New Products and Industry News
Wound imaging device assesses for bacteria
MolecuLight (Toronto, Canada), a fluorescence-guided wound imaging technology company, developed a handheld fluorescence imaging device (i:X) that allows clinicians to easily visualize and target bacterial presence and distribution in skin and chronic wounds in real-time at the point of care. This device uses a special light to identify germs in and around the wounded area even when no symptoms of an infection are present. Currently, physicians can detect infection only once it causes obvious symptoms such as redness, swelling, or odor; when infection is suspected, swabs are taken and sent for analysis, which can take several days. The device is being tested at 2 UK hospitals and in 2 trials in Canada. The company plans to introduce it into UK hospitals within the next 3 months.
For more information, visit: www.moleculight.com.
Mobile health app coming to wound care
eKare Inc (Fairfax, VA), a medtech company, will partner with Daewoong Pharmaceutical (Rockville, MD) to market inSight™ in the Asia-Pacific region. The inSight™ Wound Assessment Solution provides accurate and convenient 3D wound measurement and documentation at the point of care for pressure ulcers, diabetic foot ulcers, and other hard-to-heal chronic wounds. Built on top of Apple iPad, this product enables clinicians to obtain a full set of 3D measurements, including depth and volume, by snapping a photo of the wound without direct patient contact. Under the terms of the partnership, Daewoong will work with eKare to obtain regulatory approvals and to manage marketing, sales, and distribution activities of the product in the territory.
For more information, visit: www.ekareinc.com.
Bioengineered blood vessels distributed for phase 3 clinical trials
AlloSource® (Centennial, CO), a provider of cartilage, cellular, bone, skin, and soft-tissue allografts for use in surgical procedures and wound care to advance patient healing, will distribute investigational bioengineered blood vessels for Humacyte’s (Morrisville, NC) phase 3 clinical trials. The first shipment of vessels will be used in the upcoming phase 3 clinical trial, which will investigate the potential of the blood vessels to improve vascular access for hemodialysis patients with end-stage renal disease. The clinical trial will compare the efficacy of the vessels to the current standard of care, synthetic blood vessel replacement with Polytetrafluoroethylene (PTFE) grafts.
The 2 companies entered into a strategic partnership in 2013; AlloSource is the sole manufacturing partner for Humacyte’s blood vessels. The investigational bioengineered vessels are produced using donated human vascular cells that are decellularized to remove the donor identity from the newly created vessels. This process results in the production of investigational human vascular grafts with the potential for implantation into any patient at the time of medical need.
In 2014, the US Food and Drug Administration gave the technology a fast-track designation to help facilitate development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
For more information, visit: www.allosource.org.
Dermal regeneration matrix packaging approved
Integra LifeSciences (Plainsboro, NJ), a global medical technology company, received approval from the US Food and Drug Administration (FDA) for the packaging of their new product, Integra® Omnigraft™ Dermal Regeneration Matrix, which clears the way for its commercial release. The product’s packaging is designed for ease of handling and application in the outpatient wound care setting.
The product is indicated for use in the treatment of partial-thickness and full-thickness neuropathic diabetic foot ulcers >6 weeks in duration, with no capsule, tendon, or bone exposed, when used in conjunction with standard diabetic ulcer care. Integra’s FOot Ulcer New DErmal Replacement (FOUNDER) Study on the product is the largest published DFU study to date evaluating a cellular and/or tissue based product (CTP); it demonstrated significantly improved healing compared to conventional therapy with a median of 1 application (competitive substitutes can require multiple applications to achieve closure), potentially reducing the financial burden for patients and the health care system. More than 124 million covered lives have access to the product through both private insurance and Medicare. Currently, 93% of Medicare patients in 47 states have access.
For more information, visit: www.integralife.com.
Experimental antibiotic soars in pivotal study
Melinta Therapeutics (Lincolnshire, IL), a privately held company developing antibiotics to treat serious bacterial infections, released results from the second phase 3 study of Baxdela, an investigational anionic quinolone in development for the treatment of patients with acute bacterial skin and skin structure infections. The antibiotic met the primary endpoints required by the US Food and Drug Administration as well as the European Medicines Agency in this confirmatory pivotal study.
In the intent-to-treat population (ITT), the IV-to-oral product met the FDA’s primary endpoint of statistical noninferiority (10% noninferiority margin) at the early clinical response at 48–72 hours after initiation of therapy (83.7%) compared to IV vancomycin combination therapy with aztreonam (80.6%). The 95% confidence interval for the treatment difference had lower and upper bounds of -2% and 8.3%, respectively.
For more information, visit: www.melinta.com.
This article was not subject to the Ostomy Wound Management peer-review process.
