Interventional Cardiology

At Biosensors, we strive to make an impact in patients’ lives by continually investing in and developing pioneering medical technology. Being at the forefront of new and innovative solutions helps us respond to the changing needs of the interventional cardiology market. We are the first company to offer a commercially available abluminal drug-eluting stent with a biodegradable limus technology on our proven stent platform, the S-Stent™.

History of Firsts

We have demonstrated and proven our commitment to innovation in interventional cardiology as we were the:

1. First cardiology device company to develop a proprietary drug specifically designed for coronary stent use — Biolimus A9™ (BA9™); the compound is proprietary to Biosensors and is not licensed from a pharmaceutical company
2. First company to successfully develop and launch an abluminal biodegradable polymer DES with a coating absorbed after 6 to 9 months (Data on file molecular weight <10kDa).
3. First company to sponsor a randomized head-to-head comparison against a sirolimus eluting stent in an all-comers setting.
4. First company to prove non-inferiority on a clinical endpoint against CYPHER® SELECT™ (trademark of Cordis Corporation)

BioMatrix™

Our new generation drug-eluting stent was created using the most advanced medical technology in its field. It offers patients many benefits by combining:

1. Proven safety of a DES with
   1. An abluminal coating that reduces systemic drug exposure, provides more targeted drug release and promotes an endothelial coverage similar to a bare metal stent (BMS)
   2. A biodegradable polymer that is absorbed after 6 to 9 months (Data on file molecular weight <10kDa).
2. Proven efficacy of our drug, BA9™, that has 10 times more lipophilicity than sirolimus, resulting in a more targeted release to the vessel wall
3. Proven flexibility with advance stent design

Gazelle™

Based on the advanced design technology behind our proprietary S-Stent™ platform, Gazelle™ (commercialized under the name S-Stent™ in Japan) is our bare metal stent (BMS) that provides cardiologists with:

1. Flexible stent design with the Quatrature Link™ technology for excellent deliverability

Powerline™

Biosensors’ balloon dilatation catheter achieves the right balance of push-track-cross to meet clinical needs

1. The MultiPleat™ folding technology provides excellent cross and re-cross properties to facilitate use in complex procedures.

Drug-eluting stent - BioMatrix™
Abluminal Coating absorbed after 6-9 months *
Proven Safety of a DES with an Abluminal Biodegradable Polymer
Proven Efficacy of a Biolimus A9 ™ Drug
Proven Flexibility with Advanced Stent Design

Drug-eluting stent - BioMatrix^TM

Biomatrix™ - The Abluminal Biodegradable Polymer DES

BioMatrix™ is Biosensors' unique abluminal biodegradable polymer DES. Its abluminal coating is absorbed after 6 to 9 months *. It combines the proven safety of a DES with an abluminal biodegradable polymer, the proven efficacy of BA9™ and an advanced stent design.

Not available for sale in the United States and certain other countries.

Abluminal Coating absorbed after 6-9 months*

Abluminal Coating

No drug carrier or drug inside the stent allowing for:

1. More targeted drug release
2. Reduced systemic exposure
3. Early BMS-like endothelial coverage¹

Proven Safety of a DES with an Abluminal Biodegradable Polymer

Biodegradable Polymer

Confirmed Safety

1. with a 12.3% reduction in MACE compared to the Sirolimus eluting stent at 12months in LEADERS²
2. with no late or very late stent thrombosis in STEALTH I³ out to 4years

Superior strut coverage at follow up

10 times better strut coverage⁴ of an abluminal biodegradable polymer BES than a durable symmetric polymer SES

1. Abluminal biodegradable polymer BES achieves 96.4% of near to complete strutcoverage
   
   
   
   
   
   

Superior stent apposition

More than 20 times better stent apposition⁴ of an abluminal biodegradable polymer BES than a durable symmetric polymer SES



Biolimus A9™ eluting stent with abluminal biodegradable polymer demonstrates preserved vasomotion⁵

1. A high pacing stimulation induced abnormal vasomotion (vasoconstruction) of theSirolimus eluting stented vessel when normal vasomotion (vasodilation) was observedin the Biolimus A9™ eluting stented vessel

