Anuncia News Archives

Anuncia Medical Announces the First Successful US Implant of the Company’s Newly Commercially Released ReFlow™ Mini Flusher Device for Hydrocephalus Patients

August 1, 2023

Intermountain Primary Children’s Hospital First in the Country to Implant this Next Generation FDA-Cleared Device

Company Welcomes Vice President of Sales & Marketing, Mark Geiger, Who Lives with Hydrocephalus

SCOTTSDALE, Ariz., August 1, 2023 – Anuncia Medical Inc. (“Anuncia” or the “Company”), a Company specializing in advancing innovations for implantable and external cerebrospinal fluid (CSF) management systems and neurocritical care, is pleased to announce the successful first implant of the Company’s FDA-cleared ReFlow™ Mini Flusher device.

Performed by neurosurgeon Samuel Cheshier, MD, at Intermountain Primary Children’s Hospital in Salt Lake City, the patient previously required at least 11 brain surgeries to manage their hydrocephalus, a chronic neurological condition in which excess CSF accumulates in the brain, often causing severe symptoms, frequent hospitalizations, and ongoing health concerns.

The second-generation, FDA-cleared ReFlow Mini Flusher is indicated for use in patients living with hydrocephalus or similar conditions. The reduced size and profile of the technology is designed to better support a broader hydrocephalus patient population, from infants to older adults.

Used in line with any shunt system brand, the ReFlow Mini Flusher is designed to flush the patient’s CSF back into the ventricular catheter to maintain, restore or increase hydrocephalus shunt flow, with just a simple finger depression of the flusher’s soft dome located beneath the patient’s scalp. Noninvasive flushing with the ReFlow Mini Flusher can be performed in-clinic by trained clinical staff, or anywhere by a trained patient/caregiver, as directed by the neurosurgeon.

The first-generation ReFlow device was successfully implanted in over 30 patients with hydrocephalus and is the subject of 11 clinical studies/reports. In May, a study on the improved outcomes of 9 ReFlow patients was published in Pediatric Neurosurgery. Patients with hydrocephalus often experience repeat brain surgeries because their shunts become occluded with tissue and cells in the CSF within cavities, or ventricles, of the brain. These obstructions prevent the shunt from working, resulting in increased intracranial pressure (ICP) that can cause brain damage or even death if left untreated.

The first neurosurgeon to implant the new ReFlow Mini Flusher, Dr. Cheshier from the University of Utah Health and Intermountain Primary Children’s Hospital, reported “Neurosurgeons treating hydrocephalus have been waiting too long for a non-surgical option to help keep implanted shunts flowing. The ReFlow is easy to implant with my preferred shunt type and just makes sense. I welcome having this tool in my toolkit.”

“I’ve had five shunt revision surgeries due to catheter occlusions and can attest to the anguish and frustration of patients and their families,” reported Anuncia Medical’s new Vice President of Sales & Marketing, Mark Geiger, who has hydrocephalus. “The ReFlow Mini Flusher developed off the “Gen 1” platform, with a decade of work and recently published clinical data with 4 plus years of follow-up, may profoundly impact hydrocephalus patients, by providing control and confidence, through noninvasive ventricular catheter flushing at home, to restore and maintain CSF flow.”

After successfully launching in June 2023, the ReFlow Mini Flusher is now being shipped to leading institutions for use by some of the most well-respected neurosurgeons in the United States. It is expected that the ReFlow Mini Flusher will be available internationally in the future.

About Anuncia Medical Inc.
Anuncia Medical is a neurological device company solving the large unmet needs in cerebrospinal fluid (CSF) management and neurocritical care, through clinically validated, noninvasive, cost-effective, ‘breakthrough’ technologies that are designed to monitor and treat patients at home, or in-clinic. Anuncia aims to empower patients in their care journey and provide peace of mind. Built on a commitment to high-quality standards, evidence-based medicine, and strong ethical behavior for almost a decade, Anuncia Medical Inc. is a trusted partner for neurosurgeons. For more information, visit www.AnunciaMedical.com, and follow Anuncia on LinkedIn, Twitter, Facebook, and Instagram.

