Intermittent Claudication

LYON, France--( BUSINESS WIRE )--Regulatory News: MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies TM (MET) dedicated to enhancing survival of patients with cancer, today announced that the DSMB reviewed safety data in the first 8 patients with Amyotrophic Lateral Sclerosis (ALS) treated with MaaT033 in the IASO clinical trial. The DSMB recommended that the trial continue without modifications. The DSMB, composed of 4 independent experts, including an ALS patient association representative, concluded that safety was good. More precisely, it should be noted that no serious or severe adverse events were observed, and no infectious events could be related to MaaT033. The preliminary results reinforce confidence in the safety of MaaT033, a drug candidate produced by combining the microbiota from multiple donors using a "pooling" process. MaaT033 is currently evaluated, in a chronic setting, in a Phase 1b pilot study ( NCT05889572 ) in ALS (also known as Lou Gehrig's disease in the US and Charcot's disease in French-speaking countries). The Company has developed the clinical trial with the French academic experts FILSLAN/ ACT4ALS-MND and in collaboration with the French patients’ association Tous en Selles contre la SLA . Data readout is now expected in early H2 2024. MaaT033 is also being evaluated in the Phase 2b trial PHOEBUS (NCT05762211) , the largest one to date in Europe for a microbiome therapy in oncology, dedicated to improving survival of patients with blood cancers receiving allogeneic hematopoietic stem cell transplantation (HSCT). About MaaT033 MaaT033, a donor-derived, high-richness, high-diversity oral Microbiome Ecosystem Therapy TM containing anti-inflammatory Butycore TM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA). About MaaT Pharma MaaT Pharma, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, MaaT Pharma launched, in March 2022, an open-label, single arm, phase 3 clinical trial in patients with acute GvHD (aGvHD), following the achievement of its proof of concept in a phase 2 trial. Its powerful discovery and analysis platform, gutPrint ® , enables the identification of novel disease targets, evaluation of drug candidates, and identification of biomarkers for microbiome-related conditions. The company’s Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice. MaaT Pharma is listed on Euronext Paris (ticker: MAAT). Forward-looking Statements All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

TAICHUNG, Feb. 24, 2024 /PRNewswire/ -- In winter, cardiovascular diseases are more prevalent, which significantly increase the likelihood of arterial blockage. In addition to increasing the possibility of accompanying myocardial infarction or stroke, seniors should be especially cautious about Peripheral Arterial Occlusive Disease (PAOD). In mild cases, impaired walking, numbness and weakness during running are experienced; in cases of severe blockage, patients are at risk of developing gangrene (a dry, black sore) and frequently have their foot amputated eventually. If the event comes quickly - so called acute PAOD, even after receiving standard treatment, the mortality and amputation rates remain in the 20-30% range. Continue Reading Chang, a 72-year-old female, (first from the right) has a history of hypertension, coronary artery occlusion, hyperthyroidism, and paroxysmal atrial fibrillation, as well as right lower extremity coldness with unusual pain. Dr. Hsu Chung-Ho (middle) examined thrombi in the popliteal artery of her right lower extremity, resulting in severe obstruction of blood flow in the lower extremity. Since 2016, China Medical University Hospital (CMUH) in Taiwan has established the "24-hour thrombolysis team" to conduct research and treatment in response to this deadly disease. For acute PAOD patients, after emergent survey at Emergency Room (ER), Pharmacomechanical Thrombectomy (PMT) with Rotarex based atherectomy with or without Ekosonic Endovascular System (EKOS) are performed to treat patients with acute and severe arterial blockage in the lower extremities if indicated. The clinical amputation and mortality rates in regard of acute PAOD significantly reduced from 20-30% to 3%. The clinical results were published in the medical journal "International Angiology." "To prevent permanent necrosis of the muscle tissues and to lower mortality, a 24-hour standby medical team must be available to perform emergent thrombi removal within 'golden' hours before irreversible events develop." says Dr. Chung-Ho Hsu, director of the section of peripheral vascular disease, division of cardiovascular medicine, department of internal medicine, CMUH, Taiwan. Miss Chang, a 72-year-old female, has a history of hypertension, coronary artery occlusion, hyperthyroidism, and paroxysmal atrial fibrillation. In spite of this, Chang experienced right lower extremity coldness with unusual pain suddenly. Following an ultrasound examination