New Products and Industry News

Two major wound care companies combine

  Kinetic Concepts, Inc (KCI, San Antonio, TX) signed a definitive agreement to acquire Systagenix (Gatwick, UK) for a purchase price of $485 million. The combination of the two companies will augment KCI’s global position as a leading wound care company with a diverse product portfolio dedicated to addressing the complete wound healing needs of clinicians and their patients, providing best-in-class outcomes that help reduce the overall cost of patient care.

  The acquisition represents a major step in KCI’s strategy toward increased revenue diversification and geographic expansion. Systagenix has a meaningful presence in the advanced wound care market and is the market leader in collagen dressings. Moreover, as part of KCI, Systagenix’s strength in the growing categories of foam and contact layers can be leveraged to capture increased market share. Many of Systagenix’s products complement KCI’s core negative pressure wound therapy (NPWT) products. The acquisition builds on the KCI’s recent successful acquisition of the CelluTome™ System epigrafting technology and further advances KCI’s reputation as an industry leader with a strong competitive position across the entire wound care continuum.

  Systagenix has a broad portfolio of wound care products with a focus on moist wound healing dressings, including PROMOGRAN PRISMA®, the collagen dressing market leader, TIELLE® (foam), and ADAPTIC® (nonadherent contact layers). Systagenix supplies and distributes more than 20 million advanced wound care dressings each month to more than 100 countries. The company, formerly part of Johnson & Johnson, has approximately 800 employees worldwide, including research and development scientists dedicated to advancing skin and wound care.

  In addition, KCI will enter into a long-term strategic relationship with the diagnostics business for the distribution of WOUNDCHEK™ Protease Status. WOUNDCHEK™ is the flagship product of the Systagenix diagnostics business, designed to help clinicians rapidly assess and target advanced wound care therapies more effectively.

  For more information, contact mike.barger@kci1.com or Paolo.DiVincenzo@systagenix.com.

CMS recognizes Kennedy Terminal Ulcer in long-term care hospitals

  The Center for Medicare and Medicaid Services (CMS) has stated that the Kennedy Terminal Ulcer (KTU) can now be used to avoid reporting a pressure ulcer as a quality measure in long-term care hospitals (LTCHs). Until recently, the CMS had not acknowledged the KTU in its regulatory and reimbursement guidelines for hospitals and nursing homes. This step goes a long way in legitimizing the concept that certain medical conditions can lead to unavoidable pressure ulcers that are not indicative of inadequate quality of care.

  A quality reporting program has already been in effect for Medicare-certified skilled nursing facilities through mandatory documentation in the Minimum Data Set. The CMS has recognized that several conditions in hospitals are reasonably preventable, and will not pay for hospital-acquired conditions, which include Stage III and Stage IV pressure ulcers.

  The LTCH Quality Reporting Program Manual mandates data collection beginning January 1, 2014. The pressure ulcer quality measure requirement is fulfilled by completing the LTCH Continuity Assessment Record and Evaluations Data Set.

  For more information, visit www.jeffreymlevinemd.com/unavoidable-kennedy-ulcer-in-long-term-care-hospitals.

Dressing improves surgical wound outcomes

  Alliqua, Inc (New York, NY) announced the results from a post-marketing study to assess surgical wound outcomes in patients who have undergone foot and ankle surgery. In this study, the company’s SilverSeal® dressing was shown to have a lower incidence of incision complications, including infection, and a greater reduction in scar length compared to standard petroleum-based dressing.

  In this study, patients who had undergone ankle and foot (including forefoot, midfoot, or hindfoot) surgery were randomized to receive either SilverSeal (dressing A) or a standard petroleum-based dressing (dressing B). Patients were monitored for 3 months following surgery to assess degree of scarring and the incidence of incision complications, such as superficial or deep infections or wound rupture along the surgical suture. Of the nine incision complications observed, eight occurred in patients using dressing B and only one in those using dressing A (P = 0.03). Length of postsurgical scarring also was reduced to a greater extent in patients using dressing A compared to those with a standard petroleum-based dressing.

