Author: Ken Dropiewski

A New Era in Heart Surgery – Israeli Biomed Company TruLeaf Medical’s Two Needle Sticks Procedure for Mitral Valve Replacement

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AllMeD Solutions (TASE:ALMD) subsidiary TruLeaf Medical receives Helsinki Ethics Committee’s approval in Uzbekistan to conduct clinical trial in human subjects, paving the way for minimally invasive heart valve treatmentsCAESAREA, Israel, July 11, 2024 /PRNewswire/ — AllMeD Solutions announced subsidiary TruLeaf Medical’s receipt of the Helsinki Ethics Committee’s approval in Uzbekistan to conduct clinical trial in human subjects. As part of the trial, a prosthetic mitral valve will be implanted via two needle sticks in the groins in a two-stage catheterization procedure without the need for open-heart surgery (transcatheter mitral valve replacement, TMVR). The implantation of the innovative platform (the RoseDoc) developed by TruLeaf, which replaces the patient’s leaky heart valve, will be carried out in two stages.  In the first stage, a docking station will be implanted in the left atrium, followed a few weeks later by implantation of an artificial ‘biological’ mitral valve prosthesis. 

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Trueleaf’s Medical Device

Today, there are tens of millions of patients with severe, life-threatening mitral valve regurgitation (leaky valve) across the world. This leak causes heart failure, heart arrhythmia, brain strokes leading to high mortality. About 10% of the world’s population over the age of 75 suffer from a leaky mitral heart valve.  In the U.S. alone there are about 4 million patients.

These patients experience a substantial decrease in their functional capacity manifesting, such as fatigue, shortness of breath on exertion with lower and lower exertion and arrhythmias, progressively impairing their daily routine. Today, the most effective treatment for these patients is complex open-heart surgery to repair or replace the leaky heart valve.  However, it is only offered to about 2% of patients due to the high surgical risk.
The unique RoseDoc platform developed by TruLeaf is the first-of-its-kind technology allowing implantation of a biological bioprosthesis to replace the diseased valve through catheterization only. This ground-breaking procedure is minimally invasive, performed on a beating heart via two needle punctures without surgery or the use of a heart-lung machine.  As such, it is associated with substantially lower risk compared to the traditional open-heart mitral valve surgery. As a result, millions of patients around the world, who until now were deemed inoperable, will be able to get receive a new valve and experience a significant improvement in their functional capacity, quality of life and life expectancy, allowing them to resume normal life.As part of the preparations for human implantations in clinical trials in Uzbekistan, TruLeaf conducted additional implantations in large animals with the participation of Dr. Horst Sievert, one of the world’s leading interventional cardiologists, who is expected to lead TruLeaf’s clinical trials.TruLeaf Medical, Ltd was founded in 2017 by three Israeli entrepreneurs – Benjamin Spencer, Nathaniel Benisho and the late Dr. Uri Rosenstein. Benjamin and Nathaniel’s played a seminal role in the development of the first ever transcatheter aortic bioprosthesis, the Sapien valve, initially within the Israeli company PVT, that was later acquired by the medical technology giant Edwards Lifesciences. Today, the aortic valve that Benjamin and Nathaniel developed saves thousands of lives of patients with aortic stenosis every year all over the world.Benjamin Spencer, TruLeaf Medical CEO, explains, “The main challenge with existing transcatheter TMVR technologies is achieving optimal anchoring of the valve prosthesis to the heart, given the complex anatomy and physiology of the native mitral valve. The RoseDoc TMVR platform is technically simple, safe, and has proven effective in long-term animal testing. Completely eliminating the leak prevents the progressive dilation of the heart, which otherwise worsens the leak in a vicious cycle, leading to further weakening of the heart muscle and intractable heart failure. Currently, patients with severe mitral valve leaks that are unresponsive to maximal medical treatment have no effective options. The vast majority of these patients are declined surgery due to prohibitive risk. The unique RoseDoc TMVR platform provides a potential lifeline for these patients.”Professor Oz Shapira, AllMeD Solutions CEO, adds, “As a heart surgeon who has performed hundreds of open-heart surgeries to treat leaky heart valves, the possibility of replacing the mitral valve through a simple and quick needle puncture operation is a true revolution that may offer a solution to millions who currently have no other option.””The first-in-human trial is both exciting and mission-critical for TruLeaf’s success. Given the outstanding results of the preclinical experiments, I am confident that TruLeaf’s innovative RoseDoc TMVR platform will perform exceptionally well in humans and eventually save countless lives of patients who currently have no alternatives. AllMeD Solutions will continue to demonstrate its ability to identify early-stage startups and leverage its vast knowledge, experience, and expertise in the med-tech space to lead these companies to engineering, clinical, and business success.”Photo: https://mma.prnewswire.com/media/2459133/AllMeD_Solutions.jpgLogo:  https://mma.prnewswire.com/media/2459132/AllMeD_Solutions_Logo.jpgSOURCE AllMeD Solutions

