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SANTA ROSA, Calif.--(BUSINESS WIRE)--Direct Flow Medical®, Inc., an innovative structural heart company, today announced that D. Scott Lim, MD, will be joining the SALUS pivotal trial as national co-principal investigator. Dr. Lim is an associate professor of medicine and pediatrics for the Advanced Cardiac Valve Center at the University of Virginia (UVA) and medical director of the Bon Secours Virginia Advanced Cardiac Valve Center. He will be leading the SALUS Trial with co-principal investigator Isaac George, surgical director of transcatheter therapies for the Columbia Heart Valve Center at Columbia University Medical Center. Dr. Lim is noted internationally for his expertise in novel percutaneous approaches to heart valve disease, and has been at the forefront of U.S. research into transcatheter aortic valve and mitral valve replacement. Dr. Lim is also the co-director of the Advanced Cardiac Valve Center at UVA. He became the first proctor of the MitraClip procedure in the world. He created and continues to run a humanitarian charity endeavor between UVA and Cedimat hospital in Santo Domingo, Dominican Republic, for the care and education of rheumatic heart disease. Dr. Lim replaces Murat Tuzcu, MD, of the Cleveland Clinic, who was previously national co-principal investigator representing interventional cardiology for the SALUS Trial. Dr. Tuzcu has accepted a position running the Cleveland Clinic program in Abu Dhabi. “Direct Flow Medical has developed an ingenious device that improves upon the limitations of current commercial transcatheter valves,” said Dr. Lim. “I am excited to lead the U.S. research into this novel valve along with Dr. Isaac George, and we fully expect for the SALUS study to validate the clinical and real world results showing the virtual elimination of paravalvular leak and excellent survivability with a superior risk profile.” The SALUS Trial is a prospective, randomized, multi-center, core lab-adjudicated U.S. clinical trial, evaluating the Direct Flow Medical Transcatheter Aortic Valve System. The primary endpoint of the trial is a composite of all-cause mortality and disabling stroke at 12 months. Completion of enrollment in the SALUS Trial is expected by the fourth quarter of 2016. The company has also named the Steering Committee for the SALUS Trial, which will be responsible for advising the investigators and guiding the trial: “Dr. Lim is one of the top interventional cardiologists and TAVR researchers in the country, and we are enthusiastic about welcoming him to the esteemed SALUS team,” said Dan LeMaitre, Direct Flow Medical’s chief executive officer. “As we expand the SALUS Trial into high-risk patients and move from a single-arm to randomized controlled study for FDA approval, we will benefit from his expertise, and that of our Steering Committee. I also want to thank Dr. Tuzcu for his strong leadership of the SALUS Trial and look forward to continuing to benefit from his guidance as part of the Steering Committee.” The Direct Flow Medical system received the CE Mark in January 2013 for the treatment of patients with aortic stenosis who are at extreme surgical risk and is commercially available in Europe. Founded in 2004, Direct Flow Medical, Inc. is a privately-held structural heart company. The Direct Flow Medical Transcatheter Aortic Valve System is commercially available in Europe and is being studied in a pivotal trial in the U.S. The Company is headquartered in Santa Rosa, California, with technology and manufacturing facilities in Lake Forest, California. Direct Flow Medical investors include EDF Ventures, New Leaf Venture Partners, Spray Venture Partners, Foundation Medical Partners, SV Life Sciences, VantagePoint Venture Partners, ePlanet Venture Partners and strategic corporate investors. For further information, please visit the Web site at http://www.directflowmedical.com. The Direct Flow Medical Transcatheter Aortic Valve System has not been approved for sale in the USA, Canada, or Japan. Direct Flow Medical and the Direct Flow logo are registered trademarks of Direct Flow Medical, Inc.


