Clinical Accelerator is very happy to highlight its continued contribution to Alleviant Medical’s ALLAY-HF Pivotal Study in the Republic of Georgia. The global ALLAY-HF Study is designed to demonstrate the safety and effectiveness of the Alleviant System – a no-implant interatrial shunt – for the treatment of heart failure through left atrial decompression.
Pictured below are our partners at Tbilisi Heart and Vascular Clinic Prof. Tamaz Shaburishvili, Dr. Giorgi Shaishmelashvili MD, PhD Teona Zirakashvili, Maia Zhividze, Nina Khabeishvili, Nino Khatchaturiani, Levan Sulakvelidze
The Republic of Georgia remains a prime location for clinical studies with innovative medical devices, particularly in the cardiovascular field.
Below, we are re-publishing with permission the press-release issued by WhiteSwellon March 06, 2024
Patients were rehospitalized for heart failure less frequently in the six months following therapy
GALWAY, Ireland — 6 March 2024 — WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive six-month follow-up data on the initial nine patients treated in its ongoing DELTA-HF trial evaluating the WhiteSwell eLym™ System. The data were presented by William Abraham, M.D., professor of medicine, physiology, and cell biology at The Ohio State University Wexner Medical Center, at the Technology and Heart Failure Therapeutics (THT) conference today in Boston.
Nine hospitalized patients with ADHF received eLym therapy in conjunction with diuretic therapy and were followed for six months.
Summary of key findings:
Reduced tissue congestion: A biomarker of tissue congestion, CA-125, decreased 77% from baseline to a median of 23 u/ml at 90 days.
Reduced rehospitalizations: Comparing patients’ clinical course before and after eLym therapy, in the six months prior to eLym therapy there were 13 heart failure related hospitalizations, while in the six months after eLym therapy there were just two heart failure hospitalizations and one heart failure related death, for a 77% reduction.
The minimally invasive catheter system was successfully deployed and removed in all patients, with a mean treatment time of 24 hours. At hospital discharge, acute decongestion was demonstrated by a mean weight loss of approximately 6 kg and the elimination of orthopnea and reduction of peripheral edema in all patients. Kidney function was preserved in all patients during treatment and out to 30 days. The treatment was safe with no serious procedure-, device- or therapy-related adverse events in eight out of nine patients.
“These data demonstrate that the eLym System is safe and, in conjunction with loop diuretics, can support consistent improvement of multiple markers of decongestion, all while preserving renal function,” said William Abraham, M.D. “We were especially encouraged by the dramatic reductions in heart failure related events, which were reduced despite no up-titration of guideline-directed medical therapy. I look forward to additional clinical data building upon these findings.”
Patients with acute decompensated heart failure who are discharged with persistent congestion tend to experience poor outcomes, including rehospitalization and death. In the DELTA-HF trial, patients are treated with the minimally invasive, catheter-based eLym System to facilitate fluid removal from the body’s tissues and organs, concurrent with diuretic removal of excess vascular fluid. The eLym System works by targeting the body’s largest lymphatic vessel, the thoracic duct, and creates pressure conditions that support the tissue drainage capabilities of the overwhelmed lymphatic system.
“We have patients with ADHF who are frequently hospitalized with congestion, and they are very challenging to treat,” said George Khabeishvili, M.D., Principal Investigator, Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia. “The unique treatment approach with the eLym System involves a straightforward procedure. The therapy has helped my patients feel better and, importantly, helped keep them out of the hospital.”
About the DELTA-HF Trial
The Decongestion of Excess Lymphatic Fluid via the Thoracic Duct in Acute Decompensated Heart Failure (DELTA-HF) trial is a non-randomized early feasibility trial evaluating the safety and performance of the eLym System, a unique approach for the treatment of fluid overload or congestion in patients with ADHF.
About the eLym™ System
The eLym System is a minimally invasive catheter-based system designed to facilitate the removal of excess fluid from tissues and organs (interstitial fluid) in patients with ADHF by supporting the overwhelmed lymphatic system’s ability to actively drain fluid. The eLym System is deployed in the left internal jugular and innominate veins near where the lymphatic system’s major highway, the thoracic duct, connects. It creates a low-pressure zone to facilitate fluid drainage in conjunction with intravenous diuretics.
