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20220926Prodeon Medical, Inc., Announces Randomization in the Expander-2 Pivotal Clinical Trial Evaluating the Company’s Investigational Treatment for Lower Urinary Tract Symptoms Associated to Benign Prostatic Hyperplasia

Prodeon Medical, Inc., Announces Randomization in the Expander-2 Pivotal Clinical Trial Evaluating the Company’s Investigational Treatment for Lower Urinary Tract Symptoms Associated to Benign Prostatic Hyperplasia

SUNNYVALE, Calif.Sept. 26, 2022 /PRNewswire/ — Prodeon Medical, Inc., a medical device company developing an investigational outpatient treatment for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) today announced the randomization of the first patient in the EXPANDER-2 pivotal clinical trial (NCT: 05400980, A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross™ Expander System and Retrieval Sheath). The first randomization was performed by Mark Sutton, M.D., F.A.C.S. at Houston Metro Urology in Houston, TX. Dr. Sutton specializes in comprehensive urologic services for men and women including BPH.

BPH is a condition where the prostatic tissue grows over time and obstructs the urethral lumen, leading to LUTS. Sixty percent (60%) of men over the age of 60 and up to 80% of all men overall, will eventually develop BPH with LUTS, representing about 40 million men in the United States who suffer from BPH¹,². Common symptoms associated with BPH include a wide variety of uncomfortable urinary difficulties (e.g., urgency, blockage of urine flow, as well as urinary tract, kidney and bladder problems), depression, and sleepless nights which lead to loss of productivity, which lead to a significant deterioration in the patient’s quality of life. Prescription medications prescribed for BPH are commonly associated with side effects that include, but are not limited to, headaches, dizziness, low blood pressure, and possibly cognitive decline. Traditional surgical treatment options (e.g., TURP) are commonly associated with complications such as bleeding, need for urinary catheterization, incontinence, sexual dysfunction, overnight hospital stay and a longer recovery period¹.

The EXPANDER-2 Trial is a Multi-Center, Randomized, Blinded, Controlled Study to evaluate the safety and efficacy of the Urocross Expander System and Retrieval Sheath for the treatment of LUTS, secondary to BPH. The initiation of the EXPANDER-2 Trial builds on the foundation of the EXPANDER-1 Trial, a first-in-human/feasibility clinical trial (NCT:03758222) that provided promising early safety and effectiveness data during the indwell period and after the retrieval of the Urocross Expander. The interim results of the EXPANDER-1 trial were recently published in the Journal of Prostate Cancer and Prostate Diseases [The EXPANDER-1 trial: introduction of the novel Urocross™ Expander System for treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)].

The investigational Urocross Implant (deployed using the Urocross Delivery System), is designed to be placed in a patient’s obstructed prostatic urethra using a standard flexible cystoscope and, after a period of six months, the Urocross Implant is removed. Within the Expander-2 Trial, the Urocross Expander System and Retrieval Sheath will be used in a newly developed procedure called PURE™ (Prostatic Urethral REshaping) to relieve symptoms associated with BPH. The PURE procedure is a patient-friendly approach that allows for the use of flexible cystoscopy and minimal anesthesia requirement in a variety of settings.

“The PURE procedure using the investigational Urocross Expander System and Retrieval Sheath is an elegant, tissue sparing approach for treating BPH that does not surgically cut, resect, burn, ablate, lase, or leave anything behind in the prostate as seen with other BPH technologies currently offered or in development,” said Dr. Kevin McVary, Professor, Stritch School of Medicine, Loyola University and a Co-Principal Investigator of the EXPANDER-2 pivotal trial “. I am excited to help bring this technology to my patients in the future.”

“The Urocross Expander System and PURE procedure represent a, minimally invasive method of treating BPH symptoms that should help open the door for more men to seek treatment,” said Co-Principal Investigator, Dr. Dan Rukstalis, Vice Chair of Research for the Department of Surgery, Founding Member of the Section of Urology at the Virginia Tech Carilion School of Medicine. “I am encouraged by the promising results collected from the Expander-1 feasibility study, and the EXPANDER-2 Trial is an opportunity to seek further evidence that the Urocross system is a safe and effective treatment option for patients suffering from BPH.”

