New Rochelle, NY, January 10, 2012–The rapidly advancing field of tissue injury and repair has an important new forum. Advances in Wound Care will report the latest research findings, innovative wound care strategies, industry product pipeline, and developments in biomaterials and skin and tissue regeneration to optimize patient outcomes. The bimonthly online publication from Mary Ann Liebert, Inc is an Official Publication of the Wound Healing Society, offering rapid dissemination of the latest scientific discoveries, translational research, and clinical developments in acute and chronic wound care. The inaugural issue is available free online at www.liebertpub.com/wound
Tag: Inc.
Significant Reductions in Amputations, Emergency Visits, and Hospital Readmissions Associated with Advanced Treatment Using Skin Substitute Products …
MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, today announced publication of its peer-reviewed study in the Journal of Wound Care (JWC), addressing the observed impact of Advanced Treatment (AT) using all high-cost skin substitute products in lower extremity diabetic ulcers (LEDUs) based on data from the Medicare Limited Dataset (October 1, 2015 through October 2, 2018). The study assessed outcome in patients receiving AT with all high-cost skin substitute products, as designated by the Centers for Medicare and Medicaid Services (CMS), for LEDUs versus No Advanced Treatment (NAT), and found that AT use could lead to a 42% reduction in major and minor amputations and all related costs, compared to NAT. Further, the study highlights preferable outcomes when AT follows parameters for use (FPFU), underscoring the importance of early treatment with regular intervals and well-defined treatment guidelines … read more
SkinTE® Met Primary and Secondary Endpoints in Final Analysis from Diabetic Foot Ulcer Trial
SALT LAKE CITY–(BUSINESS WIRE)–PolarityTE, Inc. (Nasdaq: PTE) today announced final data from a multi-center randomized controlled trial evaluating treatment of Diabetic Foot Ulcers (DFU) with its investigational product SkinTE® plus standard of care (SOC) vs SOC alone (NCT03881254). The trial met the primary endpoint of wound closure at 12 weeks and secondary endpoint of Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks. 100 participants were evaluated across 13 sites with 50 participants receiving SkinTE plus SOC and 50 receiving SOC alone. PolarityTE is pleased to announce today the final analysis of the full data set, which includes:
- Primary Endpoint: 70% (35/50) of participants receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% (17/50) of participants receiving SOC alone (p=0.00032)
- Secondary Endpoint: Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks was significantly greater for the SkinTE plus SOC treatment group vs SOC alone (p=0.009)
- 90% (45/50) of SkinTE plus SOC treated participants received a single application of SkinTE
- Treatment with SkinTE plus SOC increased the odds of wound closure by 5.37 times versus SOC (p=0.001)
Mean (SD) values for PAR at weeks 4, 6, 8, 10, and 12 by treatment group
|
Week |
SkinTE |
SOC |
|
4 |
74.0 (27.63) |
22.0 (149.92) |
|
6 |
82.9 (26.35) |
21.2 (160.60) |
|
8 |
80.7 (35.16) |
26.8 (147.42) |
|
10 |
79.7 (54.07) |
45.6 (114.18) |
|
12 |
84.3 (39.46) |
50.5 (92.24) |
VIVEX Biologics, Inc. Launches New Family of Allografts, VIAGENEX™
MIAMI, May 19, 2021 /PRNewswire/ — VIVEX Biologics, Inc., a leading regenerative medicine company specializing in the development of naturally sourced treatments, announced the launch of VIAGENEX™, a family of amniotic allografts processed to retain the inherent mechanical properties of amniotic tissue and rich supply of extracellular matrix, growth factors, and cytokines read more
Breakthrough Evidence on Vomaris Bioelectric Technology’s
Impact on Wound Biofilm Infection
TEMPE, Ariz., Dec. 5, 2017 /PRNewswire/ — Vomaris Innovations, Inc. announced today breakthrough results of the first controlled, preclinical in vivo evidence on the anti-biofilm impact of the Company’s bioelectric antimicrobial technology. The study found that the technology can prevent and disrupt biofilm infection and restore functional wound healing. The manuscript, “Electric Field Based Dressing Disrupts Mixed-Species Bacterial Biofilm Infection and Restores Functional Wound Healing,” was published online in the Annals of Surgery. The research was led by Chandan Sen, Ph.D., Professor of Surgery and Director of the Comprehensive Wound Center at The Ohio State University’s Wexner Medical Center.
