The Latest Cardiac and Vascular News
HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, today announced the filing of a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its novel […]
TORONTO, Dec. 21, 2023 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it received approval in Turkey from the Kocaeli University Clinical Research Ethics Committee to proceed with a Phase II trial for LSALT peptide, targeting the prevention and […]
SHANGHAI, Dec. 17, 2023 /PRNewswire/ — YolTech Therapeutics today announced that the first patient has been dosed with YOLT-201, the company’s first in vivo genome editing candidate being developed as a single dose, potentially curative therapy for hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM).
The study by YolTech is a single-arm, open-label, dose-escalation clinical trial (Clinicaltrials.gov: NCT06082050). This trial’s primary objectives are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of YOLT-201 as well as the identification of an Optimal Biologically Active Dose (OBD).
ATTR-CM, a rare, progressive and debilitating disease. It is caused by the misfolding of unstable Transthyretin Protein (TTR), leading to the deposition of amyloid-like buildup in the myocardial interstitium, causing stiffening of the heart muscle and subsequent heart failure. Studies have reported the median survival time of approximately 3.5 years from the first diagnosis of ATTR-CM if left untreated.
Dr. Yuxuan Wu, Founder and CEO of YolTech, expressed, “The successful FPI in this trial is a significant milestone, representing YolTech’s relentless efforts in the field of in vivo gene editing are gradually becoming a reality. We extend our gratitude to all researchers, partners, and supporters involved in the YOLT-201 project, especially to the dedicated research team at FAHZU for their steadfast support of drug development in vivo gene editing. We believe through this therapeutic intervention, we will provide a novel treatment option for ATTR-CM patients, offering them new hope and an improved quality of life.”
This study is a part of YolTech’s series of clinical trials in vivo gene editing. The company remains committed to advancing research in the treatment of ATTR and other diseases. Through close collaboration with the clinical community, we will continue to pursue excellence, push the boundaries of medical technology, and provide more advanced and innovative medical solutions for patients worldwide.
About YOLT-201
YOLT-201 Injection utilizes several lipid components including ionizable lipids as primary excipients to encapsulate mRNA and sgRNA raw materials, forming lipid nanoparticles (LNP). Upon intravenous injection into the body, plasma ApoE protein binds to the surface of LNP particles. Liver cells expressing the LDLR receptor recognize ApoE protein and engulf the LNP through endocytosis, forming endosomes. The decrease in pH within endosomes promotes electrostatic interactions between ionizable lipids and endosomal membranes, leading to membrane disruption and the release of mRNA and sgRNA. mRNA, in the cytoplasm, binds to ribosomes, translating the base editor protein. The base editor protein, in combination with sgRNA, enters the cell nucleus. sgRNA specifically locates the base editor to the TTR gene sequence, and the base editor protein modifies the bases on the target TTR gene, preventing its normal transcription into mRNA. This process stops the production of the TTR protein, achieving the goal of a one-time administration for a comprehensive cure of ATTR diseases.
About YolTech
YolTech Therapeutics is a pioneering gene editing company dedicated to develop a robust gene editing medicines to treat patients with serious diseases, which has built leading high-throughput evolution platform and innovative LNP deliver system. It possesses strong capability of novel Cas and base editor discovery and exceptional in-house LNP production capacity for GMP manufactory, with independent intellectual property rights and core patent protection globally. It has created a pipeline with 10+ genetic medicines focusing on cardiovascular diseases, metabolic diseases, infectious diseases as well as more common and rare diseases. Leading asset will enter phase I trial by end of 2023.
For more information, please visit: www.yoltx.com
SOURCE YolTech Therapeutics
TORONTO, Dec. 13, 2023 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today it has submitted a Clinical Trial Application to Health Canada to obtain permission to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment […]
WALTHAM, Mass., Dec. 12, 2023 /PRNewswire/ — FluidForm Bio, a leader in developing life-like human tissue to treat disease, shares recent advancements in building human cardiac tissues using FRESH™ 3D bioprinting. Recently published in APL Bioengineering, the research article FRESH™ 3D bioprinted cardiac tissue, a bioengineered platform for in vitro pharmacology addresses the critical need for a predictive model of human cardiac physiology in drug development. There are significant gaps in existing models due to their incomplete recapitulation of adult human cardiovascular physiology. FluidForm Bio has demonstrated potential for bridging this gap using human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) in three-dimensional tissue structure.
