New Products and Industry News

Next Science and 3M Donate $300,000 of Breakthrough Wound Treatment to New Jersey Nursing Care Facility 

BlastX donation is one of several to long-term care facilities to effectively treat chronic wounds 

Next Science, an innovative medical technology company that is the leader in treating biofilm-based infections in humans, has announced that it has donated $300,000 worth of BlastX Antimicrobial Wound Gel to Hampton Ridge Healthcare and Rehabilitation in Toms River, NJ. 

This gift is part of a $500,000 donation program with 3M Company, the exclusive distributor of BlastX, that helps caregivers treat patients with chronic wounds at nursing and rehabilitative care facilities.

“Wound care is crucial for patients in long-term care facilities, particularly for aging patients,” said Dustin Haines, chief commercial officer for Next Science. “This donation is one way we can help frontline caregivers provide the best treatment possible and deliver on our mission to heal people and save lives with our innovative technologies.” 

The support to Hampton Ridge is the latest of several donations of BlastX that Next Science and 3M will make to long-term care facilities. Previously, the company set up donation programs to help patients who were unable to receive treatment at wound care clinics that were closed as a result of COVID-19. 

“With Next Science’s BlastX gel, we can be sure patients receive the best care possible to treat chronic wounds and mitigate infection by preventing bacterial resistance,” said Dr. Matthew Regulski, DPM, a surgeon who regularly treats patients at Hampton Ridge Healthcare and Rehabilitation. “We are grateful to Next Science and their generous support in treating current and future patients at our facility.”

BlastX is a breakthrough antimicrobial wound gel that is powered by Next Science’s patented, non-toxic, biofilm-disruption Xbio technology. BlastX breaks down biofilm, destroys bacteria within the gel, and defends against reinfection.

Biofilm, which is a naturally occurring substance, accounts for a significant percentage of hard-to-manage bacterial proliferations worldwide. The Centers for Disease Control and Prevention estimate that 80% of infections in humans are located in biofilm. In the United States, these infections contribute to approximately 500 000 deaths each year and cost an estimated $94 billion to treat. 

About Next Science

Next Science is a medical technology company headquartered in Sydney, Australia, with a research and development center based in Jacksonville, FL. Established in 2012, the company’s primary focus is on the development and continued commercialization of its proprietary Xbio technology to reduce the impact of biofilm-based infections in human health. Xbio is a unique, non-toxic technology with proven efficacy in eradicating both biofilm-based and free-floating bacteria. Next Science owns 100% of the patent protected intellectual property relating to its Xbio technology. For further information visit www.nextscience.com.

About Hampton Ridge Healthcare and Rehabilitation

Hampton Ridge Healthcare and Rehabilitation is one of New Jersey’s premier centers for skilled nursing and rehabilitative care. Hampton Ridge is a comprehensive nursing care facility, providing a full range of health care services, including rehabilitative therapy, skilled nursing care, post-surgical care, long-term care, Alzheimer’s and dementia care, as well as respite and palliative care. Hampton Ridge offers outstanding healthcare in a comfortable and pleasant environment with beautiful accommodations and fine amenities. The facility is located in Tom’s River. For further information visit https://hamptonridgehealth.com.

About 3M

At 3M, we apply science in collaborative ways that improve lives daily. With $32 billion in sales, our 96,000 employees connect with customers all around the world. Learn more about 3M’s creative solutions to the world’s problems at https://www.3m.com/ or on Twitter @3M or @3MNews.

Optimizing Postoperative Care 

PREVENA RESTOR Therapy portfolio optimizes postoperative care by delivering negative pressure therapy to the incision and surrounding soft tissue to enhance recovery

3M has announced the availability of the PREVENA RESTOR AXIO•FORM Incision Management System, which is designed to manage postoperative incisions, as well as the surrounding soft tissue envelope, following the orthopedic surgical repair of lower extremity fractures. PREVENA RESTOR AXIO•FORM helps stabilize the incision and surrounding soft tissue, reduces edema, and helps enhance postoperative recovery. This is the third offering in this therapy’s portfolio, launched in 2019, to optimize postsurgical care and expand the company’s specialty surgical offerings.

