Other News

Medtronic announces cash dividend for third quarter of fiscal year 2024

DUBLIN, Dec. 7, 2023 /PRNewswire/ — The board of directors of Medtronic plc (NYSE:MDT) on Thursday, December 7, 2023, approved the company’s cash dividend for the third quarter of fiscal year 2024 of $0.69 per ordinary share. This quarterly declaration is consistent with the dividend increase announcement made by the company in May 2023. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 46 consecutive years. The dividend is payable on January 12, 2024, to shareholders of record at the close of business on December 20, 2023.
About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:

Erika Winkels           
 Ryan Weispfenning

Public Relations       
 Investor Relations

+1-763-526-8478       
 +1-763-505-4626

SOURCE Medtronic plc

Ajax Health Establishes Cortex, a Comprehensive AFib Ablation Technology Company, with $90 Million Investment Led by KKR and Hellman & Friedman

Cortex’s fully integrated solution will include advanced diagnostic and therapeutic pulsed field ablation catheters supported by innovative mapping technology.
MENLO PARK, Calif., Dec. 7, 2023 /PRNewswire/ — Ajax Health announced today the formation and funding of Cortex, a medical technology company developing an integrated mapping and ablation solution suite for the treatment of atrial fibrillation (AFib), the most common heart rhythm disorder, affecting more than 30 million patients worldwide. Cortex has raised $90 million in funding commitments led by KKR and Hellman & Friedman (H&F) with participation by other investors including AI Life Sciences, an affiliate of Access Industries.
Cortex brings together expert teams with complementary innovations in electrophysiology to accelerate the continued development and clinical validation of next-generation ablation solutions and differentiated AFib mapping technology. The fully integrated solution suite is designed to enable more precise therapy planning and delivery and optimize clinical outcomes and safety for AFib patients, while simplifying workflows and improving procedural efficiency.
“Cortex’s vision is to enable more intelligent AFib treatment,” said Duke Rohlen, CEO of Ajax Health and CEO of Cortex. “We are developing solutions that prioritize precision, simplicity, and efficiency to simultaneously improve patient outcomes and lower procedural cost.”
Cortex is focused on developing diagnostic and pulsed field ablation catheters with a comprehensive mapping and navigation solution powered by Ablacon’s innovative Electrographic Flow® (EGF) mapping technology. EGF mapping allows physicians to detect AFib sources and is designed to support personalized ablation therapy to potentially improve outcomes. The recently completed randomized, controlled FLOW-AF trial (NCT04473963) showed that EGF-guided treatment of AFib sources in persistent AFib patients improved freedom from AFib at one year post-ablation by 51% on an absolute basis compared with patients randomized to control, who received conventional pulmonary vein isolation therapy only. Ablacon’s latest Ablamap® X mapping system is 510(k) cleared. Following on the favorable results of FLOW-AF, the company has launched the RESOLVE-AF trial (NCT05883631), a large, international, multi-center clinical trial to further evaluate benefits in AFib patients and support CE mark application. 
“Duke Rohlen and the Ajax team have cultivated an exceptional ecosystem of engineers and clinical experts with a clear plan to bring impactful new technology to clinical settings,” said Ali Satvat, Partner, Co-Head of Americas Health Care and Global Head of Health Care Strategic Growth at KKR. “We are pleased to continue our long-standing strategic partnership with Duke and join with a strong investor group to support Cortex as it pursues improved outcomes for cardiac arrhythmia patients.”
KKR and H&F are investing in Cortex through the Cordis Accelerator, Cordis-X, which was established in 2021 as part of their investment in Cordis, a leading provider of cardiovascular and endovascular medical devices. KKR is investing additional capital in Cortex through its Health Care Strategic Growth Fund II.
About CortexCortex (CortexEP.com) is developing an advanced, seamlessly integrated, comprehensive platform for evaluating and treating AFib. The company has assembled a proven team of highly skilled and experienced engineers and clinical experts focused on bringing this innovative suite of technologies to market.
About Ajax HealthAjax Health is a turnkey growth solution for commercial-stage medtech companies. The Ajax team draws on decades of experience as entrepreneurs, operators, and investors to create value for its strategic partners by developing product portfolios through novel business models and creative deal structures. Ajax Health is headquartered in Menlo Park, CA with offices in New York City, Los Angeles, and Austin.
SOURCE Cortex