About WhiteSwell
WhiteSwell is a patient-focused company dedicated to improving treatment of acute decompensated heart failure (ADHF), a primary cause of repeat hospitalization and emergency room visits. A privately held company, WhiteSwell is headquartered in Galway, Ireland. For more information visit www.whiteswell.com.
Clinical Accelerator is happy to announce that together with CSI we are organizing a summit on innovative medical devices: The Georgia Medtech Summit which is scheduled for September 20-22 and will take place in Tbilisi, Georgia. We look forward to seeing physicians interested in the latest developments in the world of medical devices, medtech companies developing innovative devices and medtech investors at this event in beautiful Tbilisi this autumn. If you are interested in more information about the event or would like to receive a personal invitation to attend the summit, please send an e-mail to georgiansummit@clinicalaccelerator.com
Below, we are re-publishing with permission the press-release issued by BariaTek Medicalon February 06, 2024
PARIS–(BUSINESS WIRE)–BariaTek Medical, a privately held medical device company dedicated to the development of minimally invasive endoscopically delivered solutions to treat obesity and diabetes, founded by Truffle Capital, announced it has initiated enrollment of patients in its First-in-human clinical trial in both Australia and Uzbekistan, and has successfully performed its first-in-human implantation.
Obesity is a chronic and debilitating disease affecting more than one billion people worldwide. It bears a tremendous economic burden to healthcare systems surpassing that of cardiovascular diseases and cancer and its prevalence is increasing worldwide. It often leads to diabetes, high blood pressure, heart disease and reduced life expectancy.
Bariatric surgery currently remains the most effective approach to treat obesity and limits the resulting complications, but surgery is poorly perceived, alters anatomy permanently, is costly, and can result in severe adverse events. Obesity pharmaceutical therapies could provide an effective alternative solution for some patients, but they are very expensive and poorly tolerated in many, resulting in their cessation and corresponding regain of the lost weight. Furthermore, they could be associated with multiple under-reported side-effects and off-label prescriptions. As for available minimally invasive endoscopic solutions, they enjoy variable safety but lack efficacy.
BariaTek Medical’s product candidate, the BariTon™, is a soft, atraumatic, reversible implant that is delivered via a simple endoscopy through the mouth within a few minutes and in an outpatient setting. It consists of a gastric part and an intestinal part, thereby having a dual effect: reduced food intake and calorie absorption. The BariTon™ is expected to be the first implant of its kind to potentially mimic the efficacy of sleeve gastrectomy and bypass surgery1 and offer superior safety, ease of use, reversibility, and lower cost.
Dr. Abdurashid Abdukarimov, Principal Investigator, Bariatric Surgeon at the Center of Surgery in Tashkent Uzbekistan who has led the first human implant said:“I am extremely pleased with the outcome of this first-in-human implantation. The endoscopic procedure was smooth, and the patient recovered very rapidly. She was back at work the day after she was discharged. I would like to thank the support of the BariaTek medical and engineering team, who made the trip to our center, and we look forward to the next steps in this groundbreaking first-in-human study.”
Dr. Adrian Sartoretto, Principal Investigator, Bariatric Endoscopist and Director of the BMI Clinic in Sydney Australia said: “The daily life of patients suffering from obesity can be difficult and associated with multiple comorbidities if not treated optimally. The BariTon™ device meets a growing demand for a more innovative, minimally invasive, effective, and reversible solution and we look forward to evaluating its safety and efficacy in our center.”
Dr. Thierry Manos and Dr. Christophe Bastid (Marseilles, France), Bariatric Endoscopists and co-inventors of the BariTon™ said: “We were delighted to participate in this first-in-human implantation. The procedure went according to plan and we look forward to the outcome of this clinical study.”
Youssef Biadillah, CEO of BariaTek Medical said: “Obesity is a global pandemic and none of the therapeutic options available today is optimal. We are thrilled about the prospect of bringing our highly differentiated solution, the BariTon™, to obesity gastroenterologists and surgeons and to patients worldwide. More patients need to be treated and carefully monitored and close interactions with regulatory agencies and payors need to take place, to draw conclusions on its safety, efficacy, indications and market potential.”
