axogen inc (AXGN) Key Developments
AxoGen, Inc. Announces Resignation of Jill Schiaparelli as Chief Marketing Officer, Effective July 10, 2015
Jun 19 15
AxoGen, Inc. announced that its Chief Marketing Officer, Jill Schiaparelli, has resigned from the Company, effective July 10, 2015, to become the President and CEO of a privately-held life sciences company.
Axogen, Inc. Announces Encouraging Results from Pilot Clinical Study of Cavernous Nerve Reconstruction During Radical Prostatectomy Procedures Using its Avance Nerve Graft
Jun 19 15
AxoGen, Inc. has announced encouraging 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' 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. Unfortunately, long-term outcome studies have shown that fewer than 10% of men undergoing non-nerve sparing (bilateral) surgery recover erectile function. In unilateral nerve-sparing cases (those in which one neurovascular bundle is preserved), just 33-53% of men experience recovery of erectile function. 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%. The Study was a single-center pilot study. The primary intent of this Study was to determine the technical feasibility of robotic assisted cavernous nerve reconstruction with the Avance Nerve Graft following robotic assisted laparoscopic prostatectomy. Subjects were followed prospectively in a non-controlled fashion to assess safety, functional outcomes and quality of life including rates of erectile function and continence. It is technically feasible to reconstruct neurovascular bundle using Avance Nerve Graft during robot-assisted laparoscopic prostatectomy. The procedure poses minimal extra burden to the patient without significantly increasing operative time. Recovery of erectile function is promising in patients who had normal pre-op function and underwent unilateral nerve-sparing prostatectomy with per protocol-potency population reporting 70% return of erectile function by IIEF-EF domain scores. The mean time to recovery, IIEF-EF domain score greater than or equal to 13, was 9±6.5 months. Recovery of continence is promising in patients who had normal pre-op function and underwent unilateral nerve-sparing prostatectomy. Continence was restored in 75%, 83% and 92% of subjects by 3, 12 and 24 months after surgery, respectively. The mean time of recovery was 4±6.8 months. There were no reported Avance Nerve Graft related adverse events. Future randomized, controlled studies in a larger population may be warranted to further characterize the benefits of neurovascular bundle reconstruction with Avance Nerve Graft during unilateral or bilateral non-nerve-sparing robot-assisted laparoscopic prostatectomy. Additionally, each patient outcome is dependent upon the nature and extent of nerve loss or damage, the timing between nerve loss and repair, and the natural course of the patient's recovery.
AxoGen, Inc. to Report Q1, 2015 Results on May 05, 2015
May 5 15
AxoGen, Inc. announced that they will report Q1, 2015 results After-Market on May 05, 2015
AxoGen, Inc. Announces Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015; Provides Earnings Guidance for the Year 2015
May 5 15
AxoGen, Inc. announced unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported revenue of $4.951 million for the first quarter ended March 31, 2015, a 58% increase compared to $3.138 million in the year-ago first quarter. Loss from operations was $2.543 million against $2.991 million a year ago. Net loss was $3.575 million or $0.16 per basic and diluted share against $4.239 million or $0.24 per basic and diluted share a year ago. Net cash used for operating activities was $2.513 million against $3.150 million a year ago. Purchase of property and equipment was $0.006 million against $0.195 million a year ago. Acquisition of intangible assets was $0.032 million against $0.008 million a year ago.
For the year 2015, the company announced that given the market's increasing awareness of the company’s product portfolio and the company's plans to expand its sales footprint and sales pipeline, the company is reaffirming its 2015 full year revenue guidance of at least $24 million with annual gross margin in the mid to high 70% range.
AxoGen, Inc. - Shareholder/Analyst Call
Apr 27 15
Annual Shareholders Meeting