LONDON--(BUSINESS WIRE)--The Dementia Discovery Fund (DDF), an innovative new global investment fund to support discovery and development of novel dementia treatments has launched, raising $100 Million from investors including the UK Government’s Department of Health (DoH) and Alzheimer’s Research UK alongside world-leading major pharmaceutical companies including Biogen, GlaxoSmithKline, Johnson & Johnson, Lilly, Pfizer and Takeda. SV Life Sciences (SVLS), a leading international life sciences venture capital firm, has been appointed as Fund Manager, bringing to the DDF a proven global track record of identifying and supporting the development of novel therapeutic approaches in a range of clinical indications including neuroscience. A world-class Scientific Advisory Board, with representatives from the DDF’s strategic investors and world-leading international academics is being set up to share expertise, expand the DDF’s collaborative networks and advise the investment team. The DDF has been established to deliver new drug approaches for dementia by 2025 to diagnose and intervene early to modify the course of disease while improving symptoms and thereby laying the foundations for effective therapies. The DDF will work collaboratively with universities, academic institutes and the biotechnology and pharmaceutical industry internationally to identify novel dementia research projects and nurture these through the pre-clinical phase, enabling further development in clinical trials. The DDF’s priorities are to explore and develop novel hypotheses in dementia research and to increase global interest and industry confidence in the value of dementia research. Kate Bingham, Managing Partner of SV Life Sciences, commented: “Developing new treatments for dementia is hugely important but also enormously challenging. Very few new therapies have become available in recent years and those on the market all address symptoms and have no effect on the underlying disease. By creating a new source of funding for innovative dementia research and working creatively with researchers, entrepreneurs, charities, industry and Government, we believe the DDF can make a significant difference to the identification and development of new treatment approaches.” Commenting on behalf of the pharmaceutical industry investors, Patrick Vallance, President, Pharmaceuticals R&D, GSK, said: “The scientific community's most powerful tool in its fight against dementia is collaboration, to stimulate new avenues of drug discovery. This is a complex and costly area of research, and if we're to succeed in developing innovative new treatments, we must be prepared to work together and jointly shoulder the risk of ambitious new approaches. This new fund provides the framework for us to do precisely that, bringing together world-leaders in dementia research and combining resources to invest in exciting potential new therapies and start-up companies." Sir David Cooksey GBE Hon FMedSci, who has been advising the Department of Health, added: “This unique initiative will bring much needed new money into dementia research but more importantly represents a new way of doing things. It will ensure some of the best minds in government, industry and the investment community combine their efforts on dementia and create a new path for innovative research to be turned into effective and game-changing treatments.” Dr Dennis Gillings CBE, World Dementia Envoy, added: “Dementia is a ticking bomb and with the global cost of dementia care expected to reach over $1 trillion by 2030 we must continue to do more. Research is currently not delivering the results we need; we need early and accurate diagnosis, effective treatment and improved care and support to avoid serious economic and social impacts. Emanating from the World Dementia Council, the DDF aims to unlock investment and encourage innovation in dementia research and development for this critical global health issue." Matthew Norton, Head of Policy at Alzheimer’s Research UK, said: “A fund of this type is a world-first for dementia research, and Alzheimer’s Research UK is delighted to be part of this unique collaboration to bring much-needed new investment into dementia research. By focusing on new approaches for treating the condition, we hope investments made through the fund will increase our chances of delivering treatments to the people who so desperately need them. With no treatments currently able to tackle the diseases that cause dementia, the condition is arguably our greatest medical challenge and this initiative is a vital part of the fightback.” The Dementia Discovery Fund (DDF) is an innovative global investment fund established in October 2015 to deliver new drug approaches for dementia by 2025 to diagnose, intervene early and treat to modify the course and symptoms of the disease. The DDF, managed by SV Life Sciences, has raised $100 Million from investors including the UK Government’s Department of Health, Alzheimer’s Research UK and world-leading major