Carpal Tunnel Syndrome

Millions of Americans suffer from chronic conditions that affect the hand each year, such as the 1.5 million people with rheumatoid arthritis and up to 10 million people with carpal tunnel syndrome. This week, Mayo Clinic forged a partnership aimed at improving treatment for these patients. The health system announced a collaboration with Exer AI, a Denver-based startup focused on improving care for patients with musculoskeletal and movement disorders. Under the partnership, Mayo Clinic will use Exer’s AI platform to diagnose and treat dozens of acute and chronic hand and wrist conditions. Exer, founded in 2019, trained its proprietary AI engine to understand human motion. Specifically, the company trained its technology to understand a library of important functional assessments, such as total active motion, gait analysis, Kapandji score and fall risk, explained CEO Zaw Thet. presented by Health Tech The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani “The assessments run on a tablet — with the patient standing in front of the camera — and take about 30 seconds. We don’t use sensors, straps or wearables. The measurements are accurate and objective to reduce variance among practitioners, faster than doing it manually and allow us to see ‘more stuff’ than a human can if they perform the same assessment themselves,” he declared. Exer seeks to improve diagnosis and treatment for musculoskeletal and motion disorders wherever the patient is — whether that be in their provider’s office, their home or via telehealth appointment — Thet pointed out. He also noted that the company designs its software for clinicians across multiple specialities, including orthopedics, neurology, spine, geriatrics and physical therapy. “The platform offers our healthcare customers accurate, objective functional assessments that run on common mobile devices without extra hardware or sensors, freeing up time and resources by optimizing patient volume and efficiency across the continuum of care from referral through to recovery,” Thet stated. presented by Health Tech What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat. By Stephanie Baum Under the new collaboration, Mayo Clinic will be using Exer’s technology to perform assessments in the clinic, in remote settings and via telehealth visits. Dr. Steven Moran, a Mayo Clinic surgeon and president of the American Society for the Surgery of Hands, will be working with his team to co-develop and distribute a clinical module for hand assessments inside Exer’s platform, Thet said. “We’ll develop and validate that module with their team, and we’ll aim to present the outcome findings to the society as a new global standard of care/approved protocol for hand and wrist injuries,” he stated. Exer is currently serving nine health systems, though Mayo Clinic is the only one that Thet is permitted to name at this time, he said. Though there are other digital health companies in the musculoskeletal space, such as Hinge Health, Thet said that his company is the only one with software that runs exclusively on mobile devices. “We’re often competing with legacy hardware — big machines that do these measurements, often with sensors, straps or wearables. In health systems, that could be something like a gait analysis lab, or Microsoft Kinect sensor systems,” he explained. The big difference is that Exer’s platform is “pure software,” like an app in the App Store, Thet declared. He pointed out that this brings the advantages of portability and easy implementation, which makes it easier to conduct rollouts across large health systems.

DENVER, Sept. 5, 2024 /PRNewswire/ -- Exer AI, a clinical AI company addressing musculoskeletal (MSK) and movement disorders, today announced a collaboration with Mayo Clinic to extend Exer's advanced computer-vision and AI platform to the diagnosis and treatment of dozens of acute and chronic hand and wrist disorders. This collaboration focuses on protocols to perform in-clinic, remote and telehealth assessments without the need for wearables or sensors. Continue Reading Exer AI for hand and wrist disorders, a collaboration with Mayo Clinic. Exer is a clinical AI company that helps healthcare teams drive clinical efficiency, improve accuracy, and achieve higher patient volumes for MSK and motion disorders. The proprietary AI and computer vision platform performs accurate, validated motion diagnostics and assessments across in-clinic and remote sessions. Exer's AI-based hand and wrist module analyzes human body biomarkers to measure, assess, and monitor patient movement. The resulting data helps practitioners determine prognosis, diagnose conditions accurately, streamline workflows, and expand patient access through pre- and post-visit care. The module is part of the overall Exer platform that complements existing human-centered care protocols by providing objective data to inform clinical decision-making. Millions of patients suffer chronic conditions that affect the hand like rheumatoid arthritis and carpal tunnel syndrome every year. Exer is designed to streamline care pathways, accelerate diagnosis, and improve treatment efficacy. Empowering pediatricians, primary care, and emergency room doctors to identify these pathologies with confidence leads to earlier intervention and a reduction in complications. "Our collaboration with Mayo Clinic is an exciting and foundational step towards improving care for millions of hand and wrist patients nationwide," said Zaw Thet, CEO and co-founder of Exer AI. "Our approach is to innovate on top of our proprietary AI models to produce vital clinical software modules that