The fields of tissue transplantation and regenerative medicine are expanding rapidly. These innovative and life-saving technologies require an equally innovative storage, transportation, and tracking system. The Cryo is an advanced, interactive, reusable cold storage and transport solution that ensures temperature sensitive products of all kinds remain at the appropriate temperature. With applications that go beyond the healthcare industry, the Cryo is redefining cool.
WHY CRYO?
$
Cost Effective
Out-dated shipment and storage techniques result in immeasurable loss of expensive and life saving products. Even small changes in temperature can destroy products, resulting in wasted time and wasted money.
Reliable
It has been reported that $300 million in vaccines are destroyed each year due to improper storage and shipment. The same is true for a multitude of other healthcare products, from cells, tissues, and skin substitutes to medications and chemical reagents.
Accountability
In order to achieve FDA compliance, current systems require extensive personnel to track, inventory, and monitor healthcare products. Not only is this extremely expensive, it increases the chance of error and delay, which may seriously compromise the product.
Re-usable
Recent technological advances have increased the need to transport precious healthcare products. Yet, many products are still shipped in Styrofoam boxes on dry ice! It’s time to cut the waste, ditch the outdated methods, and enter the 21st century.
The Cryo Solution
Cryo’s patent-pending cooling technology can self-regulate to, and maintain, preset temperatures for extended periods of time. The stable and well-protected system means products arrive unharmed the first time.
The Cryo keeps healthcare products sterile, intact, and at a constant temperature so that they can serve their intended purpose of saving lives.
The Cryo’s interactive operating system tracks products in real-time, automatically reporting location, temperature, position, and user. The Cryo increases accountability and safety by ensuring that only credentialed individuals are allowed to open the case.
No Styrofoam here. The Cryo is fully reusable, cutting costs and unnecessary waste. Not to mention that the Cryo can be adjusted to maintain any temperature, making it infinitely more effective than dry ice.
The Ultimate interactive reusable cryogenic carrying case
The Cryo redefines cool
The Cryo is an interactive, reusable, and versatile container for the transport, storage and use of virtually all temperature-sensitive materials. Capable of maintaining temperatures anywhere from room temperature down to an astonishing -200°C, the Cryo’s patent-pending cooling technology is unlike anything on the market today. Even with this large temperature range, the system does not require large batteries or compressors, making the Cryo small enough to be easily transported and stored. All of this while using a fraction of the energy demanded by current cooling systems.
The Cryo is also extremely versatile. It can be manufactured to be as small as a pill case or large enough to cool a cargo container, all without sacrificing quality, energy efficiency, or reliability. Able to maintain products at the correct temperature for an extended amount of time, the Cryo allows for a seamless transition from a transport device into a long-term storage device. It is even tailored to meet the needs of a specific industry. For example, when used for the transport of sensitive tissues to the operating room, the Cryo is also equipped with the sterile instruments and clean working area needed for a successful surgery. This added feature makes the Cryo uniquely attractive to healthcare facilities and physicians.
In addition, the Cryo is uniquely intelligent. Cryo’s patent-pending innovative software allows the device to collect, send, receive, and display information such as location, temperature, user, and the nature of the enclosed material. The software can easily be paired to mobile devices, allowing for real-time monitoring and GPS tracking by both the distributor and the end-user. The system even prevents uncredentialed individuals from opening the case. Never before have users had so much control.
8 places current systems fail to ensure a constant temperature
When shipping temperature sensitive cell therapies, there are at least eight links in the supply chain where temperatures can fluctuate. Each step in this process can result in compromised product, such that the patient does not receive the optimal standard of care.
warehouse
product is removed from long-term storage
transfer area
product is transferred to temporary packaging
transit vessel
product is loaded into a vehicle for delivery
distribution center
product is removed from temporary packaging and placed in storage
patient
product is placed on a tray to await administration to the patient
pre-operation
product is removed from the cryocart and transferred to a bedside processing unit
cryocart
product is moved from storage and transferred to the patient’s bedside
clinical site pharmacy
product is distributed to hospital-based storage units
Market Potential
The amazing versatility of the Cryo means a wide variety of industries will benefit from this technology. Click on the icons below to reveal the Cryo’s potential.
