Lisa Dreyer - Page 31 - Pappas Capital

Thrasos Secures $35 Million to Fund THR-184 Phase 2 Clinical Program for Treatment of Acute Kidney Injury

MONTREAL, October 25, 2012 – Thrasos Therapeutics announced that it has completed a $35 Million (U.S.) financing for the development of THR-184, its lead product candidate for the treatment of acute kidney injury (AKI). The round was led by new investor, SR One, with funds coming from the GSK Canada Life Sciences Innovation Fund, part of GlaxoSmithKline’s commitment to advance the development and commercialization of scientific innovation in Canada. Five additional new investors and existing investor, SW Co, joined in the round. The new investors were Advanced Technology Ventures (ATV), Fonds de solidarité FTQ, Lumira Capital, MP Healthcare Venture Management and Pappas Ventures. With the financing, Thrasos plans to advance THR-184 through Phase 2 clinical proof of concept in AKI.

Thrasos Therapeutics - 10/25/2012

TYRX(R) Receives Health Canada Approval

MONMOUTH JUNCTION, N.J., Oct 04, 2012 (BUSINESS WIRE) -- TYRX, Inc., the leader in the commercialization of implantable medical devices intended to help reduce surgical site infections, announced today that it has received a license from Health Canada to market its AIGISRx Antibacterial Envelope. The AIGISRx Envelope is specifically designed to stabilize pacemakers and implantable defibrillators while also releasing antimicrobial agents to help provide protection from microbial colonization of the device during surgical implantation.

TYRX - 10/04/2012

FierceMedicalDevices Names TYRX® as one of its “Fierce 15” Medical Device and Diagnostic Companies of 2012

Monmouth Junction, NJ – (October 2, 2012) – TYRX, Inc. announced today that it has been named to the FierceMedicalDevices “Fierce 15” list, designating it as one of the leading medical device and diagnostic companies of 2012.

FierceMedicalDevices Editors Mark Hollmer and Damian Garde, in conjunction with Editor-in-Chief John Carroll and Executive Editor Ryan McBride, chose this year's winners based on their top management teams, notable financial backing, and promising technologies and market opportunities. TYRX was chosen as one of the Fierce 15 based, in part, on its creativity and innovations in the industry.

TYRX - 10/02/2012

CardioDx Honored as One of FierceMedicalDevices’ Fierce 15 Most Promising Private Companies

PALO ALTO, Calif. – Oct. 2, 2012 – CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced that the company has been named one of FierceMedicalDevices’ Fierce 15 most promising privately held medical device and diagnostics companies in the world. FierceMedicalDevices editors chose this year's winners based on their top management teams, notable financial backing, promising technologies and market opportunities. The award was presented today at an event that took place during AdvaMed 2012: The MedTech Conference in Boston, Mass.

CardioDx - 10/02/2012

IlluminOss Medical Secures $28 Million Series C Financing for Minimally Invasive Bone Fracture Repair

East Providence, RI - September 27, 2012 – IlluminOss Medical, Inc., the company pioneering photodynamic orthopedic implants, announced today that it has secured a $28 million Series C round of venture capital financing. Tekla Capital Management, the registered investment advisor to H&Q Life Sciences Investors and H&Q Healthcare Investors (together, the “H&Q Funds”), based in Boston, MA, and Life Sciences Partners, a global healthcare and life science investment firm based in Amsterdam, Munich and Boston, co-led the round with the full participation of the existing investors Foundation Medical Partners, Mieza Capital and New Leaf Venture Partners. Four additional new investors also joined this latest round, including SR One, Excel Venture Management, Pappas Ventures, and the Slater Technology Fund.

Click here to read the full release.

IlluminOss Medical - 09/27/2012

Pappas-backed CoLucid gets FDA accord

September 19, 2012

Durham-based CoLucid Pharmaceuticals, Inc. has reached an agreement with the U.S. Food and Drug Administration’s Division of Neurology Products on the strategy the young pharma will follow in developing its migraine drug candidate.

The drug, lasmiditan, is intended for patients with, or at risk of, cardiovascular disease, as well as patients who haven’t gotten help from some other treatments. Six clinical studies have been successfully completed so far, including a Phase 2b double blind placebo study where the drug achieved its primary endpoint.

Durham-based Pappas Ventures launched the company in 2005. So far, CoLucid has raised about $50 million in multiple rounds, including more than $7 million last year to fund Phase 3 trials of lasmiditan.

CoLucid Pharmaceuticals - 09/19/2012

CoLucid Pharmaceuticals Details Phase 3 Development Strategy for Lasmiditan to Address Major Unmet Needs in Acute Migraine Therapy

Durham, NC, September 18, 2012 /PRNewswire/ -- CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, has reached agreement with the Food and Drug Administration’s Division of Neurology Products concerning the development strategy for lasmiditan at a recently completed End of Phase 2 meeting. Lasmiditan is a novel therapy for acute migraine and will initially be developed to address major unmet needs in two patient populations who are poorly served by currently available therapies: 1) patients with risk factors for cardiovascular disease and those with diagnosed cardiovascular disease and 2) patients who have not had adequate efficacy from triptans. The development program will be confirmed via the Special Protocol Assessment process.

