Mardil Medical Inc. has completed the first human implants of its new surgical therapy to reverse a heart disease called functional mitral valve regurgitation (FMR) that Mardil says affects nearly 6 million Americans.
Plymouth-based Mardil raised $6.1 million in 2012, mostly from a Malaysian venture fund to which it was introduced by Minnesota-based LifeScience Alley. Mardil says its VenTouch system is less invasive and more economical than open-heart surgery. A surgical team at National Heart Institute in Kuala Lumpur, Malaysia implanted the device in two patients who were very ill and part of a global clinical study.
“Our heart team was fascinated with the ease of placement, the immediate performance of the of the VenTouch and the rapid recovery of the [two] very sick patients,” Dr. Jeswant Dillon, clinical director of adult surgery and chief cardiothoracic surgeon said in a statement. The procedure was also supported by leading surgeons from the Texas Heart Institute in Houston, New York University Langone Medical Center and Toronto General Hospital.
FMR occurs when the left ventricle of the heart is enlarged, the mitral valve no longer closes properly and the blood flows back into the atrium. Untreated, the FMR overloads the enlarging heart and can lead to accelerated heart failure and death. The current treatment requires open-heart surgery.
CEO Jim Buck, a veteran of St. Jude and smaller medical companies, said the successful treatment of “two very sick patients” with the Mardil’s VenTouch system is a significant step toward eventual commercialization and widespread adaptation of “this groundbreaking therapy.”
The VenTouch technology is rooted in intellectual property acquired largely from the former Acorn Cardiovascular and another development-stage company that ran out of money.
“Our approach is less invasive, less costly and directly addresses the underlying root cause of the condition in a safe fashion,” Buck said.
The VenTouch system, purported to be the only device that treats the “root cause of FMR” is a “biomaterial sleeve fitted with an inflatable, adjustable fluid chamber that applies prescriptive pressure to a targeted location in order realign valve leaflets.” In other words, it’s designed to solve the problem and reshape the enlarged heart. The sleeve subsequently can be adjusted through a “port” just under the skin.
Mardil is seeking regulatory approval in Europe, Asia and Canada, followed by anticipated U.S. regulatory approval and commercialization. More information: www.mardil.com.
St. Paul Small-business owner returns to Ethiopia to help
Shegitu Kebede, the St. Paul restaurateur and immigrant, is in Ethiopia, planning a school for refugees for which she and her supporters raised more than $20,000.
According to Kebede’s business partner and Jane Graupman, executive director of the nonprofit International Institute of Minnesota, Kebede found a transition center in one camp that houses 400 East African children who are sleeping on the ground on plastic sheets. Kebede is trying to raise an additional $5,000 for mattresses, blankets and flashlights.
The International Institute (www.iimn.org) is the fiscal agent and a partner in Kebede’s Women at the Well International nonprofit that trains refugees in language and job skills as they prepare to immigrate to a western country. Kebede was invited to build the school last year by the United Nations refugee agency.
“This is the camp where Shegitu is going to build the school,” Graupman said last week. “She’s trying to make it happen. The average stay of a person in a refugee camps has grown from two or three [years] to 17 years. They are there for a long time.”
The column I wrote last month about Kebede’s journey from orphan to refugee to Minnesota small business owner is at: www.tinyurl.com/kjdddzc. Tax-deductible checks made to International Institute/Transition Center for Children can be sent to Frewoini Haile at The Flamingo, 490 N. Syndicate St., St. Paul 55104. Follow Kebede in Ethiopia at www.iimn.org/about/iimn-blog.
Attorney Soule starts next act
George Soule, a veteran Minneapolis attorney who helped Gov. Arne Carlson and Gov. Jesse Ventura take politics out of the judicial selection process, is branching out on his own.
A founding partner of the firm Bowman and Brooke, Soule, 59, is hanging out his own shingle with another Bowman and Brooke alum, Melissa Stull. The firm will be known as Soule & Stull with a specialty in product liability cases, commercial litigation and dispute resolution. The firm’s biggest client is Iowa-based Vermeer Corp., a farm industrial and construction equipment manufacturer.