Cappella Medical Systems Announces First Placements of its New Dual Marker Sideguard® System

GALWAY, Ireland--(BUSINESS WIRE)--Cappella Medical Systems has announced the successful initial placements of its new dual-marker Sideguard® coronary sidebranch stent system by Dr. Antonio Colombo and Dr. Azeem Latib at San Raffaele Hospital in Milan, Italy.

“The additional reference marker is a nice addition to the Sideguard system. The angiographic view that produces the least amount of foreshortening between the two reference markers is helpful and ensures proper placement of the Sideguard system.”

The Cappella Sideguard system is a self-expanding trumpet shaped nitinol stent designed to optimize treatment of bifurcation lesions. The novel, low-profile balloon-catheter delivery system includes proprietary split-sheath technology that helps ensure precise placement. Now, with the introduction of the new dual-marker system, clinicians will have an additional reference point to help visualize the position of the Sideguard system under angiography prior to deployment.

Commenting on the new dual marker Sideguard placement, Dr. Azeem Latib stated, “The additional reference marker is a nice addition to the Sideguard system. The angiographic view that produces the least amount of foreshortening between the two reference markers is helpful and ensures proper placement of the Sideguard system.”

The new Sideguard system with dual reference markers is CE mark approved and available for sale outside of the US. For additional information please visit www.cappella-med.com.

About Cappella Medical Systems

Cappella, Inc. develops novel solutions for the treatment of complex coronary artery disease (CAD) - specifically bifurcation disease. Cappella’s Sideguard® coronary sidebranch technology offers interventional cardiologists a straightforward, effective, solution that focuses on treating the sidebranch of diseased coronary arteries first, rather than the main vessel. Clinicians can then use their preferred stent of choice in the main vessel. The Sideguard delivery system features an innovative split-sheath, balloon released, technology that ensures precise placement on the ostial borderline. The Sideguard self-expanding, nitinol, stent promotes continuous wall apposition and positive remodeling and its’ unique trumpet-shaped design conforms to varying characteristics of the sidebranch ostium. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, please visit the Cappella Medical Systems website at www.cappella-med.com.

Cappella Medical Systems Wins Top Medical Technology Industry Awards

GALWAY, Ireland--(BUSINESS WIRE)--Cappella Medical Systems has received two prestigious medical device awards for 2010. It was honored with the prestigious Medical Technology Company of the Year 2010 award at the fourth annual Medical Technology Industry Excellence Awards, jointly hosted by Enterprise Ireland, IDA Ireland and the Irish Medical Devices Association (IMDA). The IMDA represents over 140 medical devices companies that reside within Ireland. Cappella Medical also won the overall Emerging Company of the Year 2010 award.

Established in Galway in May 2005 and now employing more than 30 staff, Cappella Medical won both awards for creating an innovative solution for the treatment of complex coronary artery disease. Cappella’s Sideguard® is a next-generation, self-expanding ostial protection stent with unique delivery system which offers cardiologists a straightforward, effective solution that focuses on treating the sidebranch of diseased coronary arteries. The CEO of Cappella Medical Systems, Dr. Art Rosenthal, stated, “These awards are confirmation of the unique benefits of our technology. The proprietary Sideguard® balloon activated split-sheath design overcomes the historical problem of implanting self expanding stents. The cardiologist only needs to activate the balloon in customary fashion resulting in quick and precise deployment of the Sideguard® stent. The combined innovations of the Sideguard® delivery catheter and stent design redefine the use of self expanding nitinol stents for cardiology.”

Commenting on the awards, Cappella VP of Engineering, Clinical and Regulatory Affairs, Michael Gilmore said: "I am delighted and honored to accept this award on behalf of the Cappella team. The design and testing of a medical stent is a complex process and I commend each member of the team that brought Sideguard from concept to reality. This award is a wonderful recognition of our work as we look to applying the technology we have created in the development of Sideguard to additional stents for the treatment of coronary artery disease."