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XyloCor Therapeutics and SmartCella Enter into License Agreement for Use of the Extroducer Infusion Catheter System to Administer Novel Gene Therapy XC001 to the Heart

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– The Extroducer® Infusion Catheter System ® enables local delivery of XC001 to the heart without the need for surgery. – XC001 has achieved positive Phase 1/2 results in the EXACT Trial validating its transformative potential for treatment of refractory angina in patients who have exhausted available treatment options and […]

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Phoenix Cardiology Practice Installs the First and Fastest Cardiovascular CT Scanner in the State, Arineta’s SpotLight Duo

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Caesarea, Israel – July 9, 2024 – Arineta, a leader in advancing cardiovascular imaging solutions through cutting-edge technology, proudly announces the latest installation of its SpotLight™ Duo at Cardiovascular Consultants, Ltd. (CVC) in Arizona. This makes CVC the first and only practice in the southwest region to have the world’s […]

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Adona Medical, a Shifamed Portfolio Company, Raises $33.5 Million in Series C Financing

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Funding to support next stage of product development and early clinical experience of company’s novel interatrial shunt and remote monitoring solution for patients with heart failure LOS GATOS, Calif., July 10, 2024 /PRNewswire/ — Adona Medical, a Shifamed portfolio company that aims to deliver advanced solutions for heart failure, announced today it has secured $33.5 million in Series C financing. The funds will be used to further product development and to initiate clinical use of the company’s adjustable interatrial shunt with integrated bi-atrial pressure monitoring. The financing was led by Cormorant Asset Management and TCP Health Ventures, with participation from Excelestar Ventures, the PA MedTech VC Fund II, Unorthodox Ventures, AMED Ventures, and other new and existing investors.

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The Adona Medical interatrial shunt features a flow channel with an adaptable geometry that can be made larger or smaller post-implantation via the use of a proprietary induction catheter.

“Heart failure is a complex condition that benefits from an individualized treatment paradigm, yet many of the device-based treatment options available today offer a one-size-fits-all approach,” said Paul Sorajja, MD, Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center, Minneapolis Heart Institute Foundation. “Adona’s innovative shunt and sensor pairing aims to provide a more individualized management strategy and is designed so that shunt flow can be adjusted to best suit the needs of each individual patient, both initially and as their condition evolves over time. I look forward to working with the Adona team as they move into clinical use later this year.”

