$SNWV: NEWS JUST OUT--SANUWAVE Increases Clinical
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Posted On: 10/10/2019 9:23:40 AM
$SNWV: NEWS JUST OUT--SANUWAVE Increases Clinical Symposia Presence With Three Posters at Wounds Canada
October 10, 2019 09:00 ET | Source: SANUWAVE Health, Inc.
Studies Show Significant Improvements When dermaPACE® System Was Used in the Treatment of Chronic Wounds
SUWANEE, GA, Oct. 10, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to provide an update of current clinical events and news involving the company’s dermaPACE® System, the only shockwave product cleared by FDA for the treatment of Diabetic Foot Ulcers (“DFUs”). The dermaPACE® System is by far the most studied shockwave product on the market for wound indications; having more than 16 peer-reviewed articles, including the two most recently published by Journal of Wound Care (JWC) discussing the DFU randomized, double-blinded, parallel-group, sham-controlled, multicenter, 24-week pivotal clinical trials and over 33 abstracts and posters. This work has established a strong effectiveness and safety profile. In addition, it helped us gain a solid understanding of how DFUs respond to dermaPACE® System treatment through increased perfusion, reduction in inflammation, accelerated wound area reduction, and wound healing. SANUWAVE is committed to remain at the forefront of wound care research involving the company’s proprietary Pulsed Acoustic Cellular Expression (PACE®) technology. SANUWAVE plans pharma-economic studies involving the dermaPACE® System at three major universities; these on-going case series studies will also measure the increase in perfusion after treatment with dermaPACE®.
In recent months, the following posters have been presented at major wound care symposia and research forums:
· Dr. Windy Cole, DPM, Adjunct Professor and Director of Wound Care KSUCPM and Medical Director, UH Ahuja Wound Center presented at Wounds Canada, the annual gathering held in Niagara Falls, Ontario October 3-5, 2019, a poster titled: “The Use of Non-Invasive Pulsed Acoustic Cellular Expression System to Promote Angiogenesis in Chronic Wounds.” This case series discussed results to date of the objective to measure and monitor tissue oxygen saturation levels before and after a treatment regimen using the dermaPACE® System on DFUs. Measurement of hemoglobin levels is via the Snapshot NIRS device from Kent Imaging. The on-going series reported wound improvement as measure by wound area reduction and increased granulation while also exhibiting an improvement in tissue oxygenation by 17.3%. To date, 8 patients have been treated, 4 with complete healing during the 5-week period and 4 with substantial wound area reduction.
· Brian Harper D.CH. Clinical Director Newmarket Foot Center Ontario, Clinical Adjunct Professor Michener Institute at University Health Network Toronto presented at Wounds Canada, the poster titled: “ESWT -PACE® Technology Utilizes High-Energy Acoustic Pressure Shockwaves to Produce Compressive and Tensile Stresses on Cells/Tissue Structures with Ultimate Goal of Regenerating Healthy Tissue In Chronic Foot Ulcers in a Community Clinical Setting." The case series discussed results from September 2018 through March 2019 of 9 patients treated with dermaPACE® System. The patients selected were all diabetic and had wounds that had not shown any improvements greater than a 15% reduction in wound area in the prior 12 weeks (3 months of no improvement). Out of the 9 patients enrolled, 7 had complete closure, including 4 patients with wounds present for over 14 years.
· Professor Doctor Tomasz Banasiewicz from the Department and Clinic of General, Endocrinological and Gastroenterological Oncology, Poznan University of Medical Sciences, Poznan, Poland, and Iulian Cioanta, Ph.D. Chief Science and Technology Officer, SANUWAVE Health Inc., Suwanee, Georgia, presented at Wounds Canada, the poster titled: “A Pilot Study to Determine the Effect of Different Dosage Regimens of High Energy Acoustic Shockwaves in Treating Diabetic Foot Ulcers.” The study objective was to assess in diabetic foot ulcers (DFUs) patients the effects of three (3) different regimens of shockwave pulses delivered in up to ten (10) treatment sessions using the proprietary Extracorporeal Shockwave Technology (ESWT) , known as Pulsed Acoustic Cellular Expression (PACE®) Technology, employed by the dermaPACE® System provided by SANUWAVE® Healthcare, Inc. The results have shown strong wound area improvement in 16 of the 19 enrolled patients. The study is expected to enroll over 40 patients when completed and assist in an optimized dosage to be used by dermaPACE® System for the treatment of DFU patients.
