Organovo (NYSE: ONVO) is an exciting 3D printing company that has had a volatile ride in the stock market lately. We dig into some of the factors contributing to changes in its stock price.

As we have covered in the past, Organovo specializes in Bioprinting. The company designs and creates functional, three-dimensional human tissues for medical research and therapeutic applications. The Company collaborates with pharmaceutical and academic partners to develop human biological disease models in three dimensions. These 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost.

This savings amounts to a multi-billion dollar opportunity for changing the way Big Pharma discovers drug therapies. Drug companies will be able to test on 3D printed human tissue in a lab before they even embark on the FDA approval process with animal trials, saving hundreds of millions of dollars.

Read: Bioprinting is a Multi-Billion Dollar Pharma Opportunity for 3D Printing

With all of this promise, why does Organovo only have a $700 million market capitalization? 3D Systems and Stratasys are two other public 3D printing companies that boast multi-billion dollar market caps.

Moreover, why did Organovo climb to an all-time high of $13.65 last week, only to crash nearly 40%?

Pictured above: ONVO year-to-date stock chart. Click to enlarge.

The answer is two-fold.

First, Organovo is early in its product roadmap, and has yet to realize much revenue.

Second, the price of the stock is being heavily influenced by the media.

Organovo Product Roadmap

In September, Organovo CEO Keith Murphy shared his company’s future roadmap:

• Development and launch of 3D Liver
  • Scientific proof of concept – April 2013
  • Functional validation: testing against known drugs – December 2013
  • Delivery to KOLs: alpha and beta testing – April 2014
  • Product launch – December 2014
• Follow on cell assay product launches
• Multiple additional pharma partnerships
• Developed disease models
  • Cancer model readouts over 12-24 months: kidney, others
• Therapeutic tissue proof of concept and path to clinical

Note that there is a key milestone coming in December to demonstrate functional validation. Organovo has scheduled a retail investor conference for December 5 to discuss product pipeline and revenue potential, partnership model, cash burn and R&D spend, and more.

Read the full agenda in Organovo’s press release.

Be Careful About the Media

Because ONVO has a relatively small market cap and 3D printing is a concentrated industry, one highly negative or positive story can make a difference in the markets.

Case in point: Seeking Alpha contributor Richard Pearson wrote an article called A Very Detailed Look at Organovo on November 19, saying “Investors should therefore expect the share price to quickly return to below $7.00, where it was prior to over a dozen promotional articles on Organovo released in the past few weeks.”

On that day, the stock fell 40%. Luckily for Mr. Pearson, he was shorting the stock as it read in his disclosure.

If you look across Seeking Alpha as one example of a site sharing investment advice, there has been a lot of attention paid to ONVO by contributors. There is even an article entitled Organovo At the Mercy Of The Media.

The takeaway is that investors need to be aware of this media-drive volatility and be prepared to have short-term pops and crashes until Organovo demonstrates, or fails to live up to, the achievements set out on its roadmap.

2014 will be an important year for the Bioprinting pioneer!

Disclosure: At the time of this writing, the author is long ONVO. Please consult your financial advisor on all investment decisions.

One of the most exciting and promising applications of 3D printing is bioprinting, the ability to manufacture living human tissue and possibly organs. And one of the most exciting companies in this field is Organovo.

Organovo (NYSE MKT: ONVO) designs and creates functional, three-dimensional human tissues for medical research and therapeutic applications. The Company collaborates with pharmaceutical and academic partners to develop human biological disease models in three dimensions. These 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost.

Keith Murphy, Chairman and Chief Executive Officer of Organovo, spoke last week at the Inside 3D Printing conference in San Jose, CA.

Organovo’s NovoGen Bioprinting is based on a scaffold-free bioprinting process. The cellular “bio-ink” is supported architecturally by hydrogel. The hydrogel can later be removed, leaving only the 3D cellular strcture. The system allows deposition of any structure.

“It enables the creation of tissue that is 100% cellular,” said Murphy during his keynote at the 3D printing conference.

Mr. Murphy shared several applications of his company’s bioprinting technology as well as his future roadmap. The key applications are:

• Vascular bioprinting
• Tissue patching
• Drug discovery with incredible savings for Pharma R&D

Creating Human Arteries and Living Tissue with 3D Printing

Organovo has been able to create simulated human arteries that are developed outside of the body using vascular bioprinting. They are viable tissue with layered architecture. These arteries are able to withstand 6 times the normal blood pressure and therefore may be implantable in the human body.