About BariaTek Medical
BariaTek Medical, based in Paris France, is a privately held medical device company dedicated to the development of minimally invasive endoscopically delivered medical devices to treat obesity and limit its complications. BariaTek Medical was founded by Truffle Capital, a premier life science venture capital fund (Paris) and founder (or co-founder) of multiple MedTech and Biotech companies such as Abivax (NASDAQ & Euronext : ABVX), Carmat (Euronext: ALCAR), Carbios (Euronext ALCRB), Vexim (acquired by Stryker), Symetis (acquired by Boston Scientific), Caranx Medical, Artedrone, EvextaBio and Affluent Medical (Euronext: AFME).
1 Sleeve gastrectomy is a surgical procedure consists of removing a large part of the stomach; Bypass bariatric surgery consists of both removing a large part of the stomach and shunting part of the intestine.
We are thrilled to announce a significant stride in Clinical Accelerator’s journey as we extend our business operations to Uzbekistan. This expansion marks a pivotal moment in our mission to advance clinical research and clinical trial solutions globally.
A Glimpse into Uzbekistan’s Healthcare Landscape:
With its rich history and diverse culture, Uzbekistan presents unique opportunities in the realm of clinical research with novel medical technologies. It boasts the best of both worlds, having Western-like healthcare but remaining outside of the European Union and therefore outside the scope of the EU Medical Device Regulations. Excellent access to patients will ensure fast and efficient enrolment in our clinical trials in this location. This strategic positioning opens doors to more streamlined regulatory pathways for early-stage clinical trials with novel medical devices and accelerates execution of all types of clinical studies in cardiovascular and other important therapeutic areas.
In conjunction with Clinical Accelerator’s experienced study start-up team who will work with Sponsors on putting together the CTA[1], the contract negotiation process with hospitals, acquiring local insurance, and importation logistics, setting up study files and preparing sites for the study launch, the start-up timeline that Sponsors should expect to initiate a clinical trial is approximately 8 weeks. Clinical Accelerator offers full support for management and monitoring of clinical studies in these locations together with our centralized services for medical monitoring and safety management, electronic data capture, data management, statistical analyses and medical writing.
In our commitment to excellence, we are proud to announce partnerships with a group of leading institutions in various therapetuics areas. Clinical Accelerator will be strengthening clinical research capabilities of these institutions by embedding our own clinical research co-ordinators into the sites’ structure. The sites are open to collaborating with visiting experts and strengthening ties with leading academic sites in the United States, Europe, Israel and Asia. These collaborations will amplify our ability to conduct robust clinical trials and research, propelling projects of our clients and partners towards faster commercialization of their novel medical technologies and eventually meeting unmet medical needs and improving patient care for all.
Embracing a New Chapter:
We embark on this expansion with boundless enthusiasm. Clinical Accelerator’s projects in Uzbekistan have successfully started this summer and are progressing at full speed and we are looking forward to their further evolution.
If you would like to explore these new options for your planned or on-going clinical studies, we invite you to reach out to our dedicated Business Development Representative, Anna Nikitina.
Below, we are re-publishing with permission the press-release issued by Laminar, Inc.
Santé Ventures was the sole venture capital investor in Laminar, which aims to treat persistent atrial fibrillation (AFib) with an innovative solution for the left atrial appendage (LAA)
AUSTIN, Texas, Nov. 30, 2023 /PRNewswire/ — Santé Ventures (Santé), an early-stage healthcare and life sciences investment firm, has announced the acquisition of its Fund III portfolio company, Laminar, Inc., by Johnson & Johnson Medtech. The purchase was completed with an upfront payment of $400 million and additional clinical and regulatory milestone payments expected in 2024 and beyond. As Laminar’s sole venture capital investor, Santé played an essential role in helping develop the company’s novel approach to eliminating the left atrial appendage (LAA) in patients with non-valvular AFib. Laminar will join Johnson & Johnson MedTech as part of Biosense Webster, Inc. – a global leader in cardiac arrhythmia treatment.
