The Latest Cardiac and Vascular News
Westport, CT, Dec. 06, 2023 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company delivering unprecedented accuracy and precision to intracardiac signal visualization, today issued its 2023 letter to shareholders to recap recent achievements and offer insights about the year ahead. In the letter, […]
IRVINE, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from PCR London Valves 2023, a leading, annual global valve conference. The Trilogy THV system was featured in multiple case presentations and scientific sessions throughout […]
SOUTH JORDAN, Utah, Dec. 06, 2023 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (Nasdaq: MMSI) (“Merit”), a leading global manufacturer and marketer of healthcare technology, announced the pricing of $650.0 million aggregate principal amount of 3.00% Convertible Senior Notes due 2029 (the “notes”) in a private placement (the “offering”) only to […]
Clinical investigators complete enrollment in the 177 patient, randomized, controlled study, STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in subjects with Arterial Disease Below the Knee, NCT03477604).
WILMINGTON, Mass., Dec. 6, 2023 /PRNewswire/ — Micro Medical Solutions (MMS), an innovator in the field of microvascular intervention to improve clinical outcomes and quality of life in patients with CLI/CLTI, announced today that it has completed its U.S. pivotal clinical study enrollment evaluating the safety and effectiveness of the MicroStent System compared to the current standard of care, PTA (percutaneous transluminal angioplasty). The MicroStent System has already obtained CE Mark approval for use in the EEA.
STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in subjects with Arterial Disease Below the Knee) enrolled its final patient earlier this month marking the completion of the study. MicroStent is a vascular stent specifically designed to achieve and maintain tibioperoneal arterial patency improving blood flow and wound healing for below-the-knee amputation reduction in patients with critical limb ischemia (CLI) resulting from progressive peripheral artery disease (PAD).
“I would like to thank the investigators and the research teams for their dedication, participation, collaboration and tremendous effort to help this complex and difficult patient population. I’m excited to continue to provide research expertise to the company and discuss the study results when available,” said lead investigator, Dr. Robert E. Beasley of Palm Vascular Centers in Miami Beach, Florida.
“CLI/CTI is the most severe clinical manifestation of PAD. We are excited to see the data unfold to further understand the impact of angiosome directed endovascular intervention and its impact on wound healing, limb salvage and patient living independence. We are warmly appreciative to our patient population that participated in the study. The study’s goal has always been to demonstrate a lower amputation rate thereby, lowering the devastating mortality rate associated with limb loss,” commented Rita Jacob, Vice President of Clinical Affairs.
“This is an encouraging step forward for MMS, millions of patients battling CLI every day and Clinicians treating and caring for these patients,” said CEO, Gregory Sullivan. “MMS developed the MicroStent platform in response to patients’ needs, and we are excited to move closer to putting MicroStent in the hands of U.S. interventionalists treating CLI.”
For more about Micro Medical Solutions, visit www.micromedicalsolutions.net.
SOURCE Micro Medical Solutions
PALO ALTO, Calif., Dec. 05, 2023 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that it has submitted an NDA for acoramidis to the U.S. FDA for the treatment of ATTR-CM. The application was based […]
CLICHY, France–(BUSINESS WIRE)–CorWave, a French company that develops and manufactures innovative cardiac assist devices, announces the appointment of Fairuz Hasni as Vice President Human Resources. Fairuz Hasni has over twenty years of experience in industrial companies. She will support CorWave in the development of its HR functions and in its […]
– Build to suit development will expand Ionis’ campus footprint to over 400,000 square feet; grow Oxford’s San Diego life sciences portfolio to more than 1 million square feet -CARLSBAD, Calif., Dec. 5, 2023 /PRNewswire/ – Oxford Properties Group (“Oxford”), a leading global real estate investor, developer and manager has officially broken ground on a 165,000 square foot expansion of Ionis Pharmaceuticals’ (“Ionis”) main life sciences campus. Located in the San Diego life sciences submarket of Carlsbad, Ionis’ existing campus features approximately 250,000 square feet of lab and office space. The expansion builds on Oxford and Ionis’ established partnership, with Oxford completing a purchase and long-term lease back of Ionis’ existing campus in October 2022.
