About Medical 21
Medical 21 develops the MAVERICS graft, a regenerative small-diameter graft for coronary artery bypass surgery. The graft is meant to replace the vessels surgeons now harvest from the patient's body. It combines an absorbable polymer scaffold with a nitinol wire frame. The graft is an investigational device, with no approval for commercial sale from the FDA or any other regulator.
Manny Villafaña founded the company and is its chief executive officer. Medical 21 is his eighth medical device company. He also founded St. Jude Medical in 1976 and ATS Medical. Andrea Sweeney is vice president of business administration, Jeff Vreeman is vice president of manufacturing, and Eric Solien is vice president of clinical sciences. The advisory board includes two retired cardiac surgeons and a University of Iowa professor of biomedical engineering. The company's address is 3700 Annapolis Lane North, Suite 105, in Plymouth, Minnesota.
Funding Rounds (SEC Form D)
| First sale | Filed with SEC | Amount sold | Investors | Avg. check | Terms | Filing |
|---|---|---|---|---|---|---|
| Sep 17, 2026 | Oct 23, 2026 | $550,000of $20.0M target | 3 | $183K | EquityRule 506(b) | Form D ↗ |
| Feb 9, 2023 | Apr 14, 2023amended Aug 21, 2025 | $10,017,500of $20.0M target | 39 | $256K | EquityRule 506(b) | Form D/A ↗3 earlier filings |
| Sep 13, 2022 | Sep 20, 2022 | $2,500,000of $20.0M target | 1 | $2.5M | EquityRule 506(c) | Form D ↗ |
| Feb 22, 2019 | Jan 8, 2019amended Jan 12, 2021 | $3,000,000of $10.0M target | 15 | $200K | EquityRule 506(b) | Form D/A ↗2 earlier filings |
| Dec 18, 2017 | Aug 1, 2018 | $750,000of $4.0M target | 5 | $150K | EquityRule 506(b) | Form D ↗ |
| Aug 23, 2017 | Sep 1, 2017 | $250,000of $15.0M target | 1 | $250K | EquityRule 506(b) | Form D ↗ |
| Apr 11, 2016 | May 19, 2016 | $200,000of $2.0M target | 2 | $100K | EquityRule 506(b) | Form D ↗ |
| Total, seven offerings | $17,267,500 | |||||
First sale is the date the first investor in the offering committed to invest. Companies must file Form D within 15 days of that date, so filing dates run later.
Why Investors Backed Medical 21
Medical 21 is developing the MAVERICS graft, an artificial artery for heart bypass surgery. In December 2025, it received regulatory approval in Spain to start its first study in people. Founder Manny Villafaña, who also founded St. Jude Medical, leads the company.
The problem it targets
Coronary artery bypass surgery restores blood flow to the heart. Surgeons do this with veins harvested from other parts of the patient's body. Medical 21's view is that harvesting causes pain and scarring at the harvest site, a longer recovery and a risk of infection. It also argues that many patients, including those with diabetes, varicose veins or amputations, are ineligible. It puts the failure rate of these grafts at 25 to 30 percent in the first year and 50 percent in five to 10 years.
What the product does
In Villafaña's description, the graft works within the body's own regenerative pathways to prompt angiogenesis, the natural formation of new blood vessels. The aim is an arterial-like vessel grown from the patient's own cells. The scaffold is designed to encourage cells to enter it and, over time, form native vascular tissue. The graft is meant to be assimilated by the body, so nutrients can pass through. Medical 21 expects recovery to take at least one day less in the hospital. A 2022 release from Medical Funding Professionals said the graft allows surgery on or off the heart-lung machine.
Progress so far
In December 2025, Medical 21 announced regulatory approval in Spain under the European Union Medical Device Regulation. The approval clears a first-in-human, multicenter trial called the MAVERICS Coronary Revascularization Study. Villafaña said the company is eager to begin assessing the graft's safety, performance and biological integration in patients. In 2022, a release from Medical Funding Professionals said the company was completing non-clinical testing and setting regulatory strategies for EU and other marketing authorizations.
Who backs it
Medical 21 is a private company. The Business Journal in the Twin Cities reported in April 2021 that it was nearing a goal of raising $10 million. In May 2022, the Business Journal reported that it was seeking $40 million through a Regulation A+ offering. Villafaña said he was avoiding pitches to venture capital firms. Medical Funding Professionals was engaged in 2022 to prepare the Regulation A+ offering. Renaissance Capital reported in February 2026 that Medical 21 was seeking up to $25 million in an initial public offering.
We wrote this summary from public statements by Medical 21 and its investors. It is not investment advice.
Medical 21 in the News
- Manny Villafaña says Medical 21 could be his biggest success yet
- St. Jude Medical founder looks to take Medical 21 venture public
- Medical 21, Synthetic CABG Graft Developer, Files for Not Disclosed IPO
- Manny Villafana's Medical 21 seeking $40 million through Reg A+ financing
- Manny Villafaña's new company Medical 21 close to $10M fundraising goal
- Manny Villafaña raising $10 million for project that's 'bigger … than pacemakers'
Leadership Team
Executive officers and directors listed on Medical 21's Form D filed Oct 23, 2026.
Earlier filings also listed Erik Hermansen (executive officer, last listed Aug 2025) and Chaid Schwarz (executive officer, last listed Aug 2025).
Sources
- SECMedical 21, Inc. Form D/A, filed Jul 29, 2024
- SECMedical 21, Inc. Form D/A, filed Jul 31, 2023
- SECMedical 21, Inc. Form D, filed Apr 14, 2023
- SECMedical 21, Inc. Form D/A, filed Jan 16, 2020
- SECMedical 21, Inc. Form D, filed Jan 8, 2019
- SECMedical 21, Inc. filing history
- CompanyAbout — Medical 21
- CompanyTeam — Medical 21
- CompanyContact — Medical 21
- CompanyPress — Medical 21
- CompanyMedical 21, Inc. Announces Approval to Begin Human Clinical Studies in Spain
- PressPR Newswire: Medical 21, Inc. Announces Regulatory Approval to Initiate First-in-Human Clinical Study in Spain
- PressMedical Funding Professionals release: Medical 21 engages MFP (May 10, 2022)