About ReFlow™ System Mini and ReFlow™ Mini Flusher
Available in the U.S. only, the ReFlow™ System Mini represents a platform technology designed to improve the function of CSF management devices in the OR, the ICU, and at home. The ReFlow™ System Mini and ReFlow™ Mini Flusher are 510(k) cleared by the U.S. FDA for use in the treatment of hydrocephalus as a part of a CSF shunt system. The ReFlow^TM System Mini is a small, implanted system consisting of a flushing device and ventricular catheter. When implanted in line with a commercially available shunt, it can be actuated by noninvasively pressing on the flusher dome. It is designed to deliver a small amount of fluid toward the ventricular catheter, for restoration, increase, or maintenance of flow, by clearing catheter flow holes. The implanted ReFlow^™ Mini Flusher is meant to be actuated by trained users, in clinical or non-clinical settings, at the personalized direction and supervision of the patient’s physician. The ReFlow™ System is a prescription device sold by or on the order of a physician.

Patients are advised to consult with a qualified healthcare professional to determine if this product is right for them. Important Safety Information & Risks: For Indications for Use, Warnings, Precautions, and other safety information, please refer to product labeling.

7-year-old Boy Managing His Hydrocephalus with ReFlow™ Ventricular System “Gen 1” Featured on Charleston’s ABC News 4

July 28, 2023

After struggling to conceive a child for what felt like ages, Miranda of Moncks County, South Carolina finally fell pregnant – a miracle that quickly turned into horror when she delivered at 24 weeks in late 2015. At just 1 pound and 12 ounces, her son, Sutton, arrived with life-threatening health issues, including hydrocephalus – a neurological disorder caused by an abnormal buildup of cerebrospinal fluid in the brain that affects more than one million Americans.

During Sutton’s 141-day stay in the NICU, he underwent numerous surgeries. When he was finally discharged, he left with a shunt implanted in his brain to help drain the fluid buildup caused by the hydrocephalus. However, the first few years of Sutton’s life became a blur of emergency hospitalizations and brain surgeries every time his shunt became blocked. Miranda was forced to relive the trauma from her son’s premature birth every time she saw him in another hospital bed. She also constantly worried about the next time her son would require major surgery at a moment’s notice.

In early 2020 Sutton’s neurosurgeon, Dr. Ramin Eskandari of the Medical University of South Carolina, recommended the ReFlow ™ Ventricular System – at that time, a newly FDA-cleared medical device that allows hydrocephalus patients and/or their caregivers to flush the patient’s CSF back into the ventricular catheter to maintain, restore or increase hydrocephalus shunt flow with the press of a button. Thanks to ReFlow™, Sutton hasn’t been hospitalized or needed surgery in over three years.

Now, Sutton is experiencing life as any 7-year-old would. With his hydrocephalus being managed and his ReFlow™ in place, Sutton’s parents feel a sense of control. For Miranda, that means knowing that there is a routine that requires 30 seconds to flush Sutton’s device, allowing their family to focus on the other important aspects of life like school, faith, and fun. Looking ahead, she hopes that her family’s journey helps others who may be struggling to manage a child’s hydrocephalus, and encourages them to ask their doctor about ReFlow™.

Miranda, Sutton, and Dr. Eskandari recently spoke to ABC News 4 to discuss their experiences with ReFlow™. You can watch the full segment here.