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Render for 165,000 SF expansion of Ionis’ Carlsbad life sciences campus and HQ (CNW Group/Oxford Properties Group Inc.)
Today’s announcement bolsters Oxford’s already robust global life sciences portfolio and West Coast presence, featuring additional high-quality assets in the Bay Area and Seattle. Oxford entered the San Diego life sciences market in February 2022 via a US$464 million acquisition of a 13-building portfolio. Oxford’s San Diego life sciences portfolio currently comprises more than 900,000 square feet, which will increase to over 1.3 million square feet upon completion of its development pipeline in market.
“We are very pleased to build on our significant partnership with Ionis, as we each write another chapter in our remarkable growth journeys through the expansion of their main campus,” said Tycho Suter, Vice President, Investments at Oxford. “Oxford is a long-term investor, committed to creating both economic and social value through real estate. Supporting the growth of a highly aligned partner in Ionis, who are deeply embedded in the Carlsbad community, delivers on both fronts as we help provide the infrastructure necessary to develop the life-saving therapeutics of tomorrow.”
Founded in 1989, Ionis is a publicly traded biotech company and a leader in discovering and developing RNA-targeted therapeutics. Ionis currently has four marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. It has a long history of R&D successes and has delivered multiple breakthroughs leveraging its expanding technology platform. The campus expansion supports Ionis’ strategic goals of prioritizing its wholly owned pipeline and advancing its drug discovery technology.”The state-of-the-art facility being built by our partner Oxford Properties is more than a building, it’s a testament to Ionis’ enduring commitment to discovering, developing and delivering novel medicines to patients who are living with serious diseases,” said Elizabeth L. Hougen, Executive Vice President and Chief Financial Officer of Ionis. “In the same way that Ionis-discovered therapies like SPINRAZA®, the first-ever approved medicine to treat spinal muscular atrophy, and QALSODY™, the first treatment targeting a genetic form of ALS, changed the lives of people battling these devastating diseases, we expect the science done within the walls of this building to have a positive impact on the lives of people with unmet medical needs in the years to come.”Located at 2830 Whiptail Loop in Carlsbad and slated for completion by the end of 2025, Ionis’ campus expansion will deliver 165,000 square feet of purpose-built lab and complementary office space. Bringing Ionis’ overall campus to over 400,000 square feet of space across four buildings, the buildings feature chemistry labs, biology labs and R&D support systems, as well as modern office space. Part of the prominent San Diego North County life sciences cluster, in addition to Ionis, Carlsbad is home to leading firms such as Novartis, Thermo Fisher and Genentech.San Diego continues to define itself as a top three US life sciences market, and one of the most important life sciences markets globally. Its ecosystem is anchored by renowned research institutions and non-profits including San Diego State University, UC San Diego, Scripps Research and the Sandford Burnham Prebys Medical Discovery Institute. Benefitting from this clustering of firms, institutions and associated talent established over decades, San Diego’s life sciences market has grown by 40% over the last 15 years.Oxford has invested in life sciences since 2017. It has built substantial expertise in the sector while deploying capital through a variety of equity and credit investments as well as cultivating a significant development pipeline. Oxford’s life sciences business operates across the top 10 North American life sciences markets and in leading European markets through holdings in London, Cambridge and Paris.
About Oxford Properties Group
Oxford Properties Group (“Oxford”) is a leading global real estate investor, developer and manager. Established in 1960, Oxford and its portfolio companies manage approximately C$85 billion of assets across four continents on behalf of their investment partners. Oxford’s owned portfolio encompasses logistics, office, retail, multifamily residential, life sciences, credit and hotels in global gateway cities and high-growth hubs. A thematic investor with a committed source of capital, Oxford invests in properties, portfolios, development sites, debt, securities and real estate businesses across the risk-reward spectrum. Together with its portfolio companies, Oxford is one of the world’s most active developers with over 70 projects currently underway globally across all major asset classes. Oxford is owned by OMERS, the Canadian defined benefit pension plan for Ontario’s municipal employees.
About Ionis Pharmaceuticals, Inc.
