General Frequently Asked Questions
Investor Frequently Asked Questions
Investments always come with a risk, as does this one. At Medical 21, we must make the product, get it approved, demonstrate its effectiveness, and then sell it to a group that is very conservative — namely, the cardiac surgeon. We will have to go through very high regulatory channels. This, along with the unprecedented nature of our product, presents investment risks. This is not an easy project. Over the last fifty years, many companies and health institutions — large and small — have unsuccessfully tried to develop a product similar to ours. No one has been able to get a small diameter artificial artery through human trials … yet.
Manny says that when golf is as exciting as the work we’re doing, he’ll play golf. The work we do entails helping hundreds of thousands, if not millions, of people with their health. To Manny, that is better than playing golf. He will continue to help people in this way as long as the good Lord helps him. He strongly believes Medical 21 will be his biggest company ever.
Yes, we can get it done. We have successfully gone through the process of bringing a complex medical device to market before. This is the eighth company started by our founder Manny Villafaña, seven of which were led to IPO. We will try to do things the way he has with his past successes. The only exception is, of course, that the technology we are creating is brand new. But the process is the same: develop the technology, complete our animal studies, secure funding, complete the regulatory steps, perform our clinical trials, then distribute the product throughout the world — in many cases using the same distribution network.
Physician Frequently Asked Questions
Yes, you may continue to use the same sewing techniques you already use. However, you will be spared the work of harvesting vessels from the body.
The Medical 21 team is comprised of industry professionals who excel at their work, even when the odds are stacked against them. If you look at the track record of our Founder, Manny Villafaña, he has always created medical devices that people said couldn’t be done. There was a time when pacemakers lasted only 12–18 months; Manny made a pacemaker that would last more than ten years. “That’s impossible!” everyone said, but he did it.
At St. Jude Medical, Manny and his team developed a heart valve using a technology that no one had ever used before and that people said couldn’t be done. Everyone else was making heart valves out of metal, hoping to create strength in the valve. Manny made the St. Jude valve out of glass (pyrolytic carbon), which people thought would be too fragile. The St. Jude heart is now the most used prosthesis in the world. Later, Manny started ATS Medical, and they developed an even better version of that valve using some of the same principles. Medtronic, Inc. presently owns ATS Medical.
Patient Frequently Asked Questions
By using the Medical 21 graft, your surgeon won’t have to harvest or strip vessels from your legs, arms, or other areas of your body. Our graft will decrease your time in surgery, reduce pain, prevent additional scarring, and decrease your risk of infection.