Healthpluser

Spread the love

<figure class="img_container" style="float:left;margin-right:10px;width:350px;;margin-bottom:5px;max-width:100%;"><img width="590" height="442" class="unveil" loading="eager" style="width:100%;max-height:100%" src="https://img.etb2bimg.com/files/cp/upload-1716881542-ethealthworld.webp" data-src="https://etimg.etb2bimg.com/photo/118196901.cms" captionrendered="1" alt=""><figcaption class="caption"></figcaption></figure>By Steven Scheer Jerusalem: <a id="25446172" type="General" weightage="20" keywordseo="MediWound" source="keywords" meta.keywordsubtype="org" meta.entityname="MediWound" meta.hostid="266" meta.entityid="MediWound" class="news-keywords" href="/tag/mediwound">MediWound</a>, an Israeli developer of products to treat burns and wounds using non-surgical tissue repair, said on Wednesday it was starting a <a id="23541837" type="General" weightage="20" keywordseo="Phase-III-trial" source="keywords" class="news-keywords" href="/tag/phase+iii+trial">Phase III trial</a> for its treatment for <a id="25446167" type="General" weightage="100" keywordseo="venous-leg-ulcers" source="keywords" class="news-keywords" href="/tag/venous+leg+ulcers">venous leg ulcers</a>. The company said its <a id="25446170" type="General" weightage="20" keywordseo="EscharEx" source="keywords" class="news-keywords" href="/tag/escharex">EscharEx</a> treatment had previously demonstrated its ability to effectively and rapidly remove damaged or dead tissue from chronic wounds in multiple Phase II trials. <!– PROMOSLOT_M –> "With no new <a id="25446171" type="General" weightage="20" keywordseo="FDA-approved-drugs" source="keywords" class="news-keywords" href="/tag/fda-approved+drugs">FDA-approved drugs</a> in this category since 1965, EscharEx has the potential to redefine the standard of care for chronic <a id="25446168" type="General" weightage="20" keywordseo="wound-debridement" source="keywords" class="news-keywords" href="/tag/wound+debridement">wound debridement</a>," CEO Ofer Gonen said, referring to the removal of damaged tissue. <!– PROMOSLOT –> "We are confident that EscharEx will provide meaningful benefits to patients, healthcare providers, and payors alike." Venous leg ulcers affect about 2% of individuals aged 65 and older, with over 1.5 million new cases reported annually in the U.S., the company said. <!– PROMOSLOT_M –> They typically develop on the lower extremities due to <a id="25446173" type="General" weightage="20" keywordseo="chronic-venous-insufficiency" source="keywords" class="news-keywords" href="/tag/chronic+venous+insufficiency">chronic venous insufficiency</a> and are characterized by large, shallow wounds that can cause severe pain, infection and disability, highlighting the need for effective treatment options, it said. The trial’s primary objective is to evaluate the efficacy and safety of EscharEx in achieving effective removal of damaged tissue and preparing the wound bed for healing. <!– PROMOSLOT_M –><!– PROMOSLOT –> The trial will be randomised, double-blind and placebo-controlled, and conducted across 40 sites in the United States and Europe. It will enroll 216 patients who will undergo up to eight daily applications over two weeks, followed by 10 weeks of standardized wound management. MediWound also plans to initiate a Phase II study in 2025 comparing EscharEx to collagenase in patients with venous leg ulcers. <!– PROMOSLOT_M –> MediWound, partly backed by the Point72 hedge fund founded by New York Mets baseball team owner Steve Cohen, is also preparing for a Phase II/III <a id="20663810" type="General" weightage="20" keywordseo="clinical-trial" source="keywords" class="news-keywords" href="/tag/clinical+trial">clinical trial</a> targeting diabetic foot ulcers, expected to begin in 2026. <!– PROMOSLOT –> (Reporting by Steven Scheer Editing by Bernadette Baum) </body>","next_sibling":[{"msid":118159639,"title":"Edwards Lifesciences beats profit estimate on strength in heart devices","entity_type":"ARTICLE","link":"/news/medical-devices/edwards-lifesciences-beats-profit-estimate-on-strength-in-heart-devices/118159639","link_next_mobile":"/news/medical-devices/edwards-lifesciences-beats-profit-estimate-on-strength-in-heart-devices/118159639?next=1","category_name":null,"category_name_seo":"medical-devices"}],"related_content":[],"seoschemas":false,"social_share":{"fb":"/information/medical-devices/mediwound-to-launch-phase-iii-trial-for-venous-leg-ulcers/118196473?utm_source=fb&utm_medium={{DEVICE_TYPE}}","x":"/information/medical-devices/mediwound-to-launch-phase-iii-trial-for-venous-leg-ulcers/118196473?utm_source=twitter&utm_medium={{DEVICE_TYPE}}","whatsapp":"/information/medical-devices/mediwound-to-launch-phase-iii-trial-for-venous-leg-ulcers/118196473?utm_source=wapp&utm_medium={{DEVICE_TYPE}}","linkdin":"/information/medical-devices/mediwound-to-launch-phase-iii-trial-for-venous-leg-ulcers/118196473?utm_source=linkedin&utm_medium={{DEVICE_TYPE}}","telegram":"/information/medical-devices/mediwound-to-launch-phase-iii-trial-for-venous-leg-ulcers/118196473?utm_source=telegram&utm_medium={{DEVICE_TYPE}}","copy":"/information/medical-devices/mediwound-to-launch-phase-iii-trial-for-venous-leg-ulcers/118196473?utm_source=copy&utm_medium={{DEVICE_TYPE}}"},"cat_msid":44909127,"cat_sub_msid":false,"msid":118196473,"entity_type":"ARTICLE","title":"MediWound to launch Part III trial for venous leg ulcers","synopsis":"The corporate stated its EscharEx remedy had beforehand demonstrated its potential to successfully and quickly take away broken or lifeless tissue from persistent wounds in a number of Part II trials.","titleseo":"medical-devices/mediwound-to-launch-phase-iii-trial-for-venous-leg-ulcers","standing":"ACTIVE","authors":[],"Alttitle":{"minfo":""},"next_promo_stories":[{"id":"117674599","type":"next_article"}],"artag":"Reuters","artdate":"2025-02-13 06:38:43","lastupd":"2025-02-13 07:08:25","breadcrumbTags":["venous leg ulcers","wound debridement","Phase III trial","chronic wound treatment","clinical trial","EscharEx","FDA-approved drugs","MediWound","chronic venous insufficiency"],"secinfo":{"seolocation":"medical-devices/mediwound-to-launch-phase-iii-trial-for-venous-leg-ulcers"}}” data-type=”information” id=”news_dtl_118196473″ page-title=”MediWound to launch Part III trial for venous leg ulcers”>

