cartilage is a biomimetic materials platform developed to give a single step, off-the-shelf, high strength, low friction, low wear solution, unlike other cartilage alternatives that require numerous operations and regeneration.
“Our goal is to help patients be active and stay active,” said Mira Sahney, Hyalex’s CEO. “Obtaining this designation will be an invaluable opportunity for our team to work closely with the FDA and expedite bringing the HYALEX Cartilage System to the millions of patients who face limited treatment options for knee pain caused by cartilage lesions.”
Wren Laboratories Launches First Direct-to-Consumer Saliva COVID-19 PCR Test for Children Ages Five+ and Adults Just in Time for Back-to-School and Work
On July 07, 2021, Wren Laboratories, a genomics testing company, received emergency use authorization from the US Food and Drug Administration (FDA) for the WREN PCR Saliva Test, the nation’s first direct-to-consumer saliva PCR COVID-19 test for ages five and above.
“We have heard from a number of schools that having a widely available saliva PCR test for children as young as five years old, who cannot yet be vaccinated, is a game-changer and will help facilitate the nation’s much-needed Fall reopening,” said Mark Kidd, Ph.D., Laboratory Director for Wren. “This ease of saliva PCR testing coupled with high accuracy and ability to detect all currently known variants in asymptomatic and symptomatic people is a key component to instilling peace of mind and getting back to schools and workplaces and other everyday events.”
In October 2020, Wren Laboratories was the first US lab to receive approval for a saliva-based PCR diagnostic test combined with a proprietary collection device that changes the sample’s color reassuring the user the collection of the sample has been completed correctly and the sample has been stabilized. The easy-to-use collection device enables samples to be collected at home or office without medical supervision and easily transported at room temperature as the sample is automatically stabilized.
Abbott’s XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk Patients
On June 30, 2021, Abbott received US Food and Drug Administration (FDA) approval for its XIENCE family of stents, for one-month DAPT labeling for high bleeding risk (HBR) patients in the US. Moreover, XIENCE stents recently received CE Mark approval for DAPT as short as 28 days – giving XIENCE stents the shortest DAPT indication in the world.
The company has also received FDA approval and European CE Mark approval for its next-generation XIENCE Skypoint stent, which allows physicians to treat larger blood vessels through improved stent expansion that can open clogged vessels more effectively.
Roxana Mehran, M.D., professor of medicine and director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at Icahn School of Medicine at Mount Sinai and the global principal investigator for Abbott’s Short DAPT program (XIENCE 28 and XIENCE 90) said, “The new FDA approval for DAPT for the XIENCE family of stents provides interventional cardiologists confidence they are delivering the best care to patients with high bleeding risk. A short DAPT duration minimizes risks for high bleeding risk patients and allows them to return to daily life sooner and with more assurance.”
Abbott’s XIENCE 28 and XIENCE 904 studies show that DAPT can be safely discontinued as early as 28 days with no increased risk of inpatient adverse events, solidifying the industry-leading safety profile of the XIENCE family of stents.
UK – National Institute for Health and Care Excellence (NICE) Issues MedTech Innovation Briefing on ‘Trublood®- Prostate’ for Precision Non-invasive Prostate Cancer Diagnosis Described by Experts as a ‘Game Changer’
On July 13, 2021, Datar Cancer Genetics, world-leading non-invasive cancer analytics, and diagnostics company, announced the publication of the internationally recognized MedTech Innovation Briefing (MIB) from the United Kingdom’s National Institute for Health and Care Excellence (NICE) on its CE marked ‘Trublood®- Prostate’ test to be used for precision triaging of patients to avoid unnecessary invasive biopsies.
Dr. Tim Crook, Medical Oncologist, Broomfield Hospital, Chelmsford (UK) said that “Trublood®-Prostate is an innovative, non-invasive test for prostate cancer that offers unprecedented sensitivity and specificity without the risks and morbidity associated with tissue biopsy. The utility of Trublood®-Prostate clearly demonstrates the potential of CETAC-based technology for the early detection of multiple other cancer types with implications in cancer diagnosis and screening”.