“We are excited to begin the EXPANDER-2 Clinical study which was designed in close collaboration with our Scientific Advisory Board (including our Co-Principal Investigators) and with critical inputs from the US FDA” said Paul Edwards, President and CEO of Prodeon Medical, Inc. “The Prodeon Medical Team is committed to conducting this study with the highest level of quality and compliance to gather the required clinical evidence to support this minimally invasive therapy to treat men experiencing symptoms due to an enlarged prostate.”

About Prodeon Medical, Inc.

The Prodeon Medical, Inc. initiative was started in 2016 with the mission of reimagining how men can be more easily treated for one of the most common disease states in the world affecting men, an enlarged prostate leading to Benign Prostatic Hyperplasia (BPH). Prodeon Medical, Inc. has developed and is investigating a minimally invasive and patient-friendly approach to treating LUTS secondary to BPH known as the PURE (Prostatic Urethral REshaping) procedure using the Urocross Expander System and Retrieval Sheath. The Urocross Expander System and Urocross Retrieval Sheath are investigational devices and are not for sale in the US or outside the US.

Learn more at www.prodeonmedical.com

Media contact:
Paul Edwards
669.467.1100

Source Information
  1. Management of Benign Prostatic Hyperplasia / Lower Urinary Tract Symptoms: AUA Guideline 2021.
  2. Campbell Walsh Wein Urology, 12th Edition; Prodeon data on file.

SOURCE Prodeon Medical

20220103MediBalloon Expands Operations and Establishes Mass Production Capabilities in Taiwan’s Medeologix

MediBalloon Expands Operations and Establishes Mass Production Capabilities in Taiwan’s Medeologix

MediBalloon Expands Operations and Establishes Mass Production Capabilities in Taiwan’s Medeologix
HAYWARD, California, January 3, 2022 – MediBalloon, Inc., a specialty medical balloon design and manufacturing company, today announced the partnership with Medeon Biodesign, Inc. (TPEX: 6499), a Taiwan publicly traded medical device company with operations in Taipei, Taiwan and Sunnyvale, California, to expand the US operations and footprint in Asia. The new manufacturing organization established in Taiwan will be called Medeologix and will be in full operation in 2022 to not only serve the global market, but also provide customers the one-stop-shop service from prototyping to mass production of medical devices.

MediBalloon, with over 25 years of medical device industry experience, is specialized in specialty medical balloons across a wide range of clinical applications including cardiovascular, neurovascular, structural heart, peripheral, general surgery and urology. The team is experienced in handling advanced materials to design medical balloons with a spectrum of compliance, size, shape, complexity and composite construction. MediBalloon provides the most comprehensive services in the industry for this critical component from design and development, assembly process, coating, to manufacturing and mass production of specialty medical balloons.

Mr. Anant Hegde, the founder and CTO of MediBalloon, and board member of Medeologix stated, “Our goal has been to provide our customers the ultimate solution when developing medical balloon products. We provide short turnaround time during the design and development phase, and now we will be equipped with a state-of-the-art facility and multiple production lines, which significantly boosts our capacity to meet the growing demand of mass production for our global customers. The partnership between MediBalloon and Medeon Biodesign benefits from the efficiency and manufacturing capabilities of Taiwan, with a highly educated and talented workforce, which will allow us to extend the top-notch medical balloon development know-how to mass production.”

“We are very excited to partner with MediBalloon to establish the most premier medical balloon manufacturing organization. We envision the partnership to provide cutting-edge, high quality medical products to the globe, with more efficient and effective operations.” said Dr. Yue-Teh Jang, Chairman and CEO of Medeon Biodesign.

About MediBalloon
MediBalloon is a privately held company based in Hayward, California. The company specialized in developing medical balloons across a wide range of clinical applications using Silicone, Polyurethane, Polyethylene, Polyvinylidene fluoride (PVDF), Polybutylene terephthalate (PBT), Polyethylene terephthalate (PET), PEBAX, Nylons and other thermoplastic elastomers (TPEs), etc. For more information, please visit www.mediballoon.com.

About Medeon Biodesign
Medeon Biodesign (TPEX: 6499) is a publicly traded company listed on Taipei Exchange, headquartered in Taipei, Taiwan with operation in Sunnyvale, California. The company focuses on the development of medical devices and supplying key injection molded components to the medical device industry through its Delta Asia subsidiary. For more information, please visit www.medeonbio.com/en.