“Despite advancements in heart failure therapies, challenges remain that limit patient applicability and physician adoption with first-generation devices,” said Bihua Chen, Founder and Managing Member of Cormorant Asset Management. “We are pleased to lead this round as we believe Adona’s technology has the potential to disrupt the field and benefit the millions of patients suffering from heart failure.”
The Adona device includes a shunt that features a flow channel with an adaptable geometry that can be made larger or smaller post-implantation via the use of a proprietary induction catheter. In addition, the implantable device features integrated sensors designed to capture pressure readings from both the left and right atria multiple times per day without requiring patient interaction. These daily readings can provide physicians with a more complete understanding of a patient’s hemodynamic status and can augment shunt therapy by enabling more informed medical management. Heart failure is a progressive condition that impacts approximately 6.5 million patients in the United States and as many as 26 million patients globally.1″Adona is committed to improving outcomes for patients with heart failure. We’ve developed multiple innovative technologies that we believe will elevate the impact that is achievable with device-based interventions,” commented Brian Fahey, Co-Founder and Chief Executive Officer of Adona Medical. “The team has made tremendous progress in advancing our solution for heart failure management and we are grateful for the strong ongoing support from our investors as we take the next steps in our journey.”About Adona Medical, Inc.Adona Medical, a privately held portfolio company of Shifamed, LLC, is a pre-clinical stage medical technology company developing next-generation interatrial shunting and remote patient monitoring solutions for patients with advanced heart failure. The Adona Medical heart failure management platform is an investigational device and is not approved for use in the U.S. or anywhere in the world. To learn more, please visit www.adonamed.com.About Shifamed, LLCFounded by serial entrepreneur Amr Salahieh, Shifamed is a highly specialized medical innovation hub focused on developing solutions that forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.MEDIA CONTACT:Jennie KimSPRIG Consulting, LLC[email protected]References:
Benjamin et al. Circulation 2018.
SOURCE Adona Medical

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CARMAT accelerates its sales momentum and reiterates its confidence in its development outlook

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20 implants of the Aeson® artificial heart performed in the first half of 2024 Pace of 4 implants per month in the second quarter Half-year sales at €3.2 million, higher than the 2023 full-year sales Unique safety and performance profile of Aeson® confirmed, based on more than 70 implants made since inception […]

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R3 Vascular Appoints Josh Smale as its Vice President of Global Clinical and Scientific Affairs

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MOUNTAIN VIEW, Calif., July 09, 2024 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce the appointment of Josh Smale as its Vice President of Global Clinical and Scientific Affairs. Prior to joining R3 Vascular, Mr. Smale served as Vice President of Clinical Affairs for the Peripheral Intervention business unit of Becton Dickinson (BD) where he was responsible for all aspects of clinical evidence generation and dissemination for the company’s complex and diverse device portfolio. Prior to his tenure at BD, Mr. Smale served in roles of increasing responsibility for Bard Peripheral Vascular, Inc. (BPV) which was acquired by BD, and as Regulatory Affairs Manager for SenoRX, Inc. which was acquired by BPV. He also served as Regulatory Affairs Manager for Endologix, Inc. and in various roles at BPV. Mr. Smale holds a Bachelor of Science in Engineering with an emphasis on Molecular and Cellular Engineering, and Biochemical Engineering from Arizona State University. He also served on the board of the Peripheral Intervention business unit of BD, has received numerous awards, is the co-author of several publications, and holds five Vena Cava Filter patents. Commenting on the appointment of Mr. Smale, Christopher M. Ownes, President and CEO of R3 Vascular, said, “On behalf of the R3 management team, I am very pleased to welcome Josh Smale as Vice President of Global Clinical and Scientific Affairs. Josh has a proven track record and more than 20 years of relevant medical device experience specializing in clinical and regulatory affairs strategy, clinical evidence generation and dissemination, and physician education. Among other key clinical and scientific affairs programs, Josh will lead our clinical trial efforts, including our pivotal ELITE trial for our next generation Magnitude drug eluting bioresorbable scaffold. We look forward to his contributions as we work towards establishing R3 Vascular as the leader in the development and manufacturing of fully bioresorbable vascular scaffolds.” Mr. Smale said, “I am very excited to join R3 Vascular and work closely with Chris Owens, Kamal Ramzipoor, and the rest of the R3 Vascular team to build upon the success of the company and support the adoption of its breakthrough technology for treating below-the-knee peripheral arterial disease (BTK PAD). R3 Vascular’s novel next generation bioresorbable scaffolds will transform the field of peripheral interventions by providing a new standard of care and improving the health of patients around the world.” Mr. Smale joins R3 Vascular’s leadership team which, among others, includes Christopher M. Owens, President and Chief Executive Officer and Kamal Ramzipoor, R3 Vascular’s Founder and Chief Technology Officer (CTO). In May of 2024, R3 Vascular announced the closing of its $87 million Series B financing round. About R3 Vascular Inc.R3 Vascular is a privately-held medical device company that develops a novel technology platform for the next generation of fully bioresorbable drug eluting sirolimus coated vascular scaffolds. These are designed to deliver the ‘stent-like’ support of a scaffold along with the anti-inflammatory and anti-proliferative result of sirolimus, but ‘disappearing’ over time as the vessel heals. R3 Vascular is headquartered in Mountain View, California. More information can be found at www.r3vascular.com. Media Contact:David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c861cb09-8ed9-4401-8f89-6e69934fd0d3

