Frequently Asked Questions

Frequently Asked Questions about BIOLIFE4D and its investment in science and technologies related to organ 3D bioprinting

1. Who is BIOLIFE4D?

BIOLIFE4D is a pioneering biotech company laser-focused on leveraging advances in life sciences and tissue engineering to 3D bioprint a viable human heart suitable for transplant – lifesaving technology that gives patients the gift of time.

2. How big of a problem is heart disease?

Heart disease is by far the leading health risk around the world. Heart disease is by far the leading killer in every developed country around the globe. In the USA, it is not only the leading cause of death by far but a staggering 1 in 4 men and 1 in 3 women die of heart disease every year. It takes more lives each year than every type of cancer combined. In the US alone, heart disease claims more than 610,000 lives every year and one person dies of a heart disease-related event every minute.

3. What is BIOLIFE4D’s approach?

During the 3D bioprinting process, BIOLIFE4D plans to replicate the same conditions in vitro (outside of the body) as occur naturally in vivo (within the body) while promoting natural biologic processes in an accelerated timeframe and in a manner that allows the cells to be specialized for the desired purpose.

4. What is so special about BIOLIFE4D’s approach?

BIOLIFE4D is committed to perfecting the technology to make viable organ replacement a safe, accessible and affordable reality. With BIOLIFE4D, a patient-specific, fully functioning heart will be created through 3D bioprinting and the patient’s own cells, eliminating the challenges of organ rejection and long donor waiting lists that plague existing organ transplant methods. BIOLIFE4D’s groundbreaking approach will converge recent breakthroughs in regenerative medicine, stem cell biology, 3D printing techniques and computing technology that will make organ replacement commercially viable and commonplace globally.

5. What are the benefits of BIOLIFE4D’s process

BIOLIFE4D’s process will (1) Eliminate the rejection of transplanted organs by utilizing a patient’s own cells to produce an organ, (2) Eradicate immunosuppressant therapy requirement, and bad side effects, for the patient, (3) Provide functionality with capabilities very similar to those in the original organ, (4) Decrease waiting time of patients for donated organs, (5) Minimize need for organ donors, (6) Increase patient longevity without compromising quality of life, (7) Allow for patient-specific pharmaceutical testing, and (8) Substantially reduce the reliance on animal testing for pharmaceutical research and development, and in other industries such as cosmetics

6. Does BIOLIFE4D have to make an exact replica, or clone, of the organ?

BIOLIFE4D will not have to make an exact copy or even recreate every feature set of the desired organ; it will only need to facilitate the minimum feature set which recreates the core properties of the organ. Because BIOLIFE4D’s process uses a patient’s own cells it will be an exact genetic match but will not be a copy or clone of the original.

7. What are the benefits of 3D bioprinting an organ using a patient’s own cells?

There are many benefits that 3D bioprinting an organ using a patient’s own cells as opposed to relying on a donor organ. Among these benefits are the lack of rejection of the organ by the patient, not having to undergo extensive and risky immunosuppression therapy, eliminating the long wait on donor waiting lists, reducing the need for organ donors, and increasing the patient’s longevity and quality of life. Additionally, it could also ultimately allow for patient-specific pharmaceutical testing of drugs and/or therapies.

8. How many people are currently on life-saving organ donor waiting lists?

In the US alone, every ten minutes, someone has added to the national transplant waiting list and on average 20 people die each day while waiting for a transplant. Around 120,000 people in the United States alone are currently on the waiting list for a lifesaving organ transplant, and that staggering number doesn’t even include the countless other individuals around the world who are likewise are in need of a life-saving organ transplant.

9. Other than bioprinting organs, what can BIOLIFE4D’s process be used for?

Beyond bioprinting organs, BIOLIFE4D’s process could stimulate pharmaceutical discovery and decrease related costs, boost pharmaceutical tool capabilities, improve drug efficacy and toxicity testing, streamline drug compound evaluation, and provide an alternative to pharmaceutical and cosmetic testing on animals

10. What is bioprinting?

Bioprinting is the fabrication of tissue and/or organs through the deposition of ultra-thin layers of living cells that are highly precise in shape and mechanical complexity, and thus is a biomedical application of computer-aided layered additive manufacturing.

11. What is 3D bioprinting?

3D bioprinting is the process of creating cell patterns in a confined space using 3D printing technologies, where cell function and viability are preserved within the printed construct. It is accomplished layer-by-layer with precise positioning of biological materials, biochemicals and living cells, with spatial control of the placement of functional components. Its goal is to apply the principals of engineering and life sciences towards the development of functional biological structures which can restore, maintain, improve, and/or replace existing organ function.

12. What is a bioprinter?

A bioprinter is a highly specialized 3D printer designed to protect the viable living cells during the bioprinting process. Bioprinters are capable of precisely controlling the spatial placement of the fundamental building blocks required to manufacture organs. The bioprinter deposits living cells in a bioink in multiple dimensions.