pharmaceutical companies: Biogen, GlaxoSmithKline, Johnson & Johnson, Lilly, Pfizer and Takeda. The DDF will work collaboratively with universities, academic institutes, Government, the regulatory agencies and the biotechnology and pharmaceutical industry internationally to identify and develop novel dementia research projects. SV Life Sciences is a leading international life sciences venture capital firm. SVLS affiliated funds have been investing in life sciences companies since the early 1980s and the firm closed its first dedicated life sciences fund in 1994. The SVLS team manages five private venture capital funds with approximately $1.9 billion of capital under management. The firm employs a diversified strategy within life sciences in order to selectively capitalise on an expanding opportunity in biotech, medical devices and health-care services. SVLS has offices in Boston, London and San Francisco. ARUK is the UK's leading Alzheimer's research charity aiming to defeat dementia. ARUK powers world class studies that give the best chance of beating dementia sooner and the charity’s pioneering work focuses on prevention, treatment and cure. ARUK is energising a movement across society to support, fund and take part in dementia research and they aim to empower people across all generations through greater understanding of dementia. Through cutting-edge science and medicine, Biogen discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hematologic conditions and autoimmune disorders. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative haemophilia therapies. GSK is one of the world's leading research-based pharmaceutical and healthcare companies. It is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com. Caring for the world one person at a time inspires and unites the people of Johnson & Johnson. Johnson & Johnson embraces research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Their approximately 127,000 employees at more than 265 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Johnson & Johnson Innovation - JJDC, Inc. is the venture capital subsidiary of Johnson & Johnson. It is comprised of experts and leaders in the health care and technology venture communities who identify early market indicators, health care trends, and strategic investment opportunities. Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. It was founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today it remains true to that mission in all its work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit www.lilly.com and http://newsroom.lilly.com/social-channels. Pfizer applies science and its global resources to bring therapies to people that extend and significantly improve lives. It strives to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Its global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer staff work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with their responsibility as one of the world's premier innovative biopharmaceutical companies, they collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on them. To learn more, please visit www.pfizer.com. Located in Osaka, Japan, Takeda is a research-based global company with a main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com. THE INFORMATION IN THIS PRESS RELEASE IS INTENDED TO PROVIDE GENERAL BACKGROUND INFORMATION ABOUT DDF FOR THOSE WITH AN INTEREST IN DEMENTIA RESEARCH. PLEASE NOTE THAT AN INVESTMENT IN DDF IS NOT AVAILABLE TO THE GENERAL PUBLIC. INTERESTS IN DDF ARE BEING DISTRIBUTED ON A PRIVATE PLACEMENT BASIS TO PERSONS WHO ARE, OR MAY BE TREATED ON REQUEST AS, PROFESSIONAL CLIENTS WITHIN THE MEANING OF ANNEX II OF THE MARKETS IN FINANCIAL INSTRUMENTS DIRECTIVE (2004/39/EC)). THIS ANNOUNCEMENT IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA. THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE INTO THE UNITED STATES. THE SECURITIES REFERRED TO HEREIN HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE U.S. SECURITIES ACT OF 1933, AS AMENDED, AND MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES, EXCEPT PURSUANT TO AN APPLICABLE EXEMPTION FROM REGISTRATION. NO PUBLIC OFFERING OF SECURITIES IS BEING MADE IN THE UNITED STATES.


News Article | August 26, 2015
Site: blogs.wsj.com

Venture firm Formation 8 has surpassed its $100 million target for its new hardware fund, and it is eyeing a final close with an undisclosed amount of capital, Yuliya Chernova reports for Dow Jones VentureWire. Formation 8 is among other accelerators and firms that have raised funds, including Lemnos Labs, Bolt, Root Ventures and Playground Global LLC from Android creator Andy Rubin. Formation Partner Lior Susan saidthat startups are increasingly centering their business models not on the hardware but on the data collected by the hardware and on selling the resulting analysis in software form. Soon enough, Mr. Susan said, companies will give hardware away free. Hardware attracted a record amount of venture dollars last year, with $2.76 billion invested, according to data from