Proven Efficacy of a Biolimus A9™Drug

Biolimus A9™ (BA9™)

Low late loss

1. Lower level of late loss achieved in the LEADERS trial with the BiolimusA9™ eluting stent at 9 months compared to Sirolimus elutingstent⁶
2. In Stent late loss in LEADERS = 0.13mm⁶

Highest lipophilicity of the common limus drugs⁸

1. Minimizes systematic exposure and reduces the circulating drug into the bloodstream
2. Due to high lipophilicity, the drug is rapidly absorbed by tissue

Proven Flexibility with Advanced Stent Design

S-Stent Platform

High Flexibility without compromising vessel support

Quadrature link™ design increases stent flexibility while preserving stent security and vessel scalfolding



Low Recoil⁹ and high radial strength⁹ for enhanced vessel support

Unmatched side branch access⁹

1. Largest cell opening compared to current market leading DES

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* Data on file - molecular weight <10kDa
1. Virmani R., Are resorbable coatings better?, oral presentation, PCR 2008
2. Serruys P.W., LEADERS: Taking the LEAD in DES Clinical Excellence - 12 months results, oral presentation, TCT 2008. Data applicable to the stent used in the LEADERS trial
3. Grube E., Safety and Performance Evaluation of Biosensors Biolimus A9™ Eluting Stent (BioMatrix™) STEALTH I: a 4-year safety follow-up, e-poster, TCT 2008
4. Di Mario C., OCT: Differences between biodegradable and durable polymers - Insights from the LEADERS trial, oral presentation, TCT 2008. Data applicable to the stent used in the LEADERS trial
5. Hamilos M. et al. on behalf of the Nobori Core investigators, Differential Effects of Drug-Eluting Stents on Local Endothelium-Dependent Coronary Vasomotion, J Am Coll Cardiol 2008 51:2123-2129. Data applicable to the stent used in the Nobori Core trial
6. Windecker S. et al., Biolimus-eluting stent with biodegradable polymer versus Sirolimus-eluting stent with durable polymer for coronary revascularization (LEADERS): a randomised non inferiority trial; The Lancet 2008; 372 No. 9644: 1163-1173. Data applicable to the stent used in the LEADERS trial
7. Windecker S. et al., NEJM 2005; Morice M.-C. et al., JAMA 2006; Serruys P.W. et al., EuroIntervention 2006; Stone G.W. et al., JAMA 2008; Costa M. et al., Am J Card 2006; Chevalier B. et al., EuroIntervention 2006; Ostojic M. et al., EuroIntervention 2008; Stone G.W. et al., NEJM 2004; Krukoff M.W., JACC 2008; Verheye S. et al., ACC/SCAI 2008
8. Data on file
9. Schmidt W. et al., A comparison of the mechanical performance characteristics of seven drug-eluting stent systems; CCI 2009 73: 350-360
10. The graph only represents DES that are commercially available

GAZELLE™ - Rapid Exchange Coronary Stent System^TM

High Flexibility without compromising Vessel Support

• Flexible stent design with the Quatrature Link™ technology for excellent deliverability
• Enhanced vessel support with minimal recoil (3.67%)¹

Not available for sale in the United States and certain other countries.

1. Schmidt W. et al., A comparison of the mechanical performance characteristics of seven drug-eluting stent systems; CCI 2009 73: 350-360. Internal bench testing was performed on the mechanical characteristics of the Gazelle coronary stent system to support data published on the mechanical characteristics of the BioMatrix™ DES in the report. The internal bench testing concluded that the mechanical characteristics of the Gazelle stent are not impacted by the addition of the drug/polymer coating

Balloon Dilatation Catheters: Powerline™

Take the Fast Track to Superior Patient Outcomes

The advanced catheter technology of Powerline™ is designed to offer the right balance of PUSH, TRACK and CROSS to ensure optimal balloon placement and expansion:

A. PUSH

The PTFE-coated hypotube in combination with the power stylet transition in the middle shaft provides the right balance between pushability and trackability offering a smoother force transmission from the proximal to distal portion of the catheter shaft.

