The MAVERICS graft system is a revolutionary functional artificial artery that is designed to eliminate the need for vessel harvesting in cardiac bypass surgery patients — creating a more efficient, cost-effective, and less invasive procedure.
MINNEAPOLIS, June 7, 2022 /PRNewswire/ — Led by founder and CEO Manny Villafaña, Ph.D. Sc., Medical 21 is a next-generation medical technology company seeking to reshape the future of cardiac bypass surgery procedures with their groundbreaking MAVERICS graft system.
The MAVERICS graft is a small, flexible tube encasing a nitinol scaffold designed to eliminate the need to harvest vessels from a heart bypass patient. Medical 21 has developed a strong and cost-effective graft system that is less invasive than traditional methods. Eliminating vessel harvesting will increase patients’ quality of life, speed up recovery, and even open up access to the surgery for patients who were previously ineligible.
Many attempts at similar grafts have failed due to issues around biocompatibility and structural load. Medical 21’s animal studies in sheep have shown positive results surpassing the requirement of 90 days. In fact, the positive results have continued for over 250 days after the initial procedure.
Villafaña, the recipient of the Living Legend of Medicine award by The World Society of Cardiothoracic Surgery in 2006, said, "This has the potential to be the most-used single implantable device developed for medicine. Heart disease is the number one killer in the world and we are trying to do something about it. We are focusing on improving cardiac surgery with the graft we have developed. People have attempted this for many years, but we have been able to get it done. We’ve had successful animal trials and now are getting ready for human clinical trials."
Hearts are complex organs that are difficult to replicate and repair; a graft must be biocompatible, flexible, and strong — but traditional methods have often failed, clogged, and created further complications for patients. Medical 21 has developed a graft that is biocompatible, structurally sound, and resilient enough to withstand the intense and specific conditions the cardiovascular system requires while offering a less invasive and less time-consuming procedure.
Cardiovascular disease (CVD) is the #1 cause of death globally, with roughly two billion adults at risk for heart disease. There are currently 800,000–1,000,000 cardiac bypass surgery procedures performed worldwide annually, requiring 2.5–3.5 million grafts. As these numbers rise each year, the global need increases as well. Medical 21’s MAVERICS graft will be available to patients regardless of the condition of their own arteries and veins, giving a group of previously unviable candidates a chance at surgery. Patients with varicose veins, severe diabetes, and amputations will have access to heart bypass surgery since Medical 21’s graft system eliminates vessel harvesting.
This innovative technology is designed to eliminate disfigurement from vessel harvesting and reduce a patient’s pain, discomfort, and post-op wound healing complications. With the significant reduction in recovery time, patients may spend at least one less day in the ICU compared to traditional methods.
Medical 21’s MAVERICS graft system can benefit surgeons by reducing operating room time and reducing costs through shorter hospital stays and fewer post-op complications per patient.
Medical 21 recently opened a Regulation A+ equity round for $40 million and is receiving investments on its website (www.investinmanny.com). Learn more about Medical 21’s groundbreaking strides in cardiac bypass surgery procedures by visiting Medical21.com.
Medical 21, Inc. is a developmental stage medical device company founded by Manny Villafaña, Ph.D. Sc., located in Minneapolis, Minnesota. Medical 21 has developed and intends to commercialize and market an artificial graft to bypass blockages in the heart. This revolutionary product is supported by a team that collectively possesses decades of experience in the successful development, manufacturing, sales, and marketing of medical products to the domestic and international healthcare markets. The Medical 21 artificial graft is not yet FDA approved or cleared. For investigational use only. Not yet available for commercial sale.
Certain statements in this press release constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995 and "forward-looking information" as such term is defined in applicable US and Canadian securities legislation. The words "may," "would," "could," "should," "potential," "will," "seek," "intend," "plan," "anticipate," "believe," "estimate," "expect" and similar expressions as they relate to the Medical 21, Inc. (the "Company"). Such statements reflect the Company’s current views and intentions with respect to future events, and current information available to the Company, and are subject to certain risks, uncertainties and assumptions, including, without limitation: the conditions to closing of the transaction being satisfied, including obtaining all necessary approvals for the transaction. Should any factor affect the Company in an unexpected manner, or should assumptions underlying the forward-looking information or statements prove incorrect, the actual results or events may differ materially from the results or events predicted. Any such forward-looking information or statement is expressly qualified in its entirety by this cautionary statement. Moreover, the Company does not assume responsibility for the accuracy or completeness of such forward-looking information or statement. The forward-looking information and/or statements included in this press release are made as of the date of this press release and the Company undertakes no obligation to publicly update or revise any forward-looking information, other than as required by applicable law.
This press release is for information purposes only and does not constitute an offer or sale of the securities referenced herein. Any such offer will only be made in compliance with applicable state and federal securities laws pursuant to Regulation A, Tier 2 of the Securities Act of 1933. A link to the qualified offering circular and related offering documents is attached hereto and all prospective investors should carefully review these materials, which includes important disclosures and risk factors associated with an investment in Medical 21, Inc.
The information is provided for convenience only, is not investment advice and may not be relied upon in considering an investment in Medical 21, Inc. No representation or warranty, express or implied, is made as to the accuracy or completeness of any information contained herein, and any investment decision should be based solely on the information contained in the offering circular and related materials, and the investors independent research. No representation or warranty, express or implied, is made as to the future performance of any investment in Medical 21, Inc., or that investors will or are likely to achieve favorable results, will make any profit at all or will be able to avoid incurring a loss on their investment. In addition, prospective investors are encouraged to consult with their financial, tax, accounting or other advisors to determine whether an investment in Medical 21, Inc. is suitable for them. A copy of the offering circular filed with the SEC may be obtained at the following URL: http://medical21.com/offering-circular
Media Contact
Andrea Sweeney
+1 (952) 221-3104
337882@email4pr.com
SOURCE Medical 21
