Lower Urinary Tract Symptoms

Inclusion on Group Purchasing Organization Contracts Can Offer Greater Patient Access CENTER VALLEY, Pa., March 28, 2024 /PRNewswire/ -- Olympus, a leading global medtech company providing innovative solutions for medical and surgical procedures, announced today a milestone for its iTind™ device with its availability and greater patient access through the largest healthcare group purchasing organization (GPO) contracts in the United States. The iTind procedure is a minimally invasive procedure for the treatment of benign prostatic hyperplasia (BPH) or enlarged prostate. The iTind device is now available on 13 GPO contracts in the U.S. Continue Reading The iTind procedure, now available on 13 GPO contracts in the U.S., is a minimally invasive procedure for the treatment of benign prostatic hyperplasia (BPH) or enlarged prostate. GPOs exist to help healthcare providers, such as hospitals, ambulatory surgical centers and nursing homes, save money by aggregating their purchasing power and standardizing and streamlining purchasing. The Healthcare Supply Chain Association estimates nearly all hospitals and a majority of non-acute care centers in America belong to at least one GPO.1 "The availability of the iTind device through major GPO contracts marks an important milestone for Olympus," said Jay Sullivan, Group Vice President, Enterprise Solutions, Medical Systems Group, Olympus. "Most importantly, it means greater physician and patient access to a minimally invasive treatment option for a common urological condition that does not require medications, permanent implants or the removal of tissue." BPH is a common health problem for men over 50 as the risk increases with age. Symptoms of BPH include frequent urination with a sense of urgency and a weak urinary stream and excessive urination at night.2 About the iTind procedure Evidence shows the iTind procedure is an effective alternative to pharmaceutical therapy, as well as an alternative to surgeries and permanent implants, and is proven to relieve symptoms without affecting sexual and ejaculatory function3,4 or urinary continence.5 The iTind procedure involves the placement of a temporarily implanted nitinol device that reshapes the prostatic urethra without burning or cutting out the prostate. The device can be placed in an outpatient setting or physician office. It remains in place for five to seven days while the patient is at home. Upon removal, patients experience rapid and effective relief of their symptoms.3,4 Recently published data show that the iTind™ procedure provides long-lasting relief of more than four years. The long-term study data demonstrates that the iTind procedure leads to significant and durable reduction of BPH-related LUTS (lower urinary tract symptoms) and improved IPSS (International Prostate Symptom Score) and QoL (Quality of Life) for over 50 months and up to 79 months (6.6 years) following treatment.6 AUA Guidelines The iTind procedure has also been included in the American Urological Association (AUA) clinical practice guideline for management of LUTS attributed to BPH. The iTind procedure is reflected in the new procedure category, Temporary Implanted Prostatic Devices (TIPD).7 The addition of the TIPD category is based on expert opinion reflecting peer-reviewed treatment recommendations and research updates. The iTind procedure may not be for everyone. Please consult with a doctor to see if the iTind procedure is right for you. As with any medical procedure, implantation of the iTind device comes with the possibility of side effects, including pelvic discomfort, blood in urine, and/or painful or urgent urination. In rare cases, the iTind device may cause urinary tract infection or a sudden difficulty to urinate. More information about the iTind procedure is available at BPHTherapy.com/iTind. About Olympus At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 4,500 employees throughout locations in North and South America. For more information, visit olympusamerica.com. 1 Healthcare Supply Chain Association, supplyassociation.org, Frequently Asked Questions 2 Urology Care Foundation, urologyhealth.org, "Urology A-Z: Benign Prostatic Hyperplasia (BPH)." Updated September 2023 3 Elterman, D; Alshak, M; Martinez Diaz, S; et al. "An Evaluation of Sexual Function in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men Treated with the Temporarily Implanted Nitinol Device." Journal of Endourology, pub. December 2022 4 Chughtai, B; Elterman, D; Shore, N; et al. "The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial." Journal of Urology, pub. July 2021 5 De Nunzio C, Cantiello F, Fiori C, et al. Urinary and sexual function after treatment with temporary implantable nitinol device (iTind) in men with LUTS: 6-month interim results of the MT-06-study. World J Urol. 2021 6 Amparore, D; De Cillis, S; Schulman, C; Kadner, G; Fiori, C; Porpiglia, F. "Temporary implantable nitinol device for benign prostatic hyperplasia-related lower urinary tract symptoms: over 48-month results." [published online ahead of print, 2023 Jun 23] 7 Sandhu, JS; Bixler, BR; Dahm, P; et al. « Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH): AUA Guideline amendment 2023." Journal of Urology 2023 SOURCE Olympus Corporation of the Americas

