Carolinas Medical Center-NorthEast

BMI OrganBank™ is developing novel organ perfusion systems with potential to greatly reduce the waitlist for lifesaving organ transplants. Partnership includes early access to BMI technologies, collaboration on product design, clinical studies, clinical integration pilots and an undisclosed capital arrangement. CHARLOTTE, N.C., Feb. 22, 2024 /PRNewswire/ -- Atrium Health's Division of Abdominal Transplant, Carolinas Medical Center (DAT Atrium), LifeShare Carolinas, one of nation's leading Organ Procurement Organizations, and BMI OrganBank, a developer of organ perfusion systems based in Winston-Salem, North Carolina, announced today that their organizations have partnered to develop and launch the nation's first Organ Banking technology, which will greatly expand the possibilities for organ preservation and reconditioning. DAT Atrium is part of the nation's fifth largest Integrated Delivery Network. The initial focus of the collaboration will be kidney transplantation. Millions of registered organ donors die every year, but relatively few have their kidneys recovered and transplanted. As a result, over 90,000 Americans are on the waiting list for lifesaving kidney transplants. This imbalance in supply and demand could be addressed by the greater use of kidneys from older donors and donors after circulatory death (DCD). With current organ preservation approaches, which use cold temperatures, these kidneys are vulnerable to significant injury during the period before transplantation, leading to increased rates of organ transplant failure. As such, clinicians and patients are reluctant to utilize these kidneys. To improve the preservation and acceptance of these kidneys, BMI OrganBank has developed a unique room temperature oxygenated perfusion platform which has shown great promise for extending preservation times and improving post-transplant outcomes. With this partnership, DAT Atrium and LifeShare Carolinas will be the first clinical organizations to have access to this technology. They will take a leadership role in adapting the technology to clinical settings. Dr. Dionisios Vrochides, Chief of Transplant Oncology Section and Vice Chairman of the Department of Surgery at Atrium Health Division of Abdominal Surgery stated, "This technology has potential to fill important needs of our organ procurement and transplant teams to make more use of donor organs that have been entrusted to us and to improve transplant outcomes. We are excited to help bring it into the clinic." Carrie DiMarzio, CEO of BMI OrganBank, added, "Atrium's Carolinas Medical Center abdominal transplant team is widely admired across the nation, and we are delighted to have partners of this caliber join our efforts to bring this lifesaving innovation to patients who have been waitlisted for organs." The partnership will span product development, clinical studies, clinical integration pilots and educational initiatives and includes an undisclosed capital arrangement. About BMI OrganBank™ BMI OrganBank develops novel perfusion systems that can preserve and recondition organs and tissues. BMI has research facilities in the Innovation Accelerator at the Wake Forest Institute for Regenerative Medicine in Winston-Salem, NC and in Research Triangle Park, NC. BMI OrganBank has multiple medical devices in development that use its patented and proprietary technologies. Its first product to launch will be the OrganBank Transport device, which was developed in partnership with Duke University researchers at the Duke Ex-Vivo Organ Laboratory (DEVOL). BMI is currently conducting a seed funding round. To learn more, visit bmiorganbank.com. About Division of Abdominal Transplant at Carolinas Medical Center, at Atrium Health The Division of Abdominal Transplant, Carolinas Medical Center, is part of Atrium Health Transplant Center, one of the busiest transplant centers in North Carolina, performing nearly 200 organ transplants every year. It is one of just six in the US with its own hospital-based organ procurement program, which has resulted in shorter average wait times for organs for their patients. Atrium Health is a nationally recognized leader in shaping health outcomes through innovative research, education and compassionate patient care. Based in Charlotte, North Carolina, Atrium Health is an integrated, nonprofit health system with more than 70,000 teammates serving patients at 40 hospitals and more than 1,400 care locations. Atrium Health is part of Advocate Health, the fifth-largest nonprofit health system in the United States, which was created from the combination with Advocate Aurora Health. It provides care under the Atrium Health Wake Forest Baptist name in the Winston-Salem, North Carolina, region, as well as Atrium Health Navicent and