Rotation Medical touts regenerative rotator cuff repair data

Rotation Medical today released results from a study of its regenerative rotator cuff system, touting significant new tissue formation and no tear progression in patients at 24 months.

The Plymouth, Minn.-based company said that results from the study were published in the Muscle, Ligaments and Tendons Journal.

Rotation makes a regenerative treatment for repairing the shoulder’s rotator cuff – a group of muscles and tendons that attach the humerus to the scapula. The system won 510(k) clearance in March 2014.

The 13-patient study aimed to assess the ability of Rotation Medical’s implant to induce new tissue formation and limit tear progression. Data from the study indicated new tissue formation in all 13 patients at 3 months, with tissue maturing over time and becoming radiologically indistringuishable from the underlying tendon.

Results also indicated no tear progression as observed via MRI in any of the patients during the 24-month post-operative period, and patients reported significant improvements on Constant and American Shoulder and Elbow Society clinical scores.

“Partial-thickness rotator cuff tears frequently enlarge due to increased local strain and often progress to full-thickness tears. The results of this study demonstrate the ability of the bioinductive implant to induce new tendon-like tissue, enabling partial-thickness rotator cuff tears to decrease in size and in most cases disappear. The ability to heal partial-thickness rotator cuff defects, and thus prevent tear propagation and progressive tendon degeneration, represents a novel interventional treatment paradigm for these lesions,” lead study investigator Dr. Desmond Bokor of Australia’s Macquarie University said in a press release.

“This study is further evidence that the Rotation Medical rotator cuff system has the potential to transform the treatment of rotator cuff disease. Our bioinductive implant addresses both the biomechanics and biology required to heal a rotator cuff tendon tear, preventing rotator cuff tears from becoming larger over time, reducing the incidence of re-tears and, in some cases, shortening patient recovery time,” CEO Martha Shadan said in prepared remarks.

In August, Rotation Medical said that it added $12 million to a Series B round that’s already brought in $27 million.

The company said existing investors New Enterprise Assoc., Life Sciences Partners and Pappas Ventures all participated in the Series B extension. It consists of an $8 million round this year and another $4 million slated for next year, Rotation said.

Rotation’s treatment, a biologic implant derived from the achilles tendons of cows, is designed to spur new growth to thicken and strengthen damaged rotator cuff tendons. Last year, the company said it raised more than $27 million in the Series B, to support a commercial launch and post-market clinical studies.

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