DUBLIN, March 20, 2024 /PRNewswire/ -- ProVerum Limited, an Irish medical device company developing a minimally invasive solution to treat benign prostatic hyperplasia (BPH) in the doctor's office, today announced completion of enrollment of the ProVIDE pivotal clinical trial to evaluate the safety and effectiveness of the ProVee System, a 'stent-like' expander designed to gently 'open-up' the obstructed urethra and alleviate the symptoms caused by BPH. Steve Kaplan, M.D., Professor of Urology at the Icahn School of Medicine at Mount Sinai in New York is the Global Lead Investigator for the ProVIDE study. "The ProVee System has the potential to be a first-line interventional therapy (FIT) for BPH that can be safely and reliably performed in the office setting" said Dr. Kaplan. "This large international, multi-center clinical study, which is now fully enrolled, thoroughly evaluates the safety, efficacy and long-term durability of the ProVee device and I look forward to presenting the data." ProVerum Announces First Enrollment in the ProVIDE II: Bridging Study The company also announced the commencement of the ProVIDE II: Bridging Study to evaluate the performance of its new low profile flexible, steerable delivery system for deploying the ProVee expander. This second-generation delivery system is the same diameter as a diagnostic cystoscope and ideally suited to an office or out-patient setting. Given its flexible and steerable nature, it also facilitates patients to lay flat during the procedure rather than having to have their legs in stirrups, which some men find uncomfortable. There is no change to the ProVee expander. The first procedure was successfully performed by Brian Mazzarella, M.D., Principle Investigator at Urology Austin, Texas. According to Dr Mazzarella, "The new delivery system is straightforward to use and works similarly to a flexible cystoscope that all urologists use routinely in the office setting." He continued, "I see many dissatisfied patients whose BPH symptoms are not resolved by medication yet they are unwilling to undergo more invasive surgical procedures. The atraumatic nature of ProVee may make it an option that patients would actually choose to have and thus improve their lives and avoid further bladder damage." About the ProVIDE Study The ProVIDE clinical trial is a prospective, multi-center, double-blind controlled study to evaluate the safety, performance, and effectiveness of the ProVee System in patients with lower urinary tract symptoms secondary to BPH. 221 subjects have been enrolled across 15 investigational sites in the US and 2 international sites. About the ProVIDE II: Bridging Study The ProVIDE II: Bridging Study is a prospective, multi-center, open-label, non-randomized bridging study to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with lower urinary tract symptoms secondary to BPH. Up to 50 subjects will be enrolled across 7 investigational sites in the US and 1 international site. About ProVerum Ltd ProVerum Ltd. is an innovative Dublin based SME focused on the development of novel minimally invasive technologies to treat BPH. The ProVee System is an investigational device and is not approved for commercial sale. For more information, please visit SOURCE ProVerum

Grant awards to fund novel clinical projects and scientific tools aimed at improving quality of life for individuals impacted by spinal cord injury SHORT HILLS, N.J., March 6, 2024 /PRNewswire/ -- The Christopher & Dana Reeve Foundation, a leading nonprofit organization dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis, announced today three new spinal cord injury (SCI) research grants totaling $3.1 million. The grants support clinical trials and research tools aimed at accelerating the therapeutic development of SCI treatments. Two grants have been awarded to .NeuroRestore, a research, innovation and treatment center that develops and applies bioengineering strategies involving neurosurgical interventions to restore neurological functions. PsychoGenics, a CNS-focused contract research organization that designs and executes preclinical drug discovery and early development programs, received