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 […]
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Acesion Pharma announces Nature Medicine publication of clinical results in Atrial Fibrillation
AP30663 achieved proof of mechanism with first-in-class SK channel inhibition compound in atrial fibrillation – primary endpoint met: 99.9% probability of superiority over placebo
AP31969, a novel compound being developed for sinus rhythm maintenance in atrial fibrillation, commences dosing in phase 1
COPENHAGEN, Denmark, Dec. 13, 2023 /PRNewswire/ — Acesion Pharma (“Acesion” or “the Company”), a biotech company pioneering first-in-class novel therapies for atrial fibrillation (“AF”), the most common cardiac arrhythmia, today announces the publication of data in Nature Medicine with the full results from its Phase 2 proof-of-concept trial of AP30663, a first-in-class SK ion channel inhibitor for conversion of AF to normal sinus rhythm. As previously announced, the trial met its primary endpoint, thereby demonstrating the first ever proof mechanism for SK channel inhibition as a novel treatment for AF.
AP30663 Phase 2 trial results
In the trial, patients with a current episode of AF lasting for seven days or less were randomized to receive an intravenous infusion of 3 or 5 mg/kg of AP30663 or placebo. The primary endpoint of the trial was cardioversion from AF to sinus rhythm within 90 min from the start of the intravenous infusion, analysed using Bayesian statistics.
The primary endpoint occurred in 42% (5 of 12), 55% (12 of 22) and 0% (0 of 25) of patients treated with 3 mg/kg AP30663, 5 mg kg/1 AP30663, or placebo, respectively. Both doses demonstrated more than 99.9% probability of superiority over placebo, surpassing the prespecified 95% threshold. No ventricular arrhythmias were observed, and adverse event rates were comparable between active and placebo group. The results are now published in the high-impact journal Nature Medicine (https://www.nature.com/articles/s41591-023-02679-9).
AP31969 Phase 1 trial initiated
In addition to the publication of the above phase 2 trial results, the company has also successfully dosed the first healthy volunteer subjects in a phase 1, first-human-dose, clinical trial of AP31969, an oral first-in-class SK ion channel inhibitor designed to maintain sinus rhythm in patients suffering from AF.
The phase 1 trial is planned to consist of two parts: single ascending dose and multiple ascending dose. In addition, the effect of food on the absorption of the compound will be investigated. Results from the trial are expected in Q3 2024.
AP31969 is being developed for chronic oral maintenance treatment to prevent AF recurrence (maintain sinus rhythm) and has shown strong pre-clinical efficacy combined with a promising safety profile.
Anders Gaarsdal Holst, MD, PhD, Chief Executive Officer of Acesion, said “We are pleased that Nature Medicine has recognised the importance of our AP30663 results for conversion of AF to sinus rhythm and accepted them for publication in their prestigious journal. Based on this achievement of clinical proof-of-mechanism, and enabled by our recent successful Series B financing, we have now also moved our oral SK inhibitor AP31969 into clinical development. Through this study, we will learn about the safety, as well as the pharmacokinetics of AP31969 and it is an important step towards addressing the large unmet need within atrial fibrillation.”
AF is the most common type of cardiac arrhythmia and is forecast to affect 25 million people in the US and EU by 2030. Existing drug therapies for AF are associated with the risk of serious cardiac or other adverse effects, resulting in a great need for safer drugs. Yet, there has been a lack of innovation and development with no new chronic AF drug approved for nearly 20 years. With AP31969, Acesion is aiming to develop a safer alternative.
