Medifocus, Inc. Announces Successful Completion of FDA Post Approval Study (PAS) for the Prolieve® Thermodilatation™ System
Prolieve® is the only Transurethral Thermodilatation™ Therapy for BPH approved by the FDA
COLUMBIA, MD and Toronto, ON- June 5, 2018 – Medifocus, Inc. (OTCQX:MDFZF and TSXV:MFS.V) (“Medifocus” or the “Company”), a biotechnology company with a portfolio of medical products encompassing thermotherapy systems for the treatment of Benign Prostatic Hyperplasia (BPH) and Breast Cancer, is pleased to announce that the United States Food and Drug Administration (FDA) has completed the review of the company’s rigorous FDA mandated Post Approval Study (PAS). The 5-year follow-up study has satisfactorily fulfilled the PAS requirements. The PAS was conducted on a cohort of 225 symptomatic BPH patients treated with the Company’s Prolieve® Thermodilatation™ System. The 12-year PAS with 5-year follow-up data confirms long-term safety, efficacy and durability with improved lower urinary tract symptoms, urinary flow rate, quality of life, and minimal sexual side effects when compared to an untreated age-matched male population.
Employing a patented 46 Fr. dilating balloon that enhances the efficiency of thermotherapy via a small microwave antenna embedded within a disposable 18 Fr. treatment catheter, Prolieve® Transurethral Thermodilatation™ (TUTD™) is the only FDA-approved Thermodilatation device on the market for treating BPH. Prolieve® TUTD™ is a fast in-office procedure performed under local anesthesia, with more than 100,000 cases thus far successfully performed in the U.S. since the initial FDA approval for the device. Nearly 90% of all treated patients do not require a post treatment urinary catheter, in contrast to the vast majority of patients treated with other minimally-invasive BPH therapies. Thus, in addition to providing immediate symptomatic relief for BPH patients, Prolieve® has demonstrated long-term durable clinical benefits in the completed study accepted by the FDA.
Dr. William Jow, President and CEO of Medifocus stated, “The successful completion of this PAS is a significant milestone and achievement for Medifocus. As a practicing urologist, I am glad that the PAS has demonstrated both excellent short-term and long-term clinical benefits. I am even more excited that the study has demonstrated stabilization of serum Prostate-Specific Antigen (PSA) level and prostate size during the 5-year follow-up period. These findings clearly indicate that Prolieve® TUTD™ has proven itself as a safe and effective clinical tool to provide relief of BPH symptoms, improve quality of life and stabilize PSA and prostate size.” He continued, “More importantly, stabilization of serum PSA translates into fewer unnecessary prostate biopsies and helps to allay the anxiety of the aging male who may otherwise undergo repeated prostate biopsies due to rising PSA which often results from natural BPH progression.”
Dr. Jow commented, “Such clinical outcome contributing to the prevention of BPH progression and minimizing the need for prostate biopsies may have enormous impacts from a public health perspective. The clinical findings from the PAS were made public at the recent American Urological Association Annual Meeting in San Francisco and will be formally presented by me at the upcoming International Microwave Symposium to be held in Philadelphia on June 14th.”
“The official completion of the PAS will allow us to devote more financial resources and manpower to explore other clinical applications of Prolieve® TUTD™ including Focal Therapy for Prostate Cancer.” Dr. Jow added, “Now with the PAS behind us and strong clinical data, we are poised to expand our Prolieve® markets both domestically and internationally.”
About The Prolieve® Thermodilatation™ System
The Prolieve® Thermodilatation™ System offers potential relief to the millions of men who suffer from Benign Prostatic Hyperplasia (BPH), a condition that becomes common as men age. Half of men over 50 have some enlargement of the prostate gland, and this rises to 90% among those over 70. As the prostate enlarges, it constricts the urethra, thereby restricting the passage of urine. Persistent restriction and further progression of BPH, if left untreated, often results in worsening of lower urinary tract symptoms (LUTS). Further complications of this process may result in urinary retention, bladder stones and infection, as well as compromised bladder and kidney function.
The Prolieve® System is a novel focused heat therapy which utilizes a unique combination of focused heat energy directed at the prostate in combination with a patented, cooled and pressurized dilatation balloon to achieve immediate and long-term relief of BPH symptoms with very minimal treatment related side effects after a brief in-office procedure performed under local anesthesia. The unique advantage of this combined “heat plus compression” therapy is twofold: first, the heat denatures local tissue proteins of the (balloon) dilated urethra, resulting in an expanded and stiffened urethral lumen functioning as a biological stent. Second, the compression reduces local blood flow thus increasing the thermal efficiency of the microwave energy to achieve apoptosis in the targeted prostate gland.
About Medifocus, Inc.:
Medifocus, Inc. (TSXV-MFS, OTC-MDFZF) Medifocus, Inc. (TSXV-MFS, OTC-MDFZF) is a Biotechnology Company with a portfolio of medical technologies that utilize patented Focal Thermal Technology to treat conditions ranging from Prostate Diseases to Breast Cancer. Its Prolieve® Thermodilatation™ System offers symptomatic relief to men with Benign Prostatic Hyperplasia (BPH) through a simple, fast, in-office treatment. Prolieve® is both FDA and Medicare approved for treating symptomatic BPH with over 100,000 cases performed in the U.S. alone, and with proven long-term safety, efficacy and durability. Its APA 1000 Breast Cancer Treatment System was licensed from Massachusetts Institute of Technology and developed by the Medifocus team. The Targeted Focal Thermotherapy has been demonstrated in Phase 2 clinical trials to offer significantly better tumor shrinkage in patients treated with the combined Chemothermal therapy compared those treated with Chemotherapy alone. APA 1000 was also shown to be effective in reducing margin positivity among patients treated with such thermotherapy prior to lumpectomy.
Please visit
www.medifocusinc.com, www.prolieve.com and //www.facebook.com/pages/Medifocus-Inc-Company-Page/546315028715627 for more details.
Forward-Looking Statements
This news release contains “forward-looking statements” and “forward-looking information”, which may not be based on historical facts. Forward-looking statements and forward-looking information, include, but are not limited to, information and statements with respect to the benefit to Medifocus’ future growth resulting from the acquisition of additional intellectual property rights, additional treatment possibilities and the expectation that sales from Prolieve® may accelerate as a consequence. Forward-looking statements are frequently characterized by words such as “plan,” “expect,” “project,” “intend,” “believe,” “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made. Such forward-looking statements and forward-looking information involve known and unknown risks, uncertainties and other factors that may cause the actual results events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or forward-looking information. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements and forward-looking information. Except as required by applicable securities laws, the Company disclaims any obligation to update any such factors or to publicly announce the results of any revisions to any of the forward-looking statements or forward-looking information contained herein to reflect future results, events or developments.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Company Relations: Medifocus, Inc. Tel: 410-290-5734