industry tracker Dow Jones VentureSource. The total for the first half of 2015 was $1.01 billion. Intercom Inc., an enterprise communications company, has raised $35 million in a round led by Iconiq Capital. Other investors in the Series C round include Bessemer Venture Partners and The Social+Capital Partnership. DynoSense Corp., the maker of a health scanner that the company says can measure 33 health metrics in under a minute, has raised a $9.4 million Series A round. The funding was provided by WI Harper Group, JKOM Cloud Health Technology Co., Plug and Play Tech Center, Jinmao Capital, and Wilson, Sonsini, Goodrich and Rosati. Velostrata, a startup developing technology for hybrid cloud solutions, has raised a $14 million Series A round from Norwest Venture Partners and 83North Venture Capital, which was previously known as Greylock IL. ReShape Medical Inc., which recently got regulatory clearance to sell its nonsurgical device for weight loss, has raised a $38 million Series D round to commercialize its technology. The round was led by HealthCor Partners Management, joined by Endeavour Vision SA and existing investors SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners and Venture Investors. CargoSense Inc. has attracted $3.7 million in funding for its logistics software platform. Investors in the seed series preferred round included the Virginia Center for Innovation Technology, New Dominion Angels, Middleburg Capital Development, IrishAngels and individual angels. ELSEWHERE AROUND THE WEB: Google Ventures Funds Swedish VR Gaming Startup. Resolution Games has raised $6 million from Google Inc.’s Google Ventures and other investors to develop virtual-reality games.The cash inflow values the small game studio at roughly $25 million, a person familiar with the matter said. Hardware Startup Augury Nails $7 Million Series A Round. The startup Augury Inc., which says it has figured out a way to troubleshoot machine problems early by listening to the sounds they emit, has raised $7 million in Series A funding, The Wall Street Journal’s Yuliya Chernova reports. Formation 8 led the round using its new hardware-focused fund. Pritzker Group, a family office that has large real estate holdings, is also investing, as well as returning backers First Round Capital and Lerer Hippeau Ventures. Snapchat Names Former Mattel Executive Drew Vollero Its Finance Chief. A former former finance executive at toy maker Mattel Inc. is joining Snapchat Inc., one of the most highly valued private tech startups, to run its finances, the WSJ’s Douglas MacMillan reports. Drew Vollero is joining Spanchat as its vice president of finance and acting chief financial officer. Prenav Seeded for Robot-Guided Drones. Drone startup PreNav has raised $1.2 million for a system that can automatically fly a an unmanned aerial vehicle within centimeters of a structure, allowing for close inspection of it by people who aren’t expert pilots, the WSJ’s Lora Kolodny reports. Investors in PreNav’s seed deal included Pejman Mar Ventures, Drone.vc, Oculus VR co-founder Michael Antonov and Toivo Annus. Airbnb to Start Collecting Tourism Taxes in Paris. Home-sharing company Airbnb Inc. announced that it will begin collecting tourist taxes in Paris as of Oct. 1, the WSJ’s Sam Schichner reports. Paris will be the ninth city in which the company collects hotel taxes. Medtronic to Buy Privately Held Twelve Inc. Medtronic PLC said it has agreed to acquire Twelve Inc. for $458 million, the WSJ’s Ezequiel Minaya reports. Twelve is developing a transcatheter mitral valve replacement device. The startup–backed by investors that include Domain Associates, The Foundry, Morgenthaler Ventures, Split Rock Partners and Versant Ventures–will join Medtronic’s coronary and structural heart division within the cardiac and vascular group. Write to Mike Billings at mike.billings@wsj.com. Follow him on Twitter at @mbillings


SANTA ROSA, Calif. & PARIS--(BUSINESS WIRE)--Direct Flow Medical®, Inc., an innovative structural heart company, today announced 30-day outcomes from the DISCOVER post-market registry that demonstrate excellent real world results for the Direct Flow Medical Transcatheter Aortic Valve System consistent with the ground-breaking results seen in the DISCOVER CE Mark Trial. The data were presented yesterday at the EuroPCR conference in Paris, France by Christoph C. K. Naber, MD, PHD, from the Contilia Heart Center in Essen, Germany. The 30-day data on 250 all-comer patients from the DISCOVER post-market study showed a 98 percent survival rate, which emulated the 99 percent survival rate previously reported at 30 days from the DISCOVER CE Mark Trial. The average age of patients in the trial was 82.5 years, with a mean logistic euroSCORE of 18.3 percent. Mild or less post-procedural aortic regurgitation was achieved in 97 percent of patients, with 80 percent of patients experiencing none to trace aortic regurgitation. The stroke rate and incidence of myocardial infarction within 30 days was low, at two percent and .8 