VA Medical Center

WEST PALM BEACH, FL, Oct. 22, 2024 (GLOBE NEWSWIRE) -- QHSLab, Inc. (the "Company") (OTCQB: USAQ), a leader in digital health and point-of-care technologies designed to empower clinicians with proactive, value-based healthcare solutions, is pleased to announce the addition of Dr. Juan D. Oms, a board-certified psychiatrist with extensive expertise in behavioral health and substance use disorders, as a medical advisor. Dr. Oms will provide strategic guidance in integrating advanced digital healthcare solutions to support the mental health and substance misuse and/or abuse needs of patients in primary care settings. Dr. Oms completed his medical degree at the Autonomous University of Guadalajara in Jalisco, Mexico, followed by residency training in Psychiatry at Jackson Memorial Hospital in Miami, in association with the University of Miami and the VA Medical Center. He is a Diplomate of the American Board of Psychiatry and Neurology and completed a fellowship in Forensic Psychiatry and a Fellow of the American Psychiatric Association. Over the course of his career, Dr. Oms has developed specialized interests in substance use disorders, serving as Medical Director at several facilities, including Miami Outpatient Detox, where he led the integration of comprehensive outpatient substance use treatment services. Dr. Oms has also made significant contributions to academic psychiatry, serving as Chairman and Program Director of the Psychiatry Residency Southern Winds Hospital. In addition, he has held various academic appointments as Assistant Clinical Professor at FIU College of Medicine, Saint George University, Ross University School of Medicine, and American University of the Antilles. His commitment to education and innovative patient care continues as he serves in various leadership roles, including Director of Psychiatry at Ketamine Health Centers, where he pioneered treatments for resistant depression and contributed to clinical research. Since joining Jackson Behavioral Health in 2020, Dr. Oms has played a key role in developing a co-occurring substance use and mental health inpatient unit and streamlining tele-psychiatric consult services across the Jackson Memorial Hospital System. His expertise in blending traditional and innovative treatment methods aligns with QHSLab’s mission to empower physicians through digital health solutions that improve patient outcomes and enhance practice efficiency. "We are excited to have Dr. Oms join QHSLab as we expand our offerings in mental health and behavioral health solutions," said Troy Grogan, President and CEO of QHSLab. "His extensive experience and leadership in psychiatry and substance use disorders will greatly benefit our mission to integrate advanced, AI-driven healthcare solutions into primary care settings." Since joining QHSLab, Dr. Oms has actively contributed to projects evaluating digital therapeutic interventions for mental health and chronic pain. These include longitudinal studies assessing the impact of QHSLab’s platform on reducing depression (PHQ-9) and anxiety (GAD-7) scores in primary care patients. Early findings from these studies show significant reductions in depression and anxiety symptoms, particularly in patients with severe depression, highlighting the potential for digital health tools to provide accessible, non-pharmacological treatment options. Dr. Oms has also been integral to the success of the Painless series—a digital health initiative designed to help patients manage chronic pain through cognitive-behavioral strategies and health journeys. These efforts align with QHSLab’s broader goal to integrate mental health solutions into primary care practices, offering both lifestyle modifications and mental health support for patients with comorbid conditions. The research mentioned above is part of two scientific abstracts submitted to the American Psychiatric Association Annual Meeting. "Dr. Oms's expertise, background in academia, and dedication to both mental health and digital innovation bring a wealth of knowledge to QHSLab,” said Marcos A. Sanchez-Gonzalez, MD, PhD,. VP of Medical & Scientific Affairs at QHSLab. “We are thrilled to have him on board as he actively contributes to advancing our digital health initiatives. His work will play a pivotal role in expanding our capabilities in behavioral health and chronic care management, ultimately improving patient outcomes in primary care settings and beyond." QHSLab, Inc. continues to push the boundaries of digital healthcare, and Dr. Oms’s insights will help accelerate the company’s growth in behavioral health services, allowing primary care physicians to better assess, monitor, and manage mental health conditions in the patients they serve. For more information about QHSLab and its digital health solutions, please visit qhslab.com/research. About QHSLab, Inc. QHSLab, Inc. (OTCQB: USAQ) is a medical device company providing digital healthcare solutions and point-of-care-diagnostic tests to primary care physicians. Digital healthcare allows doctors to assess patient responses quickly and effectively using advanced artificial intelligence algorithms. Digital healthcare can also remotely monitor patients’ vital signs and evaluate the effects of prescribed medicines and treatments on patients’ health through real-time data transferred from patient to doctor. QHSLab, Inc. also markets and sells point-of-care, rapid-response diagnostic tests used in the primary care practice. QHSLab, Inc.’s products and services are designed to help physicians improve patient monitoring and medical care while also improving their revenues. Forward-Looking Statements Certain matters discussed in this press release are ‘forward-looking statements’ intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. In particular, the Company’s statements regarding trends in the marketplace, future revenues, future products, and potential future results and acquisitions are examples of such forward-looking statements. Forward-looking statements are generally identified by words such as ‘may,’ ‘could,’ ‘believes,’ ‘estimates,’ ‘targets,’ ‘expects,’ or ‘intends,’ and other similar words that express risks and uncertainties. These statements are subject to numerous risks and uncertainties, including, but not limited to, the timing of the introduction of new products, the inherent discrepancy in actual results from estimates, projections, and forecasts made by management, regulatory delays, changes in government funding and budgets, and other factors, including general economic conditions, not within the Company’s control. The factors discussed herein and expressed from time to time in the Company’s filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release. The Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investor Relations Contact: Olivia GiamancoQHSLab, Inc.(929) 379-6503ir@usaqcorp.comhttps://twitter.com/QHSLabInc