Tissue Bioengineering & Regenerative Medicine
Pharmaceutics
Vaccines
Biomedical & Scientific Research
Data Mining & Analytics
Other Cold Chain Industries
Tissue Bioengineering & Regenerative Medicine
$26
Billion
Projected 2015 Global Tissue Market
The global market for transplantation products such as organs and tissues is enormous, and growing. With a compound annual growth rate of 8.3%, the industry is projected to reach $80 billion by 2015. Within the transplantation market, tissue products are expected to grow most rapidly. Tissue product development represented a $15.6 billion market in 2010, but is expected to reach $26 billion by 2015. In order to ensure these products are safely transplanted to the patient, the biological products must be maintained at specific temperatures in a controlled and sterile environment. The Cryo is capable of continuously monitoring and stabilizing the temperature of each individual product, possibly increasing the probability of successful transplant or implant.
There has been a recent increase in the demand for bioengineered skin substitutes (BSS), which are manufactured in remote laboratories and shipped to hospitals around the world. BSSs have proven effective in treating conditions ranging from chronic ulcers to severe burns and it is anticipated that they will represent a $550 million U.S. market by 2016. The original inspiration for the Cryo was based on the tremendous need for effective shipment of BSSs used in the treatment of chronic diabetic ulcers. It is estimated that between 5-10% of the BSSs are compromised during shipment and must be replaced by the manufacturer. With nearly 10% of the U.S. population diagnosed with diabetes and the expectation that this will reach 33% in the next few decades, the need for improved shipment of those treatments is obvious. These life-saving medical advances require a storage and transportation system as advanced as they are. Cryo is the only viable system.
Follow the links for more about regenerative medicine and bioengineered skin.
Pharmaceutics
$700
Billion
Projected 2020 U.S. Pharmaceutical Market
In 2013, the U.S. government passed the Drug Supply Chain Security Act (DSCSA), requiring an improved federal electronic system to trace prescription drug distribution throughout the United States. The Act aims to ensure a secure supply chain to eliminate the distribution of damaged and potentially harmful drugs including stolen, counterfeit, and contaminated products. Within the next ten years, the Act will require verification systems capable of tracking drugs down to the individual package while identifying and cataloging all handlers along the supply chain. The Cryo provides traceability and accountability software that will help the Food and Drug Administration and the pharmaceutical industry meet the requirements of the Act.
Approximately 10% of pharmaceutics are temperature sensitive. When such drugs are exposed to varying temperatures, it can render the drugs ineffective for, or even harmful to, the patient. The temperature stability offered by the Cryo can ensure these temperature sensitive medications are shipped at the appropriate temperature with full traceability.
See the Healthcare Distribution Management Association factsheet for more information.
Vaccines
$27
Billion
2012 Global Vaccine Market
Vaccination is a critical to effective healthcare around the world. In 2012, the global vaccine market was valued in excess of $27 billion, with a projected compound annual growth rate of 12% by 2017. Being one of the most lucrative markets in the pharmaceutical industry, there is a clear need for advances in vaccine shipment and storage. The Cryo fits this need.
Improper transport, storage, and handling of vaccines cause irreversible damage that reduces effectiveness and necessitates revaccination. The Center for Disease Control recently released an extensive Vaccine Storage and Handling Toolkit to help prevent vaccine damage. The guidelines provided are extremely time and labor intensive because of current limitations in automated monitoring, tracking, and storage. The Cryo provides a solution. It is capable of eliminating monitoring and tracking errors, wirelessly transmitting information, reducing vaccine loss, and even reducing personnel needs, freeing medical professionals to focus on more important tasks.
Biomedical & Scientific Research
$13.6
Billion
2013 Global Chemical Reagent Market
Scientists spanning a range of disciplines require a host of chemical reagents and biological materials in order to conduct effective research. Whether a geneticist handling delicate DNA samples, an ecologist utilizing a temperature sensitive chemical, or a clinical researcher using live cell cultures, scientists of all kinds rely on materials that are highly temperature sensitive. Spoiled reagents and nonviable cells can lead to experimental error, resulting in much wasted time and resources.
