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Agreement

neoSurgical signs US distribution agreement with Suture Express

The two companies will work together in order to advance the sales growth within the US

neoSurgical has signed an exclusive US distribution agreement with Suture Express, under the terms of the agreement, Suture Express will distribute the neoClose Laparoscopic Port Closure device. The two companies will work together in order to advance the sales growth within the US. Suture Express will handle all logistics while neoSurgical will be responsible for all commercial efforts.

According to both companies, neoClose brings a simple, intuitive and reliable solution to assist the surgeon in closing port site defects, up to 3cm, following laparoscopic abdominal surgery. By utilising bio-absorbable anchors and a Vector-X closure, neoClosw is changing the standard of care in port site closure. 

neoClose delivers two absorbable AutoAnchor into the abdominal wall, both consisting of a suture and an anchor. The sutures are knotted at the end of a procedure, facilitating approximation of the incision (Figure 1).

Figure 1: neoClose Overview (Credit: neoSurgical)

neoClose’ method of approximation (Vector X) is associated with reduced tension at wound sites compared to more traditional methods of closed loop approximation (Figure 2). According to the company, closed loop approximation in the lower abdomen is associated with a 5% risk of clinically significant pain due to nerve injury. neoClose has the potential to lower this risk, due to reduced tension.

Figure 2: Less Stress with neoClose means potential to reduce complications from port site closure following lap surgery. Sources - 1. Shin JH, Howard FM. Abdominal wall nerve injury during laparoscopic gynecologic surgery: incidence, risk factors, and treatment outcomes. J Minim Invasive Gynecol. 2012 Aug;19(4):448–53. 2. Nawaz Z, Bentley G. Surgical incisions and principles of wound healing. Basic Ski. 2011 Feb;29(2):59–62. 3. Greenberg JA, Clark RM. Advances in suture material for obstetric and gynecologic surgery. Rev Obstet Gynecol. 2009;2(3):146–58. 4. Independent Study completed by the National University of Ireland, Galway. Data on file at neoSurgical. (Credit: neoSurgical)

The standard for port site closure has been Closed Loop Suture. Now, there’s neoClose, which works by the use of a Vector X closure, approximating the tissue together and tying into place for a secure closure with up to 75% less tension compared to standard closed loop suture.

The company believes that minimising wound tension contributes to a suitable environment for optimal wound healing, as over-tightened sutures can lead to tissue necrosis and excessive tissue overlap, which results in reduced tensile strength in the healed tissue.

"neoSurgical is committed to providing new medical technologies that improve patient outcomes and provide clinicians improved workflow. This agreement with Suture Express solidifies our ability to partner with health systems and deliver innovative products, like neoClose, to meet their patients' needs," said Stephen Anderson, Vice President of Sales and Marketing.

"Suture Express is pleased to distribute neoClose, which fits our specialty distribution model perfectly. Customers can enjoy the same reliable, next day delivery of neoClose that they have become accustomed to from Suture Express," said Mark Kenyon, Vice President of Business Development for Suture Express.

In January 2016, neoSurgical revealed that it has begun a Postmarket Surveillance Study of its FDA-cleared device, neoClose, at University of Texas Health Sciences Center at Houston, TX. The randomised study will compare neoClose against the standard of care for closure in a bariatric surgery gastric bypass population of 70 adults aged 18-70 years with BMI>35. Principal investigators include: Drs Erik B Wilson, Professor of Surgery; Peter A Walker, Assistant Professor of Surgery and Shinil K Shah, Assistant Professor of Surgery.

neoClose is approved for sale in the US and Europe. The company’s neoClose system for port site closure has now been used more than 7,000 times in hospitals across the US.

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