Rest pain

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

The first-on-podium data were presented as a late-breaking clinical trial during VIVA 2023 NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Vibrato Medical, an innovator in the treatment of peripheral arterial disease (PAD), announced today that data from an early feasibility study of Non-Invasive Therapeutic Ultrasound (TUS) to treat Chronic Limb-Threatening Ischemia (CLTI) has successfully met its endpoint. The study evaluated patients with infrapopliteal PAD and measured changes in foot perfusion and oxygenation as well as therapy tolerance, compliance and perception. The data from the 12-patient Prelude study were presented by Mahmood Razavi, MD, Director of Clinical Trials and Research Center at the Vascular & Interventional Specialists of Orange County, as a podium presentation during the annual VIVA conference at Wynn Las Vegas on October 31, 2023. Patients in the trial had Rutherford class 3, 4 or 5 PAD, meaning severe claudication, ischemic rest pain or tissue loss including nonhealing ulcers. The trial participants received 30-40 TUS treatment sessions over two months. At the end of the treatment: Each individual patient demonstrated a statistically significant improvement in perfusion Toe perfusion increased acutely by 180 ± 34 percent (p<0.001) Tissue oxygenation increased by +17 percent (p=.02) Patients showed excellent therapy tolerance, compliance and feedback “It is hard to believe that even with so many medical advancements, almost 20 percent of patients with chronic limb-threatening ischemia will eventually need an amputation,” said Dr. Razavi. “While the findings from this study are still very early, I am impressed by the clinical improvements, compliance and patient tolerance, and think therapeutic ultrasound may prove itself to be an important treatment for patients with reduced tissue perfusion, such as those with PAD and CLTI.” Over 18 million people in the United States have PAD, a disease that occurs when the peripheral arteries narrow, making it more challenging to carry blood away from the heart to other parts of the body.1 It is estimated that two million people with PAD have blockages so extreme they have advanced to CLTI, a chronic condition that can cause extreme pain, sores and wounds that do not heal and can result in the amputation of the affected limb.2 The unmet clinical needs for this population are extremely high. “These early findings are promising for the future of non-invasive therapeutic options to treat chronic limb-threatening ischemia,” said Juliana Elstad, CEO at Vibrato. “We’re looking forward to building on these findings as we begin our next prospective multi-center randomized clinical trial.” Based on decades of therapeutic ultrasound research and the latest technological advancements, Vibrato’s technology is the first wearable therapeutic ultrasound device designed to promote vasodilation and vessel growth. About Vibrato Medical Vibrato Medical is a private company located in Newport Beach, California. The company has developed the first wearable therapeutic ultrasound device for the noninvasive, outpatient treatment of peripheral arterial disease (PAD) and chronic limb-threatening ischemia (CLTI). It is designed to promote vasodilation, collateral vessel growth and angiogenesis, and restore perfusion. Its leadership team brings deep experience in developing and commercializing medical devices and is supported by an experienced board of directors as well as recognized clinical leaders in the field of PAD. Vibrato Medical’s mission is to be the preferred therapeutic system for patients with reduced tissue perfusion. ____________________ 1 The Sage Group. Critical Limb Ischemia. Volume 1 US Epidemiology, 2010. Accessed at . October 14, 2016. 2 Duff, et al. Vascular Health and Risk Management 2019.