About Acesion Pharma
Acesion builds on 20 years of know-how with development of small-molecule SK inhibitors and is the world leader in the field of SK channel inhibition, being the only company able to identify and progress SK channel inhibitors into clinical trials. In pre-clinical studies, inhibiting the SK channels has been shown to result in pronounced antiarrhythmic effects in the atria while avoiding effects on the ventricles, the major chambers of the heart and the source of most safety issues with existing drugs. Furthermore, the SK channel has strong genetic validation, with genes encoding the SK channels having one of the strongest associations to AF in human genome-wide association studies. Acesion’s AP30663 IV is a short acting conversion therapy that has completed a phase 2 trial proving the value of this first-in-class mechanism in AF and thereby de-risking Acesion’s broader SK inhibitor pipeline. Acesion’s oral program with lead candidate AP31969 is designed and engineered using in house knowhow to optimise for, and meet, very high hurdles in both efficacy and particularly safety where existing treatments fall short of patient needs. Acesion Pharma is backed by Novo Holdings, Canaan, Alpha Wave Ventures, Global BioAccess Fund, Wellcome Trust, Broadview Ventures and FC Capital.
https://www.acesionpharma.com/
About atrial fibrillation (AF)
AF is the most common type of cardiac arrhythmia mainly affecting the elderly population. Lifetime risk for development of AF is estimated at more than one in three. It is forecast to affect 25 million people in the US and EU by 2030. AF is characterized by chaotic electrical activity in the upper chambers of the heart, the atria, resulting in an irregular and high heart rate. AF is associated with impaired quality of life, increased rate of hospitalization, and a five-fold increased risk of stroke. Increasing evidence suggests that patients with AF also face a higher risk of cognitive dysfunction and dementia.
AF is often treated by electrical shock to bring the heart back to its normal rhythm (conversion). This requires general anesthesia in a hospital setting. In addition, many patients are likely to benefit from chronic treatment to prevent AF and maintain normal sinus rhythm. Existing drug therapies for cardioversion or prevention of AF are associated with risk of serious cardiac or other adverse effects, resulting in a great need for safer drugs. Yet, there has been a lack of innovation and development with no new chronic AF drug approved for nearly 20 years. A landmark New England Journal of Medicine published clinical trial (https://doi.org/10.1056/NEJMoa2019422) has shown that sinus rhythm maintenance treatment improves survival and long-term outcomes for AF patients.
SOURCE Acesion Pharma
SYNDEO Medical Named by Business Worldwide Magazine as one of 2023’s Top 20 Most Innovative Companies to Watch
LONDON, Dec. 13, 2023 /PRNewswire/ — Belgium-based medical device design company SYNDEO Medical has made Business Worldwide Magazines 2023 “20 Most Innovative Companies to Watch” list. The list is a celebration of trailblazing organizations that are changing the game in their respective industries and altering the corporate landscape. Encompassing healthcare, banking, industry, construction, energy, and more, these companies are at the cutting edge of breakthrough technologies, innovation and modernized business structures. Those included in the list demonstrate a shared goal of developing revolutionary products and technology that drive scalable business models and disrupt established industries and markets.
Led by Justin Lampropoulos, the company is on a mission to revolutionise the way healthcare practitioners access tools they need, by bridging the gap between past and future.
At the heart of every operating theatre lies a combination of essential tools and materials needed to save and improve lives. Everything from surgical gloves to gowns, scalpels and intricate medical devices are brought together for every specific surgery, and for decades these were all conveniently provided in customised, sterile packs. This tailor-made approach worked for medical teams, and it’s what they came to expect, but over the past five to seven years custom packs have become virtually extinct due to reduced funding and other external pressures.
On average, every pack contains about 30/40 different components, which means those involved in hospital procurement have to buy all of those products independently, fly them, manage the purchase orders, and deliver. The complexity of producing an additional 10-15 purchase orders with the associated contracts and sales representatives puts a huge strain on patient care, finances, and overall efficiency. Doctors and nurses were spending hours shopping for specific items of equipment when they want to be focusing on patient care, so it became clear that a new solution was needed.
SYNDEO Medical stepped in to reinvent the approach that combined the affordability and scalability needed to meet modern pressures with the flexibility, choice and familiarity associated with traditional packs.
