The Nidra TOMAC therapy received De Novo authorisation in April 2023. Credit: PRNewswire/Noctrix Health.

Noctrix Health has secured $40m in a Series C financing round to commercialise its new Nidra Tonic Motor Activation (TOMAC) therapy for restless legs syndrome (RLS) in the US market.

The funding round was led by Sectoral Asset Management and included new investors Angelini Ventures, ResMed, and Asahi Kasei Corporation, with continued support from existing stakeholders Treo Ventures and OrbiMed.

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Noctrix Health founder and CEO Shri Raghunathan said: “We are thrilled to welcome Sectoral Asset Management and other new investors to this esteemed group of partners. This significant milestone, coupled with unwavering support from our existing investors, reflects our shared commitment to establishing a new standard of care for RLS.”

The Nidra TOMAC therapy, a non-pharmacologic, wearable device, is the first and only US Food and Drug Administration (FDA)-approved treatment for adults with drug-refractory RLS. It has been clinically validated to reduce RLS symptoms and improve sleep quality, the company said.

Treo Ventures general partner Tracy Pappas said: “Treo Ventures is thrilled to continue supporting Noctrix Health. This significant financing will allow the company to reach millions of patients with RLS. TOMAC therapy is a patient-friendly, highly effective, non-pharmacologic innovation for patients unhappy with current solutions who need better treatment options.”

The De Novo authorisation by the FDA was granted for the therapy in April 2023, after it secured breakthrough device designation in 2020.

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Last year, Noctrix Health marked significant achievements, including the FDA marketing authorisation of the TOMAC therapy.

The system is intended for the treatment of primary moderate-severe RLS.

The device is currently available in the US by prescription only.

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