OrthoClip LLC is the first technology spin-out from Palmetto Biomedical.   

 

OrthoClip LLC has developed novel medical devices that provide simple and effective local delivery of therapeutic agents to inhibit and treat infection around surgical implants. Initially, focus has been on devices used in fracture repair and spinal fusion for both human and animal markets. 

 

Problem

There has been no successful development of technologies to prevent or treat infections in bone fracture repair or spinal fusion surgery implants over the past 30 years. Quietly, the cost to treat these infections has risen to approximately $2 billion annually in the U.S. alone. Systemic antibiotics are not sufficiently effective in treating implant infection. Surgical exposure for irrigation and debridement coupled with a prolonged course of antibiotics is the standard of care. Despite the extreme nature of the treatment, this still results in a 30% failure rate both at initial treatment and for long-term recurrence of infection. These implant-associated infections are not resolved by systemic medical therapy, create insidious recurrent infections and cost in a range of $15,000-$300,000 per case to be cured. 

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Solution

OrthoClip's unique drug delivery devices are designed to easily and securely attach to fixation implants (metal plates or rods) during surgery. Our devices enable immediate and sustained local delivery of a preventive/therapeutic medical agent. The Company's delivery module consists of a hollow polymeric reservoir “clip” attached to the device that is filled with an appropriate carrier/antibiotic combination. Our device will significantly lower the cost to treat implant infections by supplying a therapeutic dosage directly to the fracture or spinal implant site. Direct delivery enhances systemic treatment improving overall outcomes.

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Market Opportunity

OrthoClip™ and SpineClip™ address a 2.8M patient world market annually. The company targets trauma related device implants in addition to spinal fixation fusion procedures. Five percent (140,000) of the 2.8M patient market are addressable for therapeutic treatment. Also among the 2.8M patient market are high-risk individuals (diabetics, smokers, obese, immune compromised) that yield an additional 506,000 patients or 20% of the target group, for future preventive treatment.

 

The combined 646,000 targeted patients drive over $4B of annual cost to payers in the world health system. OrthoClip believes it will reduce the annual $4B of cost by at least 50 % with its, localized treatment coupled with preventive therapy for a large population of risk encumbered patients. After subtracting the total cost of OrthoClip therapy at anticipated penetration levels, OrthoClip and SpineClip will yield nearly $1.8B(infection cost reduction) in system savings versus the current standard of care. 

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Intellectual Property

A U.S. patent application was filed in October of 2008. U.S. Utility and International (PCT) applications were filed in October of 2009. An additional continuation-in-part patent application was filed in October 2010 for extending the original concept to a greater range of implant applications.  One patent has been issued to OrthoClip LLC. 

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Competition

The standard of medical care (SOMC) is BioShape’s primary initial competition related to infections. However, the waning efficacy of prolonged systemic medical therapy (~30% refractory rate in 2010) signals the need to improve initial treatments with local antibiotic delivery. The healthcare community is focused on hospital-acquired infection cost reduction and timing is positive for the introduction of BioShape products.

 

The prevalence of post operative orthopedic implant infections has spawned significant industry efforts to develop antibacterial coatings for implants, primarily for joint replacement applications. As such, an implant could be manufactured with a final coating process containing an anti-infective material. One concept is that the coating itself would be an antibacterial substance or that the coating could be a carrier for such a substance. Numerous efforts to commercialize coatings including nitric oxide, polymers, polylactic acid and silver ionic plasma have been engineered. 

 

However, these inventors have achieved little success. Numerous issues of elution rate, dose, timing, toxicity and the coating’s effect on long term implant viability have curbed adoption. The concept of a successful coating formula, with the necessary delivery metrics, continues its development.

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Commercialization Strategy

The product design and intellectual property portfolio enable OrthoClip to address a large number of therapeutic delivery opportunities in the trauma and spine surgery field. The company’s IP portfolio firmly covers the marketing space we target. The company considers its product system design to be a platform for surgeons to deliver a range of medical preventive and therapeutic treatments to many types of implants. The initial focus has been the development and clinical evaluation of the OrthoClip device to prevent/treat infection around trauma plate implants. OrthoClip for trauma applications represents the most significant initial market opportunity for both civilian and military applications. 

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