CeQur Ltd. is an insulin therapy startup based in Switzerland and Massachusetts focusing on a compact 3-day insulin delivery device named PaQ. It consists of an infuser to control continuous basal insulin or bolus insulin, and a messenger unit to notify the patient when replacement is necessary.
According to Jay Warner, SVP of Marketing and Sales at CeQur, “In just the US and EU there are over 11 million people with type 2 diabetes on insulin therapy, and of those over 60% are not in target glycemic control. Current insulin delivery options – syringes, pens and pumps – are not working for this population. Insulin injections (pens or syringes) are often skipped or missed for several reasons including the pain, burden/hassle of taking them, or embarrassment (Diabetes Care 33:240-245, 2010). Pumps (continuous subcutaneous insulin infusion), while effective in insulin delivery and have several benefits, can cost over $8000 (AWP) and require significant training so are not used widely for the type 2 population. The market for devices like PaQ that provide simple insulin infusion is significant in the $40+billion diabetes market of which insulin and insulin delivery account for over half.”
Janelle Chang, Medgadget: Can you briefly describe how the product works?
Jay Warner, CeQur: When the patient fills the device with insulin they are actually filling up an elastomer bladder (aka balloon). This elastomer bladder provides the energy to provide continuous flow of insulin. Small glass tubes (capillaries) determine the preset insulin basal flow rate. The bolus is delivered when a patient pushes a button, 2 units are dosed into the body. This is a link to a quick video outlining how the product works.
Medgadget: There are many methods of administering insulin. What differentiates this product from the competing ones on the market?
Warner: In brief, the product is (1) Simple – Insulin pens have become the gold standard of insulin delivery because they are simple to train and use. Like insulin pens, PaQ is very simple to teach and train. In a very short amount of time our product can be used safely and effectively. Insulin pumps are notoriously complex, requiring days of training and office time to be “fitted” to the patient. (2) Basal and bolus – Pens (or syringes) require 1-2 basal injections and ideally a bolus injection for each time you eat. People can easily inject over 4-5 times a day. This can become tedious and challenging over time. PaQ replaces daily injections and delivers both basal infusion (slow drip of insulin) and push button bolus (mealtime dosing). (3) 3 days – [Patient] places the cannula and is set for 3 days. A person can save themselves 12+ injections over 3 days and they don’t need to worry about carrying around a bunch of pens and needles. Several of our study participants commented that for 3 days they had only one “poke” or injection, didn’t have to worry about carrying a pen and were not embarrassed to give themselves a bolus dose. Our focus is to replace multiple daily injections. That being said there is another simple insulin infuser on the market (V-Go). We hear that it is doing well. V-Go is a daily device that delivers a maximum of 76units/day. PaQ can deliver up to 110units/day with more dosing flexibility.
Medgadget: To date, what is the most important constructive criticism/limitations that physicians and patients have provided regarding the product as currently designed? Does CeQur have plans to address this and if so, how?
Warner: In [clinical] trials we asked the patients about strengths and weaknesses. We will be presenting this data at the ADA [in June]. What I can say is that we are a company dedicated to continuous improvement. The device had remarkable performance in the study, but we have identified areas that we are currently working on to improve.
Medgadget: In November 2012, CE Mark approval was granted for the device. Are there plans to introduce the platform into the US? Why or why not?
Warner: Absolutely. There are 5 million people with type 2 diabetes in the US of which most are not at their glycemic target. There is a huge need for a product like PaQ in the US. The US regulatory process is tough to predict so currently, a US PaQ [anticipated] introduction “is 1-2 years away.” The good news is V-Go and other recent insulin delivery device approvals demonstrate PaQ approval is achievable.
Medgadget: CeQur recently announced positive results from a clinical study – what was the gold standard used for the study and how did the device perform? What was the most significant outcome of the study?
(Abstracts provided by CeQur showed preliminary data that demonstrated twenty patients with Type II Diabetes Metillus successfully transitioned to PaQ with 73% using the first basal rate chosen and all patient feedback indicated they were satisfied or very satisfied with the required time to learn and administer doses with PaQ.)
Warner: More [data will be presented at the ADA in June and will] include self monitored blood glucose readings (daily finger sticks…a gold standard), continuous glucose monitoring (CGM… the newest, hottest way to measure blood glucose), and several validated patient reported outcome questionnaires.
Medgadget: What are the future development plans and expected timing for expanding the PaQ product line?
Warner: Our focus has been and is on developing the base platform we call PaQ, simple 3 day insulin delivery, for commercialization. While our focus has been on getting PaQ out we have prepared and thought a bit about the next generation. Two of the areas of product development that I can talk about are:
1) Delivery of other drugs: One of the drugs that we are developing PaQ to deliver is GLP-1. This is one of the fastest growing drug classes in diabetes with over $2billion in sales. Currently the GLP-1 class has demonstrated glycemic control with a bit of weight loss. However many people can’t tolerate the gastrointestinal side effects of this class. PaQ may be able to deliver GLP-1 more physiologically which might enhance the benefits and decrease the side effects.
2) Utilize our Messenger Unit: A challenge for healthcare providers is to understand what was the actual amount of insulin being delivered. Our Messenger Unit could be developed to track insulin delivered (both bolus and basal) over several days answering this unknown.
CeQur will present at ADA during a product theater on Sunday June 23rd (10:15a – 11:00a) and poster sessions on Saturday June 22nd (11:30a – 1:30p) and Sunday June 23rd (12:00 – 2:00p).
Company link: CeQur…