Kevin Richardson, Chairman of the Board and CEO of SANUWAVE, stated, “SANUWAVE has been the leader in wound care research using shockwave technology for more than 15 years, and we plan to be the continued leader for years to come. Our groundbreaking work in developing our understanding of the dermaPACE® System mechanism of action has brought us to the forefront in wound care using our PACE® technology. These three (3) posters featured at Wounds Canada highlight the commitment to clinical research and show a breadth of research SANUWAVE is pursuing. Dr. Cole’s focus on increased perfusion will assist all wound clinicians in improving the quality of the wound and vascularization. Brian Harper’s focus on “hard to heal” long standing wounds shows dermaPACE® System effectiveness in the hardest to heal patients. Dr. Banasiewicz and Dr. Cioanta’s work shows our on-going learnings to maximize how the efficiency of the dermaPACE® System in delivering optimal treatments for our patients. We will not slow down in furthering our understanding of how PACE® Technology affects the body’s biological response. You will see a number of posters and abstracts and SANUWAVE sponsored symposia at upcoming medical device shows this fall and next spring. Other peer-reviewed articles will be forthcoming based upon on-going research in perfusion measurement. Additionally, we expect to begin enrollment of our follow-on study supporting our DFU indication. And of course, we fully expect to be active in 2020 in setting the clinical groundwork for expansion into new indications.”
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB:SNWV) (www.SANUWAVE.com) is a shockwave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE® technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is US FDA cleared for the treatment of Diabetic Foot Ulcers. The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shockwave technology for non-medical uses, including energy, water, food and industrial markets.
Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
For additional information about the Company, visit www.sanuwave.com.
Contact:
Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com
SANUWAVE Health, Inc.
Kevin Richardson II
CEO and Chairman of the Board
978-922-2447
investorrelations@sanuwave.com
http://www.globenewswire.com/news-release/201...anada.html
October 10, 2019 09:00 ET | Source: SANUWAVE Health, Inc.
Studies Show Significant Improvements When dermaPACE® System Was Used in the Treatment of Chronic Wounds
SUWANEE, GA, Oct. 10, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to provide an update of current clinical events and news involving the company’s dermaPACE® System, the only shockwave product cleared by FDA for the treatment of Diabetic Foot Ulcers (“DFUs”). The dermaPACE® System is by far the most studied shockwave product on the market for wound indications; having more than 16 peer-reviewed articles, including the two most recently published by Journal of Wound Care (JWC) discussing the DFU randomized, double-blinded, parallel-group, sham-controlled, multicenter, 24-week pivotal clinical trials and over 33 abstracts and posters. This work has established a strong effectiveness and safety profile. In addition, it helped us gain a solid understanding of how DFUs respond to dermaPACE® System treatment through increased perfusion, reduction in inflammation, accelerated wound area reduction, and wound healing. SANUWAVE is committed to remain at the forefront of wound care research involving the company’s proprietary Pulsed Acoustic Cellular Expression (PACE®) technology. SANUWAVE plans pharma-economic studies involving the dermaPACE® System at three major universities; these on-going case series studies will also measure the increase in perfusion after treatment with dermaPACE®.
In recent months, the following posters have been presented at major wound care symposia and research forums:
· Dr. Windy Cole, DPM, Adjunct Professor and Director of Wound Care KSUCPM and Medical Director, UH Ahuja Wound Center presented at Wounds Canada, the annual gathering held in Niagara Falls, Ontario October 3-5, 2019, a poster titled: “The Use of Non-Invasive Pulsed Acoustic Cellular Expression System to Promote Angiogenesis in Chronic Wounds.” This case series discussed results to date of the objective to measure and monitor tissue oxygen saturation levels before and after a treatment regimen using the dermaPACE® System on DFUs. Measurement of hemoglobin levels is via the Snapshot NIRS device from Kent Imaging. The on-going series reported wound improvement as measure by wound area reduction and increased granulation while also exhibiting an improvement in tissue oxygenation by 17.3%. To date, 8 patients have been treated, 4 with complete healing during the 5-week period and 4 with substantial wound area reduction.