percent, respectively. A low major vascular complications rate of four percent demonstrates the system’s flexibility and trackability even in tortuous anatomy. No patient required rapid pacing during deployment or post-dilatation following deployment, minimizing the risk of hemodynamic stress. In addition, no patient required more than one valve, eliminating the need for a valve-in-valve procedure and the associated negative outcomes observed with non-retrievable transcatheter aortic valves. "Treating patients with the Direct Flow Medical valve in a real-world setting and getting the same consistent results seen in the clinical trial shows outstanding performance," said Dr. Naber. "In daily practice we are faced with patients that are normally excluded by protocol from clinical studies, but these patients need treatment, as well. It is reassuring to know that we can reproduce the same results in challenging clinical scenarios with this valve." The DISCOVER Post-Market Study is a prospective, multicenter, all-comers registry of up to 1,000 patients conducted at up to 75 European sites to evaluate the outcomes of the Direct Flow Medical valve on patients with severe aortic stenosis in routine clinical practice. The fully repositionable and retrievable Direct Flow Medical system is designed to treat patients with severe aortic stenosis, while reducing the risk of post-procedural AR, a strong predictor of long-term mortality. The system addresses this clinical concern by sealing the annulus and enabling complete assessment of hemodynamic performance with unlimited “in situ” repositioning of the valve after full deployment. The system includes a distinctive heart valve with a metal-free frame, delivered transfemorally via the same flexible delivery system for all sizes (23mm, 25mm, 27mm and 29mm). The Direct Flow Medical system received the CE Mark in January 2013 for the treatment of patients with aortic stenosis who are at extreme surgical risk. The system is currently available commercially in Europe and enrolling a pivotal trial in the United States. Founded in 2004, Direct Flow Medical, Inc. is focused on developing novel transcatheter heart valve technologies that improve patient outcomes while reducing patient complications. The company is headquartered in Santa Rosa, California, with technology and manufacturing facilities in Lake Forest, California. The company’s proprietary technology, initially aimed at aortic valve disease, is applicable to a broad range of structural heart diseases. Direct Flow Medical investors include EDF Ventures, New Leaf Venture Partners, Spray Venture Partners, Foundation Medical Partners, VantagePoint Venture Partners, ePlanet Venture Partners, SV Life Sciences and strategic corporate investors. For further information, please visit the Web site at www.directflowmedical.com. The Direct Flow Medical Transcatheter Aortic Valve System has not been approved for use in the USA, Canada, or Japan. Direct Flow Medical and the Direct Flow logo are trademarks of Direct Flow Medical, Inc.


News Article | April 10, 2015
Site: www.fiercemedicaldevices.com

A strategic device company, a former Medtronic ($MDT) president and an award-winning Stanford doctor are among the financiers of Silicon Valley's EBR Systems' attempt to commercialize the first leadless pacemaker implanted in the heart's left ventricle. Along with VCs like Split Rock Partners and SV Life Sciences, the group contributed $20 million toward the groundbreaking effort. The financing will go toward clinical trials to obtain a CE mark as well as an Investigational Device Exemption permission from the FDA to test its device in the U.S. Pacemaker (also known as CRT-D) leads--or wires for stimulating the heart--have been implicated in patient safety scares. In 2012 St. Jude Medical ($STJ) yanked its QuickFlex and QuickSite pacemaker leads from the market after a few broke through their outer insulation. The problem was similar to that experienced by the company's Riata implantable defibrillator leads. Those leads have been implicated in at least two patient deaths, and the company recently agreed to pay as much as $14.25 million to settle about 950 claims related to the component. Another advantage of leadless devices is that they are easier to install in the body, resulting in a fewer complications during surgery. Meanwhile, EBR says its leadless pacemaker would improve efficacy as well. The investigational device is supposed to be implanted inside the heart's left ventricle, allowing so-called endocardial stimulation, while traditional pacemakers perform epicardial stimulation because the leads touch only the surface of the heart. About 30% of patients do not respond to their conventional pacemaker, EBR says. "Wireless pacing enables stimulation of any site inside the heart. That degree of precision and flexibility is a huge advantage over lead-based systems requiring wires. Numerous studies make it clear that the decades-old approach of wired leads has many limitations," said Stanford