Consider patients who experience trauma or disease and need arterial transplants. 3D printed arteries could be game-changing for this class of surgeries.

With similar technology, Organovo can create living tissue, such as heart tissue, that can be implanted during surgery and thrive with the existing tissue. “We can build tissues that are significant larger than any other approach,” said Mr. Murphy. Before bioprinting full organs can be commericalized, which Murphy hinted may be in the future, simple tissue can be generated and stitched into the body.

How Bioprinting Can Save Big Pharma Billions

Over the last 15 years, the cost of Pharma R&D has dramatically increased from $15 to $50 billion per year, and yet the number of FDA approvals has remained constant if not declined. See the chart below for a visualization of new molecular entities (NMEs) vs total R&D spend per year.

(Source: Discover Management Solutions)

Mr. Murphy knows from his personal experience of working at Amgen for 10 years how much money can go into the development and testing of a potential blockbuster drug only to be rejected during human trials. Some Big Pharma companies spend upwards of $1 billion per drug before final FDA approval. Therefore, the best practice is to speed through animal trials as fast and with as little cost as possible, because the real learning comes during human trials.

This rising R&D cost creates a massive opportunity for bioprinting to give Pharma companies an opportunity to get pre-clinical data on how a drug will work in a human system before even starting animal trials.

This is a multi-billion dollar opportunity.

Organovo creates human cells, for example liver cells, that are deposited and developed into tissue. A disease can be introduced to that tissue in a controlled fashion, and then a variety of independent therapies can be applied. This means that you can outright reject or move along potential drug therapies in a matter of weeks rather than years. Just imagine the hundreds of millions of dollars in savings per blockbuster drug.

Watch the video below for to see Organovo’s process in detail.

The technique of testing therapies on human cells is not new, but Organovo’s approach using 3D printing to generate living tissue is the breakthrough. Organovo’s tissue can live up to 30 days.

“The old rule of thumb in tissue engineering is that you can’t more than 250 microns away from the surface because the cells will die from lack of oxygen,” explained Mr. Murphy, “but we can get to a millimeter by building a capillary structure, getting growth of microvascular networks.

This achievement results in nuanced improvements over what one can get in animal models.

The key applications are Pharma drug discovery and toxicology testing.

Organovo’s Future

Today, Organovo is a public company with a $430 million market cap. But in the next few years, the company could revolutionize drug discovery and tissue therapies.

Keith Murphy, CEO of Organovo, shared his outlook on the company’s future milestones:

• Development and launch of 3D Liver
  • Scientific proof of concept – April 2013
  • Functional validation: testing against known drugs – December 2013
  • Delivery to KOLs: alpha and beta testing – April 2014
  • Product launch – December 2014
• Follow on cell assay product launches
• Multiple additional pharma partnerships
• Developed disease models
  • Cancer model readouts over 12-24 months: kidney, others
• Therapeutic tissue proof of concept and path to clinical

Related stories:

• Top 9 Medical Applications for 3D Printing – Epic List
• Organovo 3D Printing: Bold Mission But Needs Cash, May Offer Secondary

Want to learn more about the evolution of bioprinting? Check out the infographic below, entitled Printing the Human Body.

How 3D Printing is Changing the Face of the Medical Industry

The list of medical applications for 3D printing was originally compiled by the team at 3D model marketplace CGTrader and has been edited for publication here.

Recently 3D printing has been a hot mainstream trend, but there are thousands of people who are still not aware of this mind-blowing technology. Obviously, 3D printing is being carefully watched by scientists, designers, futurists, and hobbyists. No doubt, it will change our lives; 3D printing is already reshaping them. In the long run, 3D printing may have the most impact in the medical field, where extrusion of living cells instead of plastic material in a 3D printer has led to bioprinting.

Here is a completely mind-blowing list of the top 9 ways 3D printing has already changed all the branches of the medicine and what to expect in the future. Moreover, this article touches upon a controversial topic of artificial organs. Keep reading!

1. 3D Printed Hearing Aids

Thousands of people do not realize that they have already become a part of 3D printing revolution by simply wearing hearing aids.

98% of hearing aids (more than 10 million) are 3D printed today. Hearing aid manufacturing began to adopt 3D printing technology in 1998 and it has been a significant improvement to manufacturing. The process has been shortened to 3 steps: scanning, modeling, and printing. One machine is able to produce 30 hearing aids in one hour and a half.