Bacteria use electrical interactions to communicate with each other in a process called quorum sensing (QS), signaling them to adhere to a wound, multiply, and encase themselves within a protective structural substance known as a biofilm. This protective biofilm barrier impedes the body’s immune defense system and renders the bacteria highly resistant to antibiotics, making biofilm infections extremely difficult to treat.
Approximately 80% of infections in chronic and surgical wounds are thought to be caused by bacteria within biofilm.1,2Chronic wounds affect an estimated 6.5 million patients a year and over $25 billion is estimated to be spent annually on their treatment.3 Surgical site infections (SSIs) occur in 2% to 5% of all patients undergoing inpatient surgery and affect up to 300,000 patients a year in the U.S. alone. Annual costs of managing SSIs range from $3.5 billion to $10 billion … full press release
Lumicell Launches Wound Care Infection and Perfusion Division
WELLESLEY, Mass.–(BUSINESS WIRE)–Lumicell, Inc., a leader in the field of image-guided cancer surgery, today announced that it has created a new division to drive the expansion of its pioneering technologies to include wound care, infection and perfusion.
According to a recent study in the Journal of The International Society for Pharmacoeconomics and Outcomes Research, each year in the U.S. there are about 8.2 million patients being treated under Medicare for chronic wounds with an estimated cost between $31.7 to $96.8 billion per year1. With the rising prevalence of obesity-related diseases, such as diabetes, and an aging population – there continues to be a growth in the number of patients suffering from chronic wounds. And with healthcare professionals making care decisions based on the limited, evidence-based knowledge of wounds and requiring patients to make weekly visits to track progress, this upward trend is predicted to continue.
“Chronic wounds have a dramatic impact on affected individuals, their families and the U.S. Health Care System, leading to reduced quality of life, limb loss and loss of life at a significant financial cost,” said Robert S. Kirsner, M.D., PhD, FAAD, Director, University of Miami Hospital and Clinics Wound Center. “Unfortunately, wound care is often a largely overlooked medical need compared to other medical challenges like cancer, despite similar effects on loss of life. There is a need for new technologies to assess the state of a wound, integrate this with clinical data, and support the best treatment, for the right patient, at the right time.”
“We created our new wound care, infection and perfusion division for the same reason we launched our pioneering cancer technology — we identified a patient population in desperate need and decided to apply our technology and leverage our world-class team to help people suffering from chronic wounds,” said W. David Lee, CSO of Lumicell. “We believe the biggest healthcare engineering breakthroughs happen outside of the biology lab. As such, Lumicell’s new division will use concurrent engineering – the convergence of engineering and biological research – to accelerate the pace of biological discoveries and create new applications to diagnose and treat patients.”
“While it will require significant research and development, it will be well worth the effort,” Lee said. “Lumicell has already established the foundational technology for this forward-thinking approach and assembled a small group of advisors to guide the team through the first stages of development. Our goal is to better understand wound healing and on a molecular level and to create an unbiased, holistic protocol that blends Lumicell’s care-leading technology, artificial intelligence and informed care options.”
Lumicell also hopes to create a community of wound care experts, including doctors, nurses, researchers and insurance company executives who are interested in providing expertise, evidence, opinions and guidance. This community will curate the statistics, biology and science needed to ensure the infection and profusion detecting technologies and accompanying standard of care protocols are accessible and adopted across disciplines.
1 Samuel R. Nussbaum MD, Marissa J. Carter PhD MA, Caroline E. Fife MD, Joan DaVanzo PhD MSW, Randall Haught, Marcia Nusgart RPh, Donna Cartwright MPA. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Journal of The International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Value in Health 21 (2018) 27-32
About Lumicell, Inc.
Lumicell is a technology leader in the field of image-guided cancer surgery. The company is developing a novel system that enables real-time detection of tumor tissue in patients so that no cancer cells are left behind during surgery. The company’s LUM System has unprecedented ability to see and remove cancer cells remaining in the surgical cavity – beyond the margin of the specimen – and has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is investigating the LUM System in patients undergoing surgery for breast cancer, prostate cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include surgeries for lung, ovarian, and brain cancers. For more information, please visit www.lumicell.com.
Contacts
For Lumicell
Ali Buckneberg, 612-334-5960
ali.buckneberg@wordsatwork.com
Clinical Evidence Presented at SAWC on Application of AMNIOX Medical Products
Four Posters Demonstrate the Clinical Benefits of NEOX® Wound Allograft Presented at SAWC
MIAMI–(BUSINESS WIRE)–AMNIOX Medical, Inc., a TissueTech, Inc. company, highlighted four clinical posters demonstrating the effectiveness of NEOX® Wound Allograft at the Symposium on Advanced Wound Care (SAWC) in April.