First cohort of REGALS (T Regulatory Cells for ALS) has been completed. Ongoing Phase 1/1b study evaluating safety and efficacy of CK0803 (Neurotrophic T regulatory cells). HOUSTON, Jan. 19, 2024 /PRNewswire/ -- Michael E. DeBakey VA Medical Center announces opening of a new clinical trial using CK0803- off-the-shelf, allogeneic T regulatory cells that have been modified to target neuroinflammation to treat the fatal neurodegenerative disease – Amyotrophic Lateral Sclerosis (ALS). Continue Reading ALS Clinical Coordinator Richel Aliboso, NP, Principal Investigator Dr. James Orengo and Study Coordinator Michelle Espiritu are thrilled to enroll Houston VA Veterans into this groundbreaking clinical trial. "We are very excited to open this first-in-class, best-in-class, cell therapy aimed to resolve neuroinflammation which fuels the ALS disease process. We believe that this novel approach of calming the inflamed microglia in the brain and spinal cord holds the promise for halting this relentlessly progressing disease", said Dr. James Orengo, principal investigator at the Michael E. DeBakey VA Medical Center and Assistant Professor of Neurology at Baylor College of Medicine. "Specifically, we are thrilled that our veterans will get the opportunity to receive such a cutting edge therapeutic that could be life altering. The incidence of ALS is elevated in Veterans and novel therapies are desperately needed. We are proud to be the first and only VA hospital in the nation to be part of this multi-center study". Please click here for the VA announcement. ALS is a rare, rapidly progressing and fatal neurodegenerative disorder that affects approximately 55,000 people globally. People with ALS experience muscle weakness, loss of movement, and difficulty breathing and swallowing, resulting in a severely declining quality of life and eventually death. The incidence of ALS has been rising in the veteran population and is a large unmet need. More than 16% of patients with ALS are veterans1. There are many health issues that veterans are at increased risk of, including ALS2. Veterans are twice as likely to be diagnosed with ALS than people who haven't served in the military3. "There is an urgent need for novel treatments for all forms of ALS, a devastating disease that affects far too many patients and their families. We made a conscious decision to make this novel cell therapy available to the veterans and remain committed to provide our continued support to those who have served our country," said Tara Sadeghi, Cellenkos' chief operating officer. "Leveraging our experience in consistently developing and manufacturing, robust, T regulatory cell therapies that are targeted towards disease specific mechanism of action and our intimate connection to the ALS patient community, Cellenkos made the decision to advance CK0803 to the clinic and, ultimately, to the market because we believe we are uniquely positioned to make it available to patients living with ALS." The first cohort of phase 1/ 1b CK0803 trial has been completed and is currently open for enrollment at Columbia University, New York, NY, led by PI, Dr Neil Shneider, M.D., Ph.D., director of Columbia University's Eleanor and Lou Gehrig ALS Center. About Amyotrophic Lateral Sclerosis (ALS) According to the National Institute of Neurological Disorders and Stroke, amyotrophic lateral sclerosis (ALS) is a group of rare neurological diseases that mainly involve the nerve cells (neurons) responsible for controlling voluntary muscle movement. In ALS, both the upper motor neurons and the lower motor neurons degenerate or die and stop sending messages to the muscles. Unable to function, the muscles gradually weaken and waste away (atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. The disease is progressive, meaning the symptoms get worse over time. The majority of ALS cases (90 percent or more) are considered sporadic. This means the disease seems to occur at random with no clearly associated risk factors and no family history of the disease. In a small (approximately 10%) of cases, ALS is caused by a mutation in a known ALS-associated gene. Most people with ALS eventually die from respiratory failure, usually within 3 to 5 years from when the symptoms first appear. However, about 10 percent of people with ALS survive for 10 or more years. Currently, there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease. About CK0803 CK0803 is a novel allogenic cell therapy product consisting of T regulatory cells, with a high cell surface expression of CD11a, that leverage CXCR3/CXCL10 axis. CK0803 is derived from clinical-grade umbilical cord blood units and manufactured using Cellenkos' proprietary CRANE® process. There is no requirement for HLA or ABO matching of CK0803 to the recipient. Multiple doses of CK0803 can be manufactured from a single umbilical cord blood unit, where the final cryopreserved product is readily available for use, at the point of care, which makes it an ideal therapy that can be infused intravenously, in the outpatient setting. About Cellenkos®, Inc. Cellenkos is a clinical-stage biotechnology company located in Houston, Texas, USA, dedicated to the development and commercialization of the allogeneic, "off-the-shelf" cell-based products for the treatment of rare inflammatory diseases and autoimmune disorders. Cellenkos' T regulatory cells (Tregs) are derived from umbilical cord blood and as such are naïve, bonafide suppressor cells that do not require HLA or ABO matching and resolve inflammation through multiple direct and indirect mechanisms. Cellenkos' proprietary CRANE® process allows for tailoring of Tregs to become disease specific. Cellenkos' current clinical portfolio includes CK0801 (bone marrow failure); CK0802 (COVID ARDS); CK0803 (ALS) and CK0804 (myelofibrosis). For more information, please visit . Contact: Stacy Minor [email protected]. SOURCE Cellenkos, Inc.