BioGenCell Announces the Launch of BioGenCell’s Fifth Chronic Limb-Threatening Ischemia Clinical Trial Site in the United States

BioGenCell has announced the inauguration of the fifth Phase II cell-therapy-based clinical trial site for Chronic Limb-Threatening Ischemia (CLTI) in the United States at the University of Maryland Medical Center. This initiative is committed to dramatically reducing the incidence of amputations in patients afflicted with severe CLTI.
BALTIMORE, Md, Dec. 7, 2023 /PRNewswire/ — BioGenCell, a pioneer in personalized cell therapy solutions, is excited to announce the launch of its fifth Phase II clinical trial site in the United States at the University of Maryland Medical Center. The trial is focused on significantly reducing the need for amputation in patients with Chronic Limb-Threatening Ischemia (CLTI). The University of Maryland Medical Center has joined this ambitious, global, placebo-controlled trial designed to offer transformative results for patients.
The prognosis for CLI patients is currently disheartening: within a year of diagnosis, nearly 20% of patients succumb to the disease while 30% will undergo amputation. Tragically, nearly 70% of these amputees do not survive beyond five years post-amputation.
BioGenCell’s innovative yet low-risk technology harnesses the immune, stem, and progenitor cells from the patient’s own blood, drawn in a simple procedure. Upon reinjection into the affected limb, these “trained” cells stimulate the formation of new, healthy blood vessels, restoring blood flow, potentially averting limb amputation or even death, and significantly enhancing patient quality of life. BioGenCell’s previous clinical trial revealed an encouraging long-term amputation-free survival rate.
“We’re thrilled to embark on this journey with a significant institution like the University of Maryland,” said Dr. Yael Porat, BioGenCell co-founder and CEO. “Our aim is to bring tangible relief to individuals who have been living with CLI.”
Patients living with CLTI, their friends and relatives and interested physicians, are encouraged to visit www.biogencelltrial.com or reach out to the Study Coordinator (details) for more information on participating in this clinical trial.
About BioGenCell
BioGenCell, based at Laniado Hospital in Netanya, Israel, is dedicated to improving the lives of patients suffering from degenerative microvascular diseases. BioGenCell aims to extend its reach to address a wider range of vascular and other diseases in the future. For more information, please visit https://www.biogencell.net.
For more info:
Ifat Shomrony I [email protected] I +972-52-874-3030
SOURCE BioGenCell

Blue Shield of California Members Can Now Treat Heart Disease From Home, with Digital Expansion of Ornish Lifestyle Medicine

Nonprofit health plan adding new virtual offering after seeing 71.4% reduction in angina and 23.3% decrease in total cholesterol from nine-week in-person program
OAKLAND, Calif., Dec. 7, 2023 /PRNewswire/ — Blue Shield of California members now have virtual access to Ornish Lifestyle Medicine, an innovative intensive cardiac rehab program designed to help prevent, treat, and even reverse heart disease through lifestyle change.
Heart disease is the leading cause of death in California and across the nation, and the expansion of this program aims to help more Californians improve their cardiac health by providing a virtual access option to a successful in-person program.
“At Blue Shield of California, we believe making lifestyle changes have the power to help people with chronic conditions,” said Jennifer Christian-Herman, Blue Shield of California vice president of MindBody Medicine. “Dr. Dean Ornish is an influential leader at the forefront of lifestyle medicine and together we are driving easier access to quality care and creating better heart health outcomes for our members.”
Ornish Lifestyle Medicine is a 72-hour, 9-week heart disease reversal program through lifestyle intervention methods. Participating members can join 4-hour virtual sessions twice a week – with the time equally dedicated to exercise, stress management, interactive lessons, and a support group.  
To enhance the experience of participating from the comfort of home, participants receive:

FOOD – Two weeks’ worth of fresh, delicious, and heart healthy premade meals (three meals a day, plus snacks) to kickstart a new way of eating.
TECHNOLOGY – A heart rate monitor, scale, and blood pressure cuff for continuous tracking.
EQUIPMENT – An activity mat and other equipment for exercise and relaxation.
SUPPORT – Throughout the 9 weeks, participants will connect with each other in support group sessions, supporting each other through making important lifestyle changes, in addition to classes and coaching.