don't rely on expensive hardware or invasive sensors. We designed the Exer platform to address motion disorders that span specialties like hand and wrist, neurology, pain/spine, PM&R, orthopedics and geriatrics to offer large health systems a complete solution they can trust to improve care at scale." The collaboration team at Mayo Clinic includes Nicholas Pulos, MD, Hand and Microvascular Surgeon, Jess Rames, MD, MEng, Plastic and Reconstructive Surgery, and Steven Moran, MD, Professor of Plastic Surgery and Orthopedic Surgery and President of the American Society for the Surgery of the Hand (ASSH). By combining AI and computer-vision technology, Exer AI and Mayo Clinic aim to create more efficient, accurate, and accessible care pathways for hand and wrist conditions. This collaboration underscores a shared commitment to innovation and excellence in patient care. About Exer AI Based in Denver, CO, Exer is a clinical AI company that helps healthcare teams drive clinical efficiency, improve accuracy, and achieve higher patient volumes for MSK and motion disorders. The proprietary AI and computer vision platform performs accurate, validated motion diagnostics and assessments across in-clinic and remote sessions, Exer AI works seamlessly without the need for sensors or wearables to improve patients' lives and providers' decision-making across complex care needs in multiple specialities, including orthopedics, neurology, pain/spine, PM&R, geriatrics, and more. Conflict of Interest Statement Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research. CONTACT: Derek Shanahan, [email protected] SOURCE Exer AI

Primary objective of the trial met with statistically significant dose response with up to 43.6% relative reduction (2.1 day improvement) in median time to solid food tolerance versus placebo in hyper-inflamed patients Statistically significant dose response with up to 61.7% reduction in severe organ failure in all patients versus placebo Up to 100% reduction in hospital stays longer than 21 days Planning End-of-Phase 2 meeting with the FDA in preparation for a pivotal trial Conference call to discuss the CARPO topline results scheduled for 8:30 a.m. ET today LA JOLLA, Calif., June 27, 2024 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today announced positive topline data from CARPO, the Company's randomized, double-blind, placebo-controlled Phase 2b trial evaluating Auxora™ for the treatment of acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS). The trial established a dose response for Auxora across multiple endpoints, identified both the target patient population and the likely drug dose for a pivotal trial, and re-affirmed Auxora's safety profile and tolerability as seen in prior clinical trials. "With these results, CARPO has added significantly to the body of evidence showing Auxora's potential as an effective treatment for critically ill patients with acute inflammatory disease and warrants advancing our drug in both AP and acute kidney injury," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "We plan to move quickly towards initiating our Phase 3 trial in AP and are eager to engage with the FDA to discuss our trial plans once we have all the data from CARPO. We look forward to unlocking Auxora's potential to treat these patients who have few treatment options." "There are currently no drugs for the treatment of AP and the CARPO data show a benefit in multiple endpoints, supporting the need for Auxora," said Joseph Miller, M.D., Clinical Associate Professor of Emergency Medicine at Henry Ford Health and Michigan State University and Associate Director Emergency Care Research at Henry Ford Health and a principal investigator in the CARPO trial. "AP is one of the costliest gastrointestinal diseases for hospitals due to prolonged lengths of stay for severe patients. By reducing the occurrence of severe organ failure and extended hospital stays, Auxora may provide significant benefits to patients with AP and to the health care system and should be welcomed by clinicians and hospitals." The CARPO Trial Topline Results: The Phase 2b CARPO trial was an international, randomized, double-blind, placebo-controlled, dose-ranging trial intended to establish Auxora's dose-response and efficacy in AP with accompanying SIRS. The trial reached its target enrollment of 216. Patients were randomized into four groups to receive either high 2.0 mg/kg dose (n=53), medium 1.0 mg/kg dose (n=56) or low 0.5 mg/kg dose (n=52) of Auxora or a matched dose of placebo (n=53) intravenously every 24 hours for a total of three doses. Treatment and observation of patients continued for 30 days. Patients were stratified by baseline hematocrit, a biomarker for inflammation severity, so that efficacy in a pre-specified hyper-inflamed sub-group of patients could be evaluated. These patients represented approximately 43% of the patients enrolled (2.0 mg/kg, n=23; 1.0 mg/kg, n=25; 0.5 mg/kg, n=24; and placebo, n=20). Patients were well-matched for all baseline characteristics with the exception that the placebo group had approximately 12% lower proportion of hyper-inflamed patients than the study overall. Summary of Efficacy Data: CARPO met its study objective by showing a dose response for time to solid food tolerance as well as other clinical endpoints. The primary endpoint of median time to solid food tolerance in the pre-specified subgroup of patients with hyper-inflammatory acute pancreatitis showed a statistically significant dose response with placebo patients requiring 4.7 days to tolerate solid food and patients in the high dose group showing a 1.9 day improvement (41.0% relative