MEDIFOCUS, INC. ANNOUNCES FDA PMA SUPPLEMENT APPROVAL FOR NEW LABELING BASED ON SUCCESSFUL COMPLETION OF FDA POST APPROVAL STUDY (PAS) FOR THE PROLIEVE® THERMODILATATION™ DEVICE
Prolieve® is a Novel Combinational Treatment for Benign Prostatic Hyperplasia (BPH)
COLUMBIA, MD and Toronto, ON- December 3, 2018 – Medifocus, Inc. (OTCQX:MDFZF and TSXV:MFS.V) (“Medifocus” or the “Company”), a biotechnology company with a portfolio of medical technologies utilizing Focused Microwave Heat Activation to treat conditions ranging from Prostatic pathologies to Breast Cancer treatment, announced that on November 21, 2018, the FDA had approved a PMA (Post Market Approval) Supplement for new labeling based on the results of our Post Approval Study (PAS). The study involved 225 men with Benign Prostatic Hyperplasia (BPH) treated using the Prolieve® system. The Prolieve® Transurethral ThermoDilatation™ Therapy (TUTD™) offers a unique “Thermodilatation” treatment for BPH. Prolieve® is the only patented and FDA approved Thermodilatation device on the market. It is a combination therapy simultaneously using Focused Microwave Heating together with Pressurized Balloon Dilatation therapy.
BPH is a medical condition resulting in enlargement of the prostate gland and affects over about 50% of all men over the age of 50. The unique combination treatment is a 45-minute, in-office, outpatient procedure which is performed and well-tolerated under local anesthesia. Patients do not require a post treatment foley catheter about 90% of the time in contrast to the other invasive or even minimally invasive treatment options. Additionally, the majority of patients experience significant and immediate relief of their BPH symptoms. With the approval of this PMA Supplement for new labeling, Medifocus Inc. can officially claim durable and lasting clinical benefits for at least 5 years of follow-up.
Dr. William Jow, President and CEO of Medifocus stated, “The successful completion of the 5 year follow-up FDA PAS and the approval of the PMA Supplement labeling are significant milestones and achievements to enable Medifocus to rebrand Prolieve® as the only FDA approved Transurethral ThermoDilatation™ Microwave Therapy (TUTD™) BPH treatment system with proven excellent short-term and long-term clinical benefits. As a practicing urologist, I am delighted that other approved key findings of the PAS include stabilization of PSA (Prostate-specific antigen) serum levels and Prostate Sizes during the entire 5 years of follow-up. It implies that the Prolieve® treatment may help Prevent the Natural Progression of BPH and even Early Prostate Cancer for select patients. Further studies may need to be performed; however, these preliminary findings may lessen the need for repeated future prostate biopsy which are not only costly but also risky and painful. Such findings can also allay the anxiety of the aging men who normally anticipate rising PSA serum levels.” He added, “Many patients elected to undergo Prolieve® treatment because they were not happy with or failed drug therapies and/or desired not to have a more invasive treatment like laser or surgery. They have found Prolieve® an excellent, safe and effective treatment alternative for their symptomatic BPH. The PAS also reported an exceedingly low incidence of sexual side effects comparable to those of an age-matched cohort followed over time – an observation commonly shared by me and many of my colleagues.”
“Since Medifocus purchased the Prolieve® technology platform from Boston Scientific in July of 2012, with a limited sales budget, the Company has been able to increase the Prolieve® user base mostly in private Urology offices. Greater than 100,000 Prolieve® treatments has been performed thus far in the U.S. alone. With an expected growth in international sales of Prolieve®, we anticipate making Prolieve® the initial Treatment of Choice for men with BPH who seek symptomatic relief beyond pharmacologic interventions worldwide.” said Dr. Jow.
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. About half of men over 50 have some enlargement of the prostate gland, and this rises to about 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, water 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 and tissue ablation in the targeted prostate gland. As the transurethral microwave energy is applied to the entire prostate, a computerized feedback system involving the rectal temperature probe renders the rectal temperature not to exceed 41-42 ◦C, thus ensuring safety of the rectal wall and neurovascular bundles essential to preservation of erectile function.
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.
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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.
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Company Relations: Medifocus, Inc. Tel: 410-290-5734, Email: info@medifocusinc.com