Calgary, Alberta--(News - April 3, 2023) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company") is pleased to announce it is completing a second round of interviews with candidates who may join the company as Executive Vice President, Business Development. The EVP Business Development will be responsible for building and leading a team focused on the following: The sale of Tranch 1 - 500 ACP treatment convertible debentures at USD $35,000 each, to raise USD $17.5M, a mostly non-dilutive financing. Thereafter, the sale of tranche 2, etc., to finance production. Commence the roll-up of USA-based Podiatry clinics. Demonstrate to Podiatrists the impact to the clinic's revenue and margins of the addition of exempt ACP-01 treatments. For example, model the sale of up to 16 ACP, 30 minute, aseptic CLI injection procedures per day in keeping with the phase II injection protocol. Sell and close podiatry clinicians on how they can monetize the value of their sweat equity, exchanging it for shares of Hemostemix. Provide direction and analyses of potential Podiatry clinic acquisitions globally, analyzing market access in the EU, Mexico, Central and South America, the Middle East, India, Japan, and S. Korea. Hire and manage articulate, multi-lingual, biotech-seasoned business development sales executives to increase the velocity of podiatry clinic acquisitions and ACP compassionate sales. The five year survival rate of CLI amputees is < 30%. ACP-01 is a safe cell therapy for the treatment of CLI, a loss of circulation (atherosclerosis) in the limbs that leads to severe chronic pain at rest, ulcerating wounds that will not heal, gangrene and amputation. ACP-01 has completed a Phase II clinical trial for CLI. In the 17 center Phase II clinical trial of 68 subjects randomized 2:1 to receive ACP, 93.5% of ACP-01 treated limbs were saved from amputation. An interim data point of the phase II trial published by UBC and U of T noted healing of ulcers and resolution of ischemic rest pain occurred in 10 of 12 patients, and that outcomes were maintained for up to 4.5 years. In the ACP-01 randomized Phase I trial of 20 subjects followed for two years, there were no deaths and 70% (7/10) of treated limbs were saved from amputation. In the control group (non-treated), there were two deaths and 75% (6/8) of limbs were lost to amputation. The annual incidence of CLI is estimated to be 220-3,500 per 1,000,000 and its prevalence is estimated to be 1% of the adult population (CLI epidemiology and clinical presentation). It is estimated there are 236 Million who suffer from peripheral arterial disease (PAD), and up to 10% of PAD patients progress to CLI (23,600,000). Hemostemix is scaling its patented automated cell therapy system ("ACTS Production) to 4,000 batches per month by the end of 2027 to optimize its costs and margins while completing its clinical trials. Thereafter, ACTS production pods may be located in centralized production plants that scale to meet demand. ACP-01 as a treatment of heart disease (ischemic cardiomyopathy), demonstrated statistically significant improvements in 245 patients who participated in one of three phase 1 studies (171 subjects), or who were consecutively treated compassionately for ischemic cardiomyopathy (74 subjects) and studied retrospectively. In the retrospective study, left ventricle ejection fraction, a key measure of heart health, improved 27% on average at 12 months after treatment (p<0.003). The potential market for these two indications alone is >$9 Billion. ABOUT HEMOSTEMIX Hemostemix is a patient's blood-sourced stem cell therapy platform that includes angiogenic cell precursors, neuronal cell precursor and cardiomyocyte cell precursors. Founded in 2003, a winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, and is scaling by the end of 2027 the manufacture of 4,000 patient treatments per month in its automated cell therapy system ("ACTS") manufacturing cell. ACP-01 is created from the patient's blood. Six published studies of ACP-01, and a retrospective study of 53 consecutively treated ischemic cardiomyopathy patients, 345 study subjects in total, demonstrate ACP-01 is safe and preliminarily efficacious in the treatment of critical limb ischemia, angina, ischemic and dilated cardiomyopathy. The Company is selling ACP-01 forward on an exempt compassionate basis (see press release of March 7th) while it completes its clinical trials to obtain exclusive market access for certain medical indications. For more information, please visit . For further information, please contact: Thomas Smeenk, President, CEO & Co-Founder EM: tsmeenk@hemostemix.com PH: 905-580-4170 Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward-Looking Information: This news release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information in relation to: the financing of the Company and its lead product ACP-01 and the commercialization of ACP-01 via the sale of compassionate treatments subject to exemption from regulatory approval. ‎‎There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the underlying value of Hemostemix and its Common Shares; the successful resolution of the litigation that Hemostemix is pursuing or defending (the "Litigation"); the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory ‎approvals for research, trials or studies; the level of activity, market acceptance and market trends in the healthcare sector; the ‎economy generally; consumer ‎interest in Hemostemix's services and products; competition and ‎Hemostemix's competitive advantages; and Hemostemix obtaining satisfactory financing to ‎ fund Hemostemix's operations including any research, trials or studies, and any Litigation. Forward-looking information is Subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete clinical trials, complete a satisfactory analyses and results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; potential litigation Hemostemix mayface; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation ‎affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in Hemostemix's markets and the markets in which it expects to compete;‎ lack of qualified, skilled labour or loss of key individuals; and risks ‎related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to ‎try to limit the pandemic, including travel restrictions, border closures, non-essential business closures service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, disruptions to economic activity and ‎financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a ‎possible national or global recession or depression;the potential impact that the COVID-19 pandemic may have on Hemostemix which may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix's ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix's disclosure documents on the SEDAR website at . Although Hemostemix has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, it is Subject to change after such date. However, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law. To view the source version of this press release, please visit