“We are not aware of any other biofabrication or tissue engineering approaches that can achieve comparable cell densities and uniaxial alignment on the market today, both of which contribute to more advanced physiologic function” said FluidForm Bio CTO and Co-founder Adam Feinberg.
The FRESH™ technology overcomes many of the limitations of other engineered cardiac tissues because it enables a high degree of cardiomyocyte alignment while minimizing hypoxia and cell death. Furthermore, by leveraging robotic fabrication, tissues are highly viable and reproducible, maintaining functional response across tissues and batches.
“This study was conducted by scientists at FluidForm and Merck & Co.,” explained FluidForm Bio CEO and Co-founder Mike Graffeo. “This is further evidence that we build the most lifelike tissue in the world with FRESH™. As we develop tissue therapeutic applications on this platform, we are thrilled to collaborate with top scientists and look forward to sharing further data.”
About FluidForm Bio FluidForm Bio is creating living human tissue for better treatment of disease. Our patented FRESH™ technology is a revolutionary platform designed to build tissue using cells, proteins, and nothing else. Through partnerships with top life science companies, our technology has been validated to produce the highest quality tissue in a variety of applications. We deliver human tissue that is indistinguishable from the real thing. Our living tissue will offer therapies to countless patients who deserve better treatment options.
FluidForm Bio was founded in 2018 on the belief that the world needs transformational technologies led by creative and passionate experts that help people lead better lives. Headquartered in Waltham, MA, learn more at http://www.fluidformbio.com/or connect on Twitter and LinkedIn.
Naomi Phaneuf, [email protected], 781-691-0978
SOURCE FluidForm Bio
Software Release Affirms CathVision’s Dedication to Advancing Data-Driven Clinical Diagnosis and TreatmentCOPENHAGEN, Denmark, Dec. 12, 2023 /PRNewswire/ — CathVision, a medical technology company developing innovative electrophysiology solutions designed to enhance clinical decision making in the EP lab, today announced the launch of ECGenius 3.1, an advanced version of the ECGenius™ System software. The new version improves workflow and streamlines processes to accelerate adoption as electrophysiologists integrate AI analyses into the EP lab, increasing the demand for high-quality signal data.1
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Intelligent automated analyses can effectively enable physicians to confirm the success of ablation efforts.
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ECGenius 3.1 is an advanced version of the ECGenius System software. The new version improves workflow and streamlines processes to accelerate adoption as electrophysiologists integrate AI analyses into the EP lab, increasing the demand for high-quality signal data
ECGenius 3.1 delivers several new and enhanced features to provide an improved user experience throughout, including:
Advanced trigger function with automatic calipers for precise local activation analyses
Enhanced comparison functionality featuring pre-sized multiple windows for virtually effortless electrogram comparisons
Increased display sweep speed of up to 800 mm/s to help identify crucial EGM details
Expanded and improved connectivity with RF generators and large monitor displays
The release of ECGenius 3.1 follows the Q3 launch of the PVI Analyzer™ and Signal Complexity™ algorithms. These algorithms are part of the CARDIALYTICS™ suite of artificial intelligence-powered analytics integrated into the ECGenius System, making it the only EP recording system with an AI algorithm to facilitate electrogram interpretation and deliver unprecedented levels of intelligent, automated analyses designed to help physicians improve ablation outcomes in complex atrial arrhythmia procedures by measuring the success of cardiac ablation.2″The enhanced features and overall clinical maturity of ECGenius 3.1 clearly demonstrate this state-of-the-art EP recording system will provide advanced clinical utility to the broader EP community throughout the US,” said Dr. Larry Chinitz, Director of Electrophysiology at NYU Langone Health. “EPs are looking for opportunities to take our work to a higher level, and there is no other recording system better positioned to help us do that. We now have the technology to replace outdated systems.””These consecutive, major software launches highlight CathVision’s considerable momentum and our expertise in developing software features that streamline procedure workflows and enhance the physician experience,” said Mads Matthiesen, CEO, CathVision. “EPs are eager to access better quality signal data. ECGenius 3.1 makes the workflow transition seamless and strengthens our leadership position in equipping electrophysiologists with the technology necessary to elevate patient outcomes.”ECGenius System is CathVision’s