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Zzoma Positional Therapy Device Leader, Sleep Specialists, Expands Manufacturing with TPI Custom Solutions to Meet Growing Demand for CPAP Alternative


Zzoma Positional Therapy Device Leader, Sleep Specialists, Expands Manufacturing with TPI Custom Solutions to Meet Growing Demand for CPAP Alternative

Philadelphia, PA– February 5, 2024 – Sleep Specialists, LLC, the owner of the Zzoma® positional therapy device, a comfortable and effective alternative to CPAP for treating positional sleep apnea, today announced a strategic partnership with TPI Custom Solutions, a leading Minnesota-based ISO 13485:2016-certified and FDA Registered, soft goods medical device manufacturer. Certification to the standard requires an organization's quality management system to pass a third-party Medical Device Single Audit Program, or “MDSAP” Audit. This collaboration aims to significantly expand Sleep Specialists' manufacturing capacity and ensure consistent, high-quality production of Zzoma to meet the surging demand in both domestic and international markets.

Driven by Global Growth and Innovation

Sleep Specialists has experienced impressive growth in recent years, fueled by the increasing awareness and adoption of the Zzoma device as an alternative option for positional sleep apnea compared to traditional CPAP therapy. The company's expansion into international markets and strategic partnerships have further accelerated this growth, necessitating an increase in manufacturing capacity to keep pace with rising demand.

"Partnering with TPI Custom Solutions, a renowned US manufacturer with a proven track record in quality and compliance, allows us to scale our production efficiently while maintaining the highest standards," said Michael J. Markus, PhD, Executive Director of Sleep Specialists. "This strategic collaboration ensures we can meet the growing demand for Zzoma and bring its benefits to more people seeking an alternative to CPAP who suffer from sleep apnea worldwide."

Enhanced Production Capabilities and Domestic Manufacturing Advantage

TPI Custom Solutions brings extensive experience in manufacturing complex medical devices to the partnership. Their state-of-the-art facilities and commitment to quality align perfectly with Sleep Specialists' values and focus on innovation.

"We are excited to partner with Sleep Specialists to help them meet the increasing demand for the Zzoma device," said Sharon Asmus, CEO at TPI Custom Solutions. "Our expertise in high- volume medical device manufacturing combined with our commitment to quality and compliance are a perfect match for Sleep Specialists' vision. We are confident this partnership will contribute significantly to their continued success."

Benefits of the Partnership:

  • Increased production capacity: TPI Custom Solutions' capabilities will significantly enhance Sleep Specialists' ability to meet global demand for Zzoma.
  • Enhanced quality control: TPI's commitment to quality, ISO certification and FDA Registration ensures the highest standards in Zzoma manufacturing.
  • Domestic manufacturing: This partnership strengthens Sleep Specialists' commitment to US manufacturing, fostering job creation and economic growth within the country.

About Sleep Specialists, LLC

Sleep Specialists, LLC is a rapidly growing medical device company dedicated to developing innovative solutions for sleep-related disorders. The company’s flagship product, Zzoma, is a clinically proven, FDA-cleared positional therapy device for OSA. Sleep Specialists is experiencing substantial momentum, marked by:

  • Strategic partnerships expanding access to Zzoma.
  • Investment in US manufacturing, ensuring product availability and domestic production.
  • International expansion, reaching new markets with their effective solution.
  • Over 500 sleep centers prescribing Zzoma, demonstrating growing recognition of its value in treating OSA patients.

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About TPI Custom Solutions

TPI Custom Solutions, located in Ham Lake, Minnesota, is a leading US-based 13485:2016 certified and FDA Registered contract manufacturer of complex soft goods medical devices, recognized for its commitment to quality, innovation, and compliance. With state-of-the-art facilities, including a Clean Room and a team of experienced professionals, TPI provides comprehensive manufacturing solutions for its clients, ensuring adherence to the highest regulatory standards.