Press Releases Archives - Page 2 of 2

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.

Anuncia ReFlow™ Tech Honored With Fast Company 2021 World Changing Ideas Awards

May 4, 2021

Anuncia’s breakthrough technology has received an honorable mention in the Health category of this year’s World Changing Ideas Awards

LOWELL, Mass., May 4, 2021 – Anuncia Inc., an emerging leader in cerebrospinal fluid (CSF) management, received an Honorable Mention in the Health category of Fast Company’s 2021 World Changing Ideas Awards for its ReFlow™ medical device platform. Those honored were announced today by Fast Company and include businesses actively engaged and deeply committed to pursuing innovation aimed at solving health and climate crises, social injustice, or economic inequality for the good of society and the planet.

Anuncia is grateful that its potentially life-saving, noninvasive therapeutic medical technology is once again bringing needed awareness to the millions of patients globally, from infants to the elderly, suffering with hydrocephalus and other CSF disorders. As many as half of all surgically-implanted intracranial shunts fail in the first two years, mainly due to blockages that impair CSF flow and often necessitate emergent, repeat brain surgery, each costing upwards of $40,000. CSF disorders require better solutions to prevent readmissions and revision surgeries for shunt patency failures. The Anuncia ReFlow platform is designed to be used noninvasively at-home by patients and caregivers or in-clinic by physicians to prevent such blockages to potentially reduce the burden of repeat brain surgeries for these patients, their families, and the healthcare system.

Now in its fifth year, the World Changing Ideas Awards showcases 33 categories, including Health and Wellness, AI & Data among the most popular. A panel of eminent Fast Company editors and reporters selected honorees from a pool of more than 4,000 entries across categories and the globe. Fast Company‘s Summer 2021 issue (on newsstands May 10) will highlight some of the world’s most inventive entrepreneurs and companies tackling exigent global challenges.

Elsa Abruzzo, President of Anuncia Inc., stated, “Anuncia is proud to be among our many fellow Health category honorees who are playing an important role in building a better world for patients now and as we emerge from the coronavirus crisis. Early clinical data with more than two (2) year follow-up give us confidence that ReFlow will provide hydrocephalus patients and their caregivers the ability to noninvasively control their health at home, under the care of their physician, by improving shunt patency. We hope to further facilitate at-home care with next generation ReFlow ‘Smart Shunt‘ features including remote monitoring of patients’ shunts by physicians and hospitals and a patient mobile app designed to improve outcomes through compliance.”

“There is no question our society and planet are facing deeply troubling times. So, it’s important to recognize organizations that are using their ingenuity, impact, design, scalability, and passion to solve these problems,” says Stephanie Mehta, editor-in-chief of Fast Company. “Our journalists, under the leadership of senior editor Morgan Clendaniel, have discovered some of the most groundbreaking projects that have launched since the start of 2020.”

About Anuncia Inc. and the ReFlow^TM System Platform
Anuncia Inc., based in Lowell, Massachusetts, is a privately held therapeutic medical device company and an emerging leader in treating conditions associated with cerebrospinal fluid (CSF) disorders through innovative devices. The current ReFlow System is FDA cleared and CE Marked for use by a qualified clinician to facilitate a safe, noninvasive retrograde fluid flush when ventriculoperitoneal shunt flow is restricted or blocked. The ReFlow System is intended for the treatment of CSF disorders requiring shunting such as hydrocephalus, a debilitating and life-threatening condition affecting millions. Anuncia received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its ReFlow^™ System Mini. The breakthrough indication would allow in-clinic or at-home prophylactic flushing noninvasively by trained patients, caregivers, and clinicians to potentially prevent blockages and extend shunt life. The ReFlow^™ System Mini and ReFlow Smart Shunt features are under development and not available for sale. The ReFlow System is a prescription device sold by or on the order of a physician. For more information, please visit www.anunciainc.com.

About the World Changing Ideas Awards: World Changing Ideas is one of Fast Company‘s major annual awards programs and is focused on social good, seeking to elevate finished products and brave concepts that make the world better. A panel of judges from across sectors choose winners, finalists, and honorable mentions based on feasibility and the potential for impact. With the goals of awarding ingenuity and fostering innovation, Fast Company draws attention to ideas with great potential and helps them expand their reach to inspire more people to start working on solving the problems that affect us all.
#FCWorldChangingIdeas

CONTACT:
Anuncia Inc.
Elsa Chi Abruzzo
President
978-942-5600
[email protected]

SOURCE Anuncia Inc.