Medical research is particularly dependent on research materials that must be kept at very specific, and often very low, temperatures. In the United States, approximately $140 billion is spent each year on medical research. Yet, a recent academic study showed that only 10% of early-stage clinical trails eventually advance to FDA approval. Outside of clinical trials, it is very difficult to estimate how many research experiments fail to yield results. Anecdotal interviews with scientists indicate that up to 50% of experiments do not provide reliable results the first time. Undoubtedly, one cause of experimental failure is outdated cold storage and transport systems that ruin chemicals and biological materials.
The Cryo’s cold storage and transport system ensures temperature sensitive chemical reagents and biological materials of all kinds remain in peak condition. The Cryo may significantly reduce experimental error resulting from spoiled products, freeing scientists to focus on developing solutions to serious disease rather than trouble shooting yet another failed experiment.
Data Mining & Analytics
$8.4
Billion
Projected 2014 Spending on Cold-Chain Logistics
Many industries are dependent on a reliable temperature mediated supply chain. In order to ensure that products survive transit and make it to their destination undamaged, a clear chain of custody must be established. For instance, the FDA requires that certain medical products be tracked, such that all temperature deviations, the number of temperature deviations, the duration of the exposure event(s), and the identity of the person who handled the material during an exposure event are recorded. Companies invest heavily in order to ensure this degree of accuracy in their temperature and location data. Within the biopharmaceutical industry alone, it is estimated that $8.4 billion will be spent globally on cold-chain logistics in 2014. Specifically, $2.8 billion will be spent on packaging and instrumentation such as “insulated boxes, blankets, phase-change materials, active temperature-control shipping containers, and various temperature sensors and recorders.”
The data gathered through these tracking devices could be invaluable to distributors, regulators, and consumers were it readily accessible through centralized databases. However, current tracking devices are separate units that are not integrated into the actual packaging. In many cases these devices only monitor the conditions in a transport vehicle, cargo container, or warehouse as a whole, and not necessarily the individual package. In addition, these tracking systems simply monitor temperature and alert the user of deviations. They do not automatically adjust the temperature to avoid potentially disastrous temperature fluctuations.
The Cryo’s ability to automatically self-regulate temperature, in and of itself provides a significant improvement over current systems - but the Cryo’s advanced, fully integrated tracking and monitoring software offers advantages that place the Cryo in a category all its own.
Other Cold Chain Industries
92.4
Million Tonnes
Perishable Food Transported by Reefers Globally in 2012
There are number of other large industries dependent on reliable cold storage and transport, including temperature sensitive chemicals and perishable food items. These “cold chain” industries rely on a dependable temperature mediated supply chain. For example, with increased globalization, the food industry has become increasingly reliant on the cold chain. In the U.S. alone, approximately 30% of food imports and 20% of food exports are perishable. Yet, one quarter of perishable foods moving along the cold chain are wasted due to temperature fluctuations. Currently, most food is transported in cold storage containers known as reefers. These large, refrigerated cargo containers are expensive, have a limited capacity to self-adjust through automated software, and demand large amounts of energy. The Cryo offers a reliable solution to these challenges.
The Cryo is scalable, meaning it can be manufactured in a size that could cool a cargo-shipping container. Its novel cooling system has extremely low energy demands, possibly making it the most efficient cooling system currently available. The Cryo has the potential to ensure that bananas from Costa Rica and apples from New Zealand arrive fresh and undamaged, all with a fraction of the energy costs and greenhouse gas emissions.
For more information see the university report: The Cold Chain and its Logistics.
The Cryo is a product of Inovatzia, Inc. Inovatzia, Inc. will license specific applications of the Cryo to relevant industries in order to generate revenue through intellectual property licensing, software licensing, fees from continued product development, and add-on products developed, patented, and provided by Inovatzia, Inc.
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