News Products and Industry News August

Second US honey-based alginate dressing patent issued

  Derma Sciences Inc (Princeton, NJ) announced that the US Patent and Trademark Office has issued patent No. 7,714,183 related to the Company’s Medihoney® Calcium Alginate Dressing. This newly issued patent increases the barriers to entry for any meaningful competition within the honey, wound, and burn care space. This is the second patent granted in the US covering the company’s line of proprietary honey-based wound dressings and further strengthens the intellectual property on the Medihoney line of dressings, especially with regard to the single-use sterile pouched dressings, most commonly used in the treatment of wounds and burns.

  Alginate is an ideal delivery mechanism for the dressings because it allows the honey to remain on the wound site for an extended period of time; plus, alginates, which are derived from seaweed, are known for their significant absorption capacity and can be removed easily from the wound bed without disrupting the healing process. Their ability to form hydrophilic gel helps contain wound secretions and reduces bacterial contamination. They are preferred dressings for a large percentage of partial-to full thickness, moderate-to-heavily exuding chronic wounds and are indicated for the management of leg ulcers, diabetic foot ulcers, pressure ulcers, first- and second-degree burns, and traumatic and surgical wounds. Alginate dressings are one of the most commonly used dressings within the global $1 billion moist wound dressing market.

  For more information, visit www.dermasciences.com.

Proposed coding to streamline reimbursement process for Medicare providers

  Advanced Biohealing Inc ([ABH] Westport, CN) announced that the Centers for Medicare and Medicaid Services (CMS) recently proposed a new G-code for the application of Dermagraft® with a 0-day global period for the 2011 calendar year. This proposal was included in the Medicare Physician Fee Schedule Proposed Rule released on Friday, June 25, 2010. Dermagraft, a bio-engineered skin substitute approved by the US Food and Drug Administration (FDA) for the treatment of diabetic foot ulcers, is indicated for up to 8 weekly applications over a 12-week period. In the proposed rule, the CMS noted the importance of “ensuring that skin substitutes are properly utilized for Medicare beneficiaries who will benefit from that treatment.” The company has been actively working with CMS officials to advocate for the creation of G-codes for the product to be consistent with the FDA-approved use of the product and to allow appropriate payment with the least administrative burden for Medicare providers and contractors. This proposed rule is a significant step in that direction. Diabetes and diabetic foot ulcers continue to be an epidemic in the US and around the world, so anything that can be done to streamline access to advanced therapies like Dermagraft will help reduce the need for lower extremity amputation and subsequent additional health care costs for both Medicare and beneficiaries.

  The CMS will accept comments on the proposed rule until August 24, 2010 and will respond to them in a final rule to be issued by November 1, 2010. Payment policies and rates adopted in the final rule will be effective for services on or after January 1, 2011. This proposed rule impacts only the application code for Dermagraft; the product code (HCPCS Q4106) will remain unchanged. For more information on this proposed change, please visit page 226 at the following link: https://federalregister.gov/OFRUpload/OFRData/2010-15900_PI.pdf.

  For more information, visit www.ABH.com.

Patent for implantable neuromodulation system and method issued

  Uroplasty Inc (Minneapolis, MN) a medical device company that develops, manufactures, and markets proprietary products for the treatment of voiding dysfunctions, announced the issuance of US Patent No. 7,729,772, which covers a method for using an implantable neuromodulation system in the treatment of urinary incontinence by neuromodulation or stimulation of the tibial nerve. The neuromodulation system includes a portable, external transmitter and a receiver implanted subcutaneously in the leg or ankle near the tibial nerve. The newly issued patent broadens the company’s portfolio of neuromodulation patents, which includes patents covering their Urgent® PC System, a product that has been commercialized in the US since 2006 for the treatment of urinary urgency, urinary frequency, and urinary urge incontinence. Although the company has yet to begin work on product development related to this implantable neuromodulation patent, this newly issued patent could offer an opportunity to broaden their product offering.

  For more information, visit www.uroplasty.com.

Research and development effort expands biotechnology company operations

  Advanced BioHealing Inc ([ABH] Nashville, TN) has expanded company operations in the Nashville area by enhancing its research and development effort. The Nashville area is becoming more widely recognized as a home to the healthcare industry and the company is proud to join the growing biotechnology community. Building on the company’s existing growth plan and its cell-based expertise, the company has established a plan to expand its existing technology and competencies into new indications and therapeutic areas, an effort made possible by their double-digit revenue growth since establishing commercial operations in 2007. To support this effort, the company will be conducting initial research efforts at the Cumberland Emerging Technologies Inc (CET) Life Sciences Center (Nashville, TN) where they are currently leasing lab space. In addition, the company has recently moved its Tennessee-based efforts into new offices in the Overlook Building in Brentwood, Tennessee where they intend to consolidate their Tennessee lab and office facilities.

  For more information, visit www.abh.com.