Rotation Medical has developed a new way to treat rotator cuff injuries that addresses both the pain and degenerative nature of this problem. The treatment includes a proprietary, reconstituted collagen scaffold and an disposable instrument system, which includes the arthroscopic scaffold delivery, the tendon staple and the bone staple instruments. The Rotation Medical Rotator Cuff System induces formation of well-integrated and new mature tendon-like tissue in the injured tendon.
Rotator cuff tendon tears are common and can lead to persistent shoulder pain. Many tears do not heal readily, and over time small ones can become larger and more painful. Current therapies involve surgical interventions based on the size and morphology of the tear.
For small tears or in the early stages of this degenerative disease, surgeons use acromioplasty, which treats only pain, not the degenerative nature of the injury.
For larger tears, the surgeon sutures the tendon to the head of the humerus bone, but the mechanically reattached sutures oten pull through the injured tendon and cause re-tears 25-40% of the time. The procedure also requires prolonged rehabilitation.
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The Rotation Medical scaffold is designed to be placed over partial-thickness tears or over small to large full-thickness tears to allow for repair. It is not intended for use on rotator cuff tears greater than 5 cm. The scaffold is derived from bovine Achilles tendon and has been reconstituted to the fiber level to achieve high purity and porosity. The proprietary scaffold design is unique in the number, size and orientation of pores in the scaffold that allow for desired porosity required for infiltration of new blood vessels and fibroblasts. This facilitates growth and formation of a new tendinous like tissue that is unlike scar tissue and provides biological support for the tendon. The low tensile strength of the scaffold reduces strain on the tendon, allowing the natural healing process to occur. The scaffold is available currently in two configurations: flat for mini-open procedures and pre-loaded into a delivery instrument for arthroscopic procedures.
The Rotation Medical instruments and the procedure used in surgery are unique. The instruments enable the scaffold to be delivered arthroscopically to a precise location and held in place while the tendon staples and bone staples are put in place. The instruments are disposable after surgery. Material used for the scaffold is biocompatible and within 6 months the scaffolds and the tendon staples are completely reabsorbed into the body. The bone staples are permanent.
Unlike other augmentation methods, increased tendon strength in the Rotation Medical System does not come from the scaffold but from the induced, remodeled tendinous tissue that augments the existing tendon biologically. As compared to other surgical methods for rotator cuff tendon tears, surgery using the Rotation Medical System can cut down rehabilitation time by 50%.
Rotation Medical was founded in 2009 and is located in St Paul, MN. The company recently announced that it has received 510(k) clearance from the Food and Drug Administration for its implantable collagen scaffold technology. Martha Shadan, appointed president and CEO of Rotation Medical in July 2013 said the company’s goal is to improve quality of life for people who with rotator cuff injuries by treating them earlier and potentially preventing the progression of disease.
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On the recent 510(k) FDA clearance she said, “This regulatory clearance enables us to begin to commercialize our bio-inductive scaffold solution, and we expect to launch in the U.S. later this year.”
The company will also be later pursuing a CE Mark approval on its collagen scaffold technology.
Rotation Medical is currently raising a Fund B for $20 million. The company has already raised $25 million in Fund A. The company is looking for new investors in addition to the primary investors who will be investing in the second round of funding or Fund B. The money will be used for commercialization of the product and will support expansion of the product into 2015. The money will also be used to conduct post market clinical studies in the US to further demonstrate the effectiveness of its collagen scaffold technology.