· Brian Harper D.CH. Clinical Director Newmarket Foot Center Ontario, Clinical Adjunct Professor Michener Institute at University Health Network Toronto presented at Wounds Canada, the poster titled: “ESWT -PACE® Technology Utilizes High-Energy Acoustic Pressure Shockwaves to Produce Compressive and Tensile Stresses on Cells/Tissue Structures with Ultimate Goal of Regenerating Healthy Tissue In Chronic Foot Ulcers in a Community Clinical Setting." The case series discussed results from September 2018 through March 2019 of 9 patients treated with dermaPACE® System. The patients selected were all diabetic and had wounds that had not shown any improvements greater than a 15% reduction in wound area in the prior 12 weeks (3 months of no improvement). Out of the 9 patients enrolled, 7 had complete closure, including 4 patients with wounds present for over 14 years.
· Professor Doctor Tomasz Banasiewicz from the Department and Clinic of General, Endocrinological and Gastroenterological Oncology, Poznan University of Medical Sciences, Poznan, Poland, and Iulian Cioanta, Ph.D. Chief Science and Technology Officer, SANUWAVE Health Inc., Suwanee, Georgia, presented at Wounds Canada, the poster titled: “A Pilot Study to Determine the Effect of Different Dosage Regimens of High Energy Acoustic Shockwaves in Treating Diabetic Foot Ulcers.” The study objective was to assess in diabetic foot ulcers (DFUs) patients the effects of three (3) different regimens of shockwave pulses delivered in up to ten (10) treatment sessions using the proprietary Extracorporeal Shockwave Technology (ESWT) , known as Pulsed Acoustic Cellular Expression (PACE®) Technology, employed by the dermaPACE® System provided by SANUWAVE® Healthcare, Inc. The results have shown strong wound area improvement in 16 of the 19 enrolled patients. The study is expected to enroll over 40 patients when completed and assist in an optimized dosage to be used by dermaPACE® System for the treatment of DFU patients.
Kevin Richardson, Chairman of the Board and CEO of SANUWAVE, stated, “SANUWAVE has been the leader in wound care research using shockwave technology for more than 15 years, and we plan to be the continued leader for years to come. Our groundbreaking work in developing our understanding of the dermaPACE® System mechanism of action has brought us to the forefront in wound care using our PACE® technology. These three (3) posters featured at Wounds Canada highlight the commitment to clinical research and show a breadth of research SANUWAVE is pursuing. Dr. Cole’s focus on increased perfusion will assist all wound clinicians in improving the quality of the wound and vascularization. Brian Harper’s focus on “hard to heal” long standing wounds shows dermaPACE® System effectiveness in the hardest to heal patients. Dr. Banasiewicz and Dr. Cioanta’s work shows our on-going learnings to maximize how the efficiency of the dermaPACE® System in delivering optimal treatments for our patients. We will not slow down in furthering our understanding of how PACE® Technology affects the body’s biological response. You will see a number of posters and abstracts and SANUWAVE sponsored symposia at upcoming medical device shows this fall and next spring. Other peer-reviewed articles will be forthcoming based upon on-going research in perfusion measurement. Additionally, we expect to begin enrollment of our follow-on study supporting our DFU indication. And of course, we fully expect to be active in 2020 in setting the clinical groundwork for expansion into new indications.”
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB:SNWV) (www.SANUWAVE.com) is a shockwave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE® technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is US FDA cleared for the treatment of Diabetic Foot Ulcers. The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shockwave technology for non-medical uses, including energy, water, food and industrial markets.
Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
For additional information about the Company, visit www.sanuwave.com.
Contact:
Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com
SANUWAVE Health, Inc.
Kevin Richardson II
CEO and Chairman of the Board
978-922-2447
investorrelations@sanuwave.com
http://www.globenewswire.com/news-release/201...anada.html
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