“Patients recovering from lower extremity fractures often experience complications which can potentially compromise the healing process, leading to delayed rehabilitation and poor functional outcomes,” said Dr. Brett D. Crist, MD, FAAOS, FACS, FAOA, Director of Orthopaedic Surgery, University of Missouri School of Medicine, who participated in the pre-market pilot. “The PREVENA RESTOR AXIO•FORM System provides a unique solution for postsurgical incision and soft tissue envelope management for the lower extremity – which can be one of the most complex and challenging anatomical areas. The expanded coverage and precision design lend themselves to better conformity on the surgical site, providing us confidence for our patients’ recovery.”

The PREVENA RESTOR AXIO•FORM System encompasses the same proven technology as the PREVENA Incision Management System, with added benefits including:

• Extended therapy time: up to 14 days (dressing change required after 7 days)

• Expanded coverage area: dressing seamlessly conforms to the patient

• Precision design: larger dressing delivers therapy to incision and surrounding soft tissue envelope

• Mechanically stabilize the incision and surrounding soft tissue

• Easy to apply, form-fitting PEEL & PLACE dressing

“Not all surgical incisions are the same size, and orthopedic fracture repairs can be complex, which is why we offer clinicians a variety of products to accommodate their individual patient’s needs,” said Ronald Silverman, MD, FACS, Chief Medical Officer, 3M. “Given the current pandemic, it is even more critical to minimize the length of hospital stays for patients and, once they return home, lessen the number of in-person visits during recovery. PREVENA RESTOR AXIO•FORM System aims to get patients home quickly and safely post-surgery, which is a priority now more than ever.”

The PREVENA RESTOR AXIO•FORM System was made commercially available in August 2020. Information on the PREVENA RESTOR AXIO•FORM System is available on the American Orthopedic Foot & Ankle Society (AOFAS) and Orthopedic Trauma Association (OTA) annual conference websites.

“Our team at 3M is pleased that, with the introduction of the PREVENA RESTOR AXIO•FORM System, we are further advancing how orthopedic surgeons care for patients recovering from lower extremity fractures by rethinking recovery and reimagining the traditional applications of negative pressure—all backed by the undisputed outcomes of PREVENA Therapy,” said Mark Colin, Vice-President, 3M Medical Solutions Division.

About PREVENA Therapy and PREVENA RESTOR AXIO•FORM Incision Management System 

The PREVENA Therapy System, launched in 2010, is the first disposable negative pressure system designed specifically for the management of closed surgical incisions. PREVENA Therapy Systems removes fluid away from the surgical incision via the application of -125 mm Hg continuous negative pressure.

The PREVENA RESTOR Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Please refer to the PREVENA RESTOR AXIO•FORM System Instructions For Use for important safety information.

About 3M

At 3M, we apply science in collaborative ways to improve lives daily. With $33 billion in sales, our 93,000 employees connect with customers all around the world. Learn more about 3M’s creative solutions to the world’s problems at www.3M.com or on Twitter @3M or @3MNews.

MiMedx Announces Largest US Commercial Payor Will Provide Coverage for EpiFix in the Treatment of Diabetic Foot Ulcers

Only amniotic product covered under updated commercial policy

MiMedx Group, Inc., an industry leader in advanced wound care and a therapeutic biologics company, has announced that the largest US commercial payor will now provide coverage for EpiFix, the company’s flagship amnion/chorion membrane tissue product, as a proven and medically necessary option in the treatment of diabetic foot ulcers. The company believes that EpiFix is the only amniotic membrane product to receive coverage under this payor’s updated commercial medical policy. Information contributing to the coverage determination included a third-party technical brief that evaluated a number of skin substitutes for treating chronic wounds, in which EpiFix was noted to have the most randomized controlled trials, a low risk of overall study bias, and statistically significant findings. Reimbursement coverage will become effective December 1, 2020.

Timothy R. Wright, MiMedx Chief Executive Officer, commented, “One of our key focus areas has been on expanding patient and healthcare provider access to our products, communicating the clinical and economic value of our portfolio, and advancing the science of amniotic tissue to bring improved healing to more people in need. We believe that this important recognition of the differentiated value of our portfolio will continue to inform decision making by payors and providers and help elevate the standard of care for millions of patients.”

