Robin Smith
ORIG3N is a biotech company based in Boston, MA. The scientific mission is to deliver a disease-modeling platform targeting rare genetically inherited diseases. By advancing screening projects using iPSC-derived differentiated cells and rapidly delivering the resulting data to inform therapeutic decisions, ORIG3N will replace trial & error guess work of treating disease and enable longer, healthier lives.
ORIG3N
CEOKent Smith
Headquartered in the greater Iowa City area, Corvida Medical innovates intelligent technologies that are designed to represent the next generation of safe handling of hazardous drugs and excellence in design. We address the problems inherent in current methods and develop smarter, simpler solutions to improve safety, productivity and quality for providers and patients. Our first technology, a novel new Closed System Transfer Device – the Halo™ — will be available in 2015.
Corvida Medical
CEODr Daniel Smith
DELSIA is a "venture philanthropy" investment affilate of the research and advocacy foundation Autism Speaks. Our purpose is to transform lives by catalyzing the development and availability of innovative products.
DELSIA is a non-dilutive funding vehicle with the goal of improving outcomes for individuals with autism spectrum disorder (ASD). DELSIA aims to do this by enabling the translation of scientific breakthroughs and technological advances into products that improve health and quality of life for individuals with ASD and their families.
Who and what do we invest in? DELSIA partners with for-profit companies to fund development activities necessary for delivering products that address the diverse unmet medical, behavioral health and quality of life needs of the autism community.
DELSIA accepts funding proposals from for-profit entities that include, but are not limited to:
• Entrepreneurs, start-up and small companies
• Life sciences, biotechnology and pharmaceutical companies
• Software, computer and electronic technology companies
Karen Spilizewski
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.
RiverVest Venture Partners
VPTom Stone
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:
- Surgeons using ProPep System range in experience from less than 200 robotic-assisted, radical prostatectomies (RARP) performed to over 2500
- Patient Benefits:
- 75% of patients achieve better erections as measured by IIEF or SHIM score (validated data collection questionnaires)
- 100% of surgeons report better continence as measured by IIEF
- Surgeon Value:
- 100% of surgeons report that using ProPep
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changes the way they handle tissue during surgery
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makes them more confident of nerve location
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- Over ½ of surgeons report that using ProPep adds less than 5 minutes to their cases
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the remainder report it adds less than 10 minutes
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- 80% feel it should be standard of care for all RARP
ProPep Surgical
CEOLaura Strong
Quintessence Biosciences, Inc. is a private, clinical stage biopharmaceutical company developing novel anti-cancer compounds based on our patented EVade™ Ribonuclease technology. The lead candidate, called QBI-139, completed a first in human dose escalation Phase I clinical trial in patients with solid tumors. Quintessence is looking for funding for a proof of concept clinical trial (Phase Ib/IIa) with a defined patient population.
Ted Tarasow
TRANSVERSE MEDICAL INC is an early stage medical device company focused on the development of innovative technologies addressing the market of aortic embolic protection for Transcatheter Aortic Valve Replacement (TAVR), cardiovascular percutaneous interventions and surgical procedures. TMI’s proprietary Point-Guard™ technology is uniquely designed with the capability to conform to the aortic arch anatomy, deflect and filter embolic material from entering the major cerebrovascular arteries, collateral and adjacent arteries, and upon completion of procedure, safely and effectively remove the system with captured embolic debris.
Stroke rate is substantial in many established and emerging cardiovascular procedures. Of particular interest in the field are the new Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Aortic Valve Implantation (TAVI) procedures. There clearly exists an unmet need for an embolic protection and capture device that can be utilized during the procedures to significantly reduce acute strokes and adverse ischemic events, particularly in heart valve implantation & repair.
The risk of cerebral events and the need for protection during Transcatheter Aortic Valve Replacement is well documented in the literature and discussed by highly recognized key opinion leaders at major medical conferences around the world. Stroke and the incidence of silent embolic events during TAVR are associated with high patient morbidity and mortaility. This awareness of stroke, reported early on in the range of 2% to 11% prior to standardized endpoint definitions, is a concerning complication during TAVR and may have been attributed to early generation devices. However, stroke continues to be reported in TAVR with rates in the range of 0.6% to as high as 7%, remaining roughly double those associated with surgical aortic valve replacment (SAVR). While the clinical and technical challenges of TAVR will continue to be addressed through lower profile devices and operator experience, the risk of stroke remains a major concern.
