Noctrix Health

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Overview

Noctrix Health is a medical device company based in Pleasanton, California, specializing in developing therapeutic wearable devices aimed at managing chronic medical conditions, notably Restless Legs Syndrome (RLS). Founded in 2016 by Shriram Raghunathan, Ph.D., and Jonathan Charlesworth, Ph.D., the company has so far raised $60.4 million across several funding rounds. Noctrix Health is recognized for its innovative approach in providing non-pharmaceutical treatments, like its flagship Nidra™ Tonic Motor Activation (TOMAC) therapy, designed to improve sleep quality and reduce symptoms in patients unresponsive to medication.

Recent Developments

  • October 2024: Noctrix Health announced new CMS reimbursement codes for their Nidra™ TOMAC therapy, allowing broader access for Medicare beneficiaries across the U.S. (source: Finance Yahoo).
  • January 2024: The company secured $40 million in Series C financing led by Sectoral Asset Management, with participation from Angelini Ventures, ResMed, and Asahi Kasei Corporation. This funding is aimed at commercializing the Nidra™ TOMAC device for RLS in the U.S. market (source: PRNewswire).
  • April 2023: Noctrix Health received FDA De Novo authorization for its NTX100 TOMAC System after obtaining Breakthrough Device Designation in 2020. This device treats symptoms of moderate-to-severe RLS in patients nonresponsive to medication (source: AASM).
  • Trial Expansion: The deployment of a multi-center post-market trial achieved the milestone of enrolling its 100th patient, which aims to assess the long-term safety and efficacy of Nidra TOMAC therapy (source: LinkedIn).

Company Information

AttributeInformation
Founding Date2016
HeadquartersPleasanton, California, USA
FoundersShriram Raghunathan, Ph.D.; Jonathan Charlesworth, Ph.D.
RevenueNot publicly disclosed
ProfitsNot publicly disclosed
Key InvestorsSectoral Asset Management, Orbimed, Treo Ventures, Angelini Ventures, ResMed, Asahi Kasei Corporation
IndustryTherapeutic Devices
Number of EmployeesApproximately 48

Early History

Noctrix Health was founded in 2016, growing out of a vision by founders Shriram Raghunathan and Jonathan Charlesworth to address chronic conditions through innovative therapeutic devices. The company first focused on developing a device to manage the side effects of Restless Legs Syndrome (RLS). Early development was supported through a small grant, and significant advancements led to the creation of the NTX100 TOMAC System. By 2020, Noctrix Health had successfully obtained the FDA's Breakthrough Device Designation for their device, indicating significant unmet needs in RLS treatments. This milestone helped catalyze subsequent development efforts and investment rounds to bring the device closer to market launch.

Company Profile and Achievements

Noctrix Health is pioneering non-pharmaceutical solutions for chronic neurological conditions, primarily through its Nidra™ TOMAC System, which is a first-of-its-kind, wearable therapy for managing RLS. Some of the key achievements and milestones in the company's journey include:

  • 2020: Received FDA Breakthrough Device Designation which laid the groundwork for accelerated development and approvals.
  • 2023: Achieved FDA De Novo authorization for its NTX100 TOMAC System.
  • Funding Success: Secured major investments, including a $40 million Series C funding round in January 2024.
  • Clinical Efficacy: Supported by multiple clinical studies, the Nidra™ TOMAC therapy is shown to reduce opioid use among patients while easing RLS symptoms.
  • Industry Recognition: The company's device has been acknowledged by the American Academy of Sleep Medicine for its superior efficacy over traditional pharmacological treatments.

Current Operations and Market Position

Noctrix Health, headquartered in Pleasanton, operates in the medical equipment manufacturing sector, focusing on therapeutic devices for neurological disorders. As of 2024, with 48 employees, the company continues to target unmet needs in sleep disorders. The CMS decision to allocate reimbursement codes significantly elevates market access for their Nidra™ device, expanding reach among Medicare beneficiaries. Noctrix Health holds a competitive edge with its non-pharmacologic approach and FDA-cleared wearable product, positioning it as a leader among comparable sector companies focused on high-impact, patient-friendly technology.

Conclusion

Noctrix Health exemplifies pioneering innovation within therapeutic healthcare devices. Through its recently FDA-authorized Nidra™ TOMAC System, Noctrix emerges as a crucial player in managing Restless Legs Syndrome without relying on pharmaceuticals. The substantial financial backing and clinical validations spurring its mission denote a promising trajectory in improving patient outcomes and life quality. As they continue to innovate, Noctrix stands to redefine RLS management, broadening access to effective treatment and setting new benchmarks in the industry.

References

  1. PRNewswire
  2. Finance Yahoo
  3. AASM
  4. Tracxn
  5. LinkedIn