The challenge

The last mile challenge of the cold supply chain

Injectable pharmaceuticals have strict temperature storage indications. Temperature control is required from the manufacturer until the end of use but it is only strictly controlled until it reaches the pharmacy. Improper storage during use degrades the potency of pharmaceuticals, put patients at risk and can cost lives.

Temperature sensitive drugs

50% of new drug products registered by the FDA in 2018 are temperature sensitive.

Pharmaceutical products worth hundreds of billions of dollars are exposed to temperatures that might damage their potency and risk lives while in use by patients.

LAST MILE REQUIREMENTS

The unmet need for last mile medical storage solutions

Reliable and trustworthy

Long active time every-day use, without maintenance

Easy to operate

Small and lightweight

Reusable and durable

Wireless connectivity

How Should Insulin be Stored?

Storage conditions

Before first use

All insulin formulations should be stored in a refrigerator at 36° to 46°F (2°-8°C) to keep their quality until the expiration date.
Max temperature 46°F (8°C ).
Should never allow to freeze.

Use conditions

After first use

Insulin can be stored at room temperature below 77°F or 86°F (25°C or 30°C) if used between 10 days-8 weeks.
Max temperature: 77°F or 86°F (25-30 °C).
Should never allow to freeze.
Should not be exposed to direct sunlight.
Some insulin pens should not be placed back in the fridge after first use.

SAFE ZONE

How to make sure that insulin is kept in the safe zone while taking it with you everywhere every day?

VIVI Cap 1 keeps your insulin in the Safe Zone

TECHNOLOGY

How does VIVI Cap1 keep insulin always in the Safe Zone?

TempraMed's patented technology combines space grade thermal insulation with self regenerative heat absorbing material and monitoring electronics to form the first protective storage solution for pharmaceuticals that is hassle free and last for years.

CUTTING EDGE

Innovative, Patented Technology for Temperature Monitoring and Protection

The cutting edge space grade insulation is used in spacecraft, avionics, cryotherapy and other demanding applications. The heat absorbing activity is guaranteed to perform every day for years on end without requiring any user intervention. The monitoring electronics provides intuitive indication of the temperature of the medication.
No need for battery or charging- Just CLICK-N-GO™!

8:00 AM - 20:00 PM 

Daytime

During the day light time, heat is blocked by the insulation and absorbed by the PCM

20:00 PM - 8:00 AM 

Nightime

At night-time, absorbed heat is spontaneously released back to the ambient and the PCM regains its absorbing capacity

temperature status indicator

VIVI Cap 1 is the only temperature storage and monitoring pen cap device

With built in insulin temperature indicator that checks temperature status by simply pressing and releasing the sensor button. The temperature sensor indicator will turn on for just a few seconds to show insulin temperature status : Green means insulin has been kept at the required temperature.

ABSORBING MATERIAL

The Activity of the Heat Absorbing Material

Graphical time and temperature representation when exposed every day to 100°F during daylight time – Insulin temp will not get above the safe zone limit temperature – without any need for user intervention or preparations

REUSABLE INSULIN PEN CAP

VIVI Cap 1 storage and monitoring insulin pen cap for pre-filled and refillable insulin pens

VIVI Cap protects insulin from overheating and freezing 24/7/365 days a year. It is scientifically validated and FDA registered. No maintenance or special preparation is needed - just CLICK-N-GO™! Includes insulin temperature indicator - is small and lightweight fits right in your pocket. Lasts for years with unlimited daily use.

The first to market product that meets ALL last mile requirements

Pharmaceuticals are carefully managed and controlled from their point of production up to and while in pharmacies or hospitals. This control is abandoned once these medications are released to the patients, provoking their safety and threatening their lives. TempraMed has developed the first temperature storage control technology that is small, lightweight and maintenance free... moving all the control into the hands of the patients.

SCIENTIFIC VALIDATION

VIVI Cap1 Clinical Evidence

In a scientific monitored experiment, even when exposed to temperatures of over 100° F for over 12 hours -VIVI Cap was found to be superior to the other tested conditions with respect to stabilizing insulin aspart during storage under extreme temperature conditions. The device provides an easy to use solution for maintaining insulin efficacy under daily life conditions. (Pfützner et al. ATTD Feb 2018).

POTENCY TEST

Insulin potency 5 day test study

Insulin Aspart without protection was shown to have more than 2% impurities already after one day, while it took 2 days for the pens in the alternative devices. The pens with VIVI Cap did not reach this level of impurities during the experiment (0.5% after 5 days). High molecular weight products >1% occurred after two days without protection, three days with the alternative device, but no high molecular weight products were seen in the pens protected with VIVI Cap.

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