New Products and Industry News

Burns treatment device granted earlier approval

Avita Medical Ltd. (Northridge, CA and Cambridge, UK), a regenerative medicine company specializing in the treatment of wounds and skin defects, announced the United States Food and Drug Administration (FDA) has ruled the ReCell^® Autologous Cell Harvesting Device is eligible for earlier regulatory approval for burns treatment in the US.

The FDA’s Center for Biologics Evaluation and Research issued the designation and will now enter into further discussions with the company to resolve a data development plan that will describe the extent of preclinical and clinical data required to support the PMA. A strategic data development plan, combined with priority review, is anticipated to underpin an earlier timeline. The company is currently close to completing enrollment in its FDA approval trial being conducted at 7 of the nation’s leading burns centers, with 26 of the 30-patient target recruited. Before receiving the notice of EAP eligibility, the company estimated regulatory approval would come in Q3 2017, pending submission to the FDA of full safety and effectiveness data, under an application on the PMA regulatory route.

In related news, a series of 12 cases showed a 63% decrease in the length of hospital stay for patients with extensive burn injuries when treated with ReCell®. The findings were presented at the 28th Annual Southern Region Burn Conference, held November 20-22, 2015 in Dallas, TX. The presentation, titled “The Use of ReCell in the Treatment of Large Burns: A Single Center Experience,” achieved second place honors at the event.

For more information, visit: avitamedical.com. 

Hemostatic device cleared for civilians

RevMedX, Inc. (Wilsonville, OR) received United States Food and Drug Administration (FDA) clearance for XSTAT™, a hemostatic device for the control of bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents. The temporary device is for use of up to 4 hours until surgical care is acquired and is intended for use in the battlefield or with patients at a high risk for immediate, life-threatening, and severe hemorrhagic shock and noncompressible junctional wounds when emergency room care is not readily available.

The product works by injecting a group of small, rapidly expanding sponges into a wound cavity using a syringe-like applicator. In a wound, the product’s sponges expand and swell to fill the wound cavity within 20 seconds of contact with blood. This creates a temporary barrier to blood flow and provides hemostatic pressure. Each sponge contains an x-ray detectable marker to aid in surgical removal. The product is contraindicated for use in the thorax, pleural cavity, mediastinum, abdomen, retroperitoneal space, sacral space above the inguinal ligament, or tissues above the clavicle.

For more information, visit: www.revmedx.com. 

Partnership strengthens vascular care franchise market position 

BSN medical (Hamburg, Germany) and Ortopédicos Futuro (Bogota, Colombia) announced a joint venture agreement to strengthen their market position in compression garments in Colombia, Ecuador, and neighboring markets. In their joint effort, the 2 companies will push for national and international expansion. As part of the collaboration, BSN provides a relevant product portfolio as well as capabilities and resources. Ortopédicos Futuro contributes its No-Varix^® compression garments assortment and customer proximity through their 23 shops in Colombia and Ecuador. The joint venture will operate in Colombia as Ortopédicos Futuro Colombia SAS and in Ecuador as Ortopédico Futuro SA, and it includes the company’s current operations in Colombia, Ecuador, and its export markets.

The partnership matches BSN’s strong focus on emerging markets, especially Latin America. BSN gains access to Ortopédicos Futuro’s distributional network in Colombia and Ecuador. This allows BSN to position its lines in an established retail channel, thus significantly increasing its market penetration in one of its strategically prioritized regions. In addition, BSN becomes the exclusive promotion partner for the No-Varix compression garments. The newly formed trading companies in Colombia and Ecuador will profit from the former owner of Ortopédicos Futuro, José Álvaro Pongutá, as he will be a member of the Board of Directors and serve as a consultant.

For more information, visit: www.bsnmedical.com. 

Clinical trials to address dialysis patient infections

ExThera Medical (Berkley, CA) will begin clinical trials in Germany with its Seraph device to treat dialysis patients with Staphylococcus aureus and methicillin-resistant S. aureus (MRSA) bloodstream infections.

Initially, the device will be used in the early treatment of bloodstream infections to prevent severe sepsis and reduce or eliminate intensive care unit stays. S. aureus and drug-resistant MRSA are the most common causes of infection in patients undergoing dialysis for kidney failure, and bloodstream infections are the second-most common cause of death in end-stage renal disease patients. Also, MRSA and S. aureus are common organisms found in wounds.

The study is currently awaiting enrollment of its first patient. Future studies will concentrate on patients whose bloodstream infections have already progressed in severe sepsis or septic shock.

For more information, visit: www.extheramedical.com. 

Cover dressing reduces joint replacement surgery wound complications

The results of a randomized, controlled trial found the use of AQUACEL® Ag SURGICAL Cover Dressing (ConvaTec, Deeside, Flintshire, UK) resulted in a significant reduction in wound complications and dressing changes. The study also showed improved patient satisfaction in patients undergoing total joint arthroplasty as compared to the use of a standard gauze surgical dressing. Results of the trial were published in the American Journal of Orthopedics.

In the trial, 262 patients were randomized to receive either the cover dressing or a standard gauze surgical dressing, following knee or hip replacement surgery.

For more information, visit: www.convatec.com. 

Laser combination therapy is promising for treating cutaneous Leishmaniasis

Research regarding “Ablative fractional laser resurfacing with topical paromomycin as adjunctive treatment for a recalcitrant cutaneous leishmaniasis wound” was selected as Editor’s Choice in the December 2015 issue of Lasers in Surgery and Medicine (LSM).

Leishmaniasis is a parasitic disease found in parts of the tropics, subtropics, and southern Europe. It is caused by an infection with Leishmania parasites, which are spread by the bite of phlebotomine sand flies. Several different forms of leishmaniasis affect people; the most common forms are cutaneous leishmaniasis, which causes skin sores, and visceral leishmaniasis, which affects several internal organs such as the spleen, liver, and bone marrow. Despite an estimated 2 million cases annually due to increased global travel with “imported” cases (particularly cutaneous leishmaniasis) becoming more common in developed, nonendemic countries, current treatment options remain limited. Ablative fractional laser resurfacing represents a treatment option and may address challenges commonly encountered in CL treatment.

To view the complete manuscript, visit: aslms.org/professional/lsmeditorschoice. 

Cellular bone allograft product receives patent

AlloSource® (Centennial, CO), a provider of cartilage, cellular, bone, skin, and soft-tissue allografts for use in surgical procedures and wound care, has been awarded a patent for its regenerative medicine product, AlloStem® Cellular Bone Allograft. The product is suitable for general bone grafting applications. The product is similar to autograft bone because it provides 3 key properties necessary for bone formation: scaffold, signal, and cells. The AlloStem® patent is one of several in the growing portfolio of AlloSource living cell and tissue patents.

For more information, visit: www.allosource.org. 

This article was not subject to the Ostomy Wound Management peer-review process.