Vitalis - Model VTS-K - Next-Generation Therapies

Postoperative Pain creates significant morbidity in patients. Current effective treatment include opiates which may lead to longer hospital stays (Barletta et al.), may decrease the chance of out-patient surgeries, and can lead to dependence (Morris et al.).

Unfortunately, there are limited alternative non-opioid pain medications with fewer adverse effects (Ramsay 2017).

Post-operative clot prophylaxis requires powerful blood-thinning medication (AAOS VTE Guideline) that can lead to bleeding and often requires the patient to self-administer injectables at home.

Ketamine is a commonly-used non-opioid anesthetic, currently approved in intramuscular and intravenous formulations, as well as an intranasal formulation for severe treatment-resistant depression. An oral formulation could represent a compelling alternative to opioids following [joint] surgeries, particularly in the out-patient setting.

VTS-K may alter the pharmacokinetic properties of ketamine and its efficacy in the body, creating the potential for a longer-lasting, steadier effect, a wider therapeutical window, and the ability to deliver a consistent baseline reduction in pain.

There are currently approximately 700,000 TKA procedures performed per year in the United States, of which 50,000 are outpatient procedures. Over the next 10 years, the number is projected to increase to 3 million, with 1.5 million outpatient procedures.

VTS-K has the potential to reduce or eliminate the need for opioids to manage post-operative pain.

Additional target indications - VTS-K for acute musculoskeletal pain, and VTS-K for acute headache.