innovative EP recording technology and proprietary hardware amplifier that acquires high-fidelity, low-noise cardiac electrograms to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including AF. Unlike traditional EP recording systems that often capture electrogram signals marred by noise and artifact, ECGenius delivers a necessary evolution in the quality of intracardiac and ECG signal acquisition, the accuracy of electrogram interpretation, and the advancement of therapy support. With exceptional data from the ECGenius System, intelligent automated analyses can effectively enable physicians to confirm the success of ablation efforts.For more information about ECGenius System and CARDIALYTICS, please visit www.cathvision.com or email [email protected].About CathVisionCathVision is a medical technology company that develops electrophysiology solutions centered around an innovative EP recording system and AI algorithm platform – the ECGenius System with CARDIALYTICS. Committed to empowering physicians to make more informed clinical decisions in the EP lab, CathVision is redefining the necessity of exceptional cardiac electrical signals to diagnose, characterize, and treat the most common heart rhythm disorders. CathVision was founded in 2013 and is headquartered in Denmark with a U.S. office in Minnesota.Follow CathVision: Twitter/X and LinkedIn 1 ECGenius System is cleared for sale in the US. Not approved for sale in the rest of the world. 2 PVI Analyzer and Signal Complexity are cleared for sale in the US. Not approved for sale in the rest of the world.SOURCE CathVision
PONTE VEDRA, Fla., Dec. 12, 2023 /PRNewswire/ — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD) a biopharmaceutical company developing tecarfarin, a late-stage, novel, oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes and deaths (due to blood clots in patients with certain orphan diseases), today announced an engagement with The Sage Group (www.sagehealthcare.com) to assist the company in exploring strategic partnerships, co-development and licensing agreements for tecarfarin.
The Sage Group is a leader in providing strategic and transactional advice to healthcare and life science companies in the pharmaceutical, diagnostics, medical devices, biotech, regenerative medicine, and cell and gene therapy fields. This partnership will give Cadrenal access to The Sage Group’s clinical and regulatory expertise, capital resources, and network of contacts, including innovators and large pharma companies.
Tecarfarin is a novel chemical entity that provides stable anticoagulation to patients with certain orphan diseases, including End-Stage Kidney Disease (ESKD) with Atrial Fibrillation (AFib); Left Ventricular Assist Devices (LVADs); and Antiphospholipid Syndrome (APS). The currently available blood thinners, including warfarin, Pradaxa, Xarelto, Eliquis, and Savaysa, fail to achieve sufficiently stable anticoagulation in these patients and are not widely prescribed for these rare medical conditions. In recent advertisements for Eliquis, the narration specifically states, ‘Don’t take Eliquis if you have an artificial heart valve…’ and ‘Eliquis is not for patients who have antiphospholipid syndrome (APS).’
Tecarfarin was designed to solve one of warfarin’s major problems, namely warfarin’s unreliable pharmacokinetic (PK) profile, due to its metabolism via the cytochrome P450 pathway. This pathway is responsible for the metabolism of many other drugs, resulting in drug-drug interactions that can lead to unstable anticoagulation. Tecarfarin was specifically designed to be metabolized via an alternate pathway, resulting in a more reliable, stable PK and anticoagulation, as evidenced in clinical trials in over 1,000 patients.
“Patients with certain orphan diseases, including ESKD with AFib, LVADs, and APS, suffer from a lack of options to achieve sufficiently stable anticoagulation,” said Quang Pham, CEO of Cadrenal. “With The Sage Group’s support, we look forward to identifying the right partner to help us advance clinical development globally in an effort to bring a much-needed blood thinner solution to the market for these underserved patients.”
Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease.
The FDA has granted tecarfarin orphan drug and fast-track designations for ESKD with AFib. Cadrenal is also developing expanded regulatory strategies for LVAD and APS. Cadrenal estimates that in the treatment of these orphan diseases, the combined addressable market opportunity is in excess of US $2 billion per year in the U.S.
ABOUT CADRENAL THERAPEUTICS, INC.Cadrenal Therapeutics is developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner), to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain rare medical conditions. Tecarfarin has orphan drug and fast-track designations for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease, or ESKD, and atrial fibrillation, or AFib. Tecarfarin has been specifically and deliberately designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.
