News

Shock Wave Therapy Receives FDA Marketing Approval

SANUWAVE Health Inc (Suwanee, GA) announced that its innovative shock wave therapy has received approval for marketing from the US Food and Drug Administration (FDA). The decision will allow dermaPACE to be marketed as a Class II Medical Device for the treatment of diabetic foot ulcers (DFUs) in the United States, the world’s largest medical device market. 

The novel therapy administers shock wave energy to a DFU over 4 to 8 applications in a 2- to 10-week period. Its noninvasive nature makes the system a safe and effective option for patients. Prior to the decision, the therapy was the focus of 2 FDA-approved investigational device exemption clinical studies. Over 24 weeks at 39 US centers, patients treated with the shock wave therapy showed increased wound healing rates with a < 10% rate of recurrence.

Visit www.sanuwave.com for more information.

Study Shows Reduction in Surgical Site Infections

New data demonstrates that PREVENA Incision Management System (Acelity, San Antonio, TX) reduces wound complications following surgical procedures. Published in the Journal of Arthroplasty, the study showed that patients had statistically significant lower rates of overall infection and were 4 times less likely to experience surgical site complications.

The closed incision negative pressure therapy is the first disposable system designed specifically for the management of closed surgical incisions. The single-center, open-label study compared 196 incisions treated with the system with 400 patients with incisions treated with traditional gauze dressings; those incisions treated with the system also had lower complication rates as well as lower pain scores 24 hours postoperatively.

Visit www.acelity.com for more information.

Senior Leadership Changes for International Company

ConvaTec Group Plc (Reading, UK) announced several changes to its organizational structure of the group and its executive committee membership. Starting on the first day of the 2018, the company’s 4 franchises will be led by franchise presidents who will report directly to the group chief executive officer and serve as members of the executive committee. The new franchise presidents include Peter Byloos, Advanced Wound Care; Erik Zimmer, Ostomy Care; Frank Gehres, Continence and Critical Care; and John Lindskog, Infusion Devices. 

Visit www.convatecgroup.com for more information.

Latest Phone Advances Wound Imaging Platform 

eKare Inc (Fairfax, VA) has combined its product, inSight 2.0, with the newest iOS platform (Apple, Cupertino, CA). The mobile phone application will take advantage of the iPhone X’s built-in optics to create 3-dimensional (3-D) wound measurements. On the app, algorithms create a detailed wound reconstruction with a point-and-shoot action; the resulting depth map, with roughly a half million data points, gives a full 3-D picture without touching the patient or requiring a reference marker.

The company’s original measurement technology is currently being used in hospitals, academic medical centers, and biologics/pharmaceutical companies across the globe.

Visit www.ekare.ai/ for more information.

European Launch of Handheld Technology

Smith & Nephew (London, UK) announced the European launch of MolecuLight i:X (Toronto, ON, Canada), an easy-to-use, handheld device that quickly and accurately measures wound surface area as well as visualizes the presence and distribution of potentially harmful bacteria. The imaging device is approved by Health Canada and has a CE Marking for sale in the European Union but is not currently available in the United States.

The European launch of this device comes after Smith & Nephew finalized an exclusive distribution agreement with the device’s manufacturer, MolecuLight, back in May 2017.

Visit www.smith-nephew.com for more information. 

Group Purchasing Agreement for Full Medical Portfolio

A group purchasing agreement was reached between AMNIOX Medical (Atlanta, GA), a TissueTech Inc (Doral, FL) company, and Premier Inc (Charlotte, NC) for regenerative skin grafting products. The agreement, effective January 1, 2018, allows Premier group members to use the full AMNIOX portfolio at special prenegotiated terms. The portfolio includes both NEOX wound and CLARIX surgical solutions, which are processed with the company’s CRYOTEK cryopreservation technology for preserving biological and structural properties.

Visit www.premierinc.com for more information.

Hemostatic Gauze Chosen for Innovative Pilot Program

A patented hemostatic gauze from United Health Products (Henderson, NV) was selected as 1 of 9 participants in the US Food and Drug Administration’s (FDA) new and innovative “Critical to Quality” (CtQ) Pilot Program. The product, HemoStyp, is derived from regenerated oxidized cellulose and absorbs exudate from superficial wounds and helps control bleeding. Its prior Class II application continues to progress into an advanced stage of review.

The CtQ Pilot Program seeks to identify products that have demonstrated safe interaction with the body to be approved for Class III internal surgical use. With the pilot program, products can enter the market more efficiently as the FDA focuses on a postmarket inspection of CtQ characteristics instead of the standard premarket approval inspection.

Visit www.unitedhealthproductsinc.com for more information.

New Evidence on Bioelectrical Impact on Biofilms

Vomaris Innovations Inc (Tempe, AZ) announced the success of its Advanced Microcurrent Technology in disrupting biofilm in the first controlled, preclinical, in vivo porcine model study. Published in Annals of Surgery, the study found that the bioelectrical antimicrobial technology circumvented biofilm formation, disrupted infection and related pathological complications, and blunted the expression of quorum-sensing genes in bacteria, effectively disabling the structural integrity of biofilm.

