New Products and Industry News

Wound and scar care portfolio available

Stratpharma Inc USA (San Diego, CA), a United States subsidiary of Stratpharma AG (Basel, Switzerland), announced the national availability of its wound care and scar management product portfolio. The innovative film-forming, full-contact topical medical products are listed by the United States Food and Drug Administration.

The newly available line includes Stratacel, a film-forming dressing for the periorbital region, lips, and nostrils; Stratamed, a film-forming, gel-based dressing for open wounds and compromised skin and burns; and Strataderm, a daily topical application for both old, new, and abnormal scar management. The company plans to add Stratamark, a treatment for stretch marks, in the near future pending clinical trials in the United States.

For more information, visit www.stratpharma.com. 

Skin infection antibiotic approved by the FDA

A new therapy, Baxdela (Melinta Therapeutics, Lincolnshire, IL), has been approved by the United States Food and Drug Administration (FDA) for treating acute bacterial skin and skin structure infections caused by susceptible bacteria in adults. The fluoroquinolone elicits activity against both gram-positive and gram-negative bacteria and is available as an intravenous or oral formulation.

FDA approval came after the results of several phase III studies demonstrating the therapy was not inferior to the combination of vancomycin and aztreonam after an early clinical response window of 48 to 72 hours. No adverse events on liver or kidney function and glucose regulation were observed, and the drug was well tolerated across all studies.

For more information, visit www.melinta.com. 

Financing agreement secured

ZipLine Medical, Inc (Campbell, CA), completed a $12 million Series E round of financing to support the worldwide commercialization activities for the Zip Surgical Skin Closure product and the development of advanced tools for reducing costs in a bundled care environment. Financing was backed by a new investor, HighCape Partners (New York, NY), and existing investor MVM Life Science Partners LLP (Boston, MA).

The company is an innovator in developing cost-effective, noninvasive surgical skin closure devices that improve surgical efficiency and patient satisfaction. Its leading surgical skin closure product is classified by the United States Food and Drug Administration as Class I, 510(k) Exempt.

For more information, visit www.ziplinemedical.com. 

Wound care integration deal combines technologies

eKare Inc (Fairfax, VA) has entered a deal with SANUWAVE Health Inc (Suwanee, GA) to develop novel wound care analysis and management solutions by integrating technology from both companies. The deal will link SANUWAVE’s wound treatment device, dermaPace, with eKare’s wound imaging and analytic system, inSight 3D.

The imaging device uses computer vision and 3-dimensional sensing technology to collect data and assess wound healing progress; it has both United States Food and Drug Administration 510(k) clearance and CE mark approval in the European Union. The wound treatment device is designed to treat skin conditions such as diabetic foot ulcers and venous leg ulcers. It is licensed for use in Canada, Australia, and South Korea and has CE mark approval in the European Union.

For more information, visit www.sanuwave.com. 

Allograft technology deal announced

Amniox Medical, Inc (Atlanta, GA), a TissueTech Inc (Miami, FL) company, has announced a partnership agreement with Intalere (St Louis, MO), a professional supply chain company serving health care providers. The agreement will fulfill Intalere’s wound care bioactive product category and includes NEOX and CLARIX CORD 1K, 100, and FLO as well as NEOX CORD RT. Member preferred pricing will extend to 3651 acute care hospitals, 174 hospital-based physicians, and 3680 ambulatory surgery centers.

For more information, visit www.amnioxmedical.com. 

Global wound care company names new CFO

Acelity LP Inc (San Antonio, TX), a major global advanced wound care company, announced Tracy Jokinen as the new Executive Vice President and Chief Financial Officer. With more than 25 years of financial experience, Jokinen comes to the position after serving as the CFO of G&K Services (Runnemede, NJ), a uniform and facility services provider. Interim CFO Todd Wyatt will transition into a leadership role within the Acelity senior management team.

For more information, visit www.acelity.com. 

