USPTO issues Notice of Allowance for INSORB Skin Closure technology

Incisive Surgical, Inc. today announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for another key patent application, "Mechanical Method and Apparatus for Tissue Fastening."  The allowed claims include subject matter covering the method of the INSORB Skin Closure technology and specific stapler features. The Company has now sold over 500,000 INSORB® Absorbable Skin Staplers since its launch in January 2005.  The INSORB Absorbable Skin Stapler is a revolutionary new method of skin closure.  Patients now have a more comfortable, convenient and cosmetic choice for closure of their surgical incisions.  This unique device has won several national awards, including the 2006 Wall Street Journal Technology Innovation of the Year Award for medical devices.  The Company will be exhibiting at the Annual Meeting of the American College of Surgeons being held in Washington, D.C. from October 4 - 6.  

"The issuance of the Notice of Allowance by the Patent Office is further recognition of the important technological advance represented by the INSORB Absorbable Skin Stapler to patients, clinicians and health care facilities," said John L. Shannon, Jr., president and chief executive officer.  The INSORB Absorbable Skin Stapler offers the speed of metal skin staplers with the cosmetic results and comfort of absorbable sutures.  The INSORB Stapler uses bioabsorbable staples that are placed underneath the skin and dissolve in the body within a matter of months.  The staples, which are comprised of the same material as the leading bioabsorbable sutures, break down naturally, meaning there is no need for post-operative removal.  Clinical experience has shown that patients overwhelmingly prefer the absorbable skin staples compared to metal skin staples.  With the issuance of the new patent, Incisive Surgical will hold 5 US Patents and 1 Japanese Patent covering the INSORB Skin Closure Technology, and has additional patents pending.

"I believe the INSORB Stapler will revolutionize the way we handle wound closures in surgery today, and in most cases will replace existing technology," said K. Anthony Shibley, M.D., F.A.C.O.G., Obstetrics and Gynecology Specialists, P.A., Edina, Minn. "In addition to the increased comfort, convenience and the cosmetic advantages of the device, I have experienced a dramatic and significant reduction in surgical site infections and wound complications in my clinical experience with over 420 patients."

Prior to the launch of the INSORB Stapler, only two options were available for closure of long surgical incisions:  sutures or metal skin staples.  While sutures tend to deliver superior cosmetic results compared to metal skin staples — a less noticeable scar evidenced by a flatter, thinner lines, the process increases operating and anesthesia time for longer incisions.  This increases the cost and the potential for patient risk.  Metal staples puncture and pinch the skin, itch and catch on clothing, making them uncomfortable and more prone to infection.  Many patients refer to their metal staple incisions as "railroad track" scars.  Metal staples require removal which may be inconvenient, costly and painful.  The INSORB Stapler offers the comfort, cosmesis and convenience of suture with the speed of a metal stapler, while eliminating the need to remove staples post-operatively.  In addition, the INSORB Stapler eliminates the potential of needlesticks for the operating room staff, and may reduce the potential for wound complications, including surgical site infections.