More than 38 million people worldwide currently live with AFib, a condition that causes an irregular and often very rapid heart rhythm, making them five times more likely to suffer from a stroke. A key driver of this is the LAA (left atrial appendage) – a small pouch in the left atrium of the heart, where blood can stagnate and form clots that enter the bloodstream. Laminar pioneered a rotational motion device to address this issue by eliminating the LAA. The company was recently granted FDA approval for a U.S. pivotal study, which will begin in 2024.
“Santé invests to help catalyze companies creating innovative life-saving solutions which can deliver better health outcomes for people while also reducing the financial burden of care. Laminar’s CEO Randy Lashinski and the team developed an elegant solution with this LAA closure device. Our investment partnership is proud to have worked with them again in this company,” noted Kevin Lalande, Founding Managing Director & Chief Investment Officer of Santé. “With so many patients suffering from AFib, we are excited to see Johnson & Johnson advance the development of this LAA treatment and expand the company’s existing footprint.”
Santé led the initial financing for Laminar in 2019 as part of the company’s Series A fundraising and remained the only institutional investor in the company through subsequent investment rounds up to the time of its acquisition by Johnson & Johnson MedTech.
To learn more about Santé and the firm’s portfolio of medtech, healthtech, and biotech investments, please visit www.sante.com.
About Santé Ventures Founded in 2006, Santé Ventures is a specialized healthcare and life sciences investment firm with roughly $800 Million in capital under management. The firm invests in early-stage companies developing innovative new medical technologies, biotechnologies, and digitally enabled healthcare services. Recent Santé successes include Laminar (Johnson & Johnson), Farapulse (Boston Scientific), Claret Medical (Boston Scientific), TVA Medical (Becton Dickinson), Millipede Medical (Boston Scientific), Molecular Templates (MTEM), AbVitro (Bristol Myers Squibb), and Explorys (IBM Corp). Santé invests nationally and has offices in Austin, TX, and Boston, MA. For more information, please visit www.sante.com.
Media Contacts Santé Ventures Press and Community Relations press@santeventures.com 512.721.1200
Clinical Accelerator, a leading contract research organization (CRO) specialising in clinical trials with novel medical devices, and Laminar Medical, a pioneering medical device company developing a Left Atrial Appendage Closure System, are proud to celebrate a three-year milestone in their ongoing collaboration on Laminar’s clinical study of their device in subjects with Non-Valvular Atrial Fibrillation (NVAF).
Atrial fibrillation, a prevalent heart rhythm disorder, poses a significant risk of stroke and thromboembolism, with the left atrial appendage being a common source of clot formation. The Laminar Left Atrial Appendage Closure System, utilizing a percutaneous delivery system, offers a potential breakthrough in addressing this critical medical need.
Laminar Medical’s study Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation has been ongoing at two of Clinical Accelerator’s partner sites in Tbilisi, Georgia and the objective of the study has been to demonstrate the system’s safety and effectiveness in reducing the risk of thromboembolism from the left atrial appendage (LAA).
The results of the study were included into an important recent publication in JACC (Journal of the American College of Cardiology) entitled “Transcatheter Left Atrial Appendage Exclusion: Preclinical and Early Clinical Results With the Laminar Device.” It was noted in the publication that the device was successfully implanted in 15 human subjects with no safety events out to 12 months post implantation. All subjects had successful protocol-defined LAA closure without DRT at 45 days by TEE and computed tomography, which remained stable through 12 months’ follow-up. The preclinical and early clinical results demonstrated a promising safety and efficacy profile for the Laminar LAA exclusion device.
Late last year it was announced that Laminar Medical was acquired by J&J. We congratulate everyone associated with Laminar Medical on this important milestone.
Clinical Accelerator continues to expand its experience in the field of developing novel LAA Closure Systems. The expertise now spans a range of clinical studies focused on the evaluation and improvement of such devices resulting in quality data being obtained in an efficient and expert manner at highly experienced partner sites.