The presentations illustrate applications of NEOX Wound Allograft in combination with other therapies, and among a range of severe wounds that are resistant to current standard of care or are under served.
“The clinical effectiveness and value of NEOX continues to be reinforced in these studies, as well as opportunities to combine different approaches to advanced wound care,” said Adrian Roji, Chief Commercial Officer of TissueTech. “The authors found that patients who received NEOX experienced closure of hard-to-heal wounds, further highlighting the unique properties of cryo-preserved umbilical cord tissue.”
The studies presented at SAWC included:
- Treatment of Post-Operative Left Temporal Wound with Umbilical Cord Based Particulate and Negative Pressure Wound Therapy, Timothy Plackett, DO
- Use of Hydrated Shelf Stable Umbilical Cord Allograft for the Treatment of Chronic Wounds, Allen Raphael, DPM
- Treatment of Close-Range Gun Shot Wound with Umbilical Cord Based Particulate (pUC) and Negative Pressure Wound Therapy Timothy Plackett, DO
- Treatment of Invasive Carcinoma Wound with Hyperbaric Oxygen and Cryopreserved Umbilical Cord, Luis Fernandez, MD
AMNIOX parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote healing. AMNIOX utilizes its proprietary CryoTek® process, a cryopreservation technology, to preserve the biological and structural integrity of these tissues more effectively than other available technologies. Since the company’s inception, clinicians have performed more than 300,000 human transplants of its products and published more than 300 peer-reviewed studies supporting its technology platform.
About AMNIOX Medical, Inc.
Founded in 2011 to serve the orthopedic and wound care markets, AMNIOX Medical is dedicated to developing and marketing products processed from umbilical cord and amniotic membrane utilizing its proprietary CryoTek technology. AMNIOX Medical procures its tissue through elective donation following healthy live birth via Cesarean section. Thorough donor screening is performed to ensure safety of its products. For additional information, please visit http://www.AMNIOXmedical.com.
About TissueTech, Inc.
TissueTech, Inc., the parent company of AMNIOX Medical, Inc. and BioTissue, Inc., pioneered the development and clinical application of amniotic tissue-based products. AMNIOX Medical develops and markets products for use in the musculoskeletal and wound care markets; BioTissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) has supported TissueTech’s research with more than 30 continuous years of research grants. Since the company’s inception, clinicians have performed more than 300,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing.
MiMedx to Highlight Efficacy of Its Allografts
in Presentations at SAWC Spring Conference
Breakfast Symposium to Underscore Statistically Significant Evidence of EpiFix® in Healing DFUs and VLUs
MARIETTA, Ga., April 23, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced the Company’s participation in the 2018 Symposium on Advanced Wound Care Spring | Wound Healing Society (SAWC Spring/WHS) meeting being held April 25-29, 2018 in Charlotte, North Carolina.
During the five-day conference, the clinical and cost-effective healing results of the Company’s allografts will be highlighted in a Breakfast Symposium, two dinner presentations, five clinical poster presentations, and in-booth education sessions. MiMedx will be exhibiting in booth #830 from April 26, 2018 through April 28, 2018.
Now in its 31st year, the SAWC Spring/WHS conference is the leading national wound healing forum connecting the foremost experts with your entire wound care team to improve patient outcomes through education. No other wound care conference offers the level of education, advanced state-of-the-art clinical reviews and emerging research findings.
MiMedx will sponsor a Breakfast Symposium entitled “EpiFix® – First and Only Amnion/Chorion Allograft with Statistically Significant Level I Evidence for healing in DFUs and VLUs” on Friday morning, April 27, 2018 from 7:30 am to 9:00 am. The Company will also host two dinner presentations on Thursday, April 26th and Friday, April 27th entitled “Using MiMedx Placental Tissues in the Lower Extremity“, which will review the use of various products in wound and surgical applications.
Hands-on product demonstrations will be provided by expert physicians during booth hours on April 26th and April 27thin the MiMedx booth.
