According to the World Health Organization (WHO), stroke (a disruption of blood to the brain) is the second most common cause of death worldwide. For those fortunate enough to survive a stroke, many suffer long-term disability and, despite the best medical technology and surgical therapy, are still at a high risk of reoccurrence. There is an immediate need for innovations that will stop strokes before they start and more effectively treat those that have suffered stroke. Recognizing this and the accompanying untapped market for such technologies, a group of experienced executives and engineers from top-tier medical device companies got together in 2002 to create a start-up firm to meet these needs.
The result was the formation of Merlin MD Pte. Ltd. (Merlin), a Singapore-based medical devices firm specializing in innovating stent devices (tools used to prop open arteries) and other technologies for the treatment and prevention of stroke and cerebral aneurysms. Coming from all over the world, Merlin’s founders chose Singapore as a base because of its strong intellectual property (IP) laws, convenient location among major Asian markets, established infrastructure and easy access to medical professionals and multinational biomedical corporations. In 2003, Merlin launched its first product line, the X*Calibur Bare Metal Coronary Stent (X*Calibur Stent). Various types of stents in this line are sold under the Joyeaux and Falchion brand names. The following year, Merlin started development of its X*Calibur Patch family of products. The first innovation in this line is the X*Calibur Aneurysm Occlusion Device (X*Calibur AOD), an innovative, minimally invasive cranial stent which can clear up aneurysms (a localized, blood filled bulge of a blood vessel caused by disease or weakening of the vessel wall) within a few months.
Merlin’s patented method for treating aneurysms with its X*Calibur AOD (as submitted in PCT application PCT/SG2004/000338, PATENTSCOPE® search)
Merlin’s research and development (R&D) department focuses on developing the X*Calibur Stent and X*Calibur Patch line of products. Building brand identity through new innovation, Merlin’s R&D ensures the company develops products that will help maintain its competitive position in the market. After developing its original X*Calibur Stent product line, Merlin’s founders spoke with medical professionals and were inspired to create a similar device for preventing and treating cranial aneurysms. In Singapore, doctors see over 200 patients a year with ruptured or burst aneurysms, and in the United States alone nearly twelve million people suffer from them. By the time people show the typical symptoms or headaches and blurred vision, they are already in considerable danger.
In 2004, Merlin thus shifted its main R&D focus to finding new ways in which cerebral stents could be produced to successfully prevent and treat brain aneurysms. The result was the creation of X*Calibur AOD, a highly flexible stent coated with a proprietary polyurethane-based polymer that can delicately maneuver through the narrow vessels of the brain. The stent essentially provides scaffolding for new tissue growth in a diseased portion of an artery while it redirects blood flow to vital nearby blood vessels. The aneurysm then slowly shrinks, completely disappearing within a few months. The technology is a vast improvement over current methods, comparatively cheaper in terms of overall hospital charges, minimally invasive, and arteries that have been treated remain clear with no incidence of aneurysm re-growth. Initial animal and human testing started in 2006, and in early 2010 formal clinical trials were started in Spain and Germany. Through these trials Merlin hopes to obtain a CE mark (a European conformity mark certifying that a product has met European Union safety, health and environmental standards) for the X*Calibur AOD in the third quarter of 2010.
Although R&D for Merlin’s innovations can be long, this is required by the nature of the developed products. Many tests must be performed and governmental approval in the country of testing must be granted before clinical trials can take place. The firm must also complete market studies to see if clinical testing is feasible in a given market. For example, Merlin chose to do its initial clinical trials in Brazil, but high costs and complex regulatory hurdles proved to be difficult challenges, so testing was moved to Mexico.
Another focus of the firm’s R&D is on creating innovations that are customized to fit the disease, physiology and market patterns of untapped Asia Pacific markets, taking specific pricing and medical requirements into account. For example, when it first introduced its X*Calibur Stent, the firm benchmarked it against existing devices on the market and in so doing was able to enhance its product design to achieve superior performance. Merlin also takes advantage of the many R&D institutions in Singapore, and has established research collaboration programs with Singapore’s National Heart Center and the Nanyang Technological University. Merlin also has a facility in Berkeley, California, United States, which supports the R&D efforts of the main Singapore office. The Berkeley facility also laser cuts X*Calibur AOD stents and then ships them to Singapore for application of the proprietary polymer.
Merlin believes that the main economic value of their company lies in its intellectual property (IP), and the asset appreciation of their IP is an important factor in securing investors and future customers. To ensure that this continues, Merlin’s IP strategy is to file regional and foreign applications to cover key markets for its products worldwide. The firm applies for intellectual property protection for both innovations under development and future products that are at the concept stage. Prior to applying for IP protection, Merlin assesses its developed technology both internally and with its law firm through prior art searches.
Merlin’s X*Calibur trademark (IPOS No. T0318533B)
Merlin filed a patent application based on its proprietary technology for its X*Calibur AOD with the Intellectual Property Office of Singapore (IPOS) in 2004 and also has made many other IPOS applications, among which include an application for its X*Calibur Stent. Merlin also files regional and foreign applications in key markets such as the United States and Europe. Merlin’s patent portfolio includes technologies in the areas of delivery systems and implant devices for intracranial and coronary applications and cellular management with coating technology. Merlin has made more than eight international applications filed via the Patent Cooperation Treaty (PCT) relating to its innovations and methods that reduce restenosis (the narrowing of blood vessels) and help to clear up aneurysms.
Merlin has filed three trademark applications with the IPOS for its X*Calibur, Joyeux and Falchion products. Merlin also has plans to file a national trademark application for its “Merlin MD” name.
Merlin is party to an exclusive licensee agreement with The Johns Hopkins University for several pioneering patents which enhance its product development strategy for stroke management and vasculature disease. Merlin also licenses selected products for the United States and Europe, which allows the company to create a portfolio of products that are ideally suited to Asia Pacific markets in the shortest time possible.
Merlin commercializes its products itself and currently markets its X*Calibur Stent throughout Asia, with most sales coming from India, China and Southeast Asia. In addition to its own products, Merlin also distributes Merit Medical (a leading manufacturer of devices for cardiology and radiology procedures) products in the region. Developing relationships with influential professionals in the medical industry in target markets is an important part of Merlin’s commercialization efforts. Doing so builds up Merlin’s credibility among local doctors who then endorse its products, thus allowing Merlin to expand its market.
Innovation through R&D is at the core of Merlin’s strategy, and this has brought in significant investment. From its founding until 2007, Merlin attracted US$7 million in investment, with another US$20 million in 2007. From 2005 – 2010, Merlin consistently received enough investment to cover its yearly average R&D expenditures of US$1.2 million. This has given Merlin the necessary resources to work with physicians in the region to develop new products and conduct clinical trials to give them the precision tools that they need to effectively treat their patients.
With the increasing prevalence of stroke related deaths, innovative tools and procedures have never been more important. Merlin has made considerable progress in developing new treatments and products. Securing IP protection for its innovations has allowed the firm to build strong brands, successfully market its products and create a strong reputation, which has given it the revenue and investment that is so critical to its success. Through its innovative R&D and use of intellectual property rights, Merlin is poised to revolutionize the treatment and prevention of aneurysms and strokes.
This case study is based on information from:
Date of publication: August 2, 2010