About Clinical Accelerator
Clinical Accelerator is an academically oriented clinical CRO focused on the needs of emerging medtech companies. The organization, founded by a heart failure cardiologist, performs many clinical investigations of cardiovascular medical devices. Studies are mostly implemented in Central and Eastern Europe, a region with well-known advantages for clinical trials such as – fast start-up timelines and good access to patients. Clinical Accelerator aims to accelerate clinical development programs of international medical technology companies through early entry into the clinic and fast and efficient implementation of both feasibility and pivotal clinical investigations.
About Laminar Medical
Laminar Medical is a leading medical device company focused on developing innovative solutions for cardiovascular diseases. The Laminar Left Atrial Appendage Closure System is designed to address the challenges associated with Non-Valvular Atrial Fibrillation and reduce the risk of thromboembolism by effectively closing the left atrial appendage.
For trial inquiries, please contact our Business Development Representative:
Below, we are re-publishing with permission the press-release issued by Laguna Tech USA on October 24, 2023
New heart valves, ALPHA and ZETA, designed to provide flexibility and optionality regardless of high, low or zero calcification status
Patients with aortic regurgitation achieve complete resolution of regurgitation immediately following procedure.
First-in-class, Aortic Valve Systems offer self-expanding or balloon-expanding versatility based on physician preference and patient case dynamics
Versatile designs expected to significantly broaden patient eligibility for implant
IRVINE, Calif., Oct. 24, 2023 (GLOBE NEWSWIRE) — Laguna Tech USA, a privately-held medical technology company dedicated to innovations in structural heart solutions to broaden useability and applicability for patients, today announced that the first-in-human clinical case was completed with the Zeta Balloon Expandable Aortic Valve System and additional patients have been successfully treated in the feasibility clinical study of its investigational ALPHA Self-Expanding Aortic Valve system to treat aortic regurgitation. To date, two patients have been successfully treated in the Alpha Aortic Valve study, with both achieving complete resolution of aortic regurgitation immediately following the procedure, which has been maintained at the 30-day follow-up examination.
The ALPHA system is a uniquely designed one-piece self-expanding transcatheter valve engineered with a low profile valve and delivery system, with six support arms for simpler, better positioning within the aortic annulus and cusps. The ZETA system is a novel balloon-expandable transcatheter valve with six expanding arms and a low profile covered delivery system. The six expanding arms allow for simple positioning of the valve into the aortic annulus and cusps.
The feasibility study is being conducted at the Instituto Nacional de Torax in Santiago, Chile, and Tbilisi Heart and Vascular Clinic in Georgia.
The lead primary investigator, Dr. Scott Lim, a cardiologist from the University of Virginia noted, “The Laguna Tech USA Alpha Self Expanding Aortic Valve and Zeta balloon Expandable Aortic Valves performed as designed, allowing us to successfully and percutaneously treat these first patients at high surgical risk with severe aortic regurgitation, and in one case, with concomitant significant calcific aortic stenosis. I look forward to these novel transcatheter aortic valves being further investigated in larger studies, as this initial experience is quite encouraging toward helping us address a significant unmet patient need in those with complex aortic valve disease.”
Dr. Cristian Dauvergene, Chief of Interventional Cardiology, Instituto Nacional de Torax, added, “We were able to successfully implant the Zeta Aortic Valve very simply and efficiently aided by the low profile and straightforward transcatheter implantation allowing for advantageous placement in the heart. We are excited to be a part of the success of the first procedure of this important next-gen TAVI system, and we look forward to participating in Laguna Tech USA’s clinical study.”
“With this successful groundbreaking first in human clinical experience with the ZETA valve and the additional successful ALPHA valve implants, we have a growing body of evidence supporting the promise of our next-gen, differentiated aortic valves, which represent much-needed advancement in the field,” said Gilbert Madrid, chief executive officer of Laguna Tech USA. “Specifically, our valve designs are intended to address an unfortunate, longstanding gap in the applicability of heart solutions because of rigid and unyielding technology designs that eliminate many patients as prospective candidates. With two varying valve designs, each leveraging advanced technology and engineering of existing products on the market, we look forward to the potential of our technology to significantly expand the number of patients with aortic valve regurgitation who may be treated with our minimally invasive treatment options.”