The ReFlow™ System Mini and ReFlow™ Mini Flusher are FDA cleared for the following indication:

The ReFlow System Mini and the ReFlow Mini Flusher, used as components of a shunt system, are for use in the treatment of patients with hydrocephalus or conditions where draining or shunting of cerebrospinal fluid (CSF) is medically indicated. The miniaturized ReFlow Mini Flusher may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush of the shunt ventricular catheter to unblock inlet holes to restore, increase, or maintain CSF flow. When used with the ReFlow Ventricular Catheter, the flush can also open the ReFlow Ventricular Catheter’s relief membrane to restore, increase, or maintain CSF flow. The ReFlow System Mini components are not intended to change the diagnosis, treatment, or follow-up of patients with proximal catheter occlusions. Under the care, direction, and instruction of the treating physician, the ReFlow Mini Flusher may be used as directed for noninvasive flushing by a trained healthcare professional in-clinic or by a trained caregiver or adult patient in a non-clinical environment.

Anuncia Medical Inc. plans to work closely with the medical community and the FDA to conduct larger scale studies to further evaluate use of the ReFlow device to maintain flow.

Anuncia Medical Successfully Launches Second Generation Device to Treat Hydrocephalus at Several Leading Neurosurgical Centers Across the United States

July 27, 2023

The ReFlow™ Mini Flusher will Benefit the Lives of Patients in the US and Abroad where Access to Ongoing Advanced Clinical Care can be Limited

SCOTTSDALE, Ariz., July 26, 2023 /PRNewswire/ — Anuncia Medical Inc. (“Anuncia” or the “Company”), a Company specializing in advancing innovations for implantable and external cerebrospinal fluid (CSF) management systems and neurocritical care, is pleased to announce the successful U.S. commercial launch of the ReFlow™ Mini Flusher device. Neurosurgeons in the US and soon internationally will now have a new option to reduce the impact of hydrocephalus by providing better access to potentially life-saving therapy for the 30 million patients worldwide suffering from this neurological disorder. Hydrocephalus is a chronic neurological condition in which excess CSF accumulates in the brain, often causing severe symptoms, frequent hospitalizations, and ongoing health concerns, and may be fatal if left untreated.

Data recently published in the Journal of Pediatric Neurosurgery on the first generation ReFlow device suggests that ReFlow prophylactic use, designated as a US FDA Breakthrough Device indication Anuncia intends to further explore in future clinical studies, may reduce the high rate of shunt malfunctions due to catheter occlusions and associated repeat revision brain surgeries. The just launched second-generation ReFlow Mini Flusher is FDA-cleared for use in patients living with hydrocephalus or similar conditions. Its reduced size and profile are designed to better support a broader hydrocephalus patient population, from infants to older adults. Used in line with any shunt system brand, the patented ReFlow Mini Flusher is uniquely designed to flush the patient’s CSF back into the ventricular catheter to maintain, restore or increase hydrocephalus shunt flow with just a simple push of the flusher’s soft dome located beneath the patient’s scalp. Noninvasive flushing with the ReFlow Mini Flusher does not interfere with shunt flow regulation and can be performed in-clinic by trained clinical staff, or anywhere by a trained patient/caregiver, as directed by the treating neurosurgeon.

Since the ReFlow Mini became available earlier this month, multiple leading centers across the country have successfully implanted the technology. Patients are already using the ReFlow Mini to manage their chronic hydrocephalus. Beyond the U.S., Anuncia actively seeks opportunities to assist neurosurgeons in regions where treating the condition remains challenging. Most notably, international news organizations are currently covering a public health crisis in Uganda, highlighting how a bacterial outbreak has led to a new surge in hydrocephalus cases. The Company is currently seeking strategic partners who share the belief that the ReFlow Mini could improve the lives of undermanaged patients.