Leadership transitioned in medical technology company

Halyard Health Inc (Alpharetta, GA), a medical technology company, announced the appointment Joseph F. Woody as the company’s new Chief Executive Officer (CEO). Woody has spent his entire career in the medical technology industry, most recently serving as President and CEO of Acelity LP Inc (San Antonio, TX). The appointment comes after the retirement of Robert E. Abernathy. In addition, Woody has been elected to serve on the board of directors while Abernathy will continue as the chairman of the board.

For more information, visit www.halyardhealth.com. 

New outpatient care center opens in Kentucky

Wound Care Advantage (Sierra Madre, CA), a leader in outpatient wound care and hyperbaric treatment centers, partnered with Kentucky-based Clark Regional Medical Center (Winchester, KY) to open the Center for Wound Care. The new outpatient facility will serve Clark County, Kentucky, and the surrounding areas and offer specialized treatment for wounds associated with various conditions, including diabetes.

The medical center is the second facility this year to partner with Wound Care Advantage. In January 2017, the Clark Memorial Hospital in Jeffersonville, Indiana, enlisted the company to manage its already exisiting Wound Healing Center.

For more information, visit www.thewca.com. 

Sterility test methods presented at cell-based therapy summit

Zorina Pitkin, PhD, Senior Vice President of Quality for Organogenesis Inc (Canton, MA), presented the company’s advanced rapid sterility detection techniques to scientists, researchers, and product developers at the Future Cell Therapy Commercialization Summit, held June 26–28, 2017, in Boston, Massachusetts. The summit brings together leaders in cell-based therapy to discover and discuss successful commercialized, personalized, cell-based therapies. Dr. Pitkin’s presentation, “Rapid sterility test method for an allogeneic cell-based therapy product,” reviewed advantages of rapid sterility test methods for cell therapies, approaches to method validation, and challenges to ensuring microbiological safety. The presentation also focused on lessons learned from the implementation of a rapid sterility test method for Apligraf (Organogenesis), a US Food and Drug Administration-approved Class III medical device for treating diabetic foot and venous leg ulcers.

For more information, visit www.organogenesis.com. 

New imaging system is quicker, more accurate

CarePICS LLC (Raleigh, NC), a software developer for health care settings, debuted its Remote Clinical Imagery System at the Premier Inc 2017 Breakthrough Conference and Exhibition (Washington, DC). The product was showcased in the annual Innovation Celebration.

A HIPAA-compliant, noninvasive application, the software features an automatic calibration measurement tool that speeds up wound measurements and improves accuracy. It stores information in real time and in multiple formats, allowing for voice, text, and image sharing among the whole wound care team. The mobile app works across multiple devices and is compatible with major electronic medical record systems.

For more information, visit www.carepics.com. 

Scanner can detect pressure ulcers sooner

A recent study found that the SEM Scanner (Bruin Biometrics; Los Angeles, CA), a wireless handheld scanner, detected pressure ulcers developing under the skin earlier than visual inspection. The results from the study of 182 patients in 12 hospitals, nursing homes, and long-term rehabilitation centers from across the United States and the United Kingdom were presented at the Wound Care: From Innovations to Clinical Trials 2017 in Manchester, United Kingdom. Investigators in the study conducted daily visual skin assessments and scans for up to 20 days and found the scanner detects pressure ulcers earlier than visual evaluation by nurses.

The developer, Bruin Biometrics, included the study findings in a filing to the US Food and Drug Administration for approval to market the device in the United States. The scanner is currently available in the United Kingdom, Ireland, and Canada.

For more information, visit www.bruinbiometrics.com. 

Partnership for wound care research established

Smith & Nephew (London, UK), a global medical technology business, has announced its long-term research partnership with the University of Hull (Hull, United Kingdom). The collaboration will create one of the largest wound care research clusters and aims to develop innovative insights and treatments for advanced wound care. The 5-year deal has a co-investment of £3 million and has created 8 multidisciplinary PhD studentships.

For more information, visit www.smith-newphew.com.