Until now, Blue Shield of California members had access to the Ornish Lifestyle Medicine program in-person at Marin Health and UCLA Health. Those 159 participating members saw significant improvement in their health outcomes after nine weeks. The results include:

71.4% reduction in angina
23.3% decrease in total cholesterol
36.8% decrease in LDL cholesterol
10% decrease in triglycerides
40.4% decrease in depression
3.5% decrease in A1c levels
20.1% increase in exercise capacity

“Backed by over 45 years of research, Ornish Lifestyle Medicine remains the only program scientifically proven to often reverse heart disease without drugs or surgery,” said Dean Ornish, MD, founder of Ornish Lifestyle Medicine. “I have seen what a powerful difference this program can make to people’s lives and am proud to expand this program to reach more Californians by offering it virtually through Blue Shield of California. Everyone deserves the chance to change their health – no matter where they live, or what their mobility and transportation limitations might be.”
The program is available to members enrolled in Blue Shield’s employer-sponsored, individual and family, and Medicare PPO plans who have a history of heart disease or a cardiac event. The collaboration is part of the company’s larger effort to reimagine health care through lifestyle medicine. Members can also access Blue Shield’s award-winning Wellvolution program, which offers a suite of lifestyle medicine-based digital solutions, focusing on diabetes, mental health, tobacco cessation, and weight loss.
About Blue Shield of CaliforniaBlue Shield of California strives to create a healthcare system worthy of its family and friends that is sustainably affordable. Blue Shield of California is a tax paying, nonprofit, independent member of the Blue Shield Association with more than 4.8 million members, over 7,500 employees and more than $24 billion in annual revenue. Founded in 1939 in San Francisco and now headquartered in Oakland, Blue Shield of California and its affiliates provide health, dental, vision, Medicaid and Medicare healthcare service plans in California. The company has contributed more than $97 million to Blue Shield of California Foundation in the last three years to have an impact on California communities.
For more news about Blue Shield of California, please visit news.blueshieldca.com. 
Or follow us on LinkedIn, Twitter, or Facebook.
About Ornish Lifestyle MedicineOrnish Lifestyle Medicine is the only program that is scientifically proven to reverse the progression of heart disease in randomized controlled trials. Ornish Lifestyle Medicine has spread across the country and begun to revolutionize the way that Americans treat heart disease. Today, the program is reimbursed by Medicare and many other commercial payers, offered in more than 18 states, and delivered with a turnkey process that is optimized by years of operating knowledge. Most importantly, since 2014 alone, it has helped thousands of people from across the country take back their lives. For more information, visit www.ornish.com.

CONTACT:
Kelly Nuckols

Blue Shield of California        

510-607-2359

[email protected]

SOURCE Blue Shield of California

Artivion Appoints Lance A. Berry as Executive Vice President, Chief Financial Officer; Announces Retirement of D. Ashley Lee, Chief Financial Officer