medical professor Dr. Thomas Fogarty in a statement. He's a recipient of the Presidential National Medal of Technology. "This technology also has huge potential implications for bradycardia, which is an abnormally slow heart rate. We can finally stimulate the left ventricle--which is the best location--instead of settling for the right ventricle. All the data we've seen indicates this can be a significant advance in treatment," Fogarty continued. Another financier in the funding round is Stephen Mahle, former president of Medtronic's Cardiac Rhythm Management division. Leerink Swann equity analysts Danielle Antalffy and Puneet Souda estimate that leadless pacemakers will earn $700 million in 2016. A dual chambered leadless pacemaker that works on both side of the heart has the potential to get the vast majority of the $3.5 billion pacemaker market, they say. St. Jude Medical claims to be working on such a device. The company's leadless Nanostim is CE-marked in Europe, and Medtronic's Micra is believed to be nearing approval on the continent as well. Both are implanted in the right ventricle. Boston Scientific's ($BSX) fast-selling S-ICD has shown the potential of cardiology products that eliminate or lessen the use of leads, albeit in the related but distinct market for implantable defibrillators. Meanwhile, the Nanostim has gotten off to a slow start in Europe after it was associated with a few patient deaths soon after it received a CE mark in 2013. Related Articles: St. Jude settles 70 suits related to Riata defibrillator leads for $14.25 million Analysts bullish on leadless pacing market, call it a $700M opportunity St. Jude Medical will test its leadless pacemaker in a massive EU postmarketing trial Medtronic follows St. Jude Medical with leadless pacemaker U.S. trial milestone St. Jude Medical grabs Nanostim for $123.5M, gaining CE marked leadless pacer Tough luck, St. Jude: No retraction for you


News Article | June 25, 2015
Site: www.xconomy.com

Catabasis Pharmaceuticals has done some strategic tinkering over the past few years, and the Cambridge, MA-based company did a bit more maneuvering on Wednesday to price its IPO. Catabasis is set to debut on the Nasdaq this morning after raising $60 million in an IPO. It had to sell more shares at a lower price than planned to get there, however: Catabasis sold 5 million shares at $12 apiece, coming in just short of the 4.3 million at $13 to $15 apiece it had projected. Shares will begin trading today under the ticker symbol “CATB.” The cash is going towards some early stage trials Catabasis is running for experimental drugs for Duchenne Muscular Dystrophy and high cholesterol levels, respectively. Catabasis just started the first of those trials—a Phase 1/2 study of a prospective Duchenne treatment called CAT-1004—last week. Catabasis was formed in 2008 and built around a technology called  “SMART-Linker” used to attach two compounds together. That resulting combination forms a new chemical entity meant to hit two targets in a disease pathway at once. Its most advanced drug prospect, for instance, CAT-2003, is a chemically linked combination of niacin and the omega 3 fatty acid eicosapentaeonic acid, or EHA; CAT-1004, links a different fatty acid, docosahexaeonic acid (DHA), to salicylate. While CAT-2003 is further along than CAT-1004 in clinical trials (see below for more), Catabasis has clearly prioritized the Duchenne program first—part of a strategic shuffling the company has done to find the best path forward for its technology. CAT-1004, for instance, was first thought to be a potential treatment for type 2 diabetes and later inflammatory bowel disease before its potential for Duchenne came to the fore—it’s meant to tamp down the inflammation associated with the crippling, muscle-wasting disorder and regenerate muscle tissue. Then there’s a newer drug called CAT-2054, a next-gen version of CAT-2003. Catabasis has said that though CAT-2003 has completed three Phase 2a studies for high cholesterol, and that data “support the utility” of the drug’s technology, it’ll only move the drug forward for other serious diseases—like liver cancer—and only with the help of a partner. CAT-2054, meanwhile, began early-stage testing for patients with high cholesterol who don’t respond to other treatments, in January. Initial data from that study were released in early June; full results are expected in the third quarter. (Catabasis used a different chemical linker for CAT-2054; it’s distributed through the body differently than its predecessor, according to the IPO prospectus) With a 25.8 percent stake, SV Life Sciences is Catabasis’s largest shareholder. Others include Clarus Lifesciences II (24.9 percent), MedImmune Ventures (14.8 percent), Advanced Technology Ventures VIII (10.3 percent), and Lightstone Ventures (6.8 percent). The company has raised about $93 million in venture cash and $10 million in debt since it started up seven years ago. Citigroup, Cowen and Co., Wedbush, and Oppenheimer & Co. are underwriting the IPO.