About the ALPHA Aortic Valve System The ALPHA Aortic Valve is designed to restore heart function by placing support arms in the aortic cusps and placement of the valve within the annulus. The valve self-expands into the annulus to form a new functioning valve and seals at the annulus to prevent paravalvular leak. The system was invented at Laguna Tech USA with the first prototype entering preclinical development in 2022. The system is engineered with a unique design and to increase the versatility, flexibility, and positioning of the device in the annulus for improved placement within the patient.
About the ZETA Aortic Valve System The ZETA Aortic Valve is designed to restore heart function by placing support arms in the aortic cusps and placement of the valve within the annulus. The valve is balloon expandable into the annulus to form a new functioning valve and seals at the annulus to prevent paravalvular leak. The system was invented at Laguna Tech USA with the first prototype entering preclinical development in 2022. The system is engineered with a unique design and materials to increase the versatility, simplicity, and positioning of the device in the annulus for improved placement within the patient.
About Laguna Tech USA Laguna Tech USA is a privately held medical technology company focused on providing innovative, less invasive structural heart solutions to a significantly expanded group of patients who previously were excluded as candidates for valve replacements. Laguna Tech USA believes its highly differentiated next-generation engineering offers versatility and flexibility, and therefore feasibility, of its valves in addressing diverse heart conditions across a broad population of patients. The company’s lead investigational devices for aortic regurgitation are the ALPHA Aortic Valve, a self-expanding valve, and the ZETA Aortic Valve, a balloon-expandable valve for aortic regurgitation. In addition, the iNValve Mitral and Tricuspid valve is a transseptal valve in the R&D pipeline.
Below, we are re-publishing with permission the press-release issued by Argá Medtech on Octobe 26, 2022
Acute procedural success achieved in all patients using a novel pulsed field ablation (PFA) sine waveform and configurable catheter.
EPALINGES, Switzerland, Oct. 26, 2022 (GLOBE NEWSWIRE) — Argá Medtech announced today that it has begun enrollment in their First-in-Human Clinical Trial “Coherent Sine Burst Electroporation (CSE) System Pilot Study in Patients with Atrial Fibrillation (BURST-AF)”. The study is designed to test the acute safety and efficiency of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation (AFib). The first five patients, four with paroxysmal and one with persistent AFib, were successfully treated by Dr. Giorgi Papiashvili with support from Dr. Ante Anic, at the Healthycore Medical Center in Tbilisi, Georgia.
The CSE system consists of a configurable (circular, linear, and focal) ablation catheter and pulsed field ablation (PFA) generator. In contrast to all other PFA waveforms, CSE employs a unique sinusoidal wave instead of a square wave. CSE is designed to minimize muscle stimulation, decrease bubble formation, and increase targeted energy delivery to create transmural lesions in tissue of any thickness. CSE offers unmatched flexibility to deliver bipolar, unipolar, or a combination of both waveforms that enables the user to titrate the width and depth of the ablation lesion.
“We are very pleased with the performance of our CSE System in this initial group of patients,” stated David Neale, CEO of Argá Medtech. “The ability to deliver three different lesion sets with a single catheter, combined with a generator that titrates lesion depth and width, enables electrophysiologists to safely and efficiently treat any location in the heart.” The physicians and lab staff were excited to provide this new therapy option to their AFib patients. “It was easy to change the ablation catheter from circular to linear,” said Dr. Papiashvili, “and not having to exchange catheters for each lesion set is a game changer.” Visiting physician Dr. Ante Anic (University Hospital Split, Croatia) added, “Energy delivery was very impressive, with no muscle stimulation, no bubbles and very adaptable to the patient’s needs. The catheter flexibility allowed the pulmonary veins to be quickly isolated using the circular configuration and then easily changed to deliver a ‘linear single-shot’ roof line.”