Read More…

Anuncia Medical Inc. Announces Published Data with Promising Clinical Outcomes Using the ReFlow™ Ventricular System In-Line with Hydrocephalus Shunts

May 23, 2023

SCOTTSDALE, Ariz., May 23, 2023 /PRNewswire/ — Anuncia Medical Inc. (“Anuncia” or the “Company”), a company specializing in advancing innovations for implantable and external cerebrospinal fluid (CSF) management systems and neurocritical care, is pleased to announce that an article highlighting its FDA cleared and CE Marked ReFlow™ Ventricular System “Gen 1” with Hydrocephalus shunts in patients suffering from chronic shunt occlusions, has been published in Pediatric Neurosurgery. Two years prior to being implanted with the ReFlow™ System, 7 of the 9 patients represented in the publication experienced a combined total of 14 proximal shunt failures that required revision. In the 2-4 years following ReFlow™ implantation and use to maintain flow, only 1 proximal shunt failure occurred amongst the 9 patients. As revisions are typically associated with expensive hospital admissions for both the child and family, reducing the number of revisions needed is invaluable to those impacted.

Hydrocephalus is an abnormal accumulation of CSF in the brain, causing increased intracranial pressure (ICP). Yearly, tens of thousands of adults and children with hydrocephalus undergo revision surgeries at U.S. hospitals to replace occluded shunts. These repeat brain surgeries and hospitalizations cause significant undue emotional, health, and economic burden to patients and families worldwide.

“The failure rate of shunts after implantation is unacceptably high, with most failures happening from occlusion/clogging of the ventricular catheter. Historically, patients had only one option when this occurred, and that was brain surgery, risking brain hemorrhage and shunt infections. Surgeons have never been able to non-invasively open an occluded catheter, let alone potentially prevent the occlusion in the first place,” said Dr. Ramin Eskandari MD, pediatric neurosurgeon from Medical University of South Carolina. “Adding a ReFlow component to non-invasively clear a clogged shunt, and even prevent the blockage, may dramatically change shunt failure rates and help shunted patients get back to leading normal lives”.

Though limited, these recently published data, and others like them, suggest that use of the ReFlow device to maintain flow at home may also have potential benefits as a preventative treatment that could reduce revision surgeries. Anuncia received a U.S. Food and Drug Administration (FDA) “Breakthrough Device Designation” for this use and is working closely with the medical community and the FDA to design and conduct clinical trials to further evaluate this practice.

“Three years ago, Dr. Eskandari suggested the ReFlow device be implanted with my son’s shunt hoping that it would prevent future complications and surgeries. We were prescribed a daily “maintenance” regimen to flush Mark’s ReFlow device at home and it was not uncomfortable for him. In fact, it helped my son learn to count. The device provides us with confidence and a degree of control over his hydrocephalus. Mark is now five and thus far, it has worked like a charm. Mark has not had a single surgical intervention. The ReFlow is a brilliantly simple device that is very easy to use. We’re grateful,” shared Hillary, the mother of a young hydrocephalus patient treated with the ReFlow™ “Gen 1” by Dr. Eskandari.

With >4 years of clinical follow-up and feedback from the ReFlow “Gen 1” device, Anuncia Medical has developed a smaller, easier-to-use ReFlow System Mini “Gen 2” device. Launching in the U.S. next month, the ReFlow System Mini represents the future of hydrocephalus management by providing an easy and noninvasive way to potentially clear occlusions and/or maintain CSF flow in a shunt, by simply pressing the soft flusher dome located under the patient’s scalp. When pressed, the ReFlow Mini Flusher sends a small, controlled amount of fluid toward the ventricular catheter to unblock the catheter’s flow holes. This small component may be added in little time to the shunt system during a standard implantation or revision procedure.

“The ReFlow ‘Gen 1’ and the smaller ReFlow System Mini, represent almost a decade of work with hydrocephalus clinical experts and talented engineers,” shared Elsa Chi Abruzzo, President & CEO of Anuncia Medical. We look forward to these continued partnerships in a community dedicated to improving the care, and lives, of all patients living with hydrocephalus.”