News Article | January 8, 2015
Site: www.fiercemedicaldevices.com

CardioFocus may be gearing up to file a PMA for its HeartLight catheter ablation system. Since the start of the New Year, the company has disclosed that it raised $32 million in a new financing and partnered with Japan Lifeline in an exclusive, multi-year Japan distribution agreement for HeartLight. Expect pivotal data for HeartLight to be forthcoming soon; the startup recently said it's in the analysis phase of its U.S. pivotal trial for HeartLight in symptomatic paroxysmal atrial fibrillation (AF). The company completed enrollment for the trial in October 2013. The randomized, controlled trial involves more than 400 patients at 21 U.S. research centers. The study compares the HeartLight catheter to radiofrequency ablation using the NaviStar ThermoCool Catheter from competitor Biosense Webster. One HeartLight ablation procedure was used in the trial, while a repeat of the procedure was permitted with the ThermoCool system. The system is the first catheter ablation system to incorporate an endoscope for direct visualization of the cardiac anatomy in a beating heart, according to the company. The primary endpoint for efficacy is freedom from documented, symptomatic AF at one year after the procedure. The study also has a primary endpoint for safety. HeartLight has a CE mark. The system includes a balloon catheter, deflectable sheath inducer, endoscope and integrated console. The financial terms of the deal with Japan Lifeline are undisclosed. The partners estimate 1 million people in Japan have AF, which is the most common sustained arrhythmia and is associated with higher risk for stroke and death. "While conventional RF ablation technology to treat AF is widely used, it is typical for patients treated with conventional technology to have their arrhythmia recur after one and even after several ablations," said Dr. Hiroshi Nakagawa, professor of medicine at the University of Oklahoma Health Sciences Center and director of the Clinical Catheter Ablation Program as well as Translational Electrophysiology said in a statement. He added, "The CardioFocus HeartLight is a unique ablation technology that promises to reduce the need for multiple procedures." - here is the SEC filing on the financing - and here is the release on the Japan Lifeline partnership Related Articles: Abbott creates electrophysiology biz by moving in on a trio of NEA startups CardioFocus kicks off EU atrial fibrillation trial CardioFocus raises $30.6M


SANTA ROSA, Calif. & PARIS--(BUSINESS WIRE)--Direct Flow Medical®, Inc., an innovative structural heart company, today announced positive two year data from the DISCOVER CE Mark Trial studying its Direct Flow Medical® Transcatheter Aortic Valve System at the EuroPCR conference in Paris, France. Demonstrating excellent patient outcomes with few complications, the two year data were presented by Antonio Colombo, MD, PhD, from the Ospedale San Raffaele in Milan, Italy. The DISCOVER CE Mark Trial demonstrated an 80 percent survival rate at 24 months, continuing the positive trend showing 90 percent survival after one year and 99 percent after 30 days. All patients experienced mild or less post-procedural aortic regurgitation (AR), with 85 percent having none or trace AR. The mean gradient remained stable at 12.4mmHg at 24 months, compared to 12.6mmHg at 30 days. At the two year mark, 92 percent of patients had improved by more than one New York Heart Association (NYHA) functional class, improving upon the 83 percent of patients that had improved by more than one New York Heart Association (NYHA) functional class at 30 days. All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory and were sustained over time. The fully repositionable and retrievable Direct Flow Medical system is indicated to treat patients with severe aortic stenosis who are at extreme surgical risk, while reducing the risk of post-procedural AR, a strong predictor of long-term mortality. The system addresses this clinical concern by sealing the annulus and enabling complete assessment of hemodynamic performance with “in situ” repositioning of the valve after full deployment. “The 24 month DISCOVER results demonstrate that the initial clinical improvements seen with the Direct Flow Medical valve translate into exceptional long-term outcomes,” said Dr. Colombo. “This next generation TAVI device is the first to report such outstanding results treating an extremely sick patient population.” The DISCOVER CE Mark Trial is a prospective, multi-center study conducted at nine European sites of 100 patients with severe aortic valve stenosis who required replacement of their native aortic valve but were at extreme risk for open surgical repair. The Direct Flow Medical system also avoids both rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients. It includes a distinctive heart valve with a metal-free frame, delivered transfemorally via the same flexible delivery system for all sizes (23mm, 25mm, 27mm and 29mm). The Direct Flow Medical system received the CE Mark in January 2013. The system is currently available commercially in Europe and enrolling a pivotal IDE trial in the United States. Founded in 2004, Direct Flow Medical, Inc. is focused on developing novel transcatheter heart valve technologies that improve patient outcomes while reducing complications. The company is headquartered in Santa Rosa, California, with technology and manufacturing facilities in Lake Forest, California. The company’s proprietary technology, initially aimed at aortic valve disease, is applicable to a broad range of structural heart diseases. Direct Flow Medical investors include EDF Ventures, New Leaf Venture Partners, Spray Venture Partners, Foundation Medical Partners, VantagePoint Venture Partners, ePlanet Venture Partners, SV Life Sciences and strategic corporate investors. For further information, please visit the Web site at www.directflowmedical.com. The Direct Flow Medical Transcatheter Aortic Valve System has not been approved for use in the USA, Canada, or Japan. Direct Flow Medical and the Direct Flow logo are trademarks of Direct Flow Medical, Inc.