The IMDA director Sharon Higgins said: "Despite the current economic climate, we are very much witnessing the fruits of Ireland’s strong and dynamic national innovation strategy. As a young innovative company, Cappella is making an outstanding contribution towards establishing Ireland as ‘Innovation Ireland’ and is a perfect example of how we can retain and grow our position as a world leader in the medical technology sector. It is our pleasure to pay tribute to this up-and-coming medical devices company, and we also warmly commend the other very worthy finalists who each play a vital role in ensuring that Ireland continues to compete on the world stage."

About Cappella Medical Systems

Cappella, Inc. is a medical device company, developing novel solutions for the treatment of complex Coronary Artery Disease (CAD) and specifically bifurcation vascular disease. Cappella’s initial product, the Sideguard® Coronary Sidebranch Stent & Delivery System offers interventional cardiologists a straightforward, effective solution that focuses on treating the sidebranch of diseased coronary arteries first, rather than the main vessel. It allows the clinician’s preferred stent of choice to then be placed in the main vessel. The Sideguard® system combines a proprietary split-sheath technology delivery system that ensures precise placement with a unique trumpet-shape self expanding nitinol design that protects the ostium and promotes continuous wall apposition and positive remodeling. In addition, a new second radio-opaque marker has been added to the catheter as a reference point when visualizing under angiography to help facilitate proper positioning on the ostial borderline. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, please visit the Cappella Medical Systems website at www.cappella-med.com

Cappella, Inc. completed the first tranche of a €10.5 million Series D investment

Cappella, Inc. (Cappella) today announced that it has completed the first tranche of a €10.5 million Series D investment, from existing investors, Polytechnos Partners, ACT Venture Capital, Fountain Healthcare Partners, Mitsui & Co. Venture Partners (MCVP) and venture debt financing from Kreos Capital Limited and Silicon Valley Bank, the commercial banking division of SVB Financial Group (Nasdaq: SIVB).

"Silicon Valley Bank has been dedicated to helping entrepreneurs succeed for nearly 30 years. We are delighted to be in a position to support Cappella with its continued growth as it expands its global network and product pipeline."

Proceeds will be used to finance the expanded launch of Cappella's proprietary Sideguard™ Sidebranch stent for the treatment of Bifurcated Vascular Disease in Europe and South America, to provide additional manufacturing capacity and to advance key R&D programs in Galway on additional applications of Cappella's technology in Complex Coronary Artery Disease (CAD).

Commenting on this financing, Dr. Art Rosenthal, Cappella’s CEO, said "This funding will allow us to expand our direct Sales and Distribution network, expand our product pipeline, provide an additional 7,500 sq. ft. facility for manufacturing capacity and additional R&D laboratory space for our development programs. We believe our proprietary products will treat many types of bifurcation disease, including Left Main Bifurcation Disease and our innovative sheath delivery system for self expanding nitinol devices will give us a platform to expand our range of products and build on the positive market reception of the Sideguard launch."

During the recent Transcatheter Cardiovascular Therapeutics (TCT 2010) Congress Dr Farzin (Faz) Fath-Ordoubadi (Manchester Royal Infirmar, Manchester, UK) presented several cases where the benefit of protecting the ostium with the Sideguard device resulted in positive successful patient outcomes. "The Sideguard technology comes close to the ideal technology as it provides an easy-to-use solution that minimizes procedural time and number of steps. It protects the sidebranch vessel and ostium upon placement and secures access to the main branch at all times. Finally, the stent design is suitable for a variety of bifurcation lesions. Clinical practice with Sideguard indicates excellent acute results; however, I look forward to the 1-year data to confirm that this benefit is sustained with low target lesion revascularization (TLR)."

Phil Cox, Head of UK, Europe and Israel commented: "Silicon Valley Bank has been dedicated to helping entrepreneurs succeed for nearly 30 years. We are delighted to be in a position to support Cappella with its continued growth as it expands its global network and product pipeline."

Eamonn Hobbs, Chairman Cappella's Board stated, "This is a very exciting time for Cappella. The company’s commercial launch which began at the recent TCT meeting in Washington, D.C. is progressing very well and this latest round of funding is a key step that will allow the company to drive market penetration for its Sideguard™ Sidebranch stent product lines while continuing to broaden its product offerings to address what is a large market opportunity by providing an enhanced approach to the current provisional and other sidebranch treatment techniques."