About Anuncia Medical Inc.
Anuncia Medical is a neurological device company solving the large unmet needs in cerebrospinal fluid (CSF) management and neurocritical care through clinically validated, noninvasive, cost-effective, ‘breakthrough’ technologies designed to monitor and treat patients at home, or in clinic. Anuncia aims to empower patients in their care journey and provide peace of mind. Built on a commitment to high-quality standards, evidence-based medicine, and strong ethical behavior for almost a decade, Anuncia Medical Inc. is a trusted partner for neurosurgeons. For more information, visit www.AnunciaMedical.com, and follow Anuncia on LinkedIn and Twitter.

About ReFlow™ System Mini and ReFlow™ Mini Flusher
The ReFlow™ System Mini represents a platform technology designed to improve the function of CSF management devices in the OR, the ICU, and at-home. The ReFlow™ System Mini and ReFlow™ Mini Flusher are 510(k) cleared by the U.S. FDA for use in the treatment of hydrocephalus as a part of a CSF shunt system. The ReFlowTM System Mini is a small, implanted system consisting of a flushing device and ventricular catheter. When implanted in line with a commercially available shunt, it can be actuated by noninvasively pressing on the flusher dome. It is designed to deliver a small amount of fluid toward the ventricular catheter, for restoration, increase, or maintenance of flow, by clearing catheter flow holes. The implanted ReFlow™ Mini Flusher is meant to be actuated by trained users, in clinical or non-clinical settings, at the personalized direction and supervision of the patient’s physician.

Patients are advised to consult with a qualified healthcare professional to determine if this product is right for them. Important Safety Information & Risks: For Indications for Use, Warnings, Precautions, and other safety information, please refer to product labeling.

SOURCE Anuncia Medical, Inc.

‘Ponte Cura’ Celebrates the Conclusion of AZ Bioscience Week 2022

October 20, 2022

The Event: Ponte Cura: The Bridge to Cures

The Cause: AZ Advances

Event Date: September 30, 2022

Location: Private Residence

Honorary Co-Chairs: Elsa & Dr. Todd Abruzzo, Dr. Mitzi Krockover and Dr. Jacque Sokolov

Lead Sponsors: Millenia Music and AZ Bio

Entertainment: Michael Fitzpatrick and Will From Brazil

Caterer: Catering by Robert’s Catering

Decor: Flowers by Inspired Environments & Big Letters AZ

Notable Moments: The inaugural Ponte Cura reception was a beautiful celebration to culminate a successful Arizona Bioscience Week. The programs presented from September 26 to September 30 included the AZBio Awards, the White Hat Life Science Investor Conference and Voice of the Patient. Congratulations to all of the scientists, healthcare providers and community leaders who came together to learn and share together for the betterment of all.

To see more photographs from AZ Bioscience Week 2022, click here.

Anuncia Medical honored as participant in the 2022 Flinn Foundation Bioscience Entrepreneurship Program

March 30, 2022

Anuncia Medical, Inc. recognized as an Arizona bioscience startup to watch in 2022

SCOTTSDALE, Ariz., March 30, 2022 /PRNewswire/ — Anuncia Medical, Inc., a medtech startup developing neurotherapeutic devices for treatment of hydrocephalus and other neurological disorders, has been selected as one of seven Arizona early-stage bioscience companies to participate in the 2022 Flinn Foundation Bioscience Entrepreneurship Program. A total of 54 Arizona bioscience firms have been selected for this highly competitive program since 2014 and awarded almost $1.6 million in non-dilutive funding.

“These seven companies are working on innovations and treatments that could dramatically improve millions of lives and make for a healthier world,” said Tammy McLeod, Flinn Foundation President, and CEO, in a press release. Anuncia Medical is honored to be a part of this elite group, furthering the Flinn Foundation’s goal of creating a “hub of bioscience entrepreneurs and new enterprises across Arizona.”

The program benefits include $30,000 in funding to each company, administered by the nonprofit Arizona Bioindustry Association (https://www.azbio.org/), as well as individualized plans from industry experts, and connections with the state’s bioscience leaders in business, research, and policy.

