AxoGen, Inc. Announces Completion of a Pilot Clinical Study Assessing Cavernous Nerve Reconstruction with Avance® Nerve Graft Following Radical Prostatectomy

Study demonstrates technical feasibility and promising ability to restore erectile function and reduce incontinence.

ALACHUA, FL – June 9, 2015 – AxoGen, Inc. (NASDAQ: AXGN), a leading medical technology company focused on the peripheral nerve repair market, announced results from a pilot clinical study of cavernous nerve reconstruction during radical prostatectomy procedures using its Avance® Nerve Graft. Cavernous nerves control erectile function and continence in men and injury to these nerves contribute to some of the troubling complications associated with prostatectomy. AxoGen’s Avance® Nerve Graft is an off-the-shelf processed human nerve allograft used throughout the body for bridging gaps in peripheral nerves. The use of Avance® Nerve Graft to repair nerve discontinuities after radical prostatectomy represents yet another potential market for AxoGen’s products.

The study titled “Robot Assisted Cavernous Nerve Reconstruction with Avance® Nerve Graft following Radical Prostatectomy” (the “Study”) included twelve subjects who had at least one cavernous neurovascular bundle resected and repaired with Avance® Nerve Graft during their prostatectomy and were evaluated up to 24 months post-surgery.

In a radical prostatectomy procedure the goal is to remove cancer cells while protecting erectile function and continence. However, in some cases, to ensure cancer control, the tissue and cavernous nerves surrounding the prostate may be damaged or removed. The ability to repair the nerves at the time of surgery may improve rates of erectile function and continence.

The results of the Study, which confirmed the technical feasibility of nerve grafting using the da Vinci® Robotic Surgical System and Avance® Nerve Graft, may offer hope to patients faced with the prospect of impotence and incontinence following radical prostatectomy. According to the CDC, more than 138,000 men undergo a prostatectomy each year to treat cancer.1 Unfortunately, long-term outcome studies have shown that fewer than 10% of men undergoing non-nerve sparing (bilateral) surgery recover erectile function. 2,3,4 In unilateral nerve-sparing cases (those in which one neurovascular bundle is preserved), just 33-53% of men experience recovery of erectile function.2,3,4 Subjects in the Study who underwent unilateral nerve-sparing and had their cavernous nerves repaired using Avance® Nerve Graft, reported a return of erectile function of 70%. Additionally, continence was restored in 75% of the subjects at 3 months, 83% at 12 months and 92% at 24 months.

“With the high rates of impotence and incontinence common in prostatectomy procedures due to injuries to the cavernous nerves, there is a need for a nerve repair solution to address this problem,” commented Karen Zaderej, AxoGen President and CEO. “Historically this damage has been difficult to treat. Previous studies, in which nerve tissue harvested from elsewhere in the patient’s body (autograft nerve) was used to repair cavernous nerves, have shown inconsistent results. This Study demonstrates that our off-the-shelf Avance® Nerve Graft offers urologic surgeons a convenient tool to perform a reliable reconstruction of the cavernous nerves and provides patients and their families with a potential option to improve quality of life after radical prostatectomy. AxoGen’s products provide solutions for peripheral nerve repair and we continue to identify impactful opportunities for their use.”