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Crestone, Inc. is an early stage drug discovery and development company focused on developing novel treatments for serious bacterial infections.  The company currently has two main programs that address areas of significant and growing unmet medical need, both with novel mechanism of action agents.

1.         Novel treatment for Clostridium difficile infections.  CRS3123 is currently in clinical development for the treatment of C. difficile infection (CDI), and is nearing completion of Phase 1.  CDI occurs when toxin-producing bacteria colonize the gastrointestinal tract.  The infection spreads rapidly via spores which contaminate hospitals and nursing homes, and recurrence is a major clinical issue.  Due to the emergence of hyper-virulent drug resistant strains, mortality from CDI has increased over 700% since 1999.  In preclinical studies, CRS3123 shows much lower recurrence compared to vancomycin, a key attribute for improved therapy of CDI.  We seek funding for Phase 2 clinical studies to demonstrate clinical proof-of-concept.

2.         Novel oral agents for Gram-positive infections.  We are developing a novel class of DNA replication inhibitors, currently in advanced preclinical research.  These compounds selectively inhibit an essential component of the replicative DNA polymerase complex and are potent, orally available, and effective against all clinically-relevant Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), penicillin-resistant Streptococcus pneumoniae (PRSP) and Bacillus anthracis (anthrax).  We anticipate development of a drug similar to Zyvox in spectrum, but with key advantages such as rapid bacterial killing and improved safety.  This grant-supported program is expected to produce a clinical candidate in 2015.   

Crestone will develop these programs through key value inflection points in early clinical development, and then share the risk and expense of late-stage trials with a partner.  We have a talented core team in place, and have a plan for strategic hiring to ensure that we can accomplish critical milestones.  We have identified potential candidates to fill a number of key positions, while outsourcing activities that benefit from economies of scale/expertise, including large-scale chemical synthesis, animal testing, clinical trial execution and regulatory affairs.  We have demonstrated the ability to leverage non-dilutive financing to meet critical early milestones, maintaining a semi-virtual structure and low burn rate. 

 Iron Horse Diagnostics, Inc., founded in 2012, has developed breakthrough diagnostic tests in neurologic disorders where there is high-unmet medical need.  We generated and validated diagnostic tests for amyotrophic lateral sclerosis (ALS) and developed assays for traumatic brain injury (TBI) and concussion. Iron Horse Diagnostics has a significant  IP portfolio for these biomarkers in ALS and  TBI, which detects specific biomarker signatures in cerebrospinal fluid and blood in these disease states. We currently are performing a prospective validation of our ALS diagnostic in 4 sites in the US and 2 in Europe.

The ALS test will be commercially available by the end of 2015 anticipating over 300,000 test globally per year. TheTBI test is projected to be market-ready in 36-48 months with 8 Mill. concussion tests in the US alone per year.

Iron Horse Diagnostics has received a fast-track small business grant from the NIH  and funding from Biogen Idec to suppport the clinical validation and commerciliazation of the diagnostic tests in ALS.

Its management team  consists of a seasoned, internally recognized team of scientists, clinicians and business development/regulatory experts. Iron Horse is endorsed by the ALS Association and is working with an international network of clinicians to further the clinical adoption of the ALS test and support reimbursement strategies.

Iron Horse Diagnostics is seeking an investment of 1 Mill. USD to further support the commercialization of the ALS diagnostic test and product development of the TBI test.

WuXi Venture Fund is the corporate venture arm of WuXi AppTec, a multinational CRO based in Shanghai China with multiple offices across China and the United States. The fund makes equity investments into technology and life science companies to enhance or leverage WuXi AppTec's platform capabilities. The investment size will be varied based on a case-by-case basis. The firm invests in life science companies across the globe with an emphasis in China and the US.

Artery Therapeutics is a San Francisco Bay Area based translational biotechnology company with worldwide collaborations. Artery's novel peptide library derived from Apolipoprotein E shows promising results in various animal studies for diseases such as Alzheimer's disease, Diabetes mellitus, and Acute Coronary Syndrome.