For more than 30 years, Ionis has been a leader in RNA-targeted therapy, pioneering new markets and changing standards of care. Ionis currently has four marketed medicines and a promising late-stage pipeline highlighted by cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.To learn more about Ionis visit www.ionispharma.com and follow us on Twitter @ionispharma.SOURCE Oxford Properties Group Inc.
HALIFAX, NS, Dec. 5, 2023 /PRNewswire/ – ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces its Eye90 microspheres device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This designation is for the proposed Eye90 microspheres indication for the treatment of patients living with unresectable Hepatocellular Carcinoma (HCC). Breakthrough designation is granted to devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions for which no approved alternative exists.
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“We are pleased with the FDA’s decision to grant Breakthrough Device Designation for Eye90 microspheres Y90 radioembolization device. This confirms our belief that Eye90 represents an important evolution of radioembolization technology with the potential to significantly improve patient outcomes. Our discussions with the FDA have been productive, and this designation will allow us to streamline interactions with FDA and bring this product to market in an efficient manner. We look forward to executing our Route90 trial and our continued collaboration with the FDA,” said Mike Mangano, President, and CEO of ABK Biomedical.
ABK Biomedical’s Eye90 microspheres® device has been granted Breakthrough Device Designation by the FDA
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ABK Biomedical recently initiated enrollment in Route90, an FDA IDE approved pivotal, prospective, multicenter trial to establish the safety and efficacy of Eye90 microspheres in patients with unresectable HCC.
Dr. Aravind Arepally, Chief Medical Officer of ABK Biomedical, stated, “Eye90 microspheres radioembolization marks a significant breakthrough in the treatment of HCC. This medical device allows us to leverage multi-modality imaging, facilitate controlled visual administration and offers personalized dosimetry. This gives us the opportunity to further advance the field of Y90 radioembolization. We’re excited that FDA also recognizes the potential of ABK’s technology to improve patient outcomes.”
About FDA Breakthrough Devices Program
The FDA Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (De Novo request). This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for PMA approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.
About ABK Biomedical, Inc.
ABK Biomedical is a company focused on researching, developing and commercializing medical device therapies to improve treatment outcomes and the lives of patients with benign and malignant hypervascular tumors. ABK Biomedical holds intellectual property in the areas of inorganic polymer microspheres and unique administration systems. The company possesses advanced intellectual capital and its own R&D and manufacturing facilities for developing and commercializing unique embolotherapy products. Eye90 microspheres® is considered an investigational product and is not approved for use in any regulatory jurisdiction outside of approved clinical trials. SOURCE ABK Biomedical Inc.
In September 2023, Hypertension Became the Top-Ranked Asynchronous Telehealth Diagnosis Nationally, according to FAIR Health’s Monthly Telehealth Regional TrackerNEW YORK, Dec. 5, 2023 /PRNewswire/ — At the national level and in every US census region, telehealth utilization decreased in September 2023, according to FAIR Health’s Monthly Telehealth Regional Tracker. The decline followed an increase nationally and in every region in August. Nationally, the decrease in September was 9.3 percent (a decline from 5.4 percent of medical claim lines in August to 4.9 percent in September).1 The largest decrease, however, was in the Midwest, where utilization fell 15.0 percent. In the West telehealth utilization fell 14.7 percent, and in the Northeast the decrease was 8.2 percent. The South had the smallest decrease, 7.0 percent. The data include claims for the privately insured population and Medicare Advantage but exclude Medicare Fee-for-Service and Medicaid.
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Monthly Telehealth Regional Tracker, September 2023
Asynchronous TelehealthIn September, for the first time in 2023, hypertension ranked in first place among asynchronous telehealth diagnoses nationally.2 It had ranked in second place in the earlier months of the year. In September, hypertension increased in its share of asynchronous telehealth claim lines nationally and in every region. It ranked first that month in the Midwest, Northeast and West and second in the South.
In September, diabetes mellitus entered the national top five rankings of asynchronous telehealth diagnoses (at number five) for the first time in 2023.