13. What is 3D bioprinting?
See “What is bioprinting?”.

14. What is the history of bioprinting?

In short, the first 3D printing was done in 1984, the first medical applications of 3D printing was about 2000, bioprinting was first done in 2003, and since 2010 additional advancements in 3D printing technology enabled production of bones, ears, exoskeletons, windpipes, blood vessels, vascular networks, tissues and even simple organs.

15. How big is the potential market for bioprinting organs?

In short, huge. It has literally global scale. It could be considered the holy grail of medicine. It has the potential to positively affect everyone, and if you consider that there are an estimated 7.5 billion people around the world today the scale is almost unimaginable.

16. What are other examples of companies like BIOLIFE4D that were at the forefront of their emerging technologies and how did they do?

BIOLIFE4D is at the forefront of an emerging technology with global scale. Examples of other companies that were at the forefront of their emerging technologies who made huge contributions to life-changing technology include Apple and Microsoft. While do not want to compare BIOLIFE4D to them, if you had invested in those companies at their IPO stages it would you would have been like getting in on Microsoft at the very beginning of the computer revolution or Apple before the iPhone revolution. You would have invested in companies at the forefront of an emerging technology that is world changing before the technology goes mainstream. If you would have invested less than $1,000 in Apple when it was first offered, as of August 2017 that investment would be worth over $400,000 – a staggering return on investment of over 40,000%.

17. What is 3D printing?

3D printing, also known as additive manufacturing, refers to processes used to create a three-dimensional object in which layers of material are formed under computer control from a digital file to create an object. The creation of a 3D printed object is achieved using additive processes. In an additive process, an object is created by laying down successive layers of material until the object is created. Each of these layers can be seen as a thinly sliced horizontal cross-section of the eventual object. 3D printing is the opposite of subtractive manufacturing which is removing material from a piece of material. 3D printing enables you to produce complex (functional) shapes which otherwise couldn’t be achieved through traditional manufacturing methods.

18. What is additive manufacturing?

See “What is 3D printing?

19. What is organ printing (organ fabrication)?

Organ printing is the act of designing and ultimately printing an artificially constructed organ designed for organ replacement or other translational or clinical therapies using 3D bioprinting techniques. BIOLIFE4D’s groundbreaking approach will converge recent breakthroughs in regenerative medicine, stem cell biology, 3D printing techniques and computing technology that will make organ replacement commercially viable and commonplace globally.

20. What is crowdfunding?

Crowdfunding is a form of crowdsourcing and alternative financing for a project or venture by raising many small amounts of money from a large number of individual investors.

21. What is equity crowdfunding?

Equity crowdfunding refers to the online offering of private company securities to a large group of people who can participate in a relatively small investment.

22. What is Title IV Regulation A+

Title IV Regulation A+ was created by the Securities Exchange Commission (SEC) effective March 25, 2015, and is a part of the JOBS Act, a law that allows companies to raise up to $50 million dollars in any 12 month period by offering stock participation to the general public.

23. What is regenerative medicine?

Regenerative medicine is a branch of translational research in tissue engineering and molecular biology which deals with the “process of replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function”. It is an emerging field that applies the principals of engineering and life sciences towards the development of functional biological structures which can restore, maintain, improve, or replace existing organ function.

24. What is tissue engineering?

Tissue engineering is the use of a combination of cells, engineering and materials methods, and suitable biochemical and physiochemical factors to improve or replace biological functions in an effort to improve clinical procedures for the repair of damaged tissues and organs.

25. What is organ transplantation?

Organ transplantation is a medical procedure in which an organ is removed from one body and placed in the body of a recipient, to replace a damaged or missing organ. BIOLIFE4D is working towards providing the patient a specific-specific 3D bioprinted alternative organ for transplant to replace the need for a donor organ in this process.

26. What are the current challenges of an organ transplant?

There are numerous challenges with current organ transplantation including extremely high cost, low transplant-viable organ availability, long waiting times on donor lists, high risk of rejection of the donor organ, direct and indirect risks associated with the immunosuppressant therapy required for donor organ transplants to help prevent rejection, and even for those fortunate enough to receive a life-saving donor transplant have a high mortality rate post-transplantation. With BIOLIFE4D, a patient-specific, fully functioning heart will be created through 3D bioprinting and the patient’s own cells, eliminating the challenges of organ rejection and long donor waiting lists that plague existing organ transplant methods.

27. What is organ transplant rejection?

Organ transplant rejection occurs when the transplanted organ is rejected by the recipient’s immune system, which destroys the transplanted organ.

28. What is a biomaterial?

A biomaterial is any substance other than drugs that has been engineered to interact with biological systems for a medical purpose – either a therapeutic (treat, augment, repair or replace a tissue function of the body) or a diagnostic one. It is a natural or synthetic material (such as a metal or polymer) that is suitable for introduction into living tissue especially as part of a medical device. They are the fundamental building blocks of organ fabrication process.

29. What is biocompatible?

In the simplest terms, it is something that is not harmful to living tissue. It is something that is compatible with living tissue or a living system by not being toxic, injurious, or physiologically reactive and not causing immunological rejection.

