Memorandum

Edwards 1Q13 – Management remains “enthusiastic” about GlucoClear critical- care CGM – April 24, 2013

Executive Highlights

  • “We remain enthusiastic about the significant opportunity represented by our GlucoClear system,” said Edwards management in its quarterly conference call for 1Q13.
  • The company expects to gain clarity on a US FDA approval pathway in 2013; no further details were given.

Edwards CEO Michael Mussallem led the company’s 1Q13 financial update yesterday. Said management, “we remain enthusiastic about the significant opportunity represented by our GlucoClear system.” As a reminder, the company’s second-generation GlucoClear critical-care continuous glucose monitor, developed in partnership with Dexcom, received CE Mark earlier this year. Using the same language as in the 4Q12 update, Mr. Mussallem characterized 2013 as a “pivotal” year for GlucoClear: the company plans to complete additional studies in Europe and gain greater clarity on the path towards approval in the US. Certainly, with respect to defining a US pathway, Dexcom’s open and communicative relationship with the Agency should bode well for Edwards. Edwards did not provide additional detail on GlucoClear pricing or the company’s marketing strategy. Dexcom sells sensors to Edwards at an undisclosed transfer price and Edwards sells them commercially. As of the company’s 4Q12 update, management did not expect “significant sales” of GlucoClear in the year.

The hospital space has seen two recent EU approvals: Edwards/Dexcom’s CE Mark followed closely Medtronic’s. Medtronic received CE Mark for its Sentrino critical care CGM in December 2012 (for detail, please see our December 4 Closer Look at http://www.closeconcerns.com/knowledgebase/r/9ac84bcc). As we understood it from Medtronic sales representatives at the 6th International Conference on Advanced Technologies & Treatment for Diabetes (ATTD 2013), Medtronic had yet to gain reimbursement for its Sentrino system. We are curious what Edwards’ reimbursement outlook and strategy is for GlucoClear. A more competitive in-hospital CGM marketplace would be a positive on this front with respect to generating data and forging a pathway for reimbursement. There is certainly space as well for a range of CGM devices (see table below), given that certain systems may be more appropriate for different areas of the hospital or different patient populations.

Broadly, we feel that in-hospital CGM would represent a marked improvement over blood glucose testing every two to four hours, the current standard of care in US critical care environments (we do believe this standard has been changing in many centers). Real-time data, trending information, and alerts have the potential to address much of the fear associated with hypoglycemia (a major barrier to treating hyperglycemia), reduce glycemic variability, and help clarify insulin infusion guidelines by showing the moment-to-moment effects of insulin therapies in specific critical care populations. Many KOLs have pointed out that it will be nurses who drive ultimate adoption of the product, similar to how pulse oximeters achieved widespread use, and we look forward to greater real-world experience with in-hospital CGM to determine its effects on nursing time and care delivery. For wide-ranging discussion on the hospital space, see our Society of Critical Care Medicine Annual Congress report at http://www.closeconcerns.com/knowledgebase/r/1ea9b891.

  • At ATTD 2013, Dr. Jeffrey Joseph (Thomas Jefferson University, Philadelphia, PA) compared nine companies’ products for continuous, inpatient monitoring of blood glucose. (For the sake of formatting, we have split the information into two separate tables.)

Manufacturer, regulatory status, and sampling frequency

Product Name

Company Name

Regulatory Status - Hospital Use

Time between Measurements

GlucoClear

Edwards Lifesciences

CE Mark

5 minutes

GlucoScout

International Biomedical

FDA-approved

5 minutes

Optiscanner 

Optiscan

CE Mark

15 minutes

GluCath

GluMetrics

Pending

1 minute

Glysure System 

GlySure

Pending

1 minute

Diramo System

Flowsion

Pending

5 to 10 minutes

Eirus System

Dipylon

CE Mark

5 to 10 minutes

MicroEye

Probe Scientific 

Pending

5 to 10 minutes

GlucoDay

A. Menarini Diagnostics

CE Mark

5 to 10 minutes

Technological approaches

Product Name

Sample Location

Glucose Source

Sensor Location

Measurement Method

GlucoClear

Catheter in peripheral
or central vein

Venous blood

Sensor in
catheter
lumen

Electrochemical
/ Enzymatic

GlucoScout

Catheter in peripheral
or central vein, or
radial artery

Venous or
arterial blood

External
sensor with
tubing

Electrochemical
/ Enzymatic

Optiscanner

Catheter in central vein

Venous blood transformed into plasma

Externa sensor with tubing

Absorption spectroscopy

GluCath

Optical fiber in peripheral or central vein, or radial artery

Venous or arterial blood

Sensor in artery or vein lumen

Quenched fluorescence

Glysure System

Optical fiber in peripheral or central vein, or radial artery

Venous or arterial blood

Sensor in artery or vein lumen

Quenched fluorescence

Diramo System

Micro-dialysis catheter in peripheral or central vein, or radial artery

Dialysate from venous or arterial blood

External senosr with tubing

Quenched fluorescence

Eirus System

Micro-dialysis catheter
in peripheral or central
vein, or radial artery

Dialysate from
venous or
arterial blood

External
sensor with
tubing

Electrochemical
/ Enzymatic

MicroEye Micro-dialysis catheter
in peripheral or central
vein, or radial artery
Dialysate from
venous or
arterial blood
External
sensor with
tubing
Electrochemical
/ Enzymatic
GlucoDay Micro-dialysis catheter
in peripheral or central
vein, radial artery, or
subcutaneous tissue
Dialysate from
venous/arterial
blood, or
interstitial fluid
External
sensor with
tubing
Electrochemical
/ Enzymatic
  • Dr. Joseph also presented 72-hour data on the GlucoClear system and argued that the device was more accurate than suggested by its MARD of 8.2% and its ISO 15197 score of 93.2%. He said that many of the reference/sensor discrepancies were likely due to pre- analytical error. Arterial blood is ideal for reference measurements, explained Dr. Joseph, but arterial sampling became difficult on days two and three of the 72-hour study. Thus the researchers began making YSI reference measurements with central venous blood. Dr. Joseph noted that these venous blood measurements were used in 51% of the outlier reference/CGM data pairs, suggesting that the errors in these cases may have been due to the reference measurement rather than the CGM measurement. A detailed paper on the study by Bochicchio et al. is in press with an unspecified journal. For detail on Dr. Joseph’s talk, see page 93 of our ATTD full report.

-- by Kira Maker and Kelly Close