More coverage:

• 3D printed batteries could marry form and function for hearing aids
• TED talk by Klaus Stadlmann: The world’s smallest 3D printer
• 3D Printed Hearing Aids: A Revolution You May Have Not Heard About

2. Digital Dentistry Brings 3D Printing Into the Dental Office

3D printing’s contribution to the dental industry has been game-changing. Scientist Andrew Daewood, who works in London’s Wimpole Street, notices that before the 3D printing has become the mainstream, “dentists have been using it for 10 years, to make things that really can’t be made in any other way.”

3D printing helps to improve quality and speeds up the production. Technology enables the customer to get a transparent 3D printed teeth aligner for day-to-day use, on one’s way to the dentist 3D printer is already printing out a new dental implant as well as dental crowns, bridges, stone models and a variety of orthodontic appliances.

More coverage:

• 3D Printing Advances Dentistry in London at Daewood & Tanner Practice
• Dental Labs Redefine Personal Care with Onsite 3D Printing
• What The Hell Is Digital Dentistry?

3. 3D Printing Body Parts and Bone

Earlier this year, an American patient received a radical surgery in which 75% of his skull was replaced with a 3D printed implant. This material was not only biocompatible but also a bone-like. Scott DeFelice, President and CEO of Oxford Performance Materials, announced that his company has serious plans that between 300 to 500 patients in the U.S. alone could have skull replacement surgeries each month.

Last year an 83-year old woman has received the very first titanium jaw implant manufactured with 3D printer.

In another story, a 3D printed biopolymer of windpipe was surgically sewn as a splint to open a baby’s airways. After 2 to 3 years it will be fully absorbed in the body.

More coverage:

• Innovative and Strange 3D Printing: Chocolate, Stone, Candy, Organs
• 3D Printed Parts Inside A Human Body: A Fact or Fairy Tale?

4. The Miracles of Prosthetics: 3D Printed Face and Children Hands

Injuries and disease can cause debilitating health conditions for people, to the point where a prosthetic limb or other body part is necessary to maintain quality of life.Thanks to 3D printing, prosthetics have become easier to customize and produce. Here are three particularly inspiring cases.

Eric Moger was the first person to start a life once again with 3D printed face.

A famous Robohand project has proved that anything is possible. The idea was a goal to reach by Richard Van As from South Africa and he finally come up with the concept how to produce necessary hand prosthesis quickly, quite cheaply, and make it accessible to the wide society.

Meet Buttercup, the first and only bird that has 3D printed leg prosthesis.

Thanks to 3D printing and devoted designers, Buttercup has experienced the freedom of walking for the first time. Moreover, this duck is the worldwide superstar, that got an award for honours. Just creepy amazing.

Get Rid of Itchy and Stinky Plaster Casts! 

Were you jealous of kids who broke an arm but then got all their friends to sign their cast? With 3D printing technology, the traditional plaster cast is being replaced by a light, breathable, washable and recyclable design. And, of course, stylish.

In the U.S., a bone fracture occurs every 5 seconds. Enter the Cortex Exoskeleton cast designed by Jake Evill, a graduate from the Architecture and Design School in New Zealand. With a 3D scan, the cast can be 3D printed onsite at the emergency room.

More coverage:

• 3D Printed Legs: Giving Amputees the Power of Personal Expression
• If Lizards Can Grow Tails, Humans Should Print Limbs

5. 3D Printing and Growing a Bionic Ear

When researchers from Princeton and John Hopkins get together, expect something big. In this case, a team of researchers developed a bionic, artificial ear. With the help of 3D printing, the team created a skeletal structure which is seeded with cartilage cells, and 10 weeks later, you have a fully formed ear!

More coverage:

• The World Turns Bionic: 3D Printed Bionic Ear
• Cornell Professor Develops Technique for 3D Printing a Human Ear

6. 3D Printing Stem Cells Paves the Way to Artificial Organs

3D printing enabled a group of Heriot Watt University scientists to produce clusters of embryonic stem cells. The scientists used the method of valve-based printing in order to keep these cells in high level of viability, to stay accurate to produce spheroids of uniform size and to maintain their pluripotency that addresses to differentiation into any other cell type.

In the picture above you can see aggregated embryonic stem cells after 24 hours (left) and after 48 hours (right). Artificial organs are still in the near future, but this achievement is extremely significant for drug testing purposes while using artificial human tissue or even printing cells directly inside the body.

More coverage:

• Invest in Bioprinting to Get a 3D Printed Ear or New Hip
• A 3-D Printer for Human Embryonic Stem Cells

7. 3D Printing Endless Blood Vessels Threads

Scientists from the Fraunhofer Institute in Germany developed a technique to 3D print artificial biological molecules to form the shape of blood vessels. This technology is still quite imprecise for the fine structures of capillary vessels, so the scientists use the laser to zap the molecules and to form the material.