30. What is “in-vitro”?

In-Vitro is technically Latin for “in glass”, and it refers to organic products which remain outside of the body. During the 3D bioprinting process, BIOLIFE4D plans to replicate the same conditions in vitro (outside of the body) as occur naturally in vivo (within the body) while promoting natural biologic processes in an accelerated timeframe and in a manner that allows the cells to be specialized for the desired purpose.

31. What is bio-ink?

Bio-ink is a substance which includes living cells that can be printed into the desired shape during the bioprinting process. It is created by combining the living cells with nutrients and other materials that will help the cells not only survive the bioprinting process but also thrive as required in the post-printing environment.

32. What is an MRI?

Magnetic resonance imaging (MRI), also known as nuclear magnetic resonance imaging, is a scanning technique for creating detailed images of the human body which uses strong magnetic fields and radio waves to generate its images. It is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body.

33. What is biotechnology

Biotechnology is the use of living or biological systems and organisms to facilitate the development or production of a product.

34. What is hydrogel?

The hydrogel is a network of polymer chains that are hydrophilic which is important in tissue engineering both as acting as a host for the living cells as well as providing a 3-dimensional scaffolding construct.

35. What is an extracellular matrix (ECM)?

The extracellular matrix (ECM) is the non-cellular component present in all tissues and organs which is a collection of extracellular molecules secreted by cells that provide structural, biochemical and biomechanical support to the surrounding cells.

36. What is differentiation?

Differentiation is the ability of stem cells (less specialized cells) to change into different types of cells (more specialized cells) through gene expression.

37. What is gene expression?

Gene expression is the specific combination of genes that are turned on or off (expressed or repressed), which in turn dictates how a cell functions.

38. What is immunosuppressant therapy?

Immunosuppressant therapy is a treatment that has a purpose to lower the activity of the body’s immune system, thus reducing its ability to fight infections and other diseases, and also in cases to help a person from rejecting an organ transplant.

39. What is computational medicine?

Computational Medicine is an emerging discipline devoted to the development of quantitative approaches for understanding the mechanisms, diagnosis, and treatment of human disease through applications of mathematics, engineering, and computational science.

40. What is an iPS cell?

An iPS cell, or induced pluripotent stem cell, is a type of pluripotent stem cell (can be reprogrammed into desired specialized cell types) which was generated directly from an adult specialized cell through genetic reprogramming via gene expression manipulation. In the planned BIOLIFE4D process, iPS cells will be redirected into organ-specific cells through a process called differentiation which refers to the process by which one type of cell can be changed into different types of specialized cells.

41. What is a stem cell?

A stem cell is a cell which is undifferentiated cells that are able to differentiate into specialized cells and come from either embryo formed during embryological development (“embryonic stem cells”) or from adult tissues or cells (“adult stem cells”). All stem cells, regardless of their source, have three general properties: they are capable of dividing and renewing themselves; they are unspecialized; and under certain conditions, they can become tissue‐ or organ‐specific cells with specialized functions.

42. What is an adult stem cell?

An adult stem cell is an undifferentiated cell found throughout the body after embryonic development that can replenish dying cells and regenerate damaged tissues. Also known as somatic stem cells, they can be found among specialized cells of a tissue or organ of a child or adult and can differentiate to yield some or all of the major specialized cell types of a tissue or organ.

43. What is an embryonic stem cell?

An embryonic stem cell is an undifferentiated cell derived from a four- or five-day-old human embryo that is in the blastocyst phase of development and is pluripotent. BIOLIFE4D’s process does not utilize any embryonic stem cells.

44. What is the FDA?

The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments and is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

45. What is a scaffold?

A scaffold, when used for 3D printing, is a biocompatible and biodegradable construct that would be included with each layer printed to support the cells and hold them in place during the printing and a portion of the post-printing process.

46. What are genes?

A gene is the basic physical and functional unit of heredity and is a region DNA that is the chemical information database that encodes the complete set of instructions and acts as instructions to make molecules called proteins.

47. What is Autonomous self-assembly?

Autonomous self-assembly is the organization of components, from an initial state into final pattern or structure without external intervention such as human intervention. Once BIOLIFE4D places the appropriate cell types in the proper place, through the natural biologic process the individual cells will self-assemble forming the networks required for tissues and organs.

48. What is a bioreactor?

A bioreactor is any manufactured or engineered device or system that supports a biologically active environment by mimicking the nutrient and oxygen-rich conditions inside a human body.

49. What is a decellularized organ?

A decellularized organ is an organ which was harvested from a cadaver and subjected to a process, typically a chemical bath, to strip away all of the organic material leaving only the scaffolding which supported the organic material.

50. What is the National Institutes of Health (NIH)?

The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research, founded in the late 1870s. It is part of the United States Department of Health and Human Services and is the largest biomedical research agency in the world.

51. What are vascularized organs?

Vascularized organs are organs which contain vascular networks which supply the organ with oxygen and nutrients and also remove waste. Vascular networks serve generally as the delivery network within the body. In order for cells to become organs, they need four things: the proper environment, oxygen, nutrients, and waste removal, and vascularization allows the last 3 of these requirements to happen. Without an adequate vascular network, the cells would be starved of oxygen, as well as a means to excrete waste, causing them to die and making the printed organs worthless.

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