From medical device exec to startup leader--one woman does it all
Affiliation: Rotation Medical
Title: President and CEO
Rotation Medical has had quite a year so far--an FDA clearance for its product and a major venture financing round. At the head of the company through all of this has been Martha Shadan, who just last year made the leap to the startup from a series of executive spots at big medical device and pharma companies.
Just as information technology is rapidly encroaching upon medical devices, so are bioabsorbable and biological materials being put to ever-more-sophisticated use in implants. That's part of the premise of Rotation Medical; it markets a bioinductive implant along with the tools to implant it for repairing the rotator cuff tendon. The implants induce the formation of new tendinous tissue and is available for mini-open or artheroscopic procedures.
The implant is made of bovine Achilles tendon that is reconstituted to achieve high porosity and purity. The increased tendon strength comes from the induced, remodeled tissue rather than the bioinductive implant itself. The implant absorbs within 6 months, leaving a new layer of tendinous tissue to augment the existing tendon.
In April, Rotation Medical received FDA clearance for this implant, which it expects to launch this year. The startup secured an oversubscribed $27.2 million Series B financing in July, to support the launch and postmarketing studies. Investors include Life Sciences Partners, a new investor, and New Enterprise Associates co-led the financing, as well as new investor Pappas Ventures.
With her extensive background as a medical device executive, Shadan was likely brought in to make the leap for commercialization. She was last the president of the Trauma Division at Zimmer ($ZMH). Before that, she was the VP/GM of Vascular Therapies, Biosurgery and Sports Surgery at Covidien ($COV).
All this experience has prepared her to launch and market Rotation Medical's implant, which offers a novel surgical solution for rotator cuff tears.
"Because of my experience in big medical device companies, I understand how to navigate the complicated dynamics between supply chain, hospital admin, physicians, payer groups and patients--groups that can sometimes have competing goals and priorities," Shadan explained to FierceMedicalDevices. "My experience has also influenced my approach to developing market strategies and taught me how to align channel strategy with the type and stage of growth the business is at. I've worked with breakthrough, disruptive technologies as well as commoditized products and understand the important differences in how to sell and drive adoption for both."
Last month, Rotation Medical started a postmarketing study of the implant designed to determine the longer-term impact of the treatment.
"This study will be collecting data on a number of endpoints that are relevant from a health economics perspective, such as time in a sling, time to return to work, return to activity, the number of physical therapy sessions, patient satisfaction, etc.," Shadan said. "We believe this postmarket study will expand the body of evidence documenting the value of the Rotation Medical technology in providing relief for patients by reversing rotator cuff disease progression and restoring long-term shoulder function."
With a major FDA clearance and a venture round under her belt, the next (and highest) hurdle for Shadan now remains--executing a successful U.S. product launch.
Rotation Medical gets $27.2M to fund rotator cuff bioimplant launch
Rotation Medical, Dgimed Ortho, raise combined $12.1M
-- Stacy Lawrence (email | Twitter)