Focusing on radiology and cardiology, SYNDEO packs combine all the time-saving advantages of standardised packs with a tailored selection based on specific interventional healthcare needs. The company has partnered with healthcare professionals to create customised procedural solutions that are both efficient and improve patient outcomes.
The SYNDEO approach also saves money, thanks to a revolutionary pricing model. As a result, medical teams often find themselves paying as little as 70% less than they were on standard packs.
Approximately 80% of the components are manufactured and assembled in-house, in direct collaboration with SYNDEO’s strategic partners. This gives the company complete control of the entire process, enabling the team to maintain consistently high standards and manage supply chain speeds, establishing SYNDEO as a company that challenges the status quo.
SYNDEO’s packs also help healthcare departments reduce waste. Because the tools needed for one surgery may be completely different to the next, many packs contain unused items which end up in landfill. The customised approach means that medical departments only get the tools they need. The company also offers a new line of green and sustainable eco products, all with a great biodegradability profile.
To learn more about how SYNDEO Medical is driving a revolution in healthcare packs, visit www.syndeomedical.be
Further information about the “20 Most innovative Companies to Watch, 2023” Awards can be found at https://www.bwmonline.com/awards/20-most-innovative-companies-to-watch-2023-winners/
About Business Worldwide Magazine
Business Worldwide Magazine is the leading source of business and dealmaker intelligence throughout the world. Our quarterly magazine and online news portal enables an established audience of corporate dealmakers to track the latest news, stories and developments affecting the international markets, corporate finance, business strategy and changes in legislation. This readership includes of CEO/CFO – Banks, Corporate Lawyers and Venture Capital/Private Equity Companies to name a few.
ContactDavid Jones Awards DepartmentE: [email protected]W: www.bwmonline.com
SOURCE Business Worldwide Magazine
FluidForm Bio Successfully Demonstrates Advancements in Engineered Heart Tissues with FRESH™ 3D Bioprinting
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
West Physics Announces Acquisition of Radiation Protection Services, LTD.
ATLANTA, Dec. 12, 2023 /PRNewswire/ — West Physics Consulting, LLC (“West Physics”), the leading national provider of integrated medical and health physics consulting services, announced today that it has completed the purchase of Radiation Protection Services, Ltd. (“RPS”), a respected regional provider of medical and health physics services based in Springfield, IL.
“We are thrilled to announce the acquisition of Radiation Protection Services. This strategic addition to West Physics helps us to expand our capabilities and capacity, and will further enhance our service delivery in Illinois, Missouri, Iowa, and Indiana. We welcome the RPS team to our organization and we look forward to achieving great success by combining forces and adding RPS’ radioactive material and imaging equipment testing skills and experience to the West Physics platform,” stated Dr. Geoffrey West, President & Chief Executive Officer of West Physics.
RPS customers are expected to benefit from the stability and support of the nation’s top medical and health physics provider. RPS customers will now have access to subject matter expertise in the areas of MRI safety, CT and fluoroscopy dose optimization, and clinical image analysis and review for ACR accreditation. Additionally, West Physics is excited to bring their world-class online training and reports portals to the RPS client base. Finally, the combination will result in increased scheduling flexibility, faster report turnaround, and enhanced support for customers.
“We’ve looked at a number of options over the last few years to help us take RPS to the next level in terms of growth and sophistication, and more importantly, to allow us to serve our customers even better,” said Doug Neuweg, President of RPS. “Becoming a part of West Physics was the clear winning option. They have built an incredible reputation over the years for being innovative, smart, and reliable and for also being totally committed to customer service. Our team is excited to add the resources of West Physics to our operation and to have many more colleagues to help us and our customers going forward,” continued Mr. Neuweg.
This acquisition aligns with West Physics’ strategy to provide premier medical and health physics services nationwide and globally. With RPS now part of West Physics, our team has grown to over 130 professionals serving over 6,000 customer sites across all 50 states, U.S. territories, the Caribbean, and the Middle East. We continue to be the largest diagnostic medical physics consulting practice in the United States, enabling us to deliver unparalleled quality and value for our customers.