Lasmiditan is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies such as triptans. Lasmiditan is a member of a novel chemical class called “ditans” and, unlike triptans, penetrates the central nervous system (CNS) and selectively targets receptors expressed in the trigeminal pathway. Lasmiditan does not interact with vasoconstrictor receptors on peripheral blood vessels which are activated by triptans.

CoLucid has further evaluated lasmiditan’s cardiovascular profile by recently completing a Thorough QT/QTc study (TQT) titled COL MIG-105: A Randomized, Double-blind, Placebo-controlled, 4-way Crossover Study to Compare the Effects on the Cardiac De- and Re-polarization Duration as well as other Cardiac Safety Parameters of Two Doses of Oral Lasmiditan (100 mg and 400 mg) with those of Moxifloxacin (400 mg) and Placebo in Healthy Subjects. The statistical evaluation of the primary variable revealed that lasmiditan caused no significant QT prolongation either at 100 mg (the putative therapeutic dose) or at 400 mg (supratherapeutic dose), whereas moxifloxacin caused a QT prolonging effect similar to that seen in published studies and thus assay sensitivity for this study was demonstrated. No pro-arrhythmic effect of lasmiditan was observed in the assessments of ECGs made by a cardiologist, and safety and tolerability were similar to observations in previous studies.

”We believe that lasmiditan’s unique central mechanism of action provides acute migraine relief without the associated chest symptoms and vasoconstrictor effects seen with triptans. Lasmiditan could be a very important treatment for those patients who are warned not to take triptans, such as patients with high blood pressure or high cholesterol, obese patients or those with diabetes, smokers and patients with a strong family history of coronary artery disease, post-menopausal women or men over 40 years of age,” commented Thomas P. Mathers, Chief Executive Officer. “There are a large number of acute migraine patients who do not respond to triptan therapy. Lasmiditan could provide an excellent therapeutic alternative for these patients who now frequently turn to opioids.”

About Lasmiditan

Six clinical studies have been successfully completed, including a Phase 2b double blind placebo controlled oral dose ranging study treating a single migraine attack. In the Phase 2b study, lasmiditan achieved its primary endpoint of reducing a moderate or severe headache at baseline to mild or none 2 hours after dosing (p<0.0001) in 391 patients. Differentiation of individual doses from placebo was seen as early as 30 minutes after dosing. Lasmiditan also achieved secondary endpoints, including relief of nausea, photophobia and phonophobia. Importantly, because there was no evidence of drug-related cardiovascular effects or chest symptoms in the previous six clinical studies, CoLucid expects that the pivotal Phase 3 studies will confirm that lasmiditan's side effect profile is highly differentiated from triptans and ergotamines.

About CoLucid Pharmaceuticals, Inc.

CoLucid was founded in 2005 by Pappas Ventures to advance innovative drug candidates with the potential to provide safe and effective treatments for CNS disorders. The company's investors include Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures. The company's pipeline includes lasmiditan, a novel treatment for migraine headache. For more information, please visit CoLucid at www.colucid.com.

CoLucid Pharmaceuticals - 09/18/2012

TYRX(R) Receives New Product Innovation Award

AIGISRx Antibacterial Envelope for Pacemakers and Defibrillators Recognized by Frost & Sullivan

MONMOUTH JUNCTION, N.J., Sep 14, 2012 (BUSINESS WIRE) -- TYRX, Inc., the leader in the commercialization of implantable medical devices designed to help reduce surgical-site infections associated with cardiovascular implantable electronic devices (CIEDs) including pacemakers and implantable defibrillators, announced today that Frost & Sullivan has named the AIGISRx(R) Antibacterial Envelope as the recipient of its prestigious New Product Innovation Award for 2012.

"To date TYRX's AIGISRx is very unique in the fact that it is the first and only antibacterial product of its kind to receive U.S. Food and Drug Administration (FDA) clearance. The product not only helps in stabilizing the pacemaker or ICD, but it also helps reduce infection by delivering antibiotics directly to the surgical site in the first 7 to 10 days following implantation," said Darshana De, IP and Best Practices Analyst from Frost & Sullivan.

The AIGISRx Antibacterial Envelope is designed to address surgical-site infections which are expensive to treat and have a significant impact on patients and hospitals.

Patients suffering from surgical-site infections following CIED procedures:

spend an average of two extra weeks in the hospital
undergo repeat surgical procedures to treat the infection
cost the facility an average of $72,485
experience significant increases in morbidity & mortality, with 1-year mortality rates of 26.5% to 35.1%, depending on device type

The recipient of the Frost & Sullivan New Product Innovation Award is selected after rigorous analysis of industry's leading companies who demonstrate outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development.

"Since TYRX was founded, we have been working diligently to research, develop, and commercialize technologies which help reduce surgical-site infections and improve patient outcomes," remarked Robert White, President and CEO of TYRX. "Our team appreciates Frost & Sullivan's acknowledgement of our product leadership and innovation."

