Ascendx Spine™ Gets New Board Member, New EU Distributors and FDA Approval

It’s positive news for Ascendx with a new high profile board member, new distributors for its CE marked products in four European countries, and FDA clearance for its Acu-Cut Vertebral Compression Fracture Solution.

In short

Florida based Ascendx Spine™ has elected Dr. Magnus Persson to its board of directors, effective immediately. At the same time the company has confirmed that it now has distributors in France, Spain, Italy and Portugal for its CE marked Ascendx VCF Repair System and Ascendx Acu-Cut VCF Augmentation System and has gained FDA approval for the latter.

Background

According to a company press release, Dr. Persson has been a Partner in two life sciences-focused venture capital firms, one with its base in Sweden with global reach and one in the San Francisco Bay Area in California. He has many years of experience in medicine, the life sciences and medical technology financing. He has led development teams of Phase II and III programs in the pharmaceutical industry; he also has founded and led private as well as public biotech and medtech companies as chairman of the board and a director in Europe and the U.S. In addition, Dr. Persson has led several successful recruitment processes for senior management positions, including CEOs.

Dr. Persson received his Medical Doctor degree from Karolinska Institutet in 1986.

The Acu-Cut Product

A vertebral compression fracture forces a vertebra to collapse, and the spinal column above it to assume an abnormal forward curve, resulting in considerable back pain and a hunchbacked appearance. Current standard procedures for treating VCFs are ‘Vertebroplasty’ and ‘Kyphoplasty.’ The Acu-Cut Vertebral Augmentation System is designed to be an alternate solution for physicians who are currently treating VCF patients. Acu-Cut is a uni-pedicular vertebral augmentation system that creates a cavity for precise cement placement.

While traditional technologies require passing next to both sides of the spinal cord to reach the entire vertebral body, the Acu-Cut Vertebral Augmentation System is designed to achieve this through single-sided access.

Company comments

“Magnus Persson is a leader, an executive who has a successful track record in not only delivering results for shareholders and stakeholders but also expanding the potential of the people who report to him,” said Julian M. Mackenzie, CEO of Ascendx Spine.

“We are very pleased to welcome Magnus to the Ascendx Spine board, particularly at a time when we are ramping up our commercialization activities throughout Europe where we can leverage Dr. Persson’s vast network in the science and medical technology financing communities,” added Romano Ferrari, Ascendx Spine’s chairman.

About the FDA clearance Julain Mackenzie said “We are very excited to receive the FDA’s clearance of our first product to market in the U.S.”

Regulatory status

Ascendx products are not FDA cleared for sale in the USA

Source: Ascendx Spine

published: February 27, 2012 in: People, Regulatory, Spine

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