Top Five Telehealth DiagnosesIn September 2023, COVID-19 entered the rankings of the top five telehealth diagnoses in the Midwest (at number four) and fell out of the rankings in the South and West. COVID-19 remained in second place in the Northeast, the same rank as in August. Nationally, COVID-19 fell from third to fourth place.In September, the percentage of telehealth claim lines for mental health conditions continued to decrease nationally and in every region, as it had in August. However, mental health conditions remained the number one telehealth diagnosis nationally and in every region, as it had since March 2020.Audio-Only Telehealth UsageIn September 2023, as in previous months, rural areas showed higher utilization of audio-only telehealth than urban areas in every region except the South, where the pattern was reversed. Audio-only telehealth utilization increased in both rural and urban areas in every region and nationally, except for urban areas of the South, which had a decrease of 14.4 percent, and urban areas nationally, which had a decrease of 4.1 percent.Telehealth Cost CornerFor September 2023, the Telehealth Cost Corner spotlighted the cost of CPT®3 90846, 50-minute family psychotherapy without patient. Nationally, the median charge amount for this service when rendered via telehealth was $181.19, and the median allowed amount was $111.82.4About the Monthly Telehealth Regional TrackerLaunched in May 2020 as a free service, the Monthly Telehealth Regional Tracker uses FAIR Health data to track how telehealth is evolving from month to month. An interactive map of the four US census regions allows the user to view an infographic on telehealth in a specific month in the nation as a whole or in individual regions. Each infographic shows month-to-month changes in volume of telehealth claim lines and audio-only telehealth usage (urban versus rural); the Telehealth Cost Corner, which presents a specific telehealth procedure code with its median charge amount and median allowed amount; and that month’s top five telehealth diagnoses and top five diagnoses via asynchronous telehealth.FAIR Health President Robin Gelburd stated: “We welcome sharing these varying windows into telehealth utilization as it continues to evolve. This is one of the many ways we pursue our healthcare transparency mission.”For the Monthly Telehealth Regional Tracker, click here.Follow us on Twitter @FAIRHealthAbout FAIR HealthFAIR Health is a national, independent nonprofit organization that qualifies as a public charity under section 501(c)(3) of the federal tax code. It is dedicated to bringing transparency to healthcare costs and health insurance information through data products, consumer resources and health systems research support. FAIR Health possesses the nation’s largest collection of private healthcare claims data, which includes over 44 billion claim records and is growing at a rate of over 2 billion claim records a year. FAIR Health licenses its privately billed data and data products—including benchmark modules, data visualizations, custom analytics and market indices—to commercial insurers and self-insurers, employers, providers, hospitals and healthcare systems, government agencies, researchers and others. Certified by the Centers for Medicare & Medicaid Services (CMS) as a national Qualified Entity, FAIR Health also receives data representing the experience of all individuals enrolled in traditional Medicare Parts A, B and D; FAIR Health includes among the private claims data in its database, data on Medicare Advantage enrollees. FAIR Health can produce insightful analytic reports and data products based on combined Medicare and commercial claims data for government, providers, payors and other authorized users. FAIR Health’s systems for processing and storing protected health information have earned HITRUST CSF certification and achieved AICPA SOC 2 Type 2 compliance by meeting the rigorous data security requirements of these standards. As a testament to the reliability and objectivity of FAIR Health data, the data have been incorporated in statutes and regulations around the country and designated as the official, neutral data source for a variety of state health programs, including workers’ compensation and personal injury protection (PIP) programs. FAIR Health data serve as an official reference point in support of certain state balance billing laws that protect consumers against bills for surprise out-of-network and emergency services. FAIR Health also uses its database to power a free consumer website available in English and Spanish, which enables consumers to estimate and plan for their healthcare expenditures and offers a rich educational platform on health insurance. An English/Spanish mobile app offers the same educational platform in a concise format and links to the cost estimation tools. The website has been honored by the White House Summit on Smart Disclosure, the Agency for Healthcare Research and Quality (AHRQ), URAC, the eHealthcare Leadership Awards, appPicker, Employee Benefit News and Kiplinger’s Personal Finance. For more information on FAIR Health, visit fairhealth.org.Contact:Rachel KentSenior Director of Communications and MarketingFAIR Health646-396-0795[email protected]1 A claim line is an individual service or procedure listed on an insurance claim.2 Asynchronous telehealth is telehealth in which data are stored and forwarded (e.g., blood pressure or other cardiac-related readings transmitted electronically; A1c levels transmitted electronically).3 CPT © 2023 American Medical Association (AMA). All rights reserved.4 A charge amount is the provider’s undiscounted fee, which a patient may have to pay when the patient is uninsured, or when the patient chooses to go to a provider who does not belong to the patient’s plan’s network. An allowed amount is the total negotiated, in-network fee paid to the provider under an insurance plan. It includes the amount that the health plan pays and the part the patient pays under the plan’s in-network cost-sharing provisions (e.g., copay or coinsurance if the patient has met the deductible).SOURCE FAIR Health
The second opinion platform expands radiology second opinion services beyond Florida to accept patients in 12 US states and Canada while appointing Dr. Sunil Kini as Medical Director.COOPER CITY, Fla., Dec. 5, 2023 /PRNewswire/ — MDView, an end-to-end medical second opinion platform, announces a new partnership with Modern Teleradiology, LLC and their board certified and subspeciality radiologists to provide second opinion reports and video consultations to users of the MDView platform. In addition to the new partnership, Modern Teleradiology founder and CEO, Sunil Kini, MD, was appointed as Medical Director of MDView to aid in the platform’s expansion of features aimed at streamlining second opinion services.