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Octagos Health Secures Over $43 Million Investment to Advance AI-Driven Cardiac Device Monitoring

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HOUSTON, July 9, 2024 /PRNewswire/ — Octagos Health, an industry-leading provider of AI-driven cardiac device monitoring solutions, today announced a successful equity raise of over $43 million in investment capital. The Series B investment round was led by funds managed by Morgan Stanley Expansion Capital, with continued participation from Mucker Capital and other strategic investors. This funding will accelerate Octagos Health’s mission to use artificial intelligence to revolutionize cardiac care and provide comprehensive patient monitoring services. 

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Octagos Health provides an AI-driven platform that offers continuous monitoring and data analysis for patients with cardiac devices (pacemakers, defibrillators, ambulatory monitors, consumer wearables, and other modalities). Atlas AI, the company’s proprietary technology, ensures high accuracy and sensitivity in detecting clinically relevant events, automating physician workflows, and enabling healthcare providers to make informed decisions and improve patient outcomes. The platform’s comprehensive capabilities include seamless integration with electronic health records (EHR) and customizable reporting features, making it a preferred choice for cardiology practices. 

“By combining AI, patient services, and bidirectional EHR integration, the Octagos Health platform enables cardiologists to efficiently monitor patients, improve patient care, and enhance clinic economics.”

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“By combining AI, patient services, and bidirectional EHR integration, the Octagos Health platform enables cardiologists to efficiently monitor patients, improve patient care, and enhance clinic economics. The funding will help us accelerate our growth across the US and expand into other critical areas of cardiac care, including ambulatory monitors, consumer wearables, and sleep.  Our goal is to build a comprehensive AI-based clinical decision support engine for healthcare. We are thrilled to have Morgan Stanley Expansion Capital as our lead investor and the continued support of Mucker Capital. In a short period, we have grown from first servicing my cardiology clinic to becoming one of the largest cardiac remote monitoring companies that provides software and services,” said Dr. Shanti Bansal, cardiologist, CEO of Octagos Health and Houston Heart Rhythm. 
“This investment will enable us to accelerate enhancements to our platform, in addition to scaling our commercial team and operations. We are currently the only company that helps cardiology practices migrate their historical data from legacy software providers and fully integrates with any EHR system. We do this while enabling customized reporting supported by patient and practice decision-support analytics,” said Eric Olsen, COO of Octagos Health. “We are excited to partner with Octagos Health and support their vision of transforming cardiac care,” said Melissa Daniels, Managing Director of Morgan Stanley Expansion Capital. “Octagos Health has demonstrated exceptional growth and innovation in a critical area of healthcare. We believe their platform and vertically integrated software and services significantly improve patient care and streamline cardiac monitoring processes for healthcare providers.” “Octagos Health is poised for scale – industry leading gross margins, a very sticky product that doctors and clinical staff love, and a market ready for disruption with artificial intelligence. This is the new wave for diagnostic care,” said Will Hsu, Co-Founder and Partner at Mucker Capital. “This funding will help Octagos Health continue to add additional data sources from various diagnostic and consumer devices and further differentiate their offering.” About Octagos Health Octagos Health is a leading provider of cardiac monitoring solutions, dedicated to improving patient outcomes through advanced technology and comprehensive monitoring services. The company’s AI-driven platform offers continuous monitoring and data analysis for patients with implantable cardiac devices, enabling healthcare providers to make informed decisions and deliver timely care. Octagos Health’s solutions are designed to seamlessly integrate with electronic health records and provide customizable reporting features, making it an essential tool for modern healthcare institutions. For more information, please reach out to [email protected]. You can also follow us on LinkedIn. About Morgan Stanley Expansion Capital Morgan Stanley Expansion Capital is the growth-focused private investment platform within Morgan Stanley Investment Management. Morgan Stanley Expansion Capital targets growth equity and credit investments within technology, healthcare, consumer, and other high-growth sectors. For nearly four decades, Morgan Stanley Expansion Capital has successfully pursued growth investment opportunities and has completed investments in over 200 companies, leveraging the global brand and network of Morgan Stanley.About Mucker Capital Founded in Santa Monica, CA in 2011, Mucker Capital provides Pre-Seed, Seed, and Series A capital and support for startups in Southern California and in other, similarly underfunded ecosystems outside Silicon Valley.SOURCE Octagos Health, Inc.