TYRX - 09/14/2012

LipoScience Receives FDA Clearance for Vantera Clinical Analyzer

RALEIGH, N.C.--(BUSINESS WIRE)--September 5, 2012--LipoScience, Inc., an in vitro diagnostic company committed to advancing patient care in cardiovascular, metabolic and other diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the Vantera® Clinical Analyzer.

The Vantera Clinical Analyzer combines nuclear magnetic resonance (NMR) spectroscopic detection and proprietary signal processing algorithms to identify and quantify concentrations of lipoproteins and, potentially, small molecule metabolites. It requires no previous knowledge of NMR technology to operate and has been designed to dramatically simplify complex technology. Ease-of-use and walk-away automation provide efficient workflow to maximize laboratory resources while producing high quality results.

“LipoScience is pioneering a new field of personalized diagnostics based on NMR technology,” said Rick Brajer, Chief Executive Officer of LipoScience. “The FDA clearance of our Vantera Clinical Analyzer is a pivotal event that advances our vision of decentralizing our technology and becoming a clinical standard of care.”

The first assay cleared on this new in vitro diagnostic platform is low density lipoprotein particle number (LDL-P). LDL-P is a key component of LipoScience’s NMR LipoProfile® test, which provides physicians and their patients with actionable information to personalize management of risk for heart disease from a single blood sample. To date, over 8 million NMR LipoProfile tests have been ordered to aid in the management of patients’ heart health.

“Historically, all NMR LipoProfile tests have been performed at LipoScience’s CLIA-certified laboratory in North Carolina,” said Tom Clement, Vice President of Regulatory and Quality Affairs. “The 510(k) clearance of the Vantera Clinical Analyzer will allow us to place Vantera systems in select high-volume national and regional clinical diagnostic laboratories across the U.S., as well as at leading medical centers and hospital outreach laboratories, in order to drive both geographic expansion and the technology adoption necessary for successful execution of our market conversion strategy.”

About LipoScience, Inc.

LipoScience, Inc. is pioneering a new field of personalized diagnostics based on nuclear magnetic resonance (NMR) technology. Its first proprietary diagnostic test, the NMR LipoProfile® test, measures the number of low density lipoprotein particles (LDL-P) in a blood sample and provides physicians and their patients with actionable information to personalize management of risk for heart disease. To date, over 8 million NMR LipoProfile tests have been ordered. LipoScience’s automated clinical analyzer, Vantera has recently been cleared by the FDA and will be placed with national and regional clinical laboratories. LipoScience is driving toward a clinical standard of care by decentralizing its technology and expanding its menu of personalized diagnostic tests to address a broad range of metabolic and other diseases. For further information on LipoScience, please visit www.liposcience.com and www.theparticletest.com.

LipoScience - 09/05/2012

CardioDx Completes $58 Million Equity Financing

CardioDx Completes $58 Million Equity FinancingProceeds to Support Commercial Expansion of Corus CAD and New Product Development

PALO ALTO, Calif. – August 27, 2012 – CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced the completion of a $58 million two-tranche equity financing. The financing included Temasek, an Asia investment company based in Singapore; and existing investors Longitude Capital; Artiman Ventures; Kleiner, Perkins, Caufield & Byers; J.P. Morgan; Mohr Davidow Ventures; TPG Biotech; Intel Capital; Acadia Woods Partners; Bright Capital; the venture arm of RU-COM; Pappas Ventures; DAG Ventures; Asset Management Group; and GE Capital. All previous investors participated in the round.

Proceeds from the financing will be used to support the commercial expansion of Corus® CAD, the only clinically validated gene expression test for obstructive coronary artery disease, and to develop additional genomic diagnostics in the field of cardiovascular disease.

“This funding positions CardioDx well to capitalize on the significant opportunity to improve the diagnosis of the millions of patients who visit their physicians with symptoms suggestive of obstructive coronary artery disease each year,” said David Levison, the company’s President and Chief Executive Officer. “The favorable Medicare coverage decision that we received earlier this month is a significant milestone that further validates the clinical benefit of and economic rationale for Corus CAD. This additional capital will help us expand our sales force in the U.S., further broaden reimbursement coverage, and support continued investments in research and development of new products.”

CardioDx recently announced that Palmetto GBA, a national contractor that administers Medicare benefits, has established coverage for the Corus CAD gene expression test for the evaluation of patients presenting with typical and atypical symptoms suggestive of coronary artery disease. With this decision, the Corus CAD gene expression test is now a covered benefit for more than 40 million Medicare enrollees in the U.S.

Studies have shown that typical and atypical presentations of stable chest pain account for up to two percent of outpatient office visits each year in the U.S., which equates to up to three million patients per year in the Corus CAD intended-use population. However, a study of nearly 400,000 patients published in The New England Journal of Medicine in 2010 reported that as many as 62 percent of stable patients who undergo elective invasive angiographic procedures are found to have no obstructive coronary artery blockage, despite broad usage of prior noninvasive imaging. The authors concluded that current modalities used to identify patients for elective invasive angiography to diagnose obstructive coronary artery disease have limitations, and that better methods are needed for patient risk stratification.

As much as $5 billion is spent on noninvasive testing, imaging and elective invasive angiography in the Corus CAD intended-use population annually in the U.S.

CardioDx - 08/27/2012