risk reduction) when compared to placebo, the medium dose group a 2.1 day improvement (43.6% relative risk reduction) and the low dose group a 1.5 day improvement (31.0% relative risk reduction). In patients without hyper-inflammatory AP, Auxora did not show a measurable benefit due to the patients tolerating solid food relatively quickly in all treatment groups. Additionally, Auxora demonstrated a statistically significant dose response in reduction of severe organ failure which was defined as respiratory failure requiring invasive mechanical ventilation or 48 hours or more of high-flow nasal canula therapy, renal failure requiring renal replacement therapy, or cardiovascular failure requiring the use of vasopressor or inotropic support for greater than 48 hours. Severe organ failure occurred in 3.8% of high dose patients, 3.6% of medium dose patients, 9.6% of low dose patients, and 9.4% of placebo patients, representing a 59.6% relative risk reduction for the high dose patients when compared to placebo and 61.7% risk reduction for the medium dose patients when compared to placebo. The median length of hospital stay was 5.0 days for the placebo group while the high dose group showed a reduction in the length of stay of 1.0 day. The mean length of stay showed a greater benefit: the placebo patients had a mean stay of 7.1 days and both the high dose and medium dose patients had a reduction of 1.2 days. In the patients with hyperinflammatory acute pancreatitis, the reduction was even greater, 1.5 days for the hyper-inflamed high dose patients and 1.9 days for the hyper-inflamed medium dose patients. The proportion of patients who remained in the hospital for longer than 21 days was 0% for high dose patients, 1.8% for medium dose patients, 5.8% for low dose patients, and 5.7% for placebo patients. Comparing the combined placebo and low dose patients to the combined high and medium dose patients, this represents a 84.3% relative risk for a prolonged hospital stay. Summary of Safety Data: Auxora was well-tolerated with 20 treatment-emergent serious adverse events (TESAEs) reported in the placebo group, 14 in the high dose group, 21 in the medium dose group, and 23 in the low dose group. None of the TESAEs in the high and medium dose groups and only 1 in the low dose group were deemed to be drug-related. There were no related TESAEs in the placebo group. Treatment-emergent adverse events (TEAEs) led to drug discontinuation in 3 patients in the placebo group, 2 in the high dose group, 2 in the medium dose group, and 2 in the low dose group. TEAEs led to death in 1 patient in the placebo group and 1 in the medium dose group. There were no deaths in the high dose or low dose group. "Consistent with our prior Phase 2b CARDEA trial in severe and critical COVID pneumonia patients and with our Phase 2a trial in AP patients with SIRS and hypoxemia, CARPO has demonstrated Auxora's potential to treat some of the more severely ill patients with acute inflammatory diseases," said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. "Importantly, we found that Auxora provided patients with clinically meaningful improvements in key outcome measures, while also being well-tolerated. We have identified the target population of patients most likely to benefit from Auxora and determined the likely dose for a pivotal trial. With this information we are more confident in proceeding with a pivotal program in AP. I want to thank the patients who enrolled in the trial as well as the investigators and their study teams for their hard work and contributions to the success of this trial. CARPO has advanced our understanding of AP and brought us closer to a solution for this potentially life-threatening condition for which currently no approved therapy exists." "CARPO has demonstrated that patients with hyper-inflammation benefit most from Auxora. This is encouraging as we initiate KOURAGE where we have established enrollment criteria that select the acute kidney injury patients who are most likely to be suffering from severe inflammation and where reduction of organ failure is a key metric of efficacy," said Lakhmir Chawla, M.D., Clinical Professor of Medicine at University of California San Diego, Chief Medical Officer at ExThera Medical, Scientific Advisor to CalciMedica, and Chair of the KOURAGE Steering Committee. CalciMedica intends to present additional data from CARPO, including results from the analysis of CTs taken at baseline and 30-days post enrollment, at a medical meeting later this year. Conference Call and Webcast Details Stockholders and other interested parties may participate in the call by following the instructions below. A live webcast of the event can also be accessed in the "Upcoming Events" section of CalciMedica's IR website at . A replay of the webcast will be available following the completion of the event. Participant Webcast Link: Participant Dial-in Numbers: 1-800-836-8184 (US) and 1-646-357-8785 (international) About Auxora™ CalciMedica's lead clinical compound, Auxora™, is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels that is being developed for use in patients with acute inflammatory and immunologic illnesses. CRAC channels are found on many cell types, including immune system cells, endothelium cells and pancreatic acinar cells, where aberrant activation of these channels may play a key role in the pathobiology of acute and chronic inflammatory syndromes. Auxora is currently being evaluated in: (i) a Phase 2b trial for acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS), called CARPO, (ii) a Phase 2 trial in acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF), called