PROVIDENCE, R.I. & SAN FRANCISCO--(BUSINESS WIRE)--XIMEDICA, a leading, full service, medical technologies development firm, announced today that it has acquired Bridge Design. Bridge Design, based in San Francisco, CA, provides Ximedica with a West Coast hub and an expanded front-end offering of leading-edge design services for physical and digital products, including mHealth. The acquisition sets the stage for the East-Coast MedTech innovator to enter the country’s foremost high-tech capital, creating a bi-coastal, one-stop-shop union that marries best in class expertise with that of its new subsidiary. “This partnership has been formed to broaden the strength, reach and scale of Ximedica’s comprehensive development offering,” says Randall S. Barko, Ximedica’s Chief Executive Officer and President. “Ximedica brings the regulated systems, procedures and expertise to complement Bridge Design’s two-plus decades of award-winning design in MedTech. By combining these strengths, we bring high value to our clients, offering a cost-effective development approach and a depth of expertise aligned with industry trends for digitally connected solutions.” Aidan Petrie, Chief Innovation Officer and Co-Founder of Ximedica, says, “This is about two organizations who share the same innovative DNA locking arms and setting a new bar for the design and development of medical technologies.” Bridge Design, a Ximedica Company, will continue operating out of its current office in San Francisco, drawing on the back-end capabilities of Ximedica to expand offerings with existing clients while servicing new relationships with key clients on the West Coast. “By joining forces with Ximedica,” says Bill Evans, President of Bridge Design, “we will be able to respond to an increasing demand from our client base for a more comprehensive offering. We believe this will resonate deeply as major growth areas like mHealth build strength. In addition, we are looking forward to scaling our team and talent and fueling a common hunger to solve substantive design problems with elegant and engaging solutions.” Ximedica’s Westward move ties into an ongoing expansion strategy started in the Fall of 2014 when SV Life Sciences, a Boston-based private equity firm, purchased a majority stake in the firm. Barko says, “Ten months ago we partnered with SV Life Sciences and embarked on the next phase of our global growth strategy. The acquisition of Bridge Design moves us further down that path. Bringing together top design and integrated engineering is nothing short of a powerful synergy and we look forward to seeing the impact we can create ahead.” Ximedica is a full-service ISO 13485-certified and FDA-registered product development firm. For 30 years Ximedica has provided a unique growth platform enabling organizations to successfully deploy medical technology products into the market. Its headquarters are in Providence, R.I., with offices in Hong Kong and Minneapolis. In November of 2014, SV Life Sciences, a Boston-based private equity firm, purchased a majority stake in Ximedica. www.ximedica.com Bridge Design, based in San Francisco, has focused for more than two decades on award-winning design of medical and life sciences products – physical and digital. Bridge’s expertise in Design Strategy, Industrial Design and User Experience, fluently merges with Engineering. Clients range from Fortune 500 to startups, including device manufacturers, pharmaceutical, life science firms, as well as companies in consumer health and wellness. www.bridgedesign.com


News Article | January 15, 2015
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The round was led by SV Life Sciences. The company intends to use the funds to grow in the New York metro area. Led by Eric Schweiger, M.D., Founder and C.E.O., Schweiger Dermatology is a provider of dermatology services in the New York metro area which owns and operates 14 dermatology practices in Manhattan, Long Island, Westchester County and northern New Jersey and is pursuing a strategy of growth through selectively building and acquiring dermatology practice offices.

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