The company’s nonantibiotic antimicrobial technology is inspired by the body’s natural electrical healing process. It uses embedded microcell batteries to generate electrical fields similar to the body’s own physiologic electrical fields which are essential for cell migration and wound healing. The currently cleared product has broad indications in the prescription wound care market and is cleared for over-the-counter usage.

Visit www.vomaris.com for more information.

New Educational Program Partnership 

HMP (Malvern, PA), a global leader in health care events and education, has partnered with Daemen College (Buffalo, NY) in the Why Wound Care? initiative. The program educates nursing students, recent graduates, and nursing faculty about rewarding careers in wound care.

Daemen College nursing students and faculty will have access to free educational resources developed by professional wound care nurses, including 12 basic learning module PowerPoints about beginning a career in wound care, 4 advanced learning module PowerPoints for recent graduates and faculty to increase wound care knowledge, 2 interactive video modules, and all 25 chapters of Chronic Wound Care: The Essentials in a downloadable PDF format.

The partnership will formally kick off in the college’s spring semester when select faculty share the opportunity with their nursing students.

Visit www.hmpglobal.com for more information.

Company Purchases Another Distributor 

Coloplast (Humlebæk, Denmark) recently acquired SAS Lilial (Saint- Barthélemy-d’Anjou, Fance) for cash consideration. The deal, valued at €35.5 million or KR 264 million, gives the Danish company control of the privately owned French company which distributes catheter and ostomy supplies from several different manufacturers. In 2016, the company (US headquarters is in Minneapolis, MN) bought Comfort Medical (Coral Springs, FL), a provider of ostomy, urology, continence, and wound care supplies, for $160 million in cash.

Visit www.coloplast.com for more information.

New Patents for Implantable Sacral Neuromodulation Technology Announced

Axonics Modulation Technologies Inc (Irvine, CA) announced that its sacral neuromodulation system, r-SNM, received 7 new patents from the United States Patent and Trademark Office. The most recently issued patents include coverage of the company’s external pulse generator, implantable lead design, and internal system electronics.

The new patents follow the 2016 European CE Mark and Health Canada approvals for the treatment of overactive bladder, urinary retention, and fecal incontinence. The company also recently received an investigational device exemption grant from the US Food and Drug Administration to conduct a study for marketing approval in the United States.

Visit www.axonicsmodulation.com for more information.

Exclusive License for Wound Healing Technology

XCell Biologix (Kennesaw, GA) obtained the exclusive license to a new cell-free treatment for chronic wounds and burns developed at the Wake Forest Institute for Regenerative Medicine (WFIRM; Winston-Salem, NC). The treatment is derived from the placental amnion and can be applied to the skin in a powder, liquid, or spray form, making it a valuable tool to protect, heal, and repair wounds by accelerating wound closure and promoting skin growth.

The worldwide licensing agreement allows XCell Biologix to further develop and commercialize the technology in severe burn and chronic wound markets. In the meantime, WFIRM will complete the initial phase of development as well as a potential small group clinical study.

Visit www.xcellbiologix.com for more information.

New International Wound Care Certification Available

Wound care professionals abroad will now be able to add Wound Care Certified (WCC) to their credentials thanks to an international expansion from the National Alliance of Wound Care and Ostomy (NAWCO; St Joseph, MI). The first group of candidates sat for a proctored board certification exam on December 8, 2017, after concluding an alliance-approved skin and wound management course in Nassau, the Bahamas. 

The certification is a nationally recognized, voluntarily earned, multidisciplinary credential held by more than 22 000 professionals. The NAWCO expects to host additional international certification opportunities in 2018 with its partnership with the Wound Care Education Institute (Plainfield, IL).

Visit www.nawccb.org for more information.

Agreement Between Companies Reached

Axolotl Biologix (Phoenix, AZ) has reached an agreement with AdiMarket (Miami Lakes, FL), a subsidiary of Global Stem Cells Group (Miami Lakes, FL), for worldwide distribution of its regenerative medicine applications. Products from the Phoenix-based company that will be available through the subsidiary’s online store include AxoBioFluid C, a cryopreserved liquid amniotic allograft for the replacement of soft tissue, and AxoBioMembrane, a dehydrated amnion allograft for wound repair, skin replacement, and reconstruction. 

Visit www.axobio.com for more information.

New Satellite Office for Mobile Measurement Tech Company

A program by Cerner Corp (Kansas City, MO) has sparked Tissue Analytics (Baltimore, MD) to open a satellite office near the former’s headquarters. The new office, located in Lenexa, Kansas, will have an 8-person staff and drive strategy and sales for the mobile wound measurement technology. Through the company’s partnership and the Cerner Open Development Experience, Tissue Analytics aims to integrate its wound care image, measurement, and tracking technology into Cerner’s electronic health record systems.   

Visit www.tissue-analytics.com for more information.