The corporate stated its EscharEx remedy had beforehand demonstrated its potential to successfully and quickly take away broken or lifeless tissue from persistent wounds in a number of Part II trials.

Reuters

Up to date On Feb 13, 2025 at 07:08 AM IST

By Steven Scheer

Jerusalem: MediWound, an Israeli developer of merchandise to deal with burns and wounds utilizing non-surgical tissue restore, stated on Wednesday it was beginning a Phase III trial for its remedy for venous leg ulcers.

“With no new FDA-approved drugs on this class since 1965, EscharEx has the potential to redefine the usual of look after persistent wound debridement,” CEO Ofer Gonen stated, referring to the removing of broken tissue.

“We’re assured that EscharEx will present significant advantages to sufferers, healthcare suppliers, and payors alike.”

Venous leg ulcers have an effect on about 2% of people aged 65 and older, with over 1.5 million new instances reported yearly within the U.S., the corporate stated.

They sometimes develop on the decrease extremities attributable to chronic venous insufficiency and are characterised by massive, shallow wounds that may trigger extreme ache, an infection and incapacity, highlighting the necessity for efficient remedy choices, it stated.

The trial’s main goal is to judge the efficacy and security of EscharEx in reaching efficient removing of broken tissue and getting ready the wound mattress for therapeutic.

The trial will probably be randomised, double-blind and placebo-controlled, and performed throughout 40 websites in america and Europe. It is going to enroll 216 sufferers who will bear as much as eight each day purposes over two weeks, adopted by 10 weeks of standardized wound administration.

MediWound additionally plans to provoke a Part II examine in 2025 evaluating EscharEx to collagenase in sufferers with venous leg ulcers.

MediWound, partly backed by the Point72 hedge fund based by New York Mets baseball crew proprietor Steve Cohen, can also be getting ready for a Part II/III clinical trial focusing on diabetic foot ulcers, anticipated to start in 2026.

(Reporting by Steven Scheer Modifying by Bernadette Baum)