KOURAGE, and (iii) an investigator-sponsored Phase 1/2 trial, called CRSPA, being conducted in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) as a side effect of pediatric acute lymphoblastic leukemia treatment with asparaginase. There are currently no approved therapies to treat either AP, AKI or AIPT. In previous trials, patients responded well to Auxora regardless of severity or cause of disease. CalciMedica is also exploring the potential of Auxora treatment for other acute indications including acute respiratory distress syndrome. About AP AP, or inflammation of the pancreas, can be a life-threatening condition. Moderate or severe AP sometimes leads to pancreatic cell death or necrosis, systemic inflammation, organ failure and death. There are an estimated 275,000 hospitalizations for AP annually in the United States, of which approximately 40% present with SIRS, a predictor of moderate and severe disease which can compromise the function of other tissues or organs, especially the lungs. Organ failure is responsible for much of the mortality seen in AP. There is currently no approved therapy for AP. Details of the CARPO trial are available on clinicaltrials.gov (NCT04681066). About KOURAGE and AKI KOURAGE is a randomized, double-blind, placebo-controlled study that will evaluate 150 patients with Stage 2 and 3 AKI who have AHRF and are receiving oxygen by non-invasive mechanical ventilation, high flow nasal cannula or intermittent mandatory ventilation (IMV). AKI denotes a sudden reduction in kidney function, the organ's ability to clean and filter the blood. AKI can result as a complication of other serious illnesses such as sepsis, respiratory infections and failure, acute pancreatitis, trauma, surgery and burns. There are approximately 3.7 million patients hospitalized with AKI in the United States each year with approximately 1.1 million advancing to Stage 2 and Stage 3 AKI, over half of whom have associated AHRF. The risk of serious morbidities and mortality is significant for advanced Stage 2 and Stage 3 AKI patients. There are currently no approved therapies for AKI. About CalciMedica CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases. CalciMedica's proprietary technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases for which there are currently no approved therapies. CalciMedica's lead product candidate Auxora™, has demonstrated positive and consistent clinical results in multiple completed efficacy clinical trials. CalciMedica has completed a Phase 2b trial (called CARPO – NCT04681066) in AP with SIRS and a Phase 2b trial (called CARDEA – NCT04345614) in COVID pneumonia patients, continues to support the ongoing Phase 1/2 AIPT study (called CRSPA – NCT04195347), with data expected in 2025, and has initiated its Phase 2 study (called KOURAGE – NCT06374797) in AKI with associated AHRF with data expected in 2025. CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, CA. For more information, please visit . Forward-Looking Statements This communication contains forward-looking statements which include, but are not limited to, statements related to: CalciMedica's business strategy; the potential benefits of Auxora for treatment of AP patients and the healthcare system; the dose response for Auxora across multiple endpoints, the target patient population and the likely drug dose for a pivotal trial; CalciMedica's planned and ongoing clinical trials and the timing, design, expected patient enrollment thereof and the expected timing for the release of data from those trials, including its plans to present additional data from the Phase 2b CARPO trial of Auxora for AP with accompanying SIRS at future medical meeting later this year; plans to move forward rapidly with a pivotal trial of Auxora for AP; plans regarding its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT and its planned Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF; the potential benefits of Auxora for the treatment of AIPT and AKI; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. CalciMedica's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances, including, but not limited to, risks and uncertainties related to: the impact of fluctuations in global financial markets on CalciMedica's business and the actions it may take in response thereto; CalciMedica's ability to execute its plans and strategies; the ability to obtain and maintain regulatory approval for Auxora; results from clinical trials or preclinical studies may not be indicative of results that may be observed in the future; potential safety and other complications from Auxora; the scope, progress and expansion of developing and commercializing Auxora; the size and growth of the market therefor and the rate and degree of market acceptance thereof; economic, business, competitive, and/or regulatory factors affecting the business of CalciMedica generally; CalciMedica's ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" in CalciMedica's Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, and elsewhere in CalciMedica's subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the Securities and Exchange Commission (SEC) from time to time and available at . These documents can be accessed on CalciMedica's web page at ir.calcimedica.com/financials-filings/sec-filings. The forward-looking statements contained herein are made as of the date hereof, and CalciMedica undertakes no obligation to update them after this date, except as required by law. CalciMedica Contact: Investors and Media Argot Partners Sarah Sutton/Kevin Murphy [email protected] (212) 600-1902 SOURCE CalciMedica, Inc.