About Cappella Inc

Cappella, Inc. (“Cappella” or the “Company”) is a medical device company that is developing novel solutions for the treatment of Complex Coronary Artery Disease (CAD) and specifically bifurcation vascular disease. The Company’s initial product is the Sideguard™ Sidebranch stent. This technology addresses an unmet medical need in CAD. The company was founded in 2004 by Antonio Columbo, M.D., Chief of Invasive Cardiology at San Raffaele Hospital in Milan, Italy, and Ascher Shmulewitz, M.D., Ph.D., a cardiologist, medical device entrepreneur and founder of NeoVision, Xcardia and Labcoat Ltd., and established its European headquarters in Galway in 2005.

The Sideguard™ Sidebranch stent is an anatomically shaped self-expanding coronary stent that utilizes a unique peel-away delivery system. Both the stent and this delivery system were developed by Cappella Medical Devices Ltd. The unique delivery technology overcomes a number of delivery problems associated with existing nitinol stents, including reduced profile and improved placement accuracy over traditional delivery systems.

Cappella continues to enjoy the support of its strong investor syndicate of Irish and Internationally active venture capital;Polytechnos Venture Partners, ACT Venture Capital, Mitsui & Co Venture Partners, Fountain Healthcare Partners and Enterprise Ireland all of whom remain enthusiastic on the opportunity that Cappella represents in the next generation technologies to treat heart disease.

About Kreos Capital Limited

Kreos Capital is Europe's largest and leading provider of specialty finance to growth companies from early- to late-stage. Since 1998, as the first provider of this kind of financing dedicated to early- to late-stage companies across Europe and Israel, Kreos has adapted the experience of the US model to the European market. Having completed over 250 transactions and committing over $1 billion in 15 countries across Europe and in Israel, Kreos has a proven track record of helping portfolio companies grow throughout their business cycle whilst supporting the objectives of both the portfolio company and their equity sponsors.

About Silicon Valley Bank

Silicon Valley Bank provides commercial banking services to emerging growth and mature companies in the technology, life science, private equity and premium wine industries. Through its focus on specialized markets and extensive knowledge of the people and business issues driving them, Silicon Valley Bank provides a level of service and partnership that measurably impacts its clients’ success. Founded in 1983 and headquartered in Santa Clara, Calif., the company serves clients around the world through 26 U.S. offices and five international operations. Silicon Valley Bank is a member of global financial services firm SVB Financial Group (Nasdaq: SIVB), along with SVB Analytics, SVB Capital, SVB Global and SVB Private Client Services. More information on the company can be found at www.svb.com.

Eamonn Hobbs Accepts Appointment as Chairman of the Board of Directors of Cappella

BOSTON--(BUSINESS WIRE)--Cappella, Inc. (Cappella), a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, announced that Mr. Eamonn Hobbs has assumed the role of Chairman of the Board of Directors, effective immediately. Mr. Hobbs is President, CEO, & Director of Delcath Systems, Inc. and was previously, President and CEO of AngioDynamics (Nasdaq:ANGO), which he co-founded. Mr. Hobbs is an entrepreneurial senior executive with over 30 years of medical device experience and demonstrated outstanding success in growing profitable medical device businesses. Regarding his new position Mr. Hobbs states, “This is an exciting time for Cappella. Cappella is extremely well-positioned to grow its business and take the pole position in the emerging bifurcation market. I am impressed by the achievements of Cappella’s worldclass development team with Art Rosenthal at its helm and look forward to help transform this new medical practice which is now available to interventional cardiologists and their patients into a commercially highly successful company.”

Mr. Hobbs joined Cappella’s Board of Directors early this year and moves now into the Chairman position, previously held by Dr. Wolfgang Oster, MD, PhD, Managing Partner at PolyTechnos Venture-Partners GmbH who will remain a Director. Dr. Oster comments, “I am delighted that Eamonn elevates his presence in the leadership team by assuming the role of Chairman of Cappella. The company has arrived at a juncture which warrants emphasis on commercial objectives and I am certain that Eamonn’s strength and vision will create an eminent position for our technology in the market place.