About West Physics:
West Physics, headquartered in Atlanta, Georgia, is a global provider of medical and health physics testing and radiation safety consulting services. West Physics serves over 6,000 client sites, including hospitals, freestanding imaging centers, mobile imaging providers, and physician offices throughout the 50 U.S. states, federal territories, the Caribbean and the Middle East. West Physics specializes in assisting healthcare providers in maintaining their accreditation with organizations such as The Joint Commission, the American College of Radiology, the Intersocietal Accreditation Commission, and in radiation regulatory compliance with state and federal agencies. For more information, please visit http://www.westphysics.com.
About Radiation Protection Services, Ltd.:
Founded in 1986, Radiation Protection Services, Ltd. (“RPS”) is a privately owned company that provides radiation physics testing and consulting services for medical and industrial facilities that utilize x-ray-producing equipment or radioactive materials. RPS provides services to customers in Illinois, eastern Missouri, southeastern Iowa, and western Indiana, providing flexible and rapid response times along with personalized service. RPS staff specialize in ensuring regulatory compliance and radiation safety for their customers and their customers’ patients.
Media Contact: Denny Runnion, denny@westphysics.com
SOURCE West Physics Consulting, LLC
Karoo Health Validates Its Cardiac Value-based Care Model With High Patient Conversion and Engagement, and Cost Savings Through ED Diversions
Industry-leading conversion to and engagement with Karoo’s unique wraparound cardiac care model led to emergency department diversion in 20% of patients during proof-of-concept period
ALBUQUERQUE, N.M., Dec. 12, 2023 /PRNewswire/ — Karoo Health, the only operational provider of cardiac value-based care (VBC) enablement, today released results of its first proof of concept (POC) with participating cardiac providers. Study data was collected from June through November 2023. Among the findings:
70% of eligible patients were converted to the Karoo VBC model in the most recent month of the POC period
95% digital engagement rate was demonstrated among enrolled patients throughout the POC period
20% of the patient panel was diverted from unnecessary ED visits during the POC period, leading to significant cost-of-care savings
Karoo seamlessly integrates dedicated on-site and virtual care teams with proprietary technology to facilitate the transition to, and success in, value-based care for cardiology providers, networks, health plans, and at-risk primary care groups. Karoo’s innovative enablement model is essential for enhancing patient health, reducing overall cost of care, and amplifying performance in HEDIS and Stars measures.
“Our proof of concept affirms the effectiveness of our cardiac VBC model,” said Karoo COO Chentelle Lane. “Our recent conversion rates exceeding 70 percent of eligible patients, compared to the 25 to 30 percent typically observed in other VBC companies, along with an impressive digital patient-engagement rate of 95 percent, underscore our unwavering commitment to execution and making a significant impact on the current and future state of cardiac care. Karoo is the only operational company using VBC to improve patient outcomes and lower cost of care in cardiovascular disease.”
“Karoo is making a difference in our overall approach to patient care,” said Harvey White, M.D., Founder and Executive Director of Vessel Health, an innovative provider of cardiovascular care in Albuquerque, N.M. “Karoo effortlessly integrates with our staff’s considerable medical expertise with supporting care teams and complementary technologies to break down barriers to better health by giving our providers more time to focus on important clinically-driven interactions.”
Karoo operations are led by a team of seasoned healthcare industry veterans, with Chentelle Lane serving as the Chief Operating Officer. Lane, who previously held the position of COO of Care Services at Cityblock Health, brings a wealth of experience from executive roles at Somatus and naviHealth. Complementing this expertise, Karoo has assembled an impressive team that has helped craft and lead some of the most prominent VBC companies in the industry, including Main Street Health, naviHealth, and Contessa Health.