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Centerline Biomedical joins ORSIF

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Centerline Biomedical and ORSIF join together to raise awareness of health risks associated with fluoroscopic radiation and solutions available to medical professionals. 
CLEVELAND, July 9, 2024 /PRNewswire/ —  Centerline Biomedical, Inc. (“Centerline”), joins ORSIF, the organization for Occupational Radiation Safety in International Fluoroscopy, to raise awareness of technology options to improve safety in the work environment where fluoroscopic x-ray radiation is used in medical procedures. As a corporate partner, Centerline supports ORSIF (www.orsif.org) in a shared mission to champion innovation for safer healthcare. In addition, the developing platform aims to continue bringing together healthcare providers and their organizations, professional medical societies, and industry to provide education on radiation safety.
“We are proud to join ORSIF in its mission to create greater awareness in the medical community regarding the dangers of radiation exposure and to protect those who commit their lives to the wellness of others. To that end, IOPS® (Intra-Operative Positioning System) technology enables improved visualization with 3D navigation in endovascular procedures while minimizing the reliance on damaging radiation,” said Gulam Khan, CEO of Centerline Biomedical.  “Employees at Centerline are inspired every day to design the future of image guidance technology that enables faster, more precise transcatheter procedures while reducing the use of radiation.”  
Designed to mitigate radiation exposure during minimally invasive cardiovascular procedures, Centerline Biomedical IOPS (Intra-Operative Positioning System) is a novel technology gaining increased application in the US. IOPS includes software that creates 3D maps of vascular anatomy, enabling surgeons to visualize the arteries being treated. Using electromagnetic tracking, IOPS sensor-equipped guidewires and catheters can be guided in 3D as endovascular specialists navigate through these high-resolution intuitive visualizations during minimally invasive procedures. The images and tracking are displayed on an independent monitor, minimizing the reliance on damaging X-ray radiation typically used to produce live fluoroscopic images during interventions. 
About Centerline BiomedicalFounded in 2015, Centerline Biomedical is headquartered in Cleveland, Ohio. The company’s commercially available platform, IOPS®, Intra-Operative Positioning System, enables improved visualization and navigation in endovascular procedures. IOPS has 510(k) clearance from the US FDA for use in the descending aorta. The company continues investment in development to enhance the current technology platform and expand image guidance in transcatheter procedure applications.
Visit www.centerlinebiomedical.com for more information.
SOURCE Centerline Biomedical

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Neha Motwani Elected to Longeveron® Board of Directors