Reaffirms Financial Guidance Provided on November 2, 2023
ATLANTA, Dec. 6, 2023 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease today announced the appointment of Lance A. Berry as the Company’s Chief Financial Officer, effective as of December 4, 2023. In this role, Mr. Berry joins Artivion’s executive leadership team and replaces Mr. D. Ashley Lee, who will retire at the end of the year after a successful and long tenure with the Company and a distinguished career in the medical device industry. Artivion also reaffirmed its full-year 2023 financial guidance that was provided on November 2, 2023.
Mr. Berry, 51, most recently served from January 2019 until November 2020 as the Executive Vice President, Chief Financial and Operations Officer of Wright Medical Group N.V. (“Wright”), until Wright was acquired by Stryker in November 2020. Before that, Mr. Berry served as the Senior Vice President, Chief Financial Officer for Wright from 2009 to 2018, successfully spear-heading its merger with Tornier N.V. Additionally, Mr. Berry served as Wright’s Vice President, Corporate Controller from 2002-2009. Mr. Berry also currently serves on the Boards of two public companies, Treace Medical Concepts, Inc. and Vapotherm. Throughout his eleven years as the Chief Financial Officer and a senior executive at Wright, working with Wright’s Board and Chief Executive Officer, Mr. Berry led the Company’s strategic transformation and execution to drive shareholder value and cultivated an extensive background in, among other areas, strategy, M&A, financing, business development, digital strategy and investor relations.
“I am thrilled to welcome Lance to Artivion’s leadership team as Chief Financial Officer,” said Pat Mackin, Chairman, President, and Chief Executive Officer. “His broad experience and proven leadership in growth MedTech companies make him an ideal addition to our leadership team, and he will add significant value in advancing Artivion and its strategy through our next stage of growth.”
“I am excited to join Artivion as Chief Financial Officer and continue my commitment to driving focus, execution and significant shareholder value,” said Mr. Berry. “I look forward to working with Artivion’s exceptional team to continue to grow Artivion into a powerhouse leader in aortic technology and innovation.”
Mr. Lee, 59, who has served as the Company’s Chief Financial Officer since 2004, will retire after a transitional period. Mr. Lee, a proven leader and a winner of Georgia BioTech’s CFO of the Year award in 2018, has decades of medical device experience. He helped lead the Company’s efforts that resulted in a more than doubling of the Company’s size since 2015. Mr. Lee will remain with Artivion in an advisory capacity to ensure a seamless transition. Mr. Lee expressed his confidence in Mr. Berry’s abilities to take on the role, stating, “I have no doubt that Lance will be an excellent addition to the Artivion leadership team. His deep financial expertise and experience in the medical device industry make him ideal to lead the Company’s finance, information technology, human resources and business development functions.” 
“I want to extend my heartfelt thanks to Ashley for his leadership at Artivion during a period of incredible growth and transformation,” added Mr. Mackin. “Artivion would not be where it is today without Ashley’s deep expertise and experience, and we wish him the very best on the next leg of his journey.”
Mr. Berry officially began his role as Chief Financial Officer on December 4, 2023.
About Artivion, Inc.Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion markets and sells products in more than 100 countries worldwide. For additional information about Artivion, visit our website, www.Artivion.com.
Forward Looking StatementsStatements made in this press release that look forward in time or that express management’s beliefs, expectations, or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the views of management at the time such statements are made. These statements include our beliefs that we remain on track to achieve or exceed the revenue and EBITDA growth targets for this year; and we remain on a path to meet or exceed our current year guidance, as well as to achieve our 2024 commitments to deliver double-digit compounded annual constant currency revenue growth and adjusted EBITDA in excess of $75.0 million. These forward-looking statements are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations, including that the benefits anticipated from the Ascyrus Medical LLC transaction and Endospan agreements may not be achieved at all or at the levels we had originally anticipated; the benefits anticipated from our clinical trials may not be achieved or achieved on our anticipated timeline; our products may not be able to consistently retain their existing regulatory approvals or special regulatory approvals in order to be commercialized; products in our pipeline may not receive regulatory approval at all or receive regulatory approval on our anticipated timelines; or our products that obtain regulatory approval may not be adopted by the market as much as we anticipate or at all. These risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2022 and our Form 10-Q for the quarter ended September 31, 2023. Artivion does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise.

Contacts:

Artivion
Gilmartin Group LLC

D. Ashley Lee
Brian Johnston / Lynn Lewis

       Executive Vice President,                  
Phone:  332-895-3222

Finance
[email protected] 

Phone: 770-419-3355

SOURCE Artivion, Inc.

BioSig Issues Letter to Shareholders Detailing Technology Innovations and Strategic Focus for 2024

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, […]

JenaValve Featured at the PCR London Valves 2023

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 […]

Merit Medical Announces Pricing of Upsized Private Offering of $650.0 Million of 3.00% Convertible Senior Notes Due 2029

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 […]

Micro Medical Solutions Announces Completion of Enrollment in the STAND Pivotal Clinical Trial

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

BridgeBio Pharma Announces Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

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 […]