  These results are summarized in a poster, “Utilization of Silver Hydrogel Sheet Dressing on Post-Surgical Incisions: A Pilot Study in Foot and Ankle Surgery,” that was presented at the American Orthopaedic Foot and Ankle Society annual meeting.

  For more information, visit www.alliqua.com.

Skin allograft can be stored at room temperature

  AlloSkin™ RT, a sterile, room-temperature storage skin allograft, promoted the healing of a variety of wound types in a case series conducted by Dr. Michael Molyneaux and Nancy Chatham, RN at a rural outpatient and critical access wound care clinic.

  Providing patients with advanced wound healing solutions in rural outpatient settings is often difficult. One example is having access to human cadaveric allografts, which are a beneficial advanced technology that can be used to treat chronic wounds. Method of preservation (cryopreserved) for these grafts necessitated a -40˚C to -80˚C freezer, which has been a barrier to use in rural practice. The advent of newer room temperature stable grafts has eliminated this problem and allows for easy integration of the product into clinical settings without access to a costly cryofreezer. This was seen in a case series that identified several positives to the use of human cadaveric skin grafting in elderly patients with recalcitrant venous stasis leg ulcers.

  The product eliminates the need for a subzero freezer for storage and subsequent graft thawing in a rural practice setting. Patient benefits include wound bed coverage, migration of wound edges, and granulation, thereby promoting wound healing. In addition, reduced self-reported pain and a corresponding reduction in required pain medication were noted following allograft use.

  For more information, visit www.allosource.org.

National physician education initiative launched

  ACell, Inc (Columbia, MD) launched a national physician education initiative consisting of educational courses, hands-on training, and peer-to-peer events.

  The company is offering a series of educational courses for physicians to advance their knowledge of regenerative medicine and surgical techniques using the MatriStem extracellular matrix for a variety of indications, including hernia/abdominal wall repair, pelvic floor reconstruction, general surgery, wound care, and other indications.

  The hands-on sessions include surgical training presented by thought-leading surgeons at multiple locations across the United States. Upcoming courses will focus on hernia/abdominal wall repair, reconstructive surgery, and pelvic floor repair.

  The company also has established a Speakers Bureau of experts in regenerative medicine. These thought-leading surgeons will present at local and regional physician peer-to-peer events and via webinars to highlight positive clinical outcomes they have achieved using the extracellular matrix.

  For more information, visit www.acell.com.

Company will exceed second quarter expectations

  MiMedx Group, Inc (Marietta, GA) will slightly exceed the $13.5 million high end of its previously communicated revenue range for second quarter of 2013.

  The company’s second quarter of 2013 revenue represents an increase of greater than 175% over second quarter of 2012 revenue and for the 6 months ending June 30, 2013. The company’s revenue increased by more than 190% over its revenue for the first 6 months of 2012. The company reported the second quarter of 2013 marks the seventh consecutive quarter in which it has met or exceeded its revenue guidance.

  The company also increased its guidance for the lower end of its full year 2013 revenue range. It reported that it now expects its 2013 full-year revenue to be in the range of $54 million to $60 million. Where revenue falls within this range is dependent on the reimbursement approval of the three remaining Medicare contractors.

  For more information, visit www.mimedx.com.

Tissue banks helped by skin excision device

  In an effort to increase the yields of quality skin grafts available to patients, Exsurco Medical, Inc (Birmingham, OH), a wholly owned subsidiary of Bettcher Industries (Birmingham, OH), is launching a device for skin excision, the Amalgatome® MD Skin Recovery Device, to the tissue bank industry.

  Designed for cadaveric tissue bank use only, the device offers the only technology of its kind in the tissue excision industry. Current skin recovery technology consists of using a flat-blade device, often called a dermatome, that requires moderate force by the technician, which at times can produce inconsistent skin grafts, and be fatiguing for the operator during a recovery.

  One of many aspects of rotary technology is the improvement in the skin recovery technique; a more maneuverable device can access challenging, hard-to-reach areas. This increases the potential for more transplantable skin grafts that are used to treat severely burned patients and individuals requiring reconstructive surgery due to trauma or disease.

  For more information, visit www.exsurco.com.

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