New Products and Industry News

New advanced foam dressing line released in the US

Acelity^™ (San Antonio, TX), a global advanced wound care and regenerative medicine company, released its TIELLE^™ Foam Dressing Family in the United States. This dressing line expands the company’s industry-leading advanced wound therapeutics portfolio. This expansion complements a broad range of existing solutions for chronic and acute wounds and provides clinicians with efficient and cost-effective options for treating patients. The dressing line was designed to meet the needs of health care professionals, including exudate management and reduced pain for the patient at dressing removal. The availability of these products was announced at the joint meeting of the Symposium of Advanced Wound Care and the Wound Healing Society (SAWC Spring/WHS) in Atlanta, GA, April 13–17, 2016.

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

$30 million secured in financing expansion 

Organogenesis Inc (Canton, MA), a global leader in advanced wound care innovation and technologies, raised approximately $30 million in capital from existing investors to support a significant expansion of the company’s commercial operations, sales force, PuraPly product line, and new product development in the wound care and surgical fields.

The company’s product portfolio expansion includes several additions to the PuraPly wound management line, the launch in the next year of a US Food and Drug Administration (FDA)-approved Class III PMA burn treatment, and new product offerings from the FortaFlex^™ collagen matrix technology platform for soft tissue reinforcement. These portfolio additions will continue to increase the company’s product sales in the outpatient wound healing market and position it for new growth opportunities in the surgical and hospital inpatient markets.

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

Allograft membrane eligible for reimbursement 

Derma Sciences, Inc (Princeton, NJ), a tissue regeneration company focused on advanced wound and burn care, will have their AMNIOEXCEL^® Amniotic Allograft Membrane considered for reimbursement coverage with appropriate documentation of medical necessity for the treatment of chronic wounds of the lower extremity, including both diabetic foot ulcers and venous leg ulcers. Coverage is effective as of April 1, 2016. This results from CGS Administrators, LLC (CGS), a Medicare Administrative Contractor (MAC) for Parts A and B serving Kentucky and Ohio, updating their local coverage determination for cellular or tissue-based products of the lower extremity. CGS is the sixth MAC to issue local coverage determinations for the allograft membrane product

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

Update on matrix product’s commercialization plans

Integra LifeSciences (Plainsboro, NJ), a global medical technology company, is prepared to launch Omnigraft^™ Dermal Regeneration Matrix in June 2016, pending receipt of final FDA packaging approval. The FDA approved the PMA Supplement for Integra^® Dermal Regeneration Template for the treatment of diabetic foot ulcers (DFUs) on January 7, 2016, based on results from the FOot Ulcer New DErmal Replacement (FOUNDER) Study. The published study, one of the largest to support the treatment of DFUs, demonstrated the product increases wound closure by 59%, increases the rate of wound size reduction by 50%, reduces the median time to wound closure by 5 weeks over standard of care, and treats patients with fewer applications than other DFU therapies. The product is indicated for use in the treatment of partial-thickness and full-thickness, neuropathic DFUs >6 weeks in duration, with no capsule, tendon, or bone exposed, when used in conjunction with standard diabetic ulcer care.

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

Cryopreserved umbilical cord product helps heal diabetic foot ulcers 

AMNIOX Medical, Inc. (Atlanta, GA), a TissueTech^™, Inc. company, released the results of a retrospective clinical study of cryopreserved umbilical cord and amniotic membrane tissue for chronic wound management. A review of the effectiveness of NEOX^® Wound Allograft in treating patients with chronic diabetic foot ulcers (DFUs) was presented at Superbones Superwounds East 2016 (Glenpointe, NJ), where the study’s author, Allen Raphael, DPM, was among many top speakers on faculty at the conference.

The retrospective review was conducted on 29 patients presenting with 32 wounds. All wounds were debrided in an operating room or clinic before the cryopreserved umbilical cord product was placed directly over the wound and secured in place with sutures. Of the 32 wounds, 28 demonstrated complete healing to achieve a rate of 87.5%. Initial wound area was an average of 10.6 cm², which is substantially larger than a typical DFU. The average time to healing was 13.79 weeks, and the average number of applications of the product was 1.68. Dr. Raphael concluded cryopreserved umbilical cord is effective in promoting the rapid healing of chronic DFUs, suggesting its usefulness as an advanced tissue treatment modality.

Visit www.amnioxmedical.com for more information. 

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