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Radiology Second Opinions – Connect with expert radiologists to get a second opinion report on medical imaging exams.
Dr. Kini and his team will play a crucial role in helping MDView reach more patients by affiliating with organizations seeking to improve patient care. This includes offering second opinions to reduce unnecessary procedures, expedite accurate diagnoses, and lower overall costs.
Modern Teleradiology joins the growing list of radiologists providing services via the MDView platform. Initially launched in June 2023, MDView’s expansion now offers radiology second opinions in Florida, New York, Texas, California, Arizona, Pennsylvania, Alabama, Illinois, Georgia, Montana, Nevada, Tennessee, and Canada, including subspeciality breast imaging second opinions in Pennsylvania and Florida.
Tracy Amato, CEO of MDView, emphasizes the mission to provide patients with peace of mind regarding their diagnosis. She states, “A patient’s radiology report is the foundation of their diagnosis and treatment plan. By having a radiologist provide an expert opinion report, patients and their doctors can be sure they are making the right decisions for a better outcome. We are delighted to have Dr. Kini join us in executing this mission and fueling the MDView platform with his team of expert radiologists to support our expansion.””We are thrilled to be collaborating with MDView as both organizations share the same ‘patient first’ vision,” said Dr. Kini. “These days, patients are more empowered regarding their own health. To that end, MDView’s second opinion platform aims to give patients more transparency when it comes to making decisions regarding their own well-being. We are excited to join MDView in our mission to make healthcare more patient-centric.”Philip Pullum, COO of Modern Teleradiology, adds, “We are very excited about our collaboration with MDView. We wholeheartedly support patient advocacy and embrace the ability to assist patients in the direction of their own care.”Beyond radiology second opinion services, the MDView platform offers plans to employers of any size as supplemental benefits to their current health plans. This allows employees virtual access to verify findings in their radiology imaging exams when dealing with new or uncertain medical conditions or before proceeding with invasive surgery or treatments. Additionally, MDView customizes its second opinion platform for medical institutions and practices looking to implement a turn-key second opinion program.Patients interested in getting a radiology second opinion can register for a free MDView account at https://app.mdview.com. For more information about MDView’s offerings, visit https://mdview.com.About MDViewMDView is a comprehensive medical technology platform facilitating seamless sharing of medical records, including diagnostic imaging exams. The customizable, white-label platform supports various medical use-cases, offering features such as secure video consultations, a 510k diagnostic DICOM image viewer, and medical reporting tools. MDView also provides a direct-to-patient radiology second opinion service, connecting patients with expert radiologists for virtual second opinion reports and video consultations. For details or business inquiries, visit https://www.mdview.com.About Modern TeleradiologyModern Teleradiology is a physician owned and led teleradiology service focused on providing state-of-the-art care to patients and dedicated collaboration to clients by offering remote radiology solutions customized to meet coverage needs. https://modernteleradiology.com/ Media Contact:Tracy Amato914-497-9245[email protected]SOURCE MDView Management, LLC