Z-pods significantly improved outcomes in mouse model of cutaneous lupus GREENVILLE, SC, Sept. 27, 2023 (GLOBE NEWSWIRE) -- The Z-pod® topical delivery platform was used in various in vivo studies that were highlighted in a peer-reviewed paper just published online by Experimental Dermatology titled, “Nano-encapsulated anandamide (AEA) reduces inflammatory cytokines in vitro and lesion severity in a murine model of cutaneous lupus erythematosus [CLE].” In these studies, AEA—a primary endocannabinoid that has been demonstrated to have anti-inflammatory and immunomodulatory effects—was loaded into Zylö’s proprietary Z-pod drug-delivery system and used as follows: (i) in an in vivo skin-penetration study in mice that showed dramatic improvements—at the 1-hour, 8-hour, and 24-hour timepoints—with regard to: (a) AEA penetration into the dermis and (b) persistence of AEA in the follicle base (ii) in a prophylactic CLE study conducted at Albert Einstein College of Medicine (AECOM) that demonstrated significantly reduced lupus-lesion severity and significantly decreased presence of inflammatory markers as compared to the no-treatment group and a control group of unloaded Z-pods (iii) in an interventional study conducted by Jackson Laboratory, an independent contract research organization, that demonstrated significantly reduced lupus-lesion severity as compared to the no-treatment group (p<0.0001) and to the AEA without Z-pods (p<0.01); the study also demonstrated significant improvement in tissue histology scores (p<0.05 and p<0.01, respectively). Zylö’s head of product development, Andrew Draganski PhD, was an author of the paper, prepared all the Z-pod test preparations, and helped in the design of some of the studies. His colleagues at George Washington University (GWU) and AECOM wrote the paper, designed the studies, and performed some of the studies. Included in the list of authors were Joel Friedman MD PhD, professor at AECOM, and Adam Friedman MD, professor and chair of dermatology at GWU, both of whom are scientific co-founders of Zylö and continue on Zylö’s Scientific Advisory Board. In addition, Victoria Werth MD, professor at U. of Pennsylvania and chief of dermatology at VA Medical Center in Philadelphia, was acknowledged for her interpretation of the results and the significance to human CLE. Dr. Werth is one of the world’s foremost authorities on cutaneous lupus. Approximately 500,000 people in the U.S. suffer from cutaneous lupus erythematosus (CLE), with a significant impact on quality of life. Unfortunately, there is no cure and the treatment options are severely limited. Dr. A. Friedman stated, “Cutaneous lupus is a burdensome, deforming, sun-sensitive, chronic inflammatory skin condition, one that can be independent of—or in conjunction with—systemic lupus and one that has an incredible impact on quality of life. Yet, there are no FDA-approved treatments for cutaneous lupus. The Z-pod platform technology is unique in that it sustainably delivers a nonsteroidal anti-inflammatory agent that has a proven impact on disease underpinnings and on biological activity, which translates into impressive clinical outcomes in an animal model. Moreover, the technology enables the use of a novel active ingredient that otherwise would not be an effective tool in managing this disease. Patients suffering from cutaneous lupus need effective and safe treatment options to be made available for the first time.” Zylö was recently awarded a two-year $294,000 Small Business Technology Transfer Research (STTR) grant to advance this AEA-Z-pod program. The principal investigator of the grant-work is Zylö’s A. Draganski, and the primary collaborator is Dr. Werth. About Zylö Therapeutics: Zylö is commercializing the ‘Powered by Z-pod®’ technology platform, a disruptive topical delivery system that extends duration of effect, improves targeting, and enhances product performance of many therapeutic and cosmetic agents. Notably, the Z-pod technology can also be adapted to provide sustained topical delivery of nitric oxide for multiple therapeutic indications. For more details, please visit our website, www.zylotherapeutics.com, and follow us on Twitter (@ZyloTherapies). For questions, please contact: Scott R. PancoastCEO + Founderspancoast@zylotherapeutics.com858-775-6710