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Anuncia Medical, Inc. Selects Scottsdale, Ariz. for New HQ to Further Develop Lifesaving Medtech

June 30, 2021

Move provides emerging leader in innovation with opportunity to scale and access R&D, Bioscience & Healthcare ecosystem talent

LOWELL, Mass., June 30, 2021 – Anuncia Inc., a therapeutic medical device company and an emerging leader in cerebrospinal fluid (CSF) management innovation, announced today it is moving its headquarters to Scottsdale, Ariz. and will operate at SkySong, the Arizona State University Scottsdale Innovation Center. The move is the first geographic expansion for the high growth medtech startup previously based in Massachusetts. With the new headquarters also comes a new management team of industry experts who coalesced to engineer elegant, intuitive solutions that address large unmet clinical needs in the global hydrocephalus and other CSF disorders market.

Anuncia is the developer of the US FDA cleared and EU CE Marked commercial ReFlow™ Ventricular System designed to noninvasively unblock occluded ventriculoperitoneal (VP) shunts. As many as half of all intracranial VP shunts fail in the first two years, mainly due to blockages that impair CSF flow. Failures often require emergency revision brain surgery, each costing upwards of $40,000. Early clinical evidence with up to 3-year follow-up indicates Anuncia’s planned next generation ReFlow™ System Mini may uniquely prevent VP shunt malfunctions due to occlusions, at home or in the clinic, to improve clinical outcomes and quality of life, while reducing healthcare costs. This initial clinical proof of prophylactic therapy success with ReFlow helped the ReFlow Mini earn US FDA Breakthrough Device Designation earlier this year and an honorable mention in the health category of Fast Company’s World Changing Ideas of 2021.

“As we grow and scale manufacturing, our need to expand operations into the Southwest has been met with impressive support from the thriving Greater Phoenix biomedical community, which is anchored by numerous medical centers of excellence including the Barrow Neurological Institute, the Mayo Clinic, and Phoenix Children’s Hospital and various major universities. The warm welcome and support has been unparalleled and makes us feel Arizona is truly invested in our future. As we open our next fundraising round, we also look forward to working with new VC partners who believe in our mission and the future of Anuncia,” commented Elsa Chi Abruzzo, Anuncia’s CEO.

Named to Medical Device and Diagnostic Industry’s (MDDI) ‘Ultimate List of Private Medtech Companies to Watch,’ Anuncia looks to scale utilizing Greater Phoenix’s robust talent base to make hires in engineering, clinical, manufacturing, and finance. Anuncia’s strategic move to SkySong facilitates easy access and collaboration with local higher education institutions in their efforts to keep developing medical technologies that expand access to and deliver safe and effective therapy to the millions of patients globally suffering with life threatening conditions associated with CSF disorders.

“We look forward to welcoming Anuncia into the growing, thriving medtech ecosystem in Scottsdale, and supporting them as they continue to create life-changing medical solutions,” said Scottsdale Mayor David Ortega. “Healthcare is one of the top industries in Scottsdale and SkySong is a hub for innovation, and I am confident that a rising industry leader such as Anuncia will find their new location to be a destination for ongoing and future success.”

“Anuncia’s move to SkySong is demonstrative of the ways in which ASU’s efforts to create and support groundbreaking technological collaborations is creating a dynamic medtech network with the potential for long-term societal, educational and economic impact,” said Grace O’Sullivan, Vice President, ASU Corporate Engagement and Strategic Partnerships.

“With a growing and robust healthcare, medtech and wearable ecosystem, Greater Phoenix has become a hub for advanced innovation that supports entrepreneurs in the development of lifesaving technology,” said Chris Camacho, President & CEO of the Greater Phoenix Economic Council. “We’re excited for Anuncia’s entry into the market and look forward to being a partner in their continued growth and success.”

The Coppola-Cheney Group and Lee & Associates Arizona assisted with the real estate transaction. Plaza Companies is the master developer of SkySong, in partnership with University Realty, the City of Scottsdale and Holualoa Companies.

For more information on the new corporate headquarters and Anuncia’s growth initiative, visit their website at www.anunciainc.com.

The ReFlow™ System Mini is under development and not available for sale.

https://anunciamedical.com/wp-content/uploads/2021/12/scottsdale.jpg 543 760 admin https://anunciamedical.com/wp-content/uploads/2023/12/LowResPNG__Anuncia-Stacked_COLOR_.png admin2021-06-30 02:59:462023-07-26 20:57:29Anuncia Medical, Inc. Selects Scottsdale, Ariz. for New HQ to Further Develop Lifesaving Medtech

Announcement About Anuncia ReFlow™ System Mini

June 15, 2021

Earlier this year, Anuncia Inc., a medical device company focused on the development of treatment devices for hydrocephalus and other cerebrospinal fluid (CSF) disorders, announced that the ReFlow™ System Mini received the U.S Food and Drug Administration (FDA) Breakthrough Device Designation. The ReFlow™ System Mini is the next generation version of the commercial ReFlow™ Ventricular System.

The ReFlow™ Ventricular System is composed of an in-line flusher and proprietary ventricular catheter.  By simply pressing the flusher’s dome located under the scalp, a non-invasive push of the patient’s own CSF is sent towards the ventricular catheter thereby dislodging choroid plexus that may be obstructing CSF flow through the shunt system. The catheter design is unique in that it includes an ‘emergency release.’ If the flusher is unable to unblock the standard catheter holes, pressure from the fluid injection will open an additional hole in the catheter to reestablish flow.

The next generation ReFlow™ System Mini is a smaller version of the ReFlow™ Ventricular System. Its smaller size will potentially allow it to be used in a broader population (infants to elderly patients). The ReFlow™ System Mini is also being optimized for in-clinic or at-home prophylactic (preventative) flushing of the shunt catheter – that is to flush the catheter before a blockage is present.

The ReFlow™ System Mini is not yet FDA approved, but, in a preliminary US study using the original ReFlow™ Ventricular System, prophylactic flushing of the catheter showed positive results.

The Breakthrough Device Designation means that the device is eligible for prioritized FDA regulatory review and Centers for Medicare and Medicaid (CMS) Medicare Coverage of Innovation Technology reimbursement review. This means that the product could be available to consumers and covered by Medicare sooner.

To learn more, read the press release.

https://anunciamedical.com/wp-content/uploads/2023/08/Blog-Post-Logo.png 430 760 admin https://anunciamedical.com/wp-content/uploads/2023/12/LowResPNG__Anuncia-Stacked_COLOR_.png admin2021-06-15 19:41:142023-12-12 14:23:28Announcement About Anuncia ReFlow™ System Mini

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Contact your physician to discuss if the ReFlow™ System Mini may be right for you.

Additional information about the ReFlow™ System Mini is available by contacting Anuncia.

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Disclaimer

The ReFlow™ System Mini and ReFlow Mini Flusher are FDA cleared for use in the treatment of patients with hydrocephalus or conditions where draining or shunting of cerebrospinal fluid (CSF) is medically indicated. The ReFlow™ System Mini and ReFlow™ Mini Flusher are not for everyone; please consult your doctor. The ReFlow™ System Mini and ReFlow™ Mini Flusher are only available in the United States. The ReFlow™ System Mini and ReFlow™ Mini Flusher are prescription devices sold by or on the order of a physician.

Caution: FDA (USA) law restricts this device to sale by or on the order of a physician. Refer to product package insert for instructions, warnings, precautions and complications.

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