Atrium Health Floyd in Georgia and Alabama. Atrium Health is renowned for its top-ranked pediatric, cancer and heart care, as well as organ transplants, burn treatments and specialized musculoskeletal programs. A recognized leader in experiential medical education and groundbreaking research, Wake Forest University School of Medicine is the academic core of the system, including Wake Forest Innovations, which is advancing new medical technologies and biomedical discoveries. With a commitment to every community it serves, Atrium Health seeks to improve health, elevate hope and advance healing – for all, providing $2.46 billion last year in free and uncompensated care and other community benefits. About LifeShare Carolinas LifeShare Carolinas serves more than three million people across southwestern North Carolina with headquarters Charlotte, NC. LifeShare Carolinas is a Tier 1 organ procurement organization, ranking in the top 25% of organ procurement organizations in the 2022 Centers for Medicare and Medicaid Services (CMS) Annual Report. LifeShare Carolinas is proud to fulfill its mission of giving hope, life, and healing across 23 counties and is grateful to the donors and their families who make this meaningful mission possible. To learn more, visit lifesharecarolinas.org. SOURCE BMI OrganBank

MENDOTA HEIGHTS, Minn.--(BUSINESS WIRE)-- Stimdia Medical, a medical device company developing innovative technologies to improve respiratory care, today announced the initiation of its FDA approved pivotal trial to investigate the impact of phrenic nerve stimulation (PNS) on the time to liberate patients from mechanical ventilation. The ReInvigorate Study is a randomized, controlled trial that will enroll approximately 420 patients who are receiving mechanical ventilation in the intensive care unit (ICU). Patients will be randomly assigned to receive PNS therapy utilizing Stimdia’s proprietary pdSTIMTM System or standard of care alone. The primary efficacy endpoint of the ReInvigorate Study will evaluate the time to liberation from mechanical ventilation. Dr. Kyle Cunningham, trauma and critical care physician at Atrium Health – Carolinas Medical Center had this to say about the therapy: "We are excited to have enrolled the first subject in the ReInvigorate Study. It is great to be able to investigate this new therapy in our patients who are having difficulties regaining independent breathing. This intuitive, minimally invasive approach has the potential to reverse some of the modalities that are all too common with existing ventilation techniques. We are hopeful that this therapy will make a significant difference in the lives of our patients." Dr. Steven Conrad, Louisiana State University, Division of Critical Care Medicine, the National Principal Investigator for the ReInvigorate Study, commented, "The pdSTIM System has the potential to introduce a novel approach to ICU patient management, assisting physicians, respiratory therapists, and nurses in expediting the liberation of patients from mechanical ventilation. I look forward to clinicians engaging in this therapy as part of the study and await the trial's outcomes as it progresses toward completion." The pdSTIM System uses a minimally invasive procedure to place small leads adjacent to the phrenic nerves on each side of the neck. These leads are connected to an external console that synchronizes the delivery of therapy with inhalation. The device can be programmed to deliver electrical impulses at a specific frequency and intensity. These electrical impulses are intended to awaken and recondition the diaphragm, the primary muscle used to support breathing. Strengthening the diaphragm is believed to be an avenue towards weaning patients from mechanical ventilation more quickly. “We are thrilled to partner with an outstanding group of clinicians to launch this pivotal trial that will investigate the potential of PNS to improve the outcomes of critically ill patients," said Stimdia Medical CEO Tim Miller. "We believe that the pdSTIM therapy has the potential to revolutionize respiratory care, and we are dedicated to making this therapy accessible to patients as soon as possible.” The pdSTIM System is an investigational device and is limited by federal (or United States) law to investigational use and is not available for sale or commercial use. About Stimdia Medical Headquartered in Minnesota, Stimdia Medical, has developed the pdSTIM System to facilitate weaning patients from mechanical ventilation through the use of neuromuscular stimulation to the phrenic nerves. The device is currently for investigational use only and is not for sale in any country. For more information about the ReInvigorate Study, please visit the Stimdia Medical website at or at Clinicaltrials.gov (NCT05998018).