In other findings, UPenn and MIT researchers found sugar as the best agent to 3D print blood vessels without any seams.

More coverage:

• Scientists Create Blood Vessels Using Sugar and 3D Printing
• Tissue Printer to Fabricate Artificial Blood Cells

8. New Skin, Courtesy of 3D Printing

Skin graft transplantation is nothing new in the medicine, but now 3D printing technology is enabling scientists to produce artificial skin. Researchers at the University of Toronto have developed a method of loading skin cells and various polymers into 3D printer to create thick layers of skin.

In other research, scientists from the Institute of Regenerative Medicine at Wake Forest University in Winston-Salem, North Carolina aim to print skin directly onto burn wounds. Professor James Yoo and his team were highly inspired to develop a portable bioprinting system to help address injuries in the battlefield, where around 30% of injuries involve skin damage.

More coverage:

• Printing Skin Faster and Cheaper

9. 3D Printed Organs: A Fiction or The Great Achievement of The Next Decade?

18 people die everyday in the U.S. waiting for an organ transplant. Some researchers have embarked on a bold goal of 3D printing artificial organs.

In one example, surgeon Anthony Atala demonstrated an early-stage experiment at a 2011 TED Talk, where he printed a prototype human kidney.

In other research, Wake Forest Institute For Regeneration works on more than 30 different replacement tissues and organs, including bladder, cartilage, trachea and heart healing therapies. Using similar technology to Atala, a young patient received an engineered bladder transplant, the first lab-grown organ to be implanted into a human.

The world’s first artificial liver is already on its way. A team at Heriot Watt University led by Dr. Will Shu are running experiments with this goal in mind, again using 3D printing in the manufacturing process.

Finally, San Diego-based Organovo team has already managed to create micro-livers that are half a millimeter deep and and 4 millimeters wide. The researchers used a gel to build three types of liver cells and arranged them into the same kind of 3D cell architecture found in a human liver. The company’s ultimate goal is to create human-sized structures suitable for transplant, but they might need more capital.

More coverage:

• Biofabrication: Scientists 3D Print Stem Cells to Create Human Organs
• Video: Growing New Organs with 3D Printing (TED Talk)
• Video: The Best 7 TED Talks On 3D Printing
• Organovo 3D Printing: Bold Mission But Needs Cash, May Offer Secondary
• 3D printing human organs – but where’s the money for it?

Conclusion

That’s it! 9 amazing ways that 3D printing is revolutionizing modern medical research.

Please share, RT and add your comments!

Thanks again to CGTrader for compiling this amazing list. Read their original post here.

Cover photo: The Body Shop Kevin Hand

A roundup of the top news On 3D Printing brought you from July 23 to July 29.

Monday, July 23

• 3D Printing Industry Will Reach $3 Billion by 2018 – Report

Friday, July 27

• Afinia Targets Consumer Market with New 3D Printer Priced at $1499
• Organovo 3D Printing: Bold Mission But Needs Cash, May Offer Secondary

Investor information site Seeking Alpha thinks Organovo Holdings (PINK: ONVO) is worth a deeper look. We have profiled this company and the field of bioprinting before. It’s one of the most amazing 3D printing applications.

Organovo Holdings (ONVO) is a revolutionary company that uses 3D printing technology to build organic tissues one cell at a time. The potential applications for this technology are simply astounding with the possibility of replacement organ and tissue manufacturing that would revolutionize medicine and the healthcare industry. With an innovative management team and a potentially lucrative patent portfolio, it would seem that the sky is the limit for ONVO.

Organovo’s mission is potentially revolutionary, but the question is whether the company can survive long enough to see it through. It currently trades on the pink sheets. Below is their stock chart.

The company is loaded up with debt, bleeding cash and generates little to no revenue. While the technology is amazing and the potential is huge, right now the company is generous in its filings when it says it will be able to pay the bills for the next 12 months.

So what are the options? Most likely, the company will need to take additional funding, in the form of a dilutive secondary offering. While it would reduce the equity of the founders, a secondary could given them enough cash to complete R&D and start to generate revenue. We will see if the board of directors is willing to make this deal.

(Update: a commenter pointed out that the company has no debt. We checked in Yahoo! Finance and corrected the quote from Seeking Alpha above.)

Read the full analysis at Seeking Alpha.