Anuncia Inc. Receives FDA “Breakthrough Device Designation” for ReFlow™ System Mini

March 2, 2021

LOWELL, Mass., March 2, 2021 /PRNewswire/ — Anuncia Inc., an emerging leader in Cerebral Spinal Fluid (CSF) management, received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its ReFlow^™System Mini intended for the treatment of CSF disorders requiring shunting such as hydrocephalus, a debilitating and life-threatening condition affecting more than 1 million U.S. patients. Elsa Abruzzo, President of Anuncia Inc., stated, “Our team is very pleased to achieve this significant milestone making the ReFlow^™ System Mini eligible for prioritized FDA regulatory review and Centers for Medicare and Medicaid (CMS) Medicare Coverage of Innovation Technology (MCIT) reimbursement review.”

As many as half of all intracranial shunts fail in the first two years, mainly due to blockages that impair CSF flow requiring emergency revision surgery, each costing upwards of $40,000. The breakthrough indication would allow in-clinic or at-home prophylactic flushing noninvasively by trained patients, caregivers, and clinicians to potentially prevent blockages. “The ReFlow^™ System Mini is optimized to serve a broad hydrocephalus population—infants with non-communicating hydrocephalus, young women with pseudotumor cerebri, and older patients with communicating, idiopathic normal pressure hydrocephalus (iNPH). iNPH is known as the treatable dementia and is often misdiagnosed as Alzheimer’s or Parkinson’s,” commented Mark Luciano, MD, Ph.D., Director of the Cerebral Fluid Center and Professor of Neurosurgery at John Hopkins University in Baltimore.

In a preliminary study of patients at risk for shunt occlusion by two US pediatric centers of excellence, all intracranial shunts remained patent beyond one year using prophylactic flushing with the current ReFlow System. More than half of the patients are nearing their two-year, occlusion-free shunt anniversary. Ramin Eskandari, MD MS, Chief of Pediatric Neurosurgery at the Medical University of South Carolina, remarked, “The ReFlow^™ System Mini is unique in that it could be used with any newly implanted or revised shunt system in any size patient. Coupled with at-home, noninvasive prophylactic flushing, the ReFlow^™ System Mini may decrease emergent hospitalizations, reduce patient and healthcare system costs, and improve the everyday quality of life and overall clinical outcomes for these vulnerable patients living with hydrocephalus.”

About ReFlow System and ReFlow^™ System Mini
The current ReFlow System is FDA cleared and CE Marked for use by a qualified clinician to facilitate a safe, noninvasive retrograde fluid flush when ventriculoperitoneal shunt flow is restricted or blocked. The ReFlow^™ System Mini is under development and not available for sale. The ReFlow System is a prescription device sold by or on the order of a physician.

About Anuncia Inc.
Anuncia Inc., based in Lowell, Massachusetts, is a privately held therapeutic medical device company and an emerging leader in treating conditions associated with Cerebral Spinal Fluid disorders through innovative devices. For more information, please visit www.anunciainc.com

First-in-Human Use of ReFlow™ for Treatment of Hydrocephalus

December 22, 2018

LOWELL, Mass., May 22, 2018 /PRNewswire/ — Anuncia, Inc., a privately-held company focused on better treatment of hydrocephalus and cerebrospinal fluid dysfunctions, announced, today, the successful first-in-human implantation of its Alivio ReFlow™ Ventricular System for treatment of hydrocephalus at Boston Children’s Hospital.

This announcement comes on the heels of receiving the EU CE Mark and US FDA Clearance of Alivio ReFlow™ Ventricular System for the treatment of hydrocephalus. The FDA 510(k) clearance and EU approval of the Alivio ReFlow™ Ventricular System permits Anuncia to commercialize the innovative technology for treatment of hydrocephalus in the US, and Europe, to provide qualified clinicians with the option of non-invasive retrograde flushing of the ventricular catheter, to unblock occluded inlet holes or open a relief membrane to restore or increase CSF flow in a non-flowing shunt.

Hydrocephalus is a condition in which an excess of CSF accumulates within the ventricles and increases pressure in the brain, resulting in a life-threatening situation. CSF shunts are implantable devices inserted by neurosurgeons to treat Hydrocephalus. Although shunts facilitate treatment for many cases, according to the Hydrocephalus Association, at least 50 percent of patients implanted with shunts suffer from shunt failures and blockages within two years, requiring repeated revision surgeries. Further, according to Sarkiss et al., 2014, 40 percent of obstructions, the leading cause of shunt failure, have been shown to occur within the first-year post surgery.

Dr. Joseph Madsen, in the Department of Neurosurgery in Boston Children’s Hospital, who is the co-inventor of Alivio ReFlow™ Ventricular System, commented, “I am delighted that my fellow neurosurgeons will have an option to intervene non-invasively when treating hydrocephalus patients who come in with complications related to ventricular shunt obstruction.”

The costs of these often-emergent, revision surgeries to restore CSF flow and alleviate painful symptoms, present a heavy emotional and financial burden to patients, families, and healthcare facilities. Though the Alivio Flusher is not intended to change standard care practices for diagnosis, treatment, or follow-up of patients with proximal catheter occlusions; it is designed to provide a non-invasive option for neurosurgeons to restore CSF flow in a non-flowing shunt, which may potentially avert emergency revision surgery.