About Cappella, Inc.

Cappella, Inc. is a medical device company, developing novel solutions for the treatment of complex Coronary Artery Disease (CAD), specifically bifurcation disease. Cappella’s initial product, the Sideguard® Coronary Sidebranch Stent & Delivery System offers interventional cardiologists a straightforward, effective solution that focuses on treating the sidebranch of diseased coronary arteries first, allowing the preferred stent of choice for the main vessel. Optimal self-expanding stent design specific to the anatomy of the sidebranch, combined with the proprietary delivery system provide a dynamic solution for treating sidebranch disease. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, see: www.cappella-med.com

David Blossom joins Cappella as Vice President, Commercial Operations

Cappella, Inc. (Cappella), a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, announced the appointment of Mr. David Blossom as Vice President of Commercial Operations. Mr. Blossom is a seasoned sales and marketing executive with 20 years of medical device experience, most recently at Covidien/Aspect Medical Systems and previously at Boston Scientific. “David provides the exceptional skills and depth of experience needed to lead the commercial effort as we continue to transition from an R&D to a commercial enterprise,” said Dr. Art Rosenthal, CEO of Cappella, “David’s record of success in market development and commercialization of innovative medical devices will have a significant impact as we implement our commercialization plans of the Sideguard® Coronary Sidebranch Stent.”

About Cappella, Inc. 

Cappella, Inc. is a medical device company, developing novel solutions for the treatment of complex Coronary Artery Disease (CAD), specifically bifurcation disease. Cappella’s initial product, the Sideguard® Coronary Sidebranch Stent & Delivery System offers interventional cardiologists a straightforward, effective solution that focuses on treating the sidebranch of diseased coronary arteries first, allowing the preferred stent of choice for the main vessel. Optimal self-expanding stent design specific to the anatomy of the sidebranch, combined with the proprietary delivery system provide a dynamic solution for treating sidebranch disease. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, see: www.cappella-med.com.

Cappella Inc. Secures $17.3 Million Series C Investment

Delaware, Us And Galway, Ireland - Cappella, Inc. (Cappella) announces today that it has completed a $17.3 million Series C investment, led by new investors, Fountain Healthcare Partners and Mitsui & Co. Venture Partners (MCVP). Enterprise Ireland also participated in this round alongside Cappella’s existing investors, Polytechnos Partners and ACT Venture Capital.

Proceeds will be used to finance the launch of Cappella’s proprietary Sideguard™ Sidebranch stent for the treatment of Bifurcated Vascular Disease in Europe and to advance key R&D programs in Galway on additional applications of Cappella’s technology in Complex Coronary Artery Disease (CAD).

Commenting on this financing, Dr. Art Rosenthal, Cappella’s recently appointed CEO, said “This funding will allow us to expand our pipeline, to supplement on-going clinical studies and to successfully launch our first product, the Sideguard™ Sidebranch stent. We believe our proprietary products will treat many types of bifurcation disease, including Left Main Bifurcation Disease. In 2008, this was a $1.0 billion worldwide market and it is growing annually”.

Dr Rosenthal previously served as Chairman and CEO of Labcoat Ltd. and as Chief Scientific Officer of Boston Scientific Corporation. Cappella has also appointed additional senior management to lead European sales and manufacturing activities.

Dr Ena Prosser of Fountain Healthcare Partners commented “We are delighted to invest in Cappella at a very strategic point in the company’s development. From our perspective, Cappella have a differentiated product offering for the treatment of coronary heart disease. Cappella’s impressive management team and top-class scientific advisory board will drive rapid adoption of the Sideguard™ Sidebranch stent in Europe and its successful clinical development in the US”.

Masashi Kiyomine, Principal at Mitsui & Co. Venture Partners, commented: “We are very pleased to have co-led this important round of financing for Cappella, to support the global commercial success of the Sideguard™ Sidebranch stent. With an experienced management team led by Dr. Rosenthal, we believe Cappella is ideally positioned to become the leading provider of innovative solutions for the treatment of bifurcation vascular disease – an area of high unmet medical need”.