The market opportunity and adoption for TAVR continues to grow worldwide with a CAGR estimated at 19.8% (2014 to 2018) and worldwide market sales projection of $2.9 Billion in 2018. (Source: David Roman, Managing Dir., Global Investment Research, Goldman, Sachs & Co.). The TMI Leadership Team estimates the Cerebral Embolic Protection Device (CPD) market to be at a conversion rate to CPD during TAVR at 50% by 2018, with worldwide market sales for CPD estimated at approx. $280 to $480 Million with an ASP of $3-5K. The Point-Guard™ advantages are expected to allow it to be used in 50% or more of such cases, projecting gross worldwide revenues of around $146 million by 2018. Complications are limiting market growth (i.e., stroke) - - Controlling stroke (i.e., Point-Guard) can expand the markets and accelerate the expansion of TAVR use to lower risk patients, capture a larger portion of high/intermediate risk patients, set the "standard of care" (e.g 100% carotid filter use in US), and set the standard for other procedures (EP, AF, LAA, etc.). Preliminary data presented at TCT 2014 by Dr. Axel Linke of University of Leipzig Heart Center in Leipzig, Germany showed significant reduction in early cerebrovascular accidents (CVA). Median Total Lesion Volume reported a 65% Reduction; Median Lesion Number reported a 57% Reduction; Rate of CVA reported a 67% Reduction.
TMI is currently developing the POINT-GUARD™ Cerebral Embolic Protection System with VARIFLEX™ Conforming Technology. Point-Guard™ is the first complete embolic protection system engineered with VariFlex™ conforming technology, uniquely designed to conform to the aortic arch and branch artery ostia addressing the concern and possibility of residual flow redirecting around current embolic protection devices. The integration of VariFlex technology allows for maximum wall apposition to cover the aortic arch branch arteries with variable flexibilty and positioning. All other CPDs in the market have only met one or two areas of concern for CPD (Freeman, et al – “With all the embolic protection devices, potential limitations exist.”). The Point-Guard is the only aortic embolic protection device designed to address all key features and functions of embolic protection during TAVR: conformity, deflection, filtration, and capture of emboli upon removal. Point-Guard will be the first cerebral embolic protection system to completely meet operator and procedural needs through ease of use, a low profile, safety and efficacy, compatible, and rapid delivery.
The Point-Guard™ is a class II product in the USA and can be cleared using the 510(k) process, with clinical trial results. The number of clinical trial patients required is to be determined, but anticipated to be fewer than 100, including EU CE Mark clinical trial patients. The CE Mark will be pursued first and is expected to require 50 or fewer patients with 30 day post-procedure follow-up.
TMI has raised $500K in private funding to date, is seeking additional seed funding of $1 million and series A funding of $6 million.
Seed Funding will allow for completion of concept development & design freeze, pre-clinical development, testing, in vitro & in vivo studies, and first in human experience. Full Series A Funding will support European clinical trials (FDA Compatible), clinical product manufacturing & readiness, CE Mark approval & European pre-commercialization launch, strengthen IP and Filings, and general operation & administration.
Transverse Medical, Inc.
DirectorDenise Terry
EmbraceHer is the women's reproductive health club developed by clinicians. We support the lifetime reproductive health of every woman from menstruation, fertility preservation, conception, infertility/IVF, maternity, postpartum, lactation, sexual health and menopause. Our digital platform provides targeted, clinically-sound health education, subscription-based telehealth services, and doctor-curated medical and health products for women.
Our maternity product is the only mobile digital health offering developed and prescribed by Board-certified obstetricians, used by over half a million pregnant mothers.
EmbraceHer Innovations, Inc.
Cofounder & CEODr Scott Thacher
Orphagen’s focus is small molecule discovery at novel drug targets. We create programs leading to first-in-class drugs. Our goal is to partner these with development stage pharmaceutical companies.
We have been first mover in creating three discovery programs for novel targets, including one program that initiated Phase 1 clinical trials with a strategic partner (JT Pharma) in 2013 for autoimmune disease.
We work with novel drug targets from a very productive target class, the nuclear receptors.
Our work has so far been funded by $15 M in federal grants and partnership revenue. Orphagen is in the process of raising equity funding to accelerate current programs.
Orphagen’s lead internal program is for retinitis pigmentosa, the major form of hereditary blindness. Closely following are antagonists to SF-1, a promising target for treatment of Cushing’s syndrome, a life-threatening endocrine disorder, and two cancers with an endocrine connection: prostate cancer and adrenocortical cancer. New target screening may lead to first-in-class programs for glioblastoma, sickle cell anemia, and cancer immunotherapy.