Atrial Fibrillation and PFA Ablation AFib is the most common heart arrhythmia affecting over 33 million patients worldwide and makes them 5 times more likely to have a stroke.1 Patients with AFib have a significantly poorer quality of life when compared to healthy individuals, experiencing a variety of symptoms including lethargy, palpitations, dyspnea, chest tightness, sleeping difficulties, and psychosocial distress. Ablation using thermal energy (radiofrequency or cryogenic) has proven to be an effective treatment in alleviating AFib associated symptoms and improving quality-of-life. However, there are risks associated with the use of thermal energy that include the potential to damage critical structures such as the esophagus or nerves that surround the heart. Pulsed field ablation energy delivery is tissue selective, ablating the selected heart tissue, while sparing nearby tissues.
About Argá Medtech We are a venture-capital backed development stage company developing the next generation of pulsed field ablation and irreversible electroporation for the safe and effective treatment of patients with cardiac arrhythmias. Founded in 2020, Argá Medtech is based in Switzerland with research and development facilities in San Diego, CA.
Chugh SS et al. Worldwide epidemiology of atrial fibrillation. A global burden of disease study 2010. Circulation;129:2014.
Below, we are re-publishing with permission the press-release issued by Medcura, Inc. on January 12, 2023
January 12, 2023·3 min read
COLLEGE PARK, Md., Jan. 12, 2023 /PRNewswire/ — Medcura, Inc., a medical device company dedicated to transformatively improving the management of surgical bleeding, announces that the U.S. Food and Drug Administration (FDA) has granted the coveted Breakthrough Device Designation for its LifeGel™ Absorbable Surgical Hemostat. LifeGel™ is the first and only hemostatic agent to receive Breakthrough Device Designation seeking a new and highly differentiated indication: in surgical procedures (except in ophthalmic and urological) as an adjunctive hemostatic device when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical. Due to its no-swell properties, LifeGel can be used in surgical procedures where swelling cannot be tolerated.
The FDA’s Breakthrough Devices Program is available to therapeutic devices that establish they have the potential to provide more effective treatment of life threatening or irreversibly debilitating diseases or conditions. Breakthrough designation provides several important benefits, including quicker and more collaborative review of future regulatory submissions with greater opportunity to interact with FDA experts throughout the review process.
“We’re very pleased for the opportunity to continue working closely with the FDA to improve a surgeon’s ability to control and stop the wide range of bleeding scenarios for which the Breakthrough Designation was awarded,” said Medcura President and CEO Jim Buck. “This designation provides for a more collaborative partnership with the FDA which should expedite patient access to LifeGel as a game-changing new solution to surgical bleeding management.”
Other hemostatic agents swell after application. When used in confined spaces like the spinal canal, where up to 60% of these products are applied, hemostatic agents have been documented to cause nerve compression that can lead to severe adverse events including paralysis. Medcura’s proprietary and patented formulation was designed not to swell upon application, eliminating the chance of spinal cord compression caused by swelling hemostatic agents. Unlike many other hemostatic agents, LifeGel contains no human or animal proteins, including thrombin, and requires no pre-mixing, preparation or cold chain storage. Being ready to use, LifeGel can help avoid costly delays, risks and complications associated with uncontrolled bleeding and reduce wastage of expensive hemostatic materials in the operating room. These differentiating features, along with the platform’s disruptive cost advantage, positions Medcura’s LifeGel to become a future standard of care for surgical bleeding management.
“Over the past decade, there have not been meaningful advancements in the safe control of surgical bleeding using flowable technologies which are routinely used in many high-volume and high-value procedures,” said Medcura’s Chief Medical Officer, neurosurgeon Dr. Ken Renkens. “With the experience we’ve gained through extensive pre-clinical testing, LifeGel has shown to be easy and intuitive to use while demonstrating a remarkable ability to reliably control the wide range of challenging bleeding situations a surgeon often confronts.”
About the Company
Medcura, Inc. is a commercial-stage medical device company developing versatile hemostatic products serving large surgical, medical, and consumer market opportunities. The Company’s proprietary technology platform combines the use of safe, inert ingredients with patented chemistries, all aimed at introducing disruptively lower cost products capable of safely and effectively controlling bleeding across a broad spectrum of clinical applications. Learn more about Medcura’s growing product line at www.medcurainc.com.
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