The poster presentations will report on the clinical effectiveness of MiMedx EpiFix dHACM (dehydrated Human Amnion/Chorion Membrane) placental tissue allografts in the healing of diabetic foot ulcers, venous leg ulcers, pressure ulcers and refractory non-healing wounds, as well as the use of AmnioCord umbilical cord allografts for reducing Achilles tendon pain. These independent case studies and respective conclusions will include:
- Abstract: “EpiFix VLU Study Group: A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Dehydrated Human Amnion/Chorion Membrane Allograft for the Treatment of Venous Leg Ulcers”
Authors: Christian Bianchi, MD, FACS; Shawn Cazzell, DPM, FACFAS; Dean Vayser, DPM, FACFAS; Alexander M. Reyzelman, DPM, FACFAS; Hasan Dosluoglu, MD, FACS; Gregory Tovmassian, DPM - Abstract: “EpiFix DFU Study Group: A Confirmatory Study on the Efficacy of Dehydrated Human Amnion/Chorion Membrane (dHACM) Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study”
Authors: William Tettelbach, MD; Shawn Cazzell, DPM; Alexander M. Reyzelman, DPM; Felix Sigal, DPM; Joseph M. Caporusso, DPM; Patrick S. Agnew, DPM - Abstract: “The Application of Dehydrated Human Amnion Chorion Membrane dHACM Allografts to Expedite Healing in Patients with Six Major Types of Refractory Non-Healing Wounds, 157 Patients”
Authors: Aamir Mahmood, DPM; Justin Goldsmith, DPM; Anna Tien, DPM; Mike Czurylo, DPM; Laith Shaman, DPM; Kelda Beachy, DPM; Neal Patel, DPM; Shayan Alamgir, DPM; Matthew Garoufalis, DPM, FASPS, FACFAOM - Abstract: “Use of Umbilical Cord Allograft for Pain Reduction in Achilles Tendon Pathologies: A Case”
Authors: Brandon Brooks, DPM; Kevin Pham, DPM; Bradley Brooks, DO; Brady Brooks, MS-1; James Henry, MS-1; Terria Madison, DPM - Abstract: “Safety and Efficacy of Weekly Application of Dehydrated Human Amnion/Chorion Membrane in the Treatment of Pressure Ulcers: a Case Series”
Authors: Chi Chi Berhane, MD, MBA; Kimberly Brantley, BSN, RN, CRRN; Sandra Williams, NP-C, APN, WCN; Erica Sutton, MA; Carlyn Kappy, RD, LD, CCRP
“For more than 30 years, SAWC and WHS have been dedicated to continuous advancements in wound care and have worked tirelessly toward their goal of decreasing the number and severity of wounds of all types.” said Parker H. “Pete” Petit, MiMedx Chairman and CEO. “We are honored to be a part of this year’s meeting, and MiMedx will continue to work with SAWC and other organizations to raise the level of scientific and clinical expertise and the professional processes within the wound care sector of healthcare.”
Bill Taylor, President and COO of MiMedx, added, “We are pleased that our EpiFix, AmnioCord and AmnioFill allografts will be so prominently demonstrated at this year’s SAWC. We look forward to participating in the conference and highlighting the significant investments made in the science and clinical study of placental technology.”
About MiMedx
MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to give physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.
FDA approves shock wave device for treatment of diabetic foot ulcers
Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.
“Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”
An estimated 30.3 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention. Diabetes damages blood vessels and nerves, particularly in the feet, and can lead to severe infections that are difficult to treat. About 25 percent of people with diabetes will experience a foot ulcer in their lifetime. Amputation is sometimes necessary when circulation is so poor that a foot ulcer fails to heal or when treatment fails to stop the spread of an infection … read more
SANUWAVE Announces Exhibition at SAWC
SUWANEE, Ga., Jan. 19, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB:SNWV) is pleased to announce that the company will exhibit, SAWC (Symposium on Advanced Wound Care) in Charlotte, NC on April 25 – 29, 2018. This will be SANUWAVE’s first opportunity to present their flagship wound care device, the dermaPACE System, to the U.S. market since receiving US FDA clearance in December, allowing the Company to market the device in the US.
“We are excited to be back presenting at SAWC spring in Charlotte, our first time as an exhibitor in 8 years. Since FDA clearance, the support coming from the wound care community has been overwhelmingly positive,” Stated Kevin R. Richardson, CEO and Chairman of the Board. Mr. Richardson continued, “We are glad to be making our shift from an R&D centered company to a marketing based company. This will be the start of our reemergence in the wound care space.” The Company is using this occasion to formally introduce their lead wound care product, the dermaPACE® System. This Extracorporeal Shockwave Technology … read more