ABOUT THE SAGE GROUP, INC.The Sage Group Inc. is a leader in the provision of strategic and transactional advice to health care companies in the pharmaceutical, diagnostics, medical device, biotechnology and life science fields. Sage currently maintains offices in USA, Europe, Israel and Japan. Since its founding in 1994, The Sage Group has served more than 200 clients in the US, Europe and Asia, and completed numerous transactions including alliances, acquisitions, divestitures, and financings with values ranging from $5 million to $500 million.
The Sage Group is an organization of experienced and successful executives who are committed to the service of the very vital and dynamic health care industry and its investors.
The range of services offered includes:
* Strategic alliances and licensing/partnering* M&A, divestment, buy- and sell- side* Global product and technology acquisition searches* Strategic assessment and planning* Due diligence, technology and molecule assessment, valuation* New ventures, interim management* Facilitating investment in R&D and/or company equity through introductions, network and brokering
The Sage Group’s Principals, each an Executive Director, have been Founders, Chairmen, Presidents, CEO’s and COO’s of a number of emerging health care companies. These Principals have also held senior level management positions in large multi-national organizations. In addition to their management backgrounds, The Sage Group’s Principals also have extensive experience in providing professional management consulting services to healthcare industry clients. All these experiences are being applied by The Sage Group to assist industry participants. For more information, please visit: www.sagehealthcare.com.
Safe Harbor StatementAny statements contained in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the partnership with The Sage Group giving Cadrenal access to its clinical and regulatory expertise, capital resources, and network of contacts, including innovators and large pharma companies, the belief that tecarfarin will provide LVAD and APS patients with stable anticoagulation, identifying a partner to help Cadrenal advance clinical development globally with The Sage Group’s support, developing expanded regulatory strategies for LVAD and APS, and the estimated addressable market opportunity in excess of $2 billion per year in the U.S.
The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance tecarfarin within patients with implanted medical devices for heart diseases, the ability to penetrate the U.S. market for patients with LVADs who struggle with stable anticoagulation with warfarin, the ability to advance patient care in cardiorenal diseases and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information, please contact:
Cadrenal Therapeutics:Matthew Szot, CFO858-337-0766[email protected]
Investors:Lytham Partners, LLCRobert Blum, Managing Partner602-889-9700[email protected]
For more information about Cadrenal and partnering opportunities for tecarfarin, please contact:
Dr. Bill MasonThe Sage Group IncThe StockyardCreake Road, Syderstone PE31 8SG UKTel: +44 (0) 7785 950134[email protected]
Or
Wayne PambianchiThe Sage Group Inc.24 E. Main Street, Box 5365Clinton, New Jersey 08809Phone: +1 908 2306170[email protected]
SOURCE Cadrenal Therapeutics, Inc.
Use of CRRT increased during COVID and remained at these higher utilization levels
Study results demonstrate challenges physicians have with heparin and citrate, the two currently available CRRT anticoagulants
SAN MATEO, Calif., Dec. 12, 2023 /PRNewswire/ — AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the publication of a quantitative market research study evaluating current U.S. physician anticoagulation use during continuous renal replacement therapy (CRRT) in patients with acute kidney injury in the intensive care unit. The only FDA-approved anticoagulant for dialysis circuits is heparin, which has a half-life of 1-3 hours. Heparin is therefore classified as a “systemic” anticoagulant, as it circulates back into the patient from the dialysis circuit, resulting in anticoagulation of the patient, which is often dangerous. The FDA has given an Emergency Use Authorization (EUA) to citrate, which is classified as a “regional” anticoagulant, as its effect is reversed with a calcium infusion that is administered to the patient, therefore limiting its anticoagulant effect to the circuit.
The publication, entitled “Anticoagulation Practices for Continuous Renal Replacement Therapy: A Survey of Physicians from the United States,” is lead authored by Dr. David Boldt, and published in the journal Renal Failure. Dr. Boldt is an Associate Professor at the University of California, Los Angeles School of Medicine, Critical Care Intensivist and Division Chief of Trauma and Adult Multi-Specialty Anesthesiology. In the study, a total of 150 U.S. board-certified physicians consisting of critical care medicine specialists (n=80) and nephrologists (n=70) who specialize in CRRT were surveyed by MedSurvey from November to December 2022 regarding their current CRRT anticoagulation practices.
This study resulted in a number of key findings:
CRRT machine use increased by approximately 30% from pre-pandemic era to late 2022.