JVC Investment Partners is a private investment firm that was founded in 2000 and is based in Chicago, Illinois. The firm focuses on investments in the healthcare industry. The investment size can vary greatly and is very flexible depending on each company’s needs. The firm provides venture capital and growth capital to healthcare companies. For early-stage investments, the firm targets companies that provide solutions for hospital acquired infections, medication errors, healthcare system operational efficiency enhancements and cost reductions, and chronic disease management, and it typically invests equity or convertible preferred equity in post series A rounds. For growth investments, the firm targets companies with compelling products and strong position in niche markets and with an EBITDA in excess of $2 million. The firm primarily invests in companies based in US.

JVC Investment Partners is a private investment firm that was founded in 2000 and is based in Chicago, Illinois. The firm focuses on investments in the healthcare industry. The investment size can vary greatly and is very flexible depending on each company’s needs. The firm provides venture capital and growth capital to healthcare companies. For early-stage investments, the firm targets companies that provide solutions for hospital acquired infections, medication errors, healthcare system operational efficiency enhancements and cost reductions, and chronic disease management, and it typically invests equity or convertible preferred equity in post series A rounds. For growth investments, the firm targets companies with compelling products and strong position in niche markets and with an EBITDA in excess of $2 million. The firm primarily invests in companies based in US.

Avisa Pharma™ Inc., (AVISA) is a Point Of Care, In-Vivo Platform Technology Company With An Innovative, Integrated System For The Rapid Detection And Monitoring Of Respiratory Diseases. A paradigm shift away from lab based In Vitro testing; an In Vivo, point of care, breath test that measures the whole lung, live organisms, not a single culture sample in a petri dish or PCR;for non sputum producers - the only test that can detect lung bacteria without a sputum culture; A razor/razorblade Model to Drive Rapid Market Penetration and Growth.

Focused initially on respiratory health, the clinical study strategy is to pursue fastest route to regulatory approvals, the detection of Tuberculosis (TB), followed by Healthcare Acquired Pneumonia (HCAP), Ventilator Associated Pneumonia (VAP), Cystic Fibrosis (CF) and COPD. These applications have the potential to help save millions of lives and millions of dollars in healthcare costs each year, and a multi billion $ market opportunity.  

$6 million Series A1 Preferred round underway, $4 million received from current investors exercising preemptive rights. Q1 2015 Avisa will be launching a 40 patient pilot TB study in South Africa.

Ischemia Care (ISC) is a clinical stage, capital efficient, venture capital backed, diagnostic laboratory company commercializing ISCDX, a blood test for cause of ischemic stroke (including atrial fibrillation or “AF”), leading to timely diagnosis and treatment, resulting in hospital cost savings and improved patient outcomes. ISC is executing on the Biomarkers of Acute Stroke Etiology (BASE) study , clinicaltrials.gov identifier NCT02014896 to support clinical adoption as an LDT through a company owned CLIA laboratory. ISC's initial focus is on the 40% (320K annually) ischemic strokes which are diagnosed as unkown cause (or "cryptogenic") as these patients typically are undertreaked and at a high risk for recurrence.

Stroke is the third leading cause of death worldwide with 20M annual events. In the US, there are 800K strokes, of which 195K are recurrent. Despite advances in imaging, cardiac monitoring, patient history assessment, and clinical examination, in 40% of ischemic strokes, the cause is unknown (or “cryptogenic”) leading to high recurrence and death.  There are no blood tests for cause of stroke. The identification of cause will change outcomes per Stroke Guidelines by adoption of “cause based” treatment regimen to prevent a more massive, debilitating, and costly recurrence. For example, identifying “undetected” AF in cryptogenic patients provides a 60% risk recurrence reduction.

McDermott Will & Emery is a premier international law firm with a unique focus in representing life sciences companies and investors in a wide variety of transactional, intellectual property and regulatory matters.  Through our Life Sciences Entrepreneurs Acceleration Program ("LEAP") we provide early stage medical device, pharmaceutical, biotechnology and diagnostic companies access to sophisticated legal services.  Learn more here: http://www.mwe.com/leap/

Apple Tree Partners is a private equity fund that was established in 1999 and based in New York, NY, with satellite offices in Princeton, NJ, Cambridge, MA and Brussels, Belgium. The firm controls up to $1.75 billion in assets under management and makes equity investments ranging from $100,000 for academic spinouts to $150 million dollar in later stage deals. The firm seeks to make investments around the globe with a focus on creating and building companies located within the US and Europe.