Biosensors Brand Guidelines: Singapore 1989, BioMatrix Stents & a Blue Sail Parent

A contract manufacturer that moved into the heart.

Biosensors began in Singapore in 1989. The company’s own list of milestones says Biosensors International Pte Ltd was founded that year by Yoh-Chie Lu as a contract manufacturing company for critical care products. It says in-house research and development started in 1995 and that work on drug-eluting stents began in 1999.

The move into interventional cardiology came in 2000. The company says it entered that market by selling its CE-marked S-Stent, a bare-metal stent, and that it launched PTCA balloon catheters the same year. In 2001, it says, it bought Occam International B.V., a Dutch company. In 2003 it signed an agreement with Terumo of Japan covering the manufacture, supply and distribution of its drug-eluting stent technology, exclusive in Japan, and an asset purchase and licensing agreement with Advanced Cardiovascular Systems, then a subsidiary of Guidant.

The group, under the name Biosensors International Group, Ltd., was listed on the mainboard of the Singapore Exchange in May 2005, English Wikipedia says. It also had an American arm. In May 2008 the Orange County Business Journal described Biosensors as a Singapore-based medical device maker that was scaling back its American headquarters in Newport Beach, California, with advanced engineering in La Jolla. The paper said the company then had about 300 workers, made blood-pressure kits, drug-eluting stents and catheters, and, in the words of its finance chief, was “currently focused on Asia and Europe.” The paper added that the company had been in Newport Beach for more than four years and that staff there were offered transfers to La Jolla and to sites in Europe and Asia.

BioMatrix, BioFreedom and a drug of its own.

Biosensors built its stents on technology it developed itself. English Wikipedia describes BioMatrix, its leading product, as combining four in-house elements: a biodegradable polylactic acid polymer, the drug Biolimus A9, which it describes as a derivative of sirolimus, the S-Stent platform, and an automated process that deposits the coating directly onto the stent. The company says it was the first cardiology company to develop and patent its own limus drug, and the first stent company to launch a biodegradable polymer stent coated only on its outer, abluminal side; both are its own claims.

The company dates the steps. It says the Axxion drug-eluting stent received CE Mark approval in 2005; that BioMatrix received CE Mark approval and was launched across Europe in 2008; that BioMatrix Flex followed in 2010 and BioMatrix NeoFlex received CE Mark approval in 2013. Its polymer-free stent, BioFreedom, was first implanted in 2006, received CE Mark approval in 2013 and was launched in Japan in 2017, the company says. It added Chroma, a cobalt-chromium bare-metal stent, in 2013.

Licensing has been part of the business. English Wikipedia says Biosensors licenses its drug-eluting stent technologies to other companies, naming Terumo, Devax and Xtent. In China, English Wikipedia says, it worked with Shandong Weigao through a joint venture to market and distribute coronary stents; Biosensors says it bought the remaining half of its Chinese joint venture, JW Medical Systems, in 2011.

Biosensors presents its trials at cardiology congresses; its milestones list results shown at TCT, EuroPCR and the ESC Congress. Its current catalogue lists the BioFreedom Ultra and BioMatrix Alpha stents, the Rise NC and Rise SC catheters and the Allegra heart valve.

Design and documentation.

Cardiovascular device makers sell to a narrow audience: interventional cardiologists, electrophysiologists, cardiac surgeons, hospital buyers and regulators. Their visual language follows from that. A heart valve, a stent or a pacemaker is small, precise and usually hidden inside the body once it is in use, so the product photograph does much of the work. Valves, stents and leads tend to be shot in close-up on white or pale grey, lit to show struts, mesh and metal edges, with the device itself as the only subject.

The second register is the catheterisation laboratory. Brochures, websites and congress stands return again and again to the same scene: a patient table, a C-arm X-ray system arched over it, banks of monitors showing angiograms or mapping images, and clinicians in scrubs, lead aprons and caps. These pictures place the device in the room where it is used, without showing the patient’s body in detail.

Between the two sits illustration. Cutaway hearts, cross-sections of arteries and simplified diagrams of the conduction system explain where a valve sits, how a stent opens or how a lead reaches the heart. They are often rendered in reds and soft pinks against white, with the brand’s own colour kept for the device, the arrows and the type. Much of the copy is technical, built around product names, trial names and regulatory approvals as the companies state them.

Much of the category’s public life happens at medical congresses. TCT in the United States, EuroPCR in Paris and the ESC Congress of the European Society of Cardiology bring makers, clinicians and trade press together each year, and companies use them to show new devices and announce study results. The makers in this guide range from family-owned German engineering firms to Chinese groups with several listed subsidiaries, and their identities reflect that range more than any shared house style.

From the Singapore Exchange to Blue Sail.

Biosensors did not stay listed. On 4 November 2015 the company and its substantial shareholder CB Medical Holdings announced a proposed amalgamation; The Edge reported that day that a private-equity arm of China’s Citic group, which already controlled about a fifth of the shares, had agreed to buy the rest. The two Bermuda companies amalgamated on 8 April 2016, according to an announcement to the Singapore Exchange, and the company was voluntarily delisted.

The next owner was Chinese. In September 2019 BioSpectrum Asia described Biosensors International Group as a subsidiary of the China-based Blue Sail Medical, when Blue Sail agreed to buy NVT AG of Muri, in the Swiss canton of Aargau, a developer of heart valves for structural heart disease. Biosensors says the purchase was completed in 2020, and NVT’s Allegra valve, which the company says received CE approval in 2017, now appears in its catalogue. The company names Blue Sail Medical as the ultimate parent of both NVT and Biosensors.

The group is run from Singapore, and the company describes itself as having designed, made and marketed devices used in heart surgery and intensive care for more than 25 years. English Wikipedia says the global headquarters there houses its main manufacturing and research centres, and that the European headquarters in Morges, Switzerland, is the legal manufacturer of BioMatrix. The company says its Singapore manufacturing site was certified to the ISO 14001 environmental standard in August 2018, followed by its Dutch warehouse and Swiss offices in March 2019, and that NVT opened its own clean rooms in Hechingen, Germany, in 2014. Its website says its interventional cardiology products are not available for sale in the United States.

For a design guide, Biosensors shows how a maker can build its identity on named in-house technology and product families. Compare Terumo, its licensing partner since 2003, and Lepu Medical, a Chinese stent maker. For this guide we use a deep teal, an amber and a pale sea-grey with a sans, an unofficial interpretation; no product or logo is reproduced.

Keep Biosensors’s identity on hand — save it to a board in the Made Good inspiration library.