“This first-in-patient validation of the Alivio ReFlow System marks a key milestone for Anuncia and its efforts to advance better treatment options for patients dealing with hydrocephalus and clinicians treating these patients,” said Andrew East, Director of R&D.

PJ Anand, Founder and CEO of Anuncia, commented “The #NOMOREBS campaign by the Hydrocephalus Association, which aims to raise awareness and help improve the lives of every person living with hydrocephalus (www.nomorebrainsurgeries.org), truly inspires our innovations.”

Anuncia, Inc.
Anuncia, based in Massachusetts, is an independent privately-held company focused on developing products for better treatment of hydrocephalus and CSF dysfunctions. Anuncia was spun-off as an independent company from Alcyone Lifesciences in 2018. For more information please visit www.reflowventcath.com

Contact:
Anuncia, Inc.
PJ Anand
Chief Executive Officer
978-709-1946
[email protected]

SOURCE Anuncia, Inc.

Alcyone Lifesciences Completes Spin-Off of Hydrocephalus Business, Anuncia

February 20, 2018

Alcyone Lifesciences, Inc., announces the separation and spin-off of its Hydrocephalus business. The new company, known as Anuncia, Inc., is an independent company focused on innovative treatment of Hydrocephalus and cerebrospinal fluid dysfunctions.

LOWELL, Mass., Feb. 20, 2018 /PRNewswire/ — Alcyone Lifesciences, Inc., a privately-held company focused on transforming disease modifying therapies for central nervous system (CNS) disorders today announced the separation and spin-off of its Hydrocephalus business. The new company, known as Anuncia, Inc., is an independent company focused on innovative treatment of Hydrocephalus and cerebrospinal fluid dysfunctions.

The separation and spin-off of Anuncia from Alcyone comes on the heels of receiving the EU CE Mark and US FDA Clearance of ReFlow Ventricular System for the treatment of hydrocephalus. The FDA 510(k) clearance and EU approval of the ReFlow Ventricular System permits Anuncia to commercialize the innovative technology for treatment of hydrocephalus in the US, and Europe, to provide qualified clinicians with the option of non-invasive retrograde flushing of the ventricular catheter, to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid (CSF) flow in a non-flowing shunt.

Hydrocephalus is a condition in which an excess of CSF accumulates within the ventricles and increases pressure in the brain, resulting in a life-threatening situation. CSF shunts are implantable devices inserted by neurosurgeons to treat Hydrocephalus. Although shunts facilitate treatment for many cases, according to The Hydrocephalus Association1 at least 50 percent of patients implanted with shunts suffer from shunt failures and blockages within two years, requiring repeated revision surgeries. Further, according to Sarkiss et al., 2014, 40 percent of obstructions, the leading cause of shunt failure, have been shown to occur within the first-year post surgery.

The costs of these, often-emergent, revision surgeries to restore CSF flow and alleviate painful symptoms, present a heavy emotional and financial burden to patients, families, and healthcare facilities. Though the Alivio Flusher is not intended to change standard care practices for diagnosis, treatment, or follow-up of patients with proximal catheter occlusions; it is designed to provide a non-invasive option for neurosurgeons to restore CSF flow in a non-flowing shunt, which may potentially avert emergency revision surgery.

“Alcyone Lifesciences and Anuncia will each be stronger, more focused and more competitive as leading standalone companies in their respective markets,” said Edgar D. Jannotta, Jr., Director at Alcyone and Anuncia. “This decision comes after a thorough strategic review by the Board that showed that as independent companies, Alcyone and Anuncia, will be better positioned competitively and enjoy added flexibility to pursue strategic partnerships in their respective markets.”

Jeffrey Quillen and Patrick Connolly of Foley Hoag LLP advised Alcyone in connection with the spin-off and will represent Alcyone and Anuncia as general corporate counsel going forward.

Alcyone Lifesciences, Inc.
Alcyone Lifesciences, based in Massachusetts, is a privately-held company focused on transforming disease modifying therapies for rare, orphan and debilitating neurological disorders through an advanced precision delivery platform. For more information, please visit www.alcyonels.com

Anuncia, Inc.
Anuncia, based in Massachusetts, is an independent privately-held company focused on developing products for better treatment of hydrocephalus and CSF dysfunctions. For more information please visit www.reflowventcath.com

Announcement About Anuncia ReFlow™ System Mini

Anuncia ReFlow™ Tech Honored With Fast Company 2021 World Changing Ideas Awards

Anuncia Inc. Receives FDA “Breakthrough Device Designation” for ReFlow™ System Mini

First-in-Human Use of ReFlow™ for Treatment of Hydrocephalus

Alcyone Lifesciences Completes Spin-Off of Hydrocephalus Business, Anuncia

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

(978) 942-5600 | [email protected]