“Building on our 2021 momentum, which included recognition in Medical Device and Diagnostic Industry (MDDI) list of Private Companies to Watch, a Fast Company 2021 World Changing Ideas Healthcare Honorable Mention and being a startup innovator finalist at the AZ Governor’s Celebration of Innovation; Anuncia Medical is grateful to start 2022 with this prestigious distinction from the notable Flinn Foundation. A certified Qualified Small Business by the Arizona Commerce Authority eligible for Arizona’s angel investment tax credit program, we recently closed a significant bridge round and are proceeding with our Series A raise as we prepare to submit our Breakthrough Device designated ReFlow™ System Mini to the US FDA for commercial approval later this year,” commented Elsa Chi Abruzzo, President and CEO of Anuncia Medical.

About the Flinn Foundation
The Flinn Foundation is a privately endowed, philanthropic grantmaking organization established in 1965 by Dr. Robert S. and Irene P. Flinn that awards grants and operates programs in four areas: the biosciences, the Flinn Scholars, arts and culture, and the Arizona Center for Civic Leadership. To learn more about the Flinn Foundation Bioscience Entrepreneurship Program, visit www.flinn.org/entrepreneur.

About Anuncia Medical, Inc.
Anuncia Medical, Inc. is the developer of the ReFlow™ Ventricular System, which helps patients with cerebrospinal fluid disorders, such as hydrocephalus, a debilitating and life-threatening condition affecting more than 30 million patients worldwide. The ReFlow™ System device is placed beneath the scalp and can be used to facilitate a safe, noninvasive retrograde fluid flush of a patient’s ventriculoperitoneal (VP) shunt when flow is restricted or blocked. The ReFlow™ System Mini is under development and not available for sale. For more information visit our website at www.anunciamedical.com.

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SOURCE Anuncia Medical, Inc.

Seven Arizona bioscience startups to watch in 2022

February 24, 2022

A regenerative treatment for Alzheimer’s disease, a respiratory-assist device to improve COPD patient care, a blood-based test for colorectal cancer, and a treatment to solve bad dog breath are some of the transformative advances of the 2022 Flinn Foundation Bioscience Entrepreneurship Program participants.

The seven Arizona-based, early-stage companies competitively selected for the foundation’s program will receive $30,000 in funding support through a nonprofit partner, a personalized learning plan, and connections with the state’s bioscience leaders in business, research, and policy.

The 2022 program participants include three Tucson-based startups, two from Phoenix and one each from Scottsdale and Surprise.

“These seven companies are working on innovations and treatments that could dramatically improve millions of lives and make for a healthier world—even for our pets,” said Tammy McLeod, Flinn Foundation president and CEO. “The Flinn Foundation program provides these entrepreneurs with the tools they will need to continue to grow their firms and attract investors.”

To learn more abou tthe 2022 Flinn Foundation Bioscience Entrepreneurship Program participants, click here.

Medtech company Anuncia announces relocation to Scottsdale

July 1, 2021

Anuncia, a medical device company and innovator in cerebrospinal fluid (CSF) management, announced its plan to move its headquarters to Scottsdale.

The headquarters will be at SkySong, the Arizona State University Scottsdale Innovation Center. This location provides the company with access to research and development opportunities, as well as bioscience and healthcare talent. It also allows collaboration opportunities with local universities on new medical technologies that deliver safe and effective therapy to patients who suffer from life threatening conditions, like CSF disorders.

The relocation, which is the first geographic expansion for the Massachusetts-based company, will also bring a new management team of industry experts, who will engineer intuitive solutions that address unmet clinical needs.

Anuncia developed the ReFlow Ventricular System, which is used to relieve pressure on the brain cause by CSF. The ReFlow Mini earned the FDA Breakthrough Device Designation earlier this year, as well as an honorable mention in the health category of Fast Company’s World Changing Ideas of 2021.

To read more, click here.

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.

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.