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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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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.

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The Ultimate List of Attractive MedTech M&A Targets

May 12, 2021

These are the companies in the private sector that medtech analysts have called attention to in 2021.

Updated May 12, 2021 to reflect 10 new additions, based on recent analyst reports. We’ve also updated the existing companies on the list to reflect recent business developments.

From time to time, medtech analysts will call out companies in the private sector that they believe investors should be keeping tabs on. Here is our ultimate list, compiled from analyst reports, of private medtech companies to watch.

4C Medical

4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitral regurgitation (MR). It is the first transcatheter mitral regurgitation (MR) therapy that directly addresses MR without replacing the native mitral valve, thus preserving the native mitral annulus and left ventricle. 4C said its device is positioned supra annular to the leaking native mitral valve to stop the leak from entering the left atrium. Its atrial-only fixation ensures minimal disruption to critical cardiac structures within the left ventricle including the chordae tendineae and the left ventricular outflow tract, the company said. 4C Medical’s initial focus is to develop a therapy for MR, and subsequently for tricuspid regurgitation. The Maple Grove, MN-based company completed an over-subscribed convertible note financing in December 2020, which raised $10 million in gross proceeds.
Ablative Solutions

Ablative Solutions is one of several companies helping to reignite the renal denervation market. The Peregrine System Kit is comprised of an infusion catheter and dehydrated alcohol. The device is used in a minimally invasive procedure with the goal of deactivating the nerves surrounding the renal arteries and thereby reducing blood pressure. In 2020, the Journal of the American College of Cardiology: Cardiovascular Interventions published six-month results from a European multicenter post-market study demonstrating the safety and efficacy of the company’s CE-marked Peregrine System Infusion Catheter. The study evaluated additional safety and performance of the Kalamazoo, MI-based company’s infusion catheter using a neurolytic agent (dehydrated alcohol) delivered into the space outside of the renal (kidney) arteries in 45 patients with systemic hypertension. Patients included in the study were taking at least three anti-hypertensive medications. At six months, mean 24-h ambulatory systolic blood pressure was reduced by 11 mm Hg, and diastolic blood pressure was reduced by 7 mm Hg. Medication adherence was monitored and remained stable throughout the study. The primary safety endpoint, defined as absence of periprocedural major vascular complications, major bleeding, acute kidney injury, or death within one month, was met in 96% of patients.

Active Implants

A new addition to the list, Memphis, TN-based Active Implants develops orthopedic implant solutions designed to complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. The company’s main focus is to provide clinical validation for the NUsurface Meniscus Implant, an “artificial meniscus” designed to replace one that is damaged or deteriorating. Ryan Zimmerman, a medtech analyst at BTIG, called attention to Active Implants in his April 5 report highlighting private medtech and digital health companies. Zimmerman noted that Active Implants filed its De Novo 510(k) in July. “Following clearance, we would expect Active Implants to begin a launch targeted at clinical trial sites with physicians who are familiar with the NUsurface,” the analyst wrote.

Aerin Medical

Aerin Medical has developed the VivAer and RhinAer platform technologies to treat patients suffering from nasal airway obstruction, and chronic rhinitis, respectively. Two-year results from Aerin Medical’s multi-center, prospective study were recently published in the International Forum of Allergy and Rhinology. The study found that 97.2% of patients had a significant and sustained reduction in their nasal obstruction symptoms through two years, without any significant device-related adverse events. The study assessed symptom burden using the gold-standard NOSE score before and after treatment for the 36 participants who remained for its duration. Initial three-month improvements were maintained at 12, 18, and 24 months. In August 2020, the Sunnyvale, CA-based company closed a $48 million equity financing round and hired a new CEO, Matt Brokaw, who has a strong track record of building ear, nose, and throat businesses.

Anuncia

Anuncia is a spin-off of Alcyone that wants to develop devices for better treatment of hydrocephalus (the buildup of fluid in the cavities deep within the brain). The company’s first product is the ReFlow ventricular system, which already has FDA clearance in the United States and a CE mark in Europe. The ReFlow system is comprised of a subcutaneous flusher component and a ventricular catheter with a membrane relief feature close to the proximal end. The device is located under the scalp, much like a cerebral spinal fluid (CSF) shunt. In March, the company received FDA breakthrough device designation for its ReFlow System Mini intended for the treatment of CSF disorders requiring shunting, such as hydrocephalus.