B. TRACK

The combination of the Slip-X™ hydrophilic coating and the flexible distal shaft ensure excellent trackability and crossability for complex lesions or tortuous anatomy.

C. CROSS

The flexible low profile tip section with smooth transition and short bonding offers a gradual increase towards the balloon to facilitate lesion entry. The advanced MultiPleat™ folding technology of Powerline™ is designed to offer exceptional lesion crossability and uniform balloon expansion as well as excellent balloon re-wrap and re-cross properties for treating challenging lesions.

MultiPleat™ Folding Technology

The MultiPleat™ folding technology is designed to facilitate the treatment of multiple lesions as the machine folding provides a more consistent rewrap of the balloon. This fully automated mechanism offers exceptional lesion crossability and uniform balloon expansion, as well as improved re-cross properties that may facilitate complex procedures and reduce procedural time.

Not available for sale in the United States and certain other countries.

Critical Care Technology^TM

Biosensors International’s Critical Care Products division fosters the development of critical care catheter systems, hemodynamic monitoring, and related devices used during heart surgery procedures and intensive care treatment

	ACCUTRANS™ Disposable Blood Pressure Transducer ACCUTRANS™ is a fully disposable blood pressure transducer system that delivers vital accuracy in invasive blood pressure measurement with lowest possibility of zero drift. Its unique, Fast-Flush Device provides a means of intermittent and rapid manual flushing of the system. The Fast-Flush Device also prevents clotting and backflow of blood through the catheter. The ACCUTRANS Fully Disposable Blood Pressure Transducer System is available in standard-kits and custom-kit configurations for neonatal, pediatrics, umbilical and intracranial invasive blood pressure monitoring. Customized Kits It is possible to configure custom kits to meet your procedural needs. You may ask for any existing component to be configured with other commercially available components. The customized kits help you to increase efficiency in the set-up process and ensure accuracy in components selection. It eliminates wastage and helps you to save time and cost. ACCUTRANS™ Brochure (PDF)
	BIOTRANS™ BIOTRANS™ transducer is the first and only blood pressure transducer that combines the performance, quality and ease of use of a fully disposable blood pressure transducer with the cost savings of a re-usable system.It also incorporates a number of intelligent and exclusive features for saving caregivers’ valuable time. Features and Benefits Environmentally friendly — minimizes biological waste Greater convenience and cost savings Flexible and easy patient transfer from one environment to another Easy maintenance and setup due to straight-through fluid path "Touch Check" for full system function check Standard and custom kits are available to meet your specific monitoring needs Customized Kits It is possible to configure custom kits to meet your procedural needs. You may ask for any existing component to be configured with other commercially available components. The customized kits help you to increase efficiency in the set-up process and ensure accuracy in components selection. It eliminates waste and helps you to save time and cost. BIOTRANS™ Brochure (PDF)
	Multi-Lumen Central Venous Catheter Biosensors International offers a wide range of Central Venous Catheters (CVC) for patients, from infants to adults, to administer medication or fluids, obtain blood tests and directly obtain cardiovascular measurements such as the central venous pressure. Our CVCs are made with a special polyurethane material which softens upon insertion into the body. This creates less trauma for the patient and provides greater control to the doctor during catheter insertion. The soft-tip at the distal end allows the catheter to be navigated easily within the vessel without irritating the vessel walls. Our CVCs can be used with the commonly-available straight introducer needle, as well as the Y-Valve needle which allows for easy guide-wire insertion while minimizing air embolism and backflow of blood. Features and Benefits Superior geometric soft-tip design coupled with unique soft-blended bio-compatible material makes insertion safe and easy Specially-formulated bio-compatible polyurethane material provides strength during insertion, yet softens in the body Sufficiently radio-opaque material with clear, definite marking; ensures correct placement on the catheter tip Specially-designed guidewire has a soft, flexible tip and prevents perforation (vascular