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ProPep Surgical, LLC (www.propepsurgical.com), a privately held, Austin-based medical device company develops interoperative  nerve monitoring technologies for laparoscopic and robotic-assisted cancer surgery. 

 It has been well documented in the literature, that anatomic landmarks are not reliable in identifying the location of nerves hidden in tissue and too small to be seen. For decades surgeons have been using nerve monitoring during surgical procedures to provide real-time, accurate information on the condition and location of somatic nerves vital to a patient’s recovery and future quality of life.  The technology has proven to be so valuable that its use is considered standard of care in maxillofacial surgery, spine surgery, and neurosurgery.  

ProPep Surgical has adapted this proven technology to Laparoscopic and Robotic Radical Prostatectomy. The ProPep Nerve Monitoring system interfaces with the Laparoscopic Bipolar Instrument to enable the surgeon to stimulate the neural tissue. Knowing the location of a nerve enables the surgeon to handle that tissue differently in order to avoid nerve damage.

Additional clinical benefits:

The ProPep Nerve Monitoring System has been used during robotic-assisted prostate cancer surgery to not only identify the location of pelvic nerves critical to urinary continence but, most recently, pelvic nerves critical to erectile function.  This is a significant “game changer” because, although incontinence rates as high as 18% have been reported following “successful” robotic-assisted, prostate surgery, erectile dysfunction rates are conservatively reported to be up to 38% post-prostatectomy.  Obviously, a much bigger problem.

Completion of additional investment capital

On March 8th, 2013 our company completed a new investment round of funding with Stella Maris Capital, a venture capital firm.   This investment round included an immediate funding and additional capital based on milestones achievements. The additional capital is currently being funded based on milestone satisfaction. 

Additional Indications for Use:

We have completed  the Hysterectomy clinical study with Dr. John Crane, Director of Robotic Surgery, Banner McKee Medical Center, Loveland, CO to assess feasibility of performing intraoperative nerve monitoring (IONM) on pelvic nerves during robotic-assisted, radical hysterectomies.  Dr. Crane was able to positively identify the perineal branch of the pudendal nerve that plays a key role in urinary continence control.   The 510-k was filed with the FDA on 10/2014 for the Hysterectomy indication and we are awaiting response.  ProPep has also begun to explore the opportunity in the colorectal market and have conducted initial procedures.

Poster presentation at the American Urological Association’s annual meeting

Dr. Ronald Kuhn, Arkansas Urology, presented a poster at the American Urological Association’s annual meeting entitled Results of a Using a New Technology to Improve the Identification and Preservation of Nerve Tissue during Robotic Assisted Laparoscopic Radical Prostatectomy.  The presentation summarized the results of a 20 patient study Dr. Kuhn conducted wherein he evaluated whether the use of the ProPep Nerve Monitoring System would allow him to better identify and thus preserve nerves innervating the Levator Ani (LA) muscle known to play a critical role in urinary continence control.  

The results showed Dr. Kuhn was able to identify the nerves innervating the LA muscle in 100% of the cases.  The results also showed a correlation between 8 week post-op continence and the latency of the Compound Motor Action Potential (CMAP) waveform displayed on the ProPep Nerve Monitoring System.  (The appearance of this CMAP waveform indicates the stimulating probe of the ProPep Nerve Monitoring System is on a nerve.)    

ProPep Surgical awarded CPRIT grant award

ProPep Surgical was honored to be chosen for the Product development grant of 4.4MM from the Texas CPRIT ( Cancer Prevention and Research Institute of Texas).  ProPep plans to use the grant to conduct additional clinical studies, specifically, two clinical studies exploring how the use of the ProPep Nerve Monitoring System can help reduce nerve damage related side-effects such as erectile dysfunction and urinary incontinence in robotic-assisted prostate cancer surgery and urinary and fecal incontinence in robotic-assisted radical hysterectomy surgery. 

Sales

ProPep received FDA 510-k clearance in June of 2012 and launched in the US Q1 2013.  Since product approval  the ProPep Nerve Monitoring System has been used in more than 1000 prostatectomy procedures.   This was completed with one internal rep marketing the product in the field.  In 2014 , the ProPep Nerve Monitoring System is sold via two US distributors. Outside the United States, ProPep continues to expand its distribution network and currently has 25 distributors worldwide.

Results of user survey

ProPep surveyed its customers (surgeons)  regarding their use of the ProPep Nerve Monitoring System and the benefits they are seeing in their patients’ outcomes.  Some of the key findings were:

1. Surgeons using ProPep System range in experience from less than 200 robotic-assisted, radical prostatectomies (RARP) performed to over 2500
2. Patient Benefits:
   1. 75% of patients achieve better erections as measured by IIEF or SHIM score (validated data collection questionnaires)
   2. 100% of surgeons report better continence as measured by IIEF
3. Surgeon Value:
   1. 100% of surgeons report that using ProPep

1.  
   1.  

      1. changes the way they handle tissue during surgery

      2. makes them more confident of nerve location

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   1. Over ½ of surgeons report that using ProPep adds less than 5 minutes to their cases

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   1.  

      1. the remainder report it adds less than 10 minutes

1. 80% feel it should be standard of care for all RARP

Pulse Infoframe Inc strives to improve workflow using computer-assisted capture of patient data for specialists – our cloud based software enables better local and global sharing of the data for those who need it to make decisions – our end-user driven tools analyze the data to advance knowledge and thus patient care. Data can be directly entered into our system, and because we sit on top of any EMR system we access additional data that is not otherwise easily accessible. Once accessed, the data is de-identified, aggregated and mined producing meaningful information for our end-users. 

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We have applied our solution in various clinical verticals including speciality clinics (Melanoma, Oncology, Neonatology, etc), Imaging and PACS systems (with INFINITT PACS, ClearCanvas, etc) and clinical trials (tracking prostate cancer, Pharmacovigilance, economics, etc). Modules are versatile and can be templated to be used in a variety of systems for achieving the best workflow possible.

PxRadia is applying its HD-mAb technology platform to provide increased therapeutic potency to biosimiliar monoclonal antibodies. These antibodies are directed to validated targets such as Her-2, CD-20 and PD-1/PD-L.  We and our partners will share new IP and rights and differentiation from current products in the marketplace.