PKvitality Support – FAQs

July 2018 – We are glad to announced a major change in our system. K’Watch, which is still under development,  – along with K’apsul Glucose, will be able to measure glucose level in a continuous mode. This has led us to a series of technical changes that may not yet reflected in our web pages & communication tools. The web pages will be modified accordingly in the coming weeks.

Next steps : Pre-clinical trials should start in the coming months. This is the last step before the clinical trials and medical certification.

Product will be available as soon as medical certification is being passed. This date will vary from region to region. In the meantime, you are welcomed to subscribe to our newsletter in the home page in order to be updated about our progresses.

K’Watch measures very frequently the biomarker concentration (Glucose or lactate). It provides updated information every 5 min to the user based on the previous measurements performed by the system for maximum precision.
K’apsul is a tiny consumable that needs to be plugged at the back of K’Watch.

K’apsul can make unlimited measurements for a period of 7 days, after that it shall be changed.

Each K’apsul is composed of biosensors and of SkinTaste technology, an array of micro-needles that are in contact with the user’s interstitial fluid. SkinTaste allows a bio-chemical analysis of the interstitial fluid to determine the level of a given biomarker (e.g.: Glucose or Lactate). While the user will feel the slight pressure of the probe pressing on their skin, they feel absolutely no pain as the sensor never reaches the pain nerves or blood vessel.

K’apsul sticks to the skin thanks to an advanced patch that enables it to move with the skin. The patch is much softer than traditional sticky patch from existing CGM (Continuous Glucose Monitors). This reduces the risk of irritation due to the patch and allows the user to remove K’apsul.
Sometimes you can’t or don’t want to wear a piece of hardware on you. There are several possibilities offered to the user. It will be possible for the user to remove its K’Watch Glucose and keep the K’apsul in place. It will be also possible to remove the K’apsul and then put it back (given a few precautions). The user will have the freedom to wear it at its own convenience.
K’apsul is easy to insert and remove from the K’Watch. After 7 days of measurement, the K’apsul just needs to be changed with a brand new one.
K’Watch will go through a medical certification process.  During this process, clinical tests must be performed and officially validated, thus ensuring the accuracy of measurements. To obtain the certification, K’Watch will need to be accurate enough for the given purpose.
We received many requests for it. So, it is on our list of projects. This is one of our priorities, but it will require the adult version to pass medical certification first, then we would be able to organize clinical trials for pediatric use.
Beyond the biomarker tracking (Glucose or Lactate via K’apsul), K’Watch can provide other useful information to the user:

– Time and date, it’s a watch!

– Activity tracking (steps, distance, calories)

– Heart rate

– Sleep quality

– Alarms: either traditional alarms or specific to warn the user in case of an hypoglycemia/ hyperglycemia episode

We are working on developing an iOS and an Android application. This will allow to provide more comprehensive data and added value services to the user. K’Watch will be securely connected to the cloud enabling, if the users agree, to share data with their family or caregivers.
The K’Watch Glucose should be priced at 149.90 $/€.

The K’Watch Athlete should be priced at 199.90 $/€

The K’apsul Glucose sensors should be priced at around 99.90 $/€ per month.

The K’apsul Athlete sensors should be priced at 199.90 $/€ per month

Price may change by launch time and according to regions and local duties and taxes.

The K’Watch Glucose pack contains:

– 1 K’Watch Glucose watch

– 1 charger

– 1 mobile app (free)

– 1 user manual

The K’Watch Athlete pack contains:

– 1 K’Watch Athlete watch

– 1 K’Watch Athlete armband

– 1 charger

– 1 mobile app (free)

– 1 user manual

Once the medical certification process for marketing K’Watch Glucose is finalized, a second process must be initiated so that it can be reimbursed by local social security and/or insurances. If we succeed in getting reimbursement, the level of reimbursement will vary depending on regions, payers and patient situation. We will keep you updated via our newsletter.

We plan to launch a beta test 6 months before the end of the project. As this process is strictly controlled, you can be informed through our newsletter.

PKvitality’s office is located in Paris area, France.

Your question is not listed? Write to us at social@pkvitality.com.
 

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