Shockwave L⁶ Provides Physicians with Larger-Diameter Catheters to Expand Potential Treatment of Peripheral VesselsSANTA CLARA, Calif., March 14, 2023 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced the full U.S. commercial availability of the Shockwave L6 Peripheral IVL Catheter following clearance by the U.S. Food and Drug Administration (FDA). The Shockwave L6 catheter is purpose-built to modify calcification in otherwise difficult-to-treat lesions in large peripheral vessels, including the iliac and the common femoral arteries. Calcification in these arteries is common and associated with decreased procedural success and increased complications with standard endovascular techniques.1 “The Shockwave L6 catheter pushes the boundaries of what IVL can help physicians achieve for patients with severe peripheral arterial disease,” said Frank Arko, M.D., Chief of Vascular and Endovascular Surgery at Carolinas Medical Center, Sanger Heart and Vascular Institute in Charlotte, North Carolina. “The characteristics of the new catheter allow physicians to optimize IVL therapy in large peripheral vessels, which represent over 20% of peripheral interventions performed in the U.S. each year. The Shockwave L6 catheter may also be beneficial when IVL is utilized to facilitate transfemoral access for large bore procedures like TAVR, TEVAR and EVAR to minimize the risks of rupture and dissection.” The Shockwave L6 IVL catheter’s compact emitter configuration, in conjunction with four new device sizes (8.0, 9.0, 10.0 and 12.0 millimeter diameters), enables effective delivery of sonic pressure waves in larger vessels. The Shockwave L6 enhances the company’s peripheral IVL portfolio, extending the size offerings of the Shockwave M5+ and Shockwave S4 catheters, to provide physicians with a choice of catheters optimized for the challenges of infrapopliteal, femoropopliteal and iliac arterial territories. “Shockwave L6 is another example of our team’s commitment to developing technologies to address specific market needs while still maintaining the safety, effectiveness and ease of use of our core IVL technology,” said Doug Godshall, Chief Executive Officer of Shockwave Medical. “We are pleased with the success of our limited release and the great feedback we have received from our customers. We now look forward to offering Shockwave L6 as an additional IVL option for the most complex and high-risk large vessel cases.” 1Armstrong et. al. Cardiovascular Revascularization Medicine, 2020. https://doi-org.libproxy1.nus.edu.sg/10.1016/j.carrev.2020.02.026 About Shockwave Medical, Inc.Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com. Forward-Looking Statements This press release contains statements relating to our expectations, projections, beliefs, and prospects, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue,” and similar expressions, and the negative of these terms. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others: the impact of macroeconomic conditions, including inflation, rising interest rates, volatile market conditions, and global events, including the COVID-19 pandemic, on our operations, financial results, liquidity, capital resources, expenses, supply chain, manufacturing, research and development activities, clinical trials, and employees; our ability to develop, manufacture, obtain and maintain regulatory approvals for, market and sell, our products; our expected future growth, including the size and growth potential of the markets for our products; our ability to obtain coverage and reimbursement for procedures performed using our products; our ability to scale our organizational culture; the impact of the development, regulatory approval, efficacy and commercialization of competing products; the loss of key scientific or management personnel; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; whether the acquisition of Neovasc is completed; and our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others. These factors, as well as others, are discussed in our filings with the Securities and Exchange Commission (SEC), including in Part I, Item IA - Risk Factors in our most recent Annual Report on Form 10-K filed with the SEC, and in our other reports filed with the SEC. Except to the extent required by law, we do not undertake to update any of these forward-looking statements after the date hereof to conform these statements to actual results or revised expectations. Media Contact:Scott Shadiow+1.317.432.9210sshadiow@shockwavemedical.com Investor Contact:Debbie Kasterdkaster@shockwavemedical.com