About Karoo HealthHeart disease is currently the leading cause of death in the United States, with one person dying every 33 seconds due to cardiovascular illness. Employing an exclusive mix of specialized care teams and proprietary technology grounded in value-based principles, Karoo enables cardiology providers, networks, health plans, and at-risk primary care groups to seamlessly transition to, and succeed in, value-based care, and excel in outcomes-driven initiatives crucially required within the cardiac domain. For more information, visit the company at www.karoohealth.com or connect with them on LinkedIn.
SOURCE Karoo Health
CathVision Unveils ECGenius 3.1 To Improve Workflows and Optimize EGM AI Analyses
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
LAZA MEDICAL, INC., A SHIFAMED PORTFOLIO COMPANY, CLOSES $36M IN SERIES A FINANCING
Company accelerates development of its AI-powered robotically-assisted imaging solution for cardiovascular interventions and appoints seasoned medtech executive as General Manager
LOS GATOS, Calif., Dec. 12, 2023 /PRNewswire/ — Laza Medical, Inc., the latest Shifamed portfolio company, announced today that it has closed $36M in Series A financing. Laza Medical is developing an imaging solution for cardiac interventions enabled by artificial intelligence (AI) software and state-of-the-art robotics. Led by The Capital Partnership (TCP) with financial participation from GE HealthCare, PA MedTech VC fund, Unorthodox Ventures, and Dara Holdings, funds will be used to accelerate product development and further expand the team. Additionally, the company announced the appointment of seasoned medtech executive, Pablo Garcia, as General Manager.
“The closing of this significant financing round validates the large, unmet need Laza’s solution will address, and we are grateful for the strong support of our investors,” stated Amr Salahieh, Founder of Shifamed and Chairman of Laza Medical. “I am delighted to have Pablo join and lead Laza at this important time. His wealth of knowledge and expertise in both digital products and robotics will be critical as Laza drives towards its upcoming milestones.”
Mr. Garcia joins Laza as General Manager and brings over two decades of medical device development and leadership experience. Previously, he served as the Vice President of Digital Solutions for Johnson & Johnson and was the technical co-founder of Verb Surgical, a strategic venture between Google and Johnson & Johnson to develop a surgical robotics platform. In 2020, this venture was acquired by Johnson & Johnson to be part of their medical robotics portfolio.
“I am excited to join the Laza team and look forward to advancing this comprehensive imaging solution so that interventional operators can safely and efficiently tackle complex cases,” stated Garcia. “We have assembled a strong team with expertise in robotics, software, artificial intelligence, and medical imaging, and are committed to bringing this much needed innovation to market.”
Structural heart and electrophysiology are two large and rapidly growing segments of the interventional cardiology market. Ultrasound imaging is necessary to guide these interventional cases, yet lack of resources makes it also a leading factor limiting growth. Laza aims to optimize procedural workflows and elevate the standard of imaging for these procedures. The company’s solution is designed to enable top-quality imaging and advanced procedure navigation for a broad population of clinicians through a simple user interface.
“Obtaining high quality images of the heart is critical to improving diagnostic confidence and guiding cardiac interventions,” said Dagfinn Saetre, General Manager, Cardiovascular Ultrasound, GE HealthCare. “We appreciate the opportunity to participate in this funding round for Laza Medical, who is working to pioneer innovative AI, robotics and ultrasound technology to help overcome some of the most pressing cardiac imaging challenges facing clinicians today.”
About Laza Medical, Inc.Laza Medical is a privately held portfolio company of Shifamed, LLC., a highly specialized medical innovation hub founded by serial entrepreneur, Amr Salahieh. The company is focused on developing a high-quality AI-powered robotic imaging solution for cardiovascular interventions. For more information, visit www.lazamedical.com.
MEDIA CONTACT:Charlene HerndonSPRIG Consulting LLC[email protected]
SOURCE Laza Medical, Inc.
Cadrenal Therapeutics Engages The Sage Group to Advance Tecarfarin’s Late-Stage Development and Commercialization
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.
AcelRx Pharmaceuticals Announces Publication of Study Evaluating Anticoagulation Practices for Continuous Renal Replacement Therapy in the United States
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.
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