AppliedVR

Los Angeles, CA-based AppliedVR, a new addition to the list, is developing virtual reality-based treatments aimed at comprehensively treating chronic pain. Marie Thibault, a medtech analyst at BTIG and a former managing editor at MD+DI, called attention to AppliedVR in a May 3 report highlighting private medtech and digital health companies to watch. AppliedVR recently secured $29 million in series A funding, bringing its total funds raised to date to $35 million. The round is expected to fuel the company’s growth as it pursues FDA approval over the next year. the company’s EaseVRx solution recently became the first VR-based prescription therapeutic to receive breakthrough device designation from FDA for treatment-resistant fibromyalgia and chronic intractable lower back pain. The company also just released results from its pivotal eight-week randomized clinical trial, finding that the EaseVRx device produced clinically meaningful improvement in multiple pain outcomes, and had high participant satisfaction and engagement.

Bigfoot Biomedical

Bigfoot Biomedical is a company that MD+DI readers should be quite familiar with by now. In 2017, the diabetes company was selected as the readers’ choice for Medtech Company of the Year. The company is developing products to optimize insulin dosing and provide automated insulin delivery for people with insulin-requiring diabetes. Just this week, FDA cleared the Bigfoot Unity Diabetes Management System. Bigfoot also has friends in high places, like Abbott Laboratories, which has led notable financing efforts for Bigfoot, even during the pandemic. Bigfoot’s first commercialized product includes proprietary insulin pen caps for basal and bolus dosing, the Abbott Libre 2 sensor platform, a connected blood glucose meter with test strips, pen needles, alcohol swabs, and a mobile app. Bigfoot Unity pen caps are designed to accommodate all U.S. major brands of long-acting and rapid-acting insulin pens. The company’s pipeline also includes a system specifically for insulin-requiring people on once-a-day basal therapy, and a closed-loop automated insulin delivery pump-based system.
Image courtesy of Bigfoot Biomedical private medtech companies to watch – Bigfoot Biomedical

Cala Health

Cala Health is a Burlingame, CA-based company developing the FDA-cleared Cala Trio, a wearable neuromodulation device designed to look like a watch, with the “watch face” being the stimulator and the band housing electrodes that target the patient’s radial and median nerve, which send the stimulation into a ventral intermediate nucleus. Matson noted that the device serves the large and under-penetrated essential tremor market. The company presented new data in April at the American Academy of Neurology confirming that in-person assessments may not fully capture at-home hand tremor fluctuations for patients with essential tremor. Additional new data demonstrate that an evaluation of hand tremor can be performed via telemedicine appointment to prescribe Cala Trio, the company noted.

Cerapedics

Cerapedics developed the i-Factor peptide enhanced bone graft that is already FDA approved for use in cervical fusion and Cerapedics is pursuing a lumbar fusion indication. The Westminster, CO-based company also recently received a FDA breakthrough device designation for its P-15L bone graft for the treatment of degenerative disc disease.

CardioFocus

Marlborough, MA-based CardioFocus has developed the HeartLight X3 endoscopic ablation system for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. FDA approved the system in 2020. In February 2021, the journal Circulation: Arrhythmia and Electrophysiology (CircEP), published results from the company’s HeartLight X3 pivotal study. That study showed that all endpoints of the pivotal study were achieved, demonstrating significantly faster pulmonary vein isolation (PVI) ablation and procedures times with the HeartLight X3 System compared to the previous generation system, the HeartLight endoscopic ablation system, and with comparable safety and efficacy.

Cognito Therapeutics

Another newcomer to the list highlighted by Thibault’s May 3 report, Boston, MA-based Cognito Therapeutics is developing digital therapeutics to treat neurodegenerative disorders including Alzheimer’s disease. The company has had a busy year so far. In January, FDA granted Cognito breakthrough device designation for its lead product, for the treatment of cognitive and functional symptoms associated with Alzheimer’s disease. The product, a non-invasive neurostimulation device using gamma frequency technology, is the first in the company’s pipeline of digital therapeutics for neurodegenerative diseases and other chronic indications. The company also released results from two clinical studies at the Alzheimer’s Disease Parkinson’s Disease Conference (AD/PD) 2021. Based on those results, Cognito said it will advance the device into pivotal studies during the second half of this year. Thibault noted in her report that the company grew out of research conducted by two MIT professors.