the third grant. Together, the grants will fund projects designed to help catalyze and energize the field of SCI science by channeling resources for a robust clinical pipeline to rapidly increase the number of potential treatments, as well as drive progress and investment in spinal cord injury research by addressing the barriers that limit ambitious engagement. The projects include clinical trials focused on: bladder dysfunction – a major quality-of-life issue for the SCI community; and a trial to advance novel brain-spine interface (BSI) technology, which has been shown to enable thought to control movement. Finally, a preclinical study will focus on innovative techniques and technologies to provide standardized lab research resources that do not currently exist. Specifically: Brain-Spine Interface to Reverse Upper Limb Paralysis: .NeuroRestore will also receive $1.1 million over two years to support its Brain-Spinal Interface (BSI) technology to determine if thoughts, via cortical brain implants, can control not just lower extremity movement (which has been demonstrated in prior research), but also arm and hand function for those with cervical injuries. This technology is being developed by ONWARD® Medical, a medical technology company creating therapies to restore movement, function, and independence in people with SCI and movement disabilities. It is the only company currently advancing both brain-computer interface (BCI) and spinal cord stimulation technology together – a "digital bridge" connecting brain signals with movement. In late February, ONWARD Medical was awarded its 10th Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) for its ARC-BCI™ System, which uses brain-BCI technology in conjunction with the company's ARC-IM® Therapy to restore thought-driven lower limb mobility after spinal cord injury (SCI). Neuroprosthetic System to Manager Lower Urinary Tract Dysfunction After Spinal Cord Injury: With a $1.5 million grant, .NeuroRestore will apply epidural stimulation implants to participants with chronic incomplete spinal cord injuries to examine if the technology can be used to assist in the functionality and control of the bladder. This proof-of-concept, safety, and feasibility study over two years will determine if epidural stimulation, which has seen success in movement and blood pressure, can be used for voiding and storage of the bladder. This early-stage study will utilize ONWARD Medical's targeted ARC Therapy stimulation, which the company is actively developing with .NeuroRestore. Standardized Testing Research InVivo Endeavor (STRIVE): A preclinical grant for $522,000 is awarded to PsychoGenics to develop an in-house standardized model for testing potential therapeutics. This project will help accelerate therapeutic development by providing a validated tool to the SCI research community. The Reeve Foundation is dedicated to developing real-world treatments for people living with spinal cord injury (SCI) and paralysis. Decade by decade, the Reeve Foundation has worked to change what was deemed possible, collaborating with equally determined scientists and labs to map a path toward progress and build a vibrant research field that delivers real improvements for people living with paralysis. Today, as 21st-century technology and cumulative scientific gains converge, we are on the cusp of a new era in spinal cord injury research. "These grants represent a fresh approach to spurring the SCI scientific arena forward through our support of high-risk-high-reward endeavors that address unmet needs of individuals living with spinal cord injury," said Marco Baptista, Ph.D., Chief Scientific Officer of the Reeve Foundation. "It is our goal to facilitate rapid scientific advancement, and these grants are an important step in ensuring that the most promising science of the day is primed for accelerated success." About the Reeve Foundation The Christopher & Dana Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis. Additionally, through a cooperative agreement with the Administration for Community Living, the Reeve Foundation's National Paralysis Resource Center (NPRC) promotes the health, well-being, and independence of people living with paralysis, providing comprehensive information, resources, and referral services assisting over 125,000 individuals and families since its launch in 2002. The Reeve Foundation is committed to elevating our community's voices and needs to achieve greater representation and independence. We meet all 20 of the Better Business Bureau's standards for charity accountability and hold the BBB's Charity Seal. For more information, please visit ChristopherReeve.org or call 800-225-0292. SOURCE Christopher & Dana Reeve Foundation