by Dr. Hsu, thrombi were discovered in the right popliteal artery, resulting in severe obstruction of blood flow in the lower extremity. CMUH convened the "24-hour thrombolysis team", where an emergent catheter-based thrombectomy/thrombolysis operation was performed under local anesthesia immediately. After PMT with Rotarex and thrombolysis with EKOS, Chang's blood circulation was greatly improved, and the amputation crisis was successfully averted. Mr. Kou is another case of successful lower limb salvage treatment. Mr. Kuo is an 80-year-old patient with multiple chronic conditions: hypertension, diabetes, coronary artery occlusion, persistent atrial fibrillation, and heart failure, as well as chronic obstructive pulmonary disease. Mr.Kuo rushed to the ER in CMUH after experiencing right lower extremity coldness and sharp pain. Dr. Hsu discovered thrombi in the anterior tibial artery of Mr.Kuo's right lower extremity during an examination, resulting in poor blood circulation in the lower extremities. The thrombi were successfully removed after an emergent catheter-based thrombolysis with EKOS, as well as the use of drug-coated balloons and stents, and blood flow returned to normal, avoiding the fate of an amputation that could have resulted in severe disability. Acute PAOD is frequently the result of atrial fibrillation, which causes thrombi to fall from the heart to the arteries of the lower extremities, resulting in a sudden and severe blockage. According to Director Hsu at CMUH, acute PAOD is most prevalent in the lower extremities, and symptoms include decreased temperature of the affected limb (frequently feeling cold), pain, pallor, numbness, poor walking ability, pulselessness, and paralysis. In the most severe cases of acute PAOD, muscle tissues develop ischemic necrosis, and patients are even forced to have limbs amputated or lost their life. Mortality will be as high as 100 percent if left untreated. Importantly, after amputation, these patients are likely to face life-threatening risks again, and condition will deteriorate due to less exercise after amputation, making this disease difficult to treat. As for how to determine if one has PAOD, Dr. Hsu explains that the disease can be divided into four stages based on its severity and clinical manifestations (Fontaine stage): Stage 1 (asymptomatic): No symptoms, only diseased lower limb arteries identified. Stage 2: The legs are prone to fatigue and weakness during walking, but the patient can continue to walk after a short rest. The recurrence of the initial symptoms appears later on, which is given the name intermittent claudication. Stage 3: Severe vascular obstruction and inadequate local circulation while at rest, which results in chronic pain,so called ischemic rest pain. Stage 4: Ulcers and necrosis begin in the toes and spread to the feet and ankles as the skin changes color from pink to dark purple as a result of ischemia. However, if the symptoms worsen quickly with either pain, pallor, poikilothermia, paresthesia, pulselessness, or paralysis, one should think about acute PAOD, which is a medical emergency and need to rush to the ER immediately. For acute PAOD, CMUH will arrange vascular ultrasound immediately at ER and decide which is the clinical stage. If the condition is feasible, 24-hour thrombolysis team will be initiated to perform endovascular therapy immediately to save legs, also save lives. Acute PAOD often stems from atrial fibrillation, a condition that leads to the formation of thrombi in the heart which can then dislodge and block the arteries in the lower extremities, causing sudden and severe blockage. In light of this, Director Hsu strongly advises patients with atrial fibrillation to adhere to a regular regimen of anticoagulants to prevent thrombotic events. CMUH successfully r educed clinical amputation rates from 30% to 3%, and death rates from 30% to 3%. The clinical results were published in the medical journal "International Angiology" in April of 2022. Under the care of the "24-hour thrombolysis team" led by Director Hsu, their health and mobility have been restored. Media contact: Carolyn Chen, [email protected].tw SOURCE China Medical University Hospital

CARLSBAD, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced the publication of the first 6-month clinical evaluation of its ZIP™ fusion implant in the Journal of Pain Research. Lumbar interlaminar decompression with interspinous fixation is an established safe and effective treatment for spinal stenosis. Early maintenance of improvements in pain intensity and function are critical for durability of symptom relief. The purpose of this study is to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer term success. The scientific paper titled “Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results”, is a pivotal multi-center study of its ZIP™ Interspinous Fixation device for patients suffering from back pain due to symptomatic