On average, physicians use heparin in the CRRT circuit for 43% of patients, with citrate being used in 28% of patients and no anticoagulation used in 29% of patients.
The top reason for use of heparin is that it is readily available, but concerns with heparin included systemic bleeding and heparin-induced thrombocytopenia, which were ranked 3.5 and 3.4 respectively, on a 1-5 scale of “not challenging” to “very challenging”.
Hypocalcemia (52% of physicians) and citrate safety (42% of physicians) were ranked as the top two reasons for not using citrate in heparin-intolerant patients. Physicians who do use citrate reported that hypocalcemia occurs in 37% of patients.
When no anticoagulation is used in the CRRT circuit, 84% of physicians stated filter clogging was a problem and almost a quarter of the physicians stated an increase in transfusions was required as a result.
Study limitations include that the study was an online survey; however, physicians had to pass eight screening questions to ensure they were board-certified in critical care medicine or nephrology, worked in an ICU, and were familiar with the protocols and logistics of CRRT use in their hospital.
“It is clear from this study that physicians in charge of CRRT at their institutions are not completely satisfied with the currently available anticoagulants, heparin and citrate, for use in the dialysis circuit,” stated Dr. Pamela Palmer, AcelRx Chief Medical Officer and co-founder. “Niyad as a potentially new regional anticoagulant for patients who cannot tolerate heparin could provide a meaningful improvement to the current standard of care in this field. Allowing physicians to avoid the complexities associated with citrate and reducing the number of patients who receive no anticoagulation by offering a new alternative can hopefully improve the quality of CRRT for these very fragile patients.”
Dr. Boldt states, “We really don’t have any great choices as it relates to CRRT anticoagulation, which is why I am excited about the potential approval of Niyad as a new anticoagulant option. Nafamostat’s ultra short half-life of 8 minutes and its limited systemic effect could really change how we approach anticoagulation of CRRT circuits. Heparin is fraught with potentially significant, and often life-threatening, complications such as systemic bleeding and heparin-induced thrombocytopenia, as well as heparin resistance, all of which make using heparin challenging in many patients.” Dr. Boldt continues, “While citrate avoids the risk of systemic bleeding, its complicated administration protocol, requirement for a calcium infusion, frequent testing of calcium levels, and citrate toxicity risks can lead many clinicians to avoid its use altogether.”
AcelRx provided funding to conduct the study. Some of the authors, including Dr. Boldt, are consultants for AcelRx but were not paid for their contributions to this manuscript.
About AcelRx Pharmaceuticals
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx’s lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the FDA. AcelRx is also developing two pre-filled syringes in-licensed from its partner Aguettant: Fedsyra™, a pre-filled ephedrine syringe, and PFS-02, a pre-filled phenylephrine syringe. This release is intended for investors only. For additional information about AcelRx, please visit www.acelrx.com.
About Nafamostat
Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that will be investigated and developed as a potential anti-viral for the treatment of COVID, acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC) and acute pancreatitis.
Forward-looking statements
This press release contains forward-looking statements based upon AcelRx’s current expectations. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as “potential”, “believe”, “expect”, “expects”, “expected”, “anticipate”, “hopefully”, “upcoming”, “may”, “will”, “enable”, “should”, “seek”, “approximately”, “intends”, “intended”, “plans”, “planned”, “planning”, “estimates”, “benefits”, or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to AcelRx’s product development activities and ongoing commercial business operations; (ii) risks related to the ability of AcelRx and its business partners to implement development plans, launch plans, forecasts and other business expectations; (iii) risks related to unexpected variations in market growth and demand for AcelRx’s commercial and developmental products and technologies; (iv) risks related to AcelRx’s liquidity and its ability to maintain capital resources sufficient to conduct the required clinical studies; (v) AcelRx’s ability to retain its listing on the Nasdaq exchange; and (vi) risks relating to AcelRx’s ability to obtain regulatory approvals for its developmental product candidates. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption “Risk Factors” and elsewhere in AcelRx’s annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC) and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in AcelRx’s most recent annual, quarterly or current report as filed or furnished with the SEC. AcelRx’s SEC reports are available at www.acelrx.com under the “Investors” tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
For additional information about AcelRx, please visit www.acelrx.com.
This release is intended for investors only.
SOURCE AcelRx Pharmaceuticals, Inc.
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.
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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
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 […]
