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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

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

1.  
   1.  

      1. the remainder report it adds less than 10 minutes

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

The Problem: Pharmaceutical development has traditionally focused on intense study of an explicit molecular target related to a specific disease of interest. This strategy is costly and inefficient.

The Solution: We have developed technology that can be scaled to quickly, precisely, reliably, and simultaneously model thousands of genetic diseases in human cells and evaluate the effect of thousands of individual drugs on those disease models. We've built a computational platform that recognizes structural changes in millions of diseased cells and then identifies drugs that return those diseased cells to a healthy state.

Proof of Concept: We have already used an early version of this platform to discover a potential treatment for one genetic disease. We have IP for this drug, and have already been approached about licensing.  We are scaling our platform now to enable us to achieve our goal of discovering and partnering to bring to market treatments for at least 100 genetic diseases in 10 years.

River Cities Capital Fund is a private equity firm founded in 1994 and based in Cincinnati, Ohio. The firm manages approximately $500 million under management and is currently investing out of its 2014 vintage $200 fund. The firm looks to make investments of $5-$15 million initially up to $20 million over the investments lifetime. The firm is willing to invest throughout the United States and is looking to make approximately 4-6 equity investments over the next 6 to 9 months.

RiverVest Venture Partners is a venture capital firm that was founded in 2000 and is based in St. Louis, Missouri with additional office in Cleveland, Ohio. The firm currently has managed over $208 million of total assets. RiverVest has raised two investment funds with total committed capital of $165 million since inception. The recent fund closed at $75 million. RiverVest typically makes equity investments into global companies, and has no specific geographic preferences. The firm will consider making investments at all the stages, and focuses on investments in seed, early-stage and select later-stage companies. The typical investment size is around $6 million, though the firm can invest more or less, depending on the opportunity. 

RiverVest is extremely opportunistic when it comes to investments in the life sciences space; with that being said RiverVests specified sectors and sub sectors of interest may or may not be an area in which RiverVest is currently looking to allocate capital to. The firm invests in companies in the biotech therapeutics and diagnostics, as well the medical technology space. 

Some of the firms investments have included companies developing biotech therapeutics and diagnostics targeting diseases of the blood and blood forming organs, neoplasms, cancer, and oncology, skin and subcutaneous tissue, cardiovascular diseases, diseases of the ear, and infectious diseases. The firm has also invested in companies developing anti-body based therapeutics. The firm has also invested in firms developing medical technologies such as therapeutic radiation devices, active implantable devices, non active implantable devices, hospital hardware, and imaging devices.

SENS Research Foundation is based in Mountain View, CA. The foundation provides grants for research into rejuvenation biotechnologies that prevent or reverse age-related tissue damage. Historically grants have ranged from $40,000 to $200,000 although this range may change in the future. Grants are available to researchers worldwide. SENS requests that grants not be used to cover overhead/facilities costs. At present, 15 projects are being supported.

Seroba Kernel is a venture capital firm based in Dublin, Ireland, with representatives in the United Kingdom. The firm has approximately €100M AUM and focuses solely on the life sciences. The firm has 2 funds and plans to raise a third fund in the near future. The firm typically allocates between €5-7M of equity over the life of the investment. The firm primarily invests in companies that are based in Ireland and Europe. Exceptional opportunities in North America will also be considered. The firm is actively seeking new investment opportunities.