degenerative disc disease and spinal stenosis. The REFINE Screwless™ ZIP Study utilized patient evaluations at 3- and 6-months following treatment and is part of an actively enrolling, institutional review board (IRB) approved, single-arm, multicenter, prospective, open-label 12-month study. Clinical efficacy was assessed primarily using the change from baseline in Oswestry Disability Index (ODI), Visual Analog Scale (VAS) of the back and leg pain during walking and standing, and Zurich Claudication Questionnaire (ZCQ), and secondarily using the Patient Global Impression of Change (PGIC) and Patient-Reported Outcomes Measurement Information System (PROMIS). This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the ZIP interspinous fusion device. Our analysis showed a sustained improvement in clinical efficacy, and safety endpoints, when compared to the 3-months evaluations, across both interventional pain and neurosurgery specialties. The ZIP™ device is an alternative to more invasive traditional spinal surgery. The ZIP device's minimally invasive surgical technique works through a single, small surgical cut. Once in place, the device acts as a fusion support column to open the passageways that contain the spinal cord and nerve roots. This procedure may reduce the compression on the nerves, resulting in potential pain relief in the leg, groin, and buttocks, and then return to a more active lifestyle. "We appreciate all the support from the remarkable group of physicians from the neurosurgery and interventional pain management specialties across the country to bring the REFINE ZIP multicenter study to success," said Trent J. Northcutt, President and Chief Executive Officer of Aurora Spine. Dr. Sebastian Koga, a neurosurgeon from Covington, LA emphasized, “Our study demonstrates that the ZIP device provides a stable platform for posterior fusion. The patients go home the same day as the surgery and use less medications for chronic pain. I am happy to contribute objective clinical evidence to this area of spine surgery. In my practice I use the device as an adjuvant to most single-level decompressions.” According to a functional neurosurgeon Dr. Steven Falowski, who enrolled the first patient for the REFINE study, "Many of my patients suffering from lower back or leg pain could benefit from the ZIP minimally invasive outpatient treatment option that replaces traditional more invasive spinal decompression surgery commonly done with pedicle screws. I am very excited with these interim prospective 6 months results showing extremely positive outcomes demonstrating the strong future of the ZIP Screwless procedure. I am proud to participate as one of the Principal Investigators in this groundbreaking multicenter study. The purpose of this study is to develop the highest level of scientific evidence and bring this landmark therapy to the forefront." Dr. Jason E. Pope, one of the Principal Investigators in the study, a pain physician and anesthesiologist, highlighted that “the ZIP device procedure operationalizes the ability to perform a posterior interspinous fusion for those specially trained pain physicians, offering an additional minimally invasive option to remove pain and improve function in select patients suffering from degenerative disc disease accompanied by neurogenic claudication.” The ZIP System was 510(k) cleared by the FDA in 2013 and has been commercially available in multiple sizes in the US since 2014. With thousands of procedures already completed worldwide, the ZIP device is safe and effective in an outpatient setting. The ZIP device provides physicians the ability to remove targeted ligament, bone, and facet capsule material. This quick decompression involves minimal collateral tissue disruption and can also work under local anesthesia. A previously published retrospective study has also demonstrated the ZIP device’s safety and effectiveness in the hands of interventional pain physicians. About Aurora Spine Aurora Spine is focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies. Additional information can be accessed at or . Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward-Looking Statements This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Information" in Aurora Spine's final prospectus (collectively, "forward-looking information"). Forward-looking information in this news release includes information concerning the proposed use and success of the Company's products in surgical procedures. Aurora Spine cautions investors of Aurora Spine's securities about important factors that could cause Aurora Spine's actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward-looking statements. These statements speak only as of the date of this press release, and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances. Contact: Aurora Spine Corporation Trent Northcutt President and Chief Executive Officer (760) 424-2004 Chad Clouse Chief Financial Officer (760) 424-2004