trauma), yet has excellent stiffness that provides good torque to ensure firm insertion Soft tip available in Single Lumen 2 types of introducer needles available: Straight Needle and Y-Valve Needle. Y Valve Needle is designed for easy introduction of the guidewire. In addition, it also prevents the back-flow of blood and the occurrence of air embolism Customized Kits It is possible to configure custom kits to meet your procedural needs. You may ask for any existing component to be configured with other commercially available components. The customized kits help you to increase efficiency in the set-up process and ensure accuracy in components selection. It eliminates waste and helps you to save time and cost. Multi-Lumen Central Venous Catheters (PDF)
	Thermodilution and Pulmonary Artery Catheters Biosensors International offers two types of catheters for pulmonary artery monitoring: Thermodilution (TD) Catheters and Pulmonary Artery (PA) Catheters. TD Catheters include a thermistor in its final assembly, which helps provide Cardiac output measurements. Catheter tips often migrate to small arterial branches that are unable to safely accommodate inflated balloons. The SafetyWedge™ device has been introduced to reduce the risk of pulmonary artery rupture due to balloon over-pressurization. The most serious complication associated with PA catheter monitoring. The SafetyWedge™ device acts as a pressure relief valve to prevent over-pressurization of the distal balloon. This not only averts vessel rupture but the balloon rupture as well, and alerts the clinician to reposition the catheter.
	BIOTRAY™ The BIOTRAY™ device offers the benefits of the SafetyWedge™ Thermodilution/pulmonary artery catheter and the Introducer Kit, all in a convenient, fully-accessorized all-in-one tray. Features and Benefits Catheter is marked in 10 cm increments Radio-opaque polyurethane tubing facilitates the use of fluoroscope for greater accuracy in catheter insertion and in verifying the position of the catheter A lumen is incorporated into the catheter to provide electrical conductor isolation from electrodes to the connector pins. This provides maximum safety to the patient Optional inflatable balloon, located at the distal tip, can be inflated to enable safe floatation of the catheter to the right ventricle. This method of insertion also minimizes catheter kinkage
	Bipolar Pacing Catheter Biosensors’ Bipolar Pacing Catheter for temporary transvenous cardiac pacing was developed in response to market demand for a safe, secure and accurate device to support critical procedures in the catherization Lab, CCU, and Emergency Room settings. Features and Benefits Biosensors’ Embolectomy Catheters offer simple, rapid removal of emboli and thrombi from the arterial system Proprietary "low-profile" winding technique for balloon attachment ensures balloon symmetry, providing uniform contact with vessel walls. Soft, rounded tip promotes easy arterial insertion for reduced trauma, artery puncture and plaque avulsion Flexible polyvinylchloride body with "workhorse" latex balloon. Winged hub for easy catheter manipulation during insertion and attachment of balloon inflation syringe Available in 4 lengths and 6 diameters, ranging from 2 French to 7 French Size and balloon inflation capacity printed on proximal end for convenient and rapid identification Packaged in rigid tubes for convenient storage
	Embolectomy Catheter Biosensors’ Embolectomy Catheters offer a flexible PVC body coupled with a strong and symmetrical balloon. Its soft-tip material allows for easy arterial insertion. They come in a variety of sizes to cater to a wide range of patients from different age groups. Features and Benefits Biosensors’ Embolectomy Catheters offer simple, rapid removal of emboli and thrombi from the arterial system Proprietary "low-profile" winding technique for balloon attachment ensures balloon symmetry, providing uniform contact with vessel walls Soft, rounded tip promotes easy arterial insertion for reduced trauma, artery puncture and plaque avulsion Flexible polyvinylchloride body with "workhorse" latex balloon Winged hub for easy catheter manipulation during insertion and attachment of balloon inflation syringe Available in four lengths and six diameters, ranging from 2 French to 7 French Size and balloon inflation capacity printed on proximal end for convenient and rapid identification Packaged in rigid tubes for convenient storage

Press Releases

May 20, 2009	New Insights into LEADERS trial
Mar 6, 2009	BioMatrix 2.25mm launch
Oct 15, 2008	LEADERS 12 month follow up and OCT subset analysis
Sept 1, 2008	LEADERS 9 month data presentation
Mar 14, 2008	Launch of e-BioMatrix 5000 patient registry