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MIAMI, July 09, 2024 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, including hypoplastic left heart syndrome (HLHS) and Alzheimer’s disease, today announced that Neha Motwani, a senior healthcare investment banker, has been elected to the Longeveron Board of Directors at the Company’s recent Annual Meeting of Stockholders. “I am delighted to welcome Neha, with her tremendous healthcare industry experience, to the Board of Directors,” said Joshua Hare, Co-founder, Chief Science Officer and Chairman of the Board at Longeveron. “Her extensive knowledge of biopharma company operations, financing and capital markets will bring significant value to Longeveron as we continue to advance Lomecel-B™, our proprietary, scalable, allogeneic cellular therapy. With five positive clinical trials across three indications, we believe Lomecel-B™ has the potential to be an important therapy for some of the most difficult diseases and conditions associated with aging.” Neha Motwani has over 25 years of healthcare investment banking experience, most recently serving as Managing Director, Healthcare Investment Banking at William Blair. She previously held investment banking roles of increasing responsibility with Truist Securities, Oppenheimer and Company, Stifel Financial and Cowen and Company, where, collectively, she completed transactions raising approximately $7.0 billion. Ms. Motwani earned her B.A. in political science from Columbia University. “I am delighted to join the Board of Directors of Longeveron at this exciting phase of the Company’s clinical development,” said Ms. Motwani. “I look forward to working with this talented team to continue their mission to advance their novel cellular therapy, Lomecel-B™ for the potential treatment of HLHS, a rare and devastating congenital heart condition, and diseases of the aging.” About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. The Lomecel-B™ HLHS program has received three distinct and important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Investor Contact:Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/00f0eb5c-76f5-49b1-9994-ee363513547b

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Pulnovo Medical Announces Joining PHA’s (Pulmonary Hypertension Association) Corporate Committee

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SHANGHAI, July 9, 2024 /PRNewswire/ — Pulnovo Medical, a globally recognized device pioneer in the treatment for pulmonary hypertension and heart failure, has recently announced its partnership with the Pulmonary Hypertension Association (PHA). This partnership not only underscores Pulnovo Medical’s growing global influence but also empowers PHA’s mission to extend and improve the lives of those affected by pulmonary hypertension (PH) worldwide.
Pulnovo Medical and the PHA are united by a collective vision to a future where pulmonary hypertension is better understood and more efficiently treated. Pulnovo Medical’s PADN technology, an innovative interventional therapy in the field of pulmonary hypertension, provides a new and beneficial solution for patients troubled by traditional drug treatments. Currently Pulnovo Medical is conducting global trials in US and Europe. This strategic partnership aims to combine Pulnovo Medical’s cutting-edge PADN therapies for Pulmonary Hypertension with PHA’s extensive network to enhance public awareness and improve the care of PH patients globally. As a member of PHA, Pulnovo Medical will actively participate in PHA’s educational programs, research projects and advocacy campaigns. Our collaboration will harness the urgency of our shared mission to make a lasting impact on pulmonary hypertension patients worldwide.
About PHA
The PHA was founded in 1991 in Florida and evolved into an international community of more than 16,000 people with PH, caregivers, family members and health care professionals. As one of the largest and oldest pulmonary hypertension association in the world, the PHA acts as a trusted liaison between the pulmonary hypertension community and industry and academic partners.
About PADN
Pulmonary Artery Denervation (PADN) is a percutaneous pulmonary artery intervention procedure that uses a PADN catheter to deliver radiofrequency energy to the sympathetic nerves in the outer membrane of the pulmonary artery, resulting in the disappearance of the myelin sheath of the nerves and the fusion of the axons, which inhibits sympathetic activity, increases cardiac output, reduces pulmonary artery pressure, inhibits the pathologic remodeling of the pulmonary arteries, improves the patient’s exercise endurance and cardiac function, and achieves long-term benefits from a single minimally invasive procedure.
About Pulnovo Medical
Pulnovo Medical Limited, is a globally recognized device pioneer in the treatment for pulmonary hypertension and heart failure, is committed to leveraging our deep expertise in the science of breakthrough technologies with the goal to market our innovative therapeutic solutions and benefit patients around the world.
For more information, please visit: www.pulnovomed.us

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