About MiMedx

MiMedx is an industry leader in advanced wound care and an emerging therapeutic biologics company developing and distributing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. The company processes the human placental tissue utilizing its proprietary PURION process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied more than 2 million allografts to date. For additional information, please visit www.mimedx.com

Amniox Launches Virtual Education and Diabetic Foot Ulcer Outreach Campaign 

Month-long campaign features a host of educational activities focusing on management of complex, chronic wounds resulting from diabetes

Amniox Medical, Inc., a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, has announced that it has joined forces with key stakeholder groups around the nation who are advocating for diabetes awareness and optimal patient care, especially in chronic, debilitating conditions like late stage (Wagner grade 3 and 4) complex diabetic foot ulcers (DFUs). Amniox has rolled out a month-long virtual campaign, #DFUAvengers, targeting health care professionals who treat patients living with chronic wounds, in recognition of National Diabetes Month (November 2020). 

Health care professionals were able to learn about the NEOX family of Cryopreserved Umbilical Cord Allografts at the SAWC Fall Virtual Meeting 2020 from November 4 to 6, 2020, and at the WoundCon Fall 2020 Virtual Conference and Exhibition on November 13, 2020. NEOX wound allografts support regenerative healing and functional recovery for late stage and chronic wounds with higher closure rates, fewer applications, and reduced cost of care.¹

People with diabetes mellitus are at substantial risk of developing a foot ulcer at some point in their lifetime. Unlike other types of deep wounds, DFUs typically exhibit delayed healing and a downstream consequence of prolonged high levels of glucose in the blood. This can trigger a wide range of molecular events leading to damage of the nerves, blood vessels, tissues, and organs. Damage to blood vessels can increase the risk of heart attack and stroke, and nerve damage can lead to eye damage or kidney damage.²

“A cornerstone of this campaign is peer-to-peer education. #DFUAvengers will afford clinicians several opportunities to learn how our cryopreserved umbilical cord allograft, NEOX, is used as an adjunct therapy to expedite wound healing,” said TissueTech co-founder Amy Tseng, MBA, CEO, and President.

Amniox also proudly supports the Centers for Disease Control and Prevention’s (CDC) National Diabetes Prevention Program that addresses the increasing burden of prediabetes and type 2 diabetes in the United States. This program offers evidence-based, cost-effective interventions that help prevent type 2 diabetes. At-risk patients can be referred to a CDC-recognized lifestyle change program proven by research to cut their risk of type 2 diabetes by more than half. Participating in this program will encourage weight loss and other healthy changes to patients’ lifestyles, lowering their risk of type 2 diabetes, heart attack, and stroke.

About Amniox Medical, Inc.

Amniox Medical, Inc., a TissueTech, Inc. company, is a leader in the clinical application of human birth tissue-based products (amniotic membrane and umbilical cord) processed using TissueTech’s proprietary CRYOTEK cryopreservation technology. Established in 2011, Amniox serves an unmet need for better surgical and therapeutic outcomes for chronic and complex wounds, orthopedics, sports medicine, spine, urology, gynecology, plastics, and general surgery. Connect with Amniox on our website (www.amnioxmedical.com) and on Facebook, LinkedIn, and Twitter.

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue, Inc., is a scientific and market leader in the field of regenerative medicine. TissueTech manufactures a broad range of ocular, surgical, wound care, and soft tissue products that are marketed under these subsidiaries. Since the company’s inception, clinicians have performed more than 500 000 human implants of the company’s products and published more than 360 peer-reviewed studies supporting its platform technology. TissueTech is committed to an unwavering culture of integrity that places our patients’ safety and clinical outcomes above all else. Learn more at https://tissuetech.com/.

References

1. Marston WA, Lantis 2nd JC, Wu SC, et al. An open-label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis. Wound Repair Regen. August 2019. https://doi.org/10.1111/wrr.12754

2. Park S, Kang HJ, Jeon JH, Kim MJ, Lee IK. Recent advances in the pathogenesis of microvascular complications in diabetes. Arch Pharm Res. 2019;42(3):252–262. US-NX-2000040.