Dr Wolfgang Oster, Managing Partner at Polytechnos Venture Partners and Chairman of Cappella’s Board, noted: “As founding investors of Cappella, we are delighted to close this substantial round of finance for a company which we believe has the potential to lead the field of bifurcation devices. The commercial expertise which the new investors bring to the table in Europe, US and Japan is reassuring and will help to accelerate the company’s marketing efforts of its device portfolio. Importantly, the continued participation of our syndicate partners, in particular ACT Venture Capital, in our common cause was a prerequisite to get the company to this exciting value inflection point. ”

In addition to Dr Wolfgang Oster, Dr Art Rosenthal and Dr Ena Prosser, other Board seats will be held by Masashi Kiyomine, MCVP, Dr Ascher Shmulewitz company co-founder, Cappella’s Vice Chairman Charlie Glass of ACT Venture Capital and Dirk Kanngiesser, Polytechnos Venture Partners.

About Cappella Inc

Cappella, Inc. (“Cappella” or the “Company”) is a medical device company that is developing novel solutions for the treatment of Complex Coronary Artery Disease (CAD) and specifically bifurcation vascular disease. The Company’s initial product is the Sideguard™ Sidebranch stent. This technology addresses an unmet medical need in CAD. The company was founded in 2004 by Antonio Columbo, M.D., Chief of Invasive Cardiology at San Raffaele Hospital in Milan, Italy, and Ascher Shmulewitz, M.D., Ph.D., a cardiologist, medical device entrepreneur and founder of NeoVision, Xcardia and Labcoat Ltd., and established its headquarters in Galway, with the backing of Polytechnos Venture Partners and ACT Venture Capital. The Sideguard™ Sidebranch stent is an anatomically shaped self-expanding coronary stent that utilizes a unique peel-away delivery system. Both the stent and this delivery system were developed by Cappella Medical Devices Ltd. The unique delivery technology overcomes a number of delivery problems associated with existing nitinol stents, including reduced profile and improved placement accuracy over traditional delivery systems. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella Inc.

For more information please see http://www.cappella-med.com/

About Fountain Healthcare Partners

Fountain Healthcare Partners (“Fountain”) is a life science focused venture capital fund headquartered in Dublin, Ireland with a second office in New York, US. Fountain specialises in making investments in biotechnology, medical device, specialty pharma and diagnostic companies and allocates the majority of its capital to Europe with a primary emphasis on Ireland. Fountain launched its inaugural fund (Fountain Healthcare Partners I) in May 2008 with €75M in committed capital. www.fh-partners.com

About Mitsui & Co. Venture Partners, Inc.

Mitsui & Co. Venture Partners (MCVP) is a provider of early stage venture capital with expertise in helping U.S. start-up companies build their businesses in global markets. Over the years, MCVP has invested in breakthrough technologies and accelerated the growth of companies across the life sciences, medical devices, communication, software, information technology and cleantech industries. Located in New York, Silicon Valley and Tokyo, MCVP currently manages over $280 million in capital. For more information about MCVP, visit www.mitsuiventures.com/en/

About Polytechnos Venture Partners

PolyTechnos Venture-Partners is an independent European Venture Capital firm focusing on early stage Information Technology and Life Science investments, predominantly in Europe. Areas of expertise comprise Information Technology (communications & networking, electronics & computer hardware, and semiconductors) and Life Science (drug development & medtech), as well as opportunities arising from the convergence of these fields. PolyTechnos currently advises funds totaling approximately EUR 200 million. www.polytechnos.com

About ACT Venture Capital

ACT Venture Capital is one of Ireland's leading venture capital firms. Founded as an independent operation in 1994, ACT has raised over €350m for investment in growing Irish companies, sourced from American, European, Irish and UK institutions and since then has completed over 70 investments, principally in technology based companies serving global markets. ACT’s current portfolio of more than 20 companies comprises many Irish success stories in the Information and Communications Technology and Healthcare sectors.

About Enterprise Ireland

Enterprise Ireland is the government agency responsible for the development of Irish industry. Its core mission is to accelerate the development of world - class Irish companies to achieve strong positions in global markets resulting in increased national and regional prosperity.

www.enterprise-ireland.com

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