Cognoa

As MD+DI reported in September 2020, Palo Alto, CA-based Cognoa is seeking FDA clearance for a digital device that has the potential to diagnose autism spectrum disorder (ASD). FDA granted the company a breakthrough device designation in 2018. The firm’s digital precision health platform applies machine learning and predictive analytics to parental inputs and diagnostic data and responses to therapeutics to create more personalized care.

Conventus-Flower Orthopedics

Conventus-Flower Orthopedics has developed a 3D cage-like fracture management system that enables minimally invasive treatment of shoulder, wrist, and elbow fractures. To fully appreciate this company’s success, however, it’s worth taking a look back at the year 2013. FDA cleared the company’s implant for wrist fractures in January 2013, but soon after getting that first FDA clearance, Conventus ran out of money and some of its strongest financial supporters had given up on the company by then. The financial clouds began to recede, however, after Paul Buckman took over as CEO in October of that same year. In a 2013 interview, Buckman told MD+DI that investors warmed to his commercial background (as opposed to the previous CEO, who had a more technical background). He was previously president of St. Jude Medical’s cardiology division and later its corporate vice president of business development, and he was able to tap into some of his business contacts to help raise money for Conventus. Currently, the company has a healthy roster of investors and is currently led by CEO Rick Epstein. In May 2020, Conventus acquired Flower Orthopedics, a company that developed the FlowerCube system to eliminate expensive set processing during orthopedic surgery, thus enabling surgical facilities to complete back-to-back cases. In addition to a robust fixation portfolio, Flower’s continuum of care also extends into the fast-growing wound care market for both orthopedic and podiatric surgeons. More recently, in April 2021, the company partnered with Red One Medical, a private sector scout of medical innovation for the Department of Veterans Affairs (VA) and Department of Defense (DoD). Red One Medical CEO Charles Pollak said the partnership will help bring Conventus-Flower’s innovative technology to VA hospitals and DoD medical facilities throughout the United States.

EarLens

Another new addition to the list, thanks to Zimmerman’s April 5 report, EarLens’ soultion is designed to deliver the broadest bandwidth available today and superior sound quality, the medtech analyst noted. The nonsurgical hearing solution uses a small lens to directly vibrate the eardrum, replicating the natural hearing process. FDA cleared the Earlens Contact Hearing Solution in 2019 for a second generation of the Earlens technology. Zimmerman says Earlens is in the process of commercializing its technology with select ear, nose, and throat practices, and audiology practices, across the United States. Last year the company inked a strategic agreement with Verily to develop next-generation capabilities for the Earlens Contact Hearing Solution, the medtech analyst noted.

Endotronix

Endotronix is developing an integrated platform to provide comprehensive, reimbursable health management tools for patients suffering from chronic heart failure. The company’s comprehensive solution includes a cloud-based disease management data system and outpatient hemodynamic management with a breakthrough implantable wireless pulmonary artery sensor for early detection of worsening heart failure. The Lisle, IL-based company raised $45 million in a series D round that closed in September 2018, but expanded the financing in 2019 by an additional $35 million. The company is using the proceeds from the financing for a more robust clinical trial to nab FDA approval and National Coverage Determination for the Cordella Pulmonary Artery Sensor. That trial began enrolling patients in February 2020.
Image courtesy of Endotronixprivate medtech companies to watch – Endotronix

Enlitic

Enlitic is developing a clinical artificial intelligence platform focused on radiology. In September 2020, Enlitic received an award from the U.S. Defense Innovation Unit that enables a two-year pilot of its AI platform at select Defense Health Agency and Veterans Affairs medical facilities. The pilot will include training for clinicians and staff, an assessment of how the software affects the efficiency and accuracy of diagnosis, and use of secure anonymized data to help develop AI algorithms.

Fractyl Laboratories

Fractyl is developing a minimally invasive procedure (Revita DMR) for a variety of metabolic conditions, including Type 2 diabetes, polycystic ovarian syndrome, nonalcoholic fatty liver disease, and nonalcoholic steatohepatitis. In April 2021, Fractyl scored a breakthrough device designation from FDA for Revita DMR (duodenal mucosal resurfacing), a treatment that has the potential to eliminate the need for daily insulin. The Lexington, MA-based company’s therapy uses thermal ablation to ablate a portion of the duodenum mucosa, which may improve glucose control in patients struggling to manage diabetes. Last year Fractyl raised $55 million in a series E round to support the pivotal trial of Revita DMR.

Magnolia Medical Technologies

Seattle, WA-based Magnolia Medical Technologies is on a mission to prevent blood culture contamination and false-positive central line-associated bloodstream infections. The company has developed the FDA-cleared Steripath Initial Specimen Diversion Device (ISDD) platform. TheSteripath ISDD is designed to divert the initial 1.5 milliliters to 2.0 milliliters of blood while maintaining a vein-to-bottle closed system which reduces blood culture contamination rates and false-positive central line-associated bloodstream infections to improve patient outcomes. Thibault highlighted Magnolia Medical Technologies in her May 3 report. The medtech analyst noted that the company offers a money-back guarantee that the technology will reduce blood culture contamination rates by at least 50% on a sustained basis (and studies have shown 81-100% reduction in blood culture contamination rate with use of the Steripath technology).

Mahana Therapeutics

Another newcomer to the list that BTIG’s Thibault called attention to in her May 3 report, Mahana Therapeutics is a prescription digital therapeutics company based in San Francisco, CA. Parallel, Mahana’s debut product, has FDA clearance and CE mark to treat patients with irritable bowel syndrome. Mahana is also working on internal development for other GI and chronic disease therapeutics, starting with inflammatory bowel disease, Thibault noted. The company acquired the worldwide exclusive licensing rights for Parallel (formerly known as Regul8) in January 2020 from King’s College London.

Mainstay Medical

Mainstay Medical received FDA approval in June 2020 for its ReActiv8 neuromodulation system for chronic lower back pain, and the company just recently launched the device in Australia. Earlier this year, the Dublin, Ireland-based company raised $108 million to support the company’s commercial launch in the United States, continued expansion in Europe and Australia, additional post-market clinical studies and research, and general operations.

MedRhythms

MedRhythms, a Portland, ME-based medtech company, is developing direct stimulation prescription digital therapeutics. In April 2021, the company launched a clinical trial that will study MR-010, MedRhythms’ acute stroke asset. The trial will be in partnership with UMass Memorial Healthcare and will examine the impact of MR-010 on acute stroke walking outcomes. Also in April, MedRhythms initiated a multi-site clinical trial, in collaboration with Boston University and a leading hospital, of its pipeline asset MR-005 in Parkinson’s disease (PD) as well as the expansion of the company’s pipeline into aging. This follows MedRhythms’ announcement of the advancement of its pipeline into PD and multiple sclerosis in 2020.

Miracor Medical

Miracor Medical developed the Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy to be used during percutaneous coronary intervention in patients with acute myocardial infarction. This is another new addition to the list, and one that BTIG’s Thibault highlighted in her May 3 report. She writes that the PiCSO Impulse System consists of a patient monitoring console and a balloon catheter. Once in position, the balloon is inflated cyclically and used to intermittently block the coronary sinus outflow in order to ensure blood reaches the ischemic heart tissue. Balloon deflation helps wash out harmful agents from the microcirculation.

Paragonix Technologies

Paragonix Technologies has developed the SherpaPak technology platform, which incorporates precision cooling technology to advance organ preservation and transportation. The company has won regulatory clearances in the United States and Europe for all solid organs. The company’s first product, the SherpaPak Cardiac Transport System (CTS), is designed to protect heart transplants from physical and thermal trauma in a dual-canister compartment. Paragonix also has a system for donor lung preservation, and a SherpaPak Pancreas Transport System. In late April, the First Report of the GUARDIAN Registry was presented at the International Society for Heart and Lung Transplantation 2021 Annual Meeting. The GUARDIAN study is the largest multi-center, international registry specifically focused on donor heart preservation. Clinical investigators from the first five enrolling centers collaborated to pool their data and analyze the differences in clinical outcomes of 224 patients who received donor hearts preserved either in the Paragonix SherpaPak CTS or with traditional ice storage. David D’Alessandro, MD, surgical director of heart transplantation at Massachusetts General Hospital, presented the study results and summarized the authors’ conclusions that, “Heart preservation utilizing the Paragonix SherpaPak CTS compares favorably to ice storage preservation in this registry analysis. Despite unfavorable donor and recipient characteristics in the [Paragonix] cohort of patients, early clinical outcomes including Intensive Care Unit length of stay are improved.” The investigators reported that the donor hearts preserved by the Paragonix SherpaPak had statistically significant increases in total ischemic time and travel distance. Total ischemic time, the time a donor heart is out of the body before implanted in a recipient, is a known risk factor for negative outcomes. Despite this increased risk the authors found significant reductions in ICU length of stay, with median ICU durations reduced by three days, in the Paragonix SherpaPak cohort. An analysis of patients with extended ischemic times, those greater than 3 hours, found even more pronounced favorable differences. In this group, the portion of patients in the ICU for two weeks or more was reduced by 50% in the Paragonix SherpaPak cohort, and the portion of patients in the ICU for only a week or less were more than double compared to ice storage.

Promaxo

Oakland, CA-based Promaxo received FDA clearance in March for its office-based MRI system. The Promaxo MRI is intended for urologists and interventional/urologic radiologists to perform surgical localization of prostatic lesions under Promaxo MRI guidance in an office or outpatient surgical setting. Multiple validation studies have demonstrated the first-of-its-kind platform technology to be safe, accurate, and effective. The Promaxo MR imager is currently being used under an investigational device exemption to perform targeted prostate biopsies at Mississippi Urology. The device has a limited fringe field, and can be easily installed in an office with no shielding or facility upgrades. The company touts that the truly open single-sided design, and quiet operation without the need for endorectal coils, leads to a comfortable patient experience. The MRI platform’s unique configuration is built upon an inherent z-gradient and array of permanent magnets arranged to provide a uniform in-plane magnetic field within the field of view. The product incorporates patented technologies to capture, reconstruct, and display magnetic resonance images of prostate and surrounding tissues. The device leverages pre-programmed sequences and artificial intelligence to enhance image quality.

Quantum Surgical

Quantum Surgical is a Montpellier, France-based company that has developed a platform that combines robotics, advanced image processing software, and artificial intelligence to treat liver cancer. Earlier this year, Quantum said it completed a first multicenter clinical study with its Epione medical robot dedicated to minimally invasive liver cancer treatment. The Epione platform is designed to assist the physician in performing safer and more efficient percutaneous ablations in the liver (a minimally invasive treatment in which a needle is inserted through the skin to the lesion to burn it).

Relievant Medsystems

Another newcomer to our list of private medtech companies to watch, Relievant Medsystems also received a shoutout from BTIG’s Zimmerman on his April 5 report. “Relievant Medsystems is a privately-held medical device company that is transforming the treatment of chronic low back pain (CLBP) with the Intracept Procedure – a novel, clinically- proven, and commercially-available treatment designed to improve the quality of life for the millions of patients suffering CLBP from degenerative disk disease that can be seen on MRI’s with Modic changes, a biomarker indicating that their pain is vertebrogenic in origin,” Zimmerman wrote. Just this week, Relievant named Tyler Binney as the company’s new president and CEO. Binney most recently served as president and general manager of interventional urology at Teleflex.

Think Surgical

Yet another new addition highlighted in Zimmerman’s April 5 report, Think Surgical develops active robotics for orthopedic surgery. The TSolution One Total Knee Application includes the only commercially available active robot for total knee arthroplasty (TKA) utilizing an open implant library, supporting a variety of implant options. The first generation TSolution One Total Knee Application received FDA 510(k) clearance in October 2019.  The second-generation system received FDA clearance in November 2020 and is commercially available in the United States. Most recently, Think Surgical and Ortho Development, an orthopedic device design and manufacturing company, reported FDA clearance to use Ortho Development’s Balanced Knee System (BKS), and BKS TriMax implants, with Think Surgical’s TSolution One Total Knee Application. “We expect the company to build its installed base in the U.S. with an emphasis on ASCs [ambulatory surgical centers] as reconstruction procedures continue to shift to that setting of care,” Zimmerman wrote.

Vertos Medical

Zimmerman’s April 5 report also called attention to Vertos Medical, a Aliso Viejo, CA-based company developing minimally invasive treatments for lumbar spinal stenosis (LSS). Mild, Vertos Medical’s technology, is designed to restore space in the spinal canal through an incision smaller than the size of a baby aspirin. The BTIG analyst noted that the procedure has been performed on more than 30,000 patients and its safety and efficacy have been analyzed in 13 clinical studies and over 25 publications.

https://anunciamedical.com/wp-content/uploads/2021/12/anunica-news-article-min.jpg 400 600 admin https://anunciamedical.com/wp-content/uploads/2021/12/anuncia_logo-800.png admin2021-05-12 02:56:392022-03-31 07:18:27The Ultimate List of Attractive MedTech M&A Targets

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 ReFlowTM 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
info@anunciainc.com

SOURCE Anuncia Inc.

https://anunciamedical.com/wp-content/uploads/2021/12/anuncia-honored-fast-company.jpg 400 600 admin https://anunciamedical.com/wp-content/uploads/2021/12/anuncia_logo-800.png admin2021-05-04 02:58:322022-03-31 07:27:26Anuncia ReFlow™ Tech Honored With Fast Company 2021 World Changing Ideas Awards

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

https://anunciamedical.com/wp-content/uploads/2021/12/fda-approved-medical-device-reflow-anuncia-min.jpg 400 600 admin https://anunciamedical.com/wp-content/uploads/2021/12/anuncia_logo-800.png admin2021-03-02 02:57:152022-03-31 07:03:31Anuncia Inc. Receives FDA “Breakthrough Device Designation” for ReFlow™ System Mini

Looking to the Future of Neuro Devices: Exclusive Interview with Alcyone Lifesciences CEO PJ Anand

May 7, 2019

Alcyone Lifesciences is a medical technology company based out of Lowell, MA, which specializes in central nervous system (CNS) drug delivery platforms for targeted infusions of the brain or spinal cord. Their Thecaflex DRx System was recently awarded Breakthrough Device designation by the FDA, for spinal infusion of therapeutic medications.

Medgadget had the opportunity to speak with Alcyone Lifesciences CEO, PJ Anand, about his inspiration for cutting edge medical technology and the future direction of neurological devices.

Kurt Yaeger, Medgadget: Great to talk to you, PJ. Please first give us a sense of your background.

PJ Anand, Alcyone Lifesciences: My academic background is in biochemistry; however, I branched into the business of medicine, particularly medical devices, working for a CRO focused on preclinical to regulatory development of devices and therapeutics by both large and small MedTech and biopharma companies. While there I realized my true interest was in building products versus pure service industry. I moved companies and took a role working for a firm focused on coating services for orthopedic implants; my job was to vertically integrate the business into a finished medical device for treatment for ESRD (kidney disorder). That business I helped build was acquired by a large MedTech for multiples ROI. I then joined a group out of MIT and Harvard as a founding executive of a venture-funded company focused on advanced materials bio-composite platform for several applications including cardiovascular disease such as peripheral vascular diseases and separately trauma management. After helping that company advance its products towards clinical studies, I left with a vision to start Alcyone, Anuncia, Inc. (an Alcyone spin-out company focused on hydrocephalus management), and Arthromeda, which is developing patient-specific navigation system for arthroplasty surgery.

 

Medgadget: What inspired you to form Alcyone?

PJ: I have always felt that a linear pathway to the development of medical technology or therapeutics is ineffective. What I mean by this is that most diseases are multifactorial and hence a single linear solution, whether a device intervention or a drug therapy, doesn’t really work well. The inspiration for Alcyone came from a strong conviction that “convergence” between treatment enabling device systems combined with disease modifying drug therapies pioneered by biopharma, ranging from genetic medicines to immuno-oncolytics, is the key to more powerful patient care, improved quality of life, and better clinical outcomes. Based on data from early stages of gene therapy, antisense oligonucleotide therapy, monoclonal and oncolytics, I realized that there is a profound unmet need for well-designed sophisticated therapy enabling technologies for treating some of the most difficult to treat diseases in neurology and oncology. These sophisticated tools for intrathecal medicines or intratumoral medicines are exactly what we are able to offer clinicians treating disease-modifying therapies to patients with debilitating conditions.

 

Medgadget: Why did you take on this difficult problem for patients with neurological disorders?

PJ: We feel the value and the purpose of Alcyone is to address some of the most challenging problems in medicine. We feel addressing the significant unmet medical need associated with chronic neurological conditions represents one of the most pressing challenges facing medical science today that we simply cannot ignore just because it is hard to solve. In addition, we feel strongly committed to helping patients dealing with debilitating neurological conditions, many of them children and/or orphan populations.

 

Medgadget: Why is Alcyone uniquely poised to tackle this problem?

PJ: The answer is sincerely is that we have a uniquely talented team and intellectual property position that provides an unfair competitive advantage to us and our biopharma partners. The Alcyone Team includes immensely talented engineers, neuroscientists, preclinical development, regulatory and clinical development experts who take a data centric approach to development of our innovations in treatment of neurological conditions and cancers. A multi-factorial, agile approach combining biomedical engineering, physics, biology, physiology, drug chemistry and patient-specific conditions, has allowed us to develop first-in-class / best-in-class technology.

 

Medgadget: How has developing neurological devices changed since you entered this space?

PJ: There have been tremendous developments in both traditional and endovascular neurosurgery. Neurological Imaging and machine-aided surgical techniques now allow our clinicians to address precisely where intervention is needed in the central nervous system. With these developments, we now have much better devices to treat complicated conditions including epilepsy, movement disorders, pain and spasticity.

 

Medgadget: What are your biggest accomplishments in this space?

PJ: Three specific areas we are making a meaningful impact are in the areas of intrathecal therapy delivery, precise and effective targeting for immune-oncology, and hydrocephalus management.

  1. In intrathecal medicines our more recent success has been with our Breakthrough Device Designated ThecaFlex DRxTM System for intrathecal therapies. This platform technology is designed for a broad set of patients including those with complex spine conditions and children who may be greatly affected by repeat anesthesia required to receive chronic therapy. We hope to have a positive impact in the treatment of spinal muscular atrophy (SMA) and neurodegenerative disease such as Huntington’s disease, Parkinson’s disease and potentially Alzheimer’s disease.
  2. In immuno-oncology, we are currently in groundbreaking clinical trials with our Alcyone Micro-tip Multi-port Cannula (AMCTM System) for intratumoral therapies. We have made significant contributions in intratumoral drug therapy to treat glioblastoma multiforme (GBM) and DIPG, a brainstem glioma, with our AMC platform. This technology is incorporated into Phase 3 studies for both GBM and DIPG, driving benefit through targeted precision delivery that drastically improves biodistribution of an immuno-oncolytic virus. Additionally, we are exploring the benefit of this technology for application to solid tumors in other parts of the body.
  3. In hydrocephalus management, we have the opportunity to prolong shunt life and provide peace of mind to patients, their families, and clinicians treating these patients with our ReFlowTM System designed for non-invasive intervention for ventricular shunt occlusion. The Anuncia ReFlow Ventricular Shunt System is designed to reduce repeat invasive brain surgeries due to shunt occlusion.

 

Medgadget: Where do you see the biggest opportunities in the neurological device space over the next ten years?

PJ: I go back to my conviction in convergence in medicine. Going forward, I see opportunities in convergence of neuro devices coupled with bio-monitoring, artificial intelligence, and deep machine learning. There is much to learn about the biology and interaction of biology with a device interface towards sustained therapeutic solutions with improved outcomes.

 

Medgadget: Where do you see the biggest challenges in the neurological device space over the next ten years?

PJ: I see two major challenges. One is that there is going to be a need for much more thoughtful and deliberate clinical trials that include clear outcome measures including biological and imaging parameters. Two, the immense consolidation in the industry that may not naturally allow for disruptive innovation which requires sustained funding and commercial access. We need to address both of these challenges forward facing.

 

Medgadget: What obstacles do you see in the current political climate to pursuing your goals at Alcyone?

PJ: We need to innovate thinking globally more than ever. If you think about Central Nervous System malignancies, Spinal Muscular Atrophy, Huntington’s Disease, Amyotrophic lateral sclerosis (ALS) also known as Lou Gehrig’s Disease, Parkinson’s Disease or Alzheimer’s Disease there are significant patients outside of United States that we need to serve in addition to within United States. Having a tense and uncertain political climate and unpredictable foreign regulations and policies makes it a challenge to bring certainty to global launch plans.

 

Medgadget: How do you see the device portfolio at Alcyone evolving over the next few years?

PJ: We believe that the cerebral spinal fluid (CSF), the CSF space and CSF dynamics are an untapped area to bring significant treatment options for patients with complicated neurological conditions. We will build our portfolio on some exciting fundamental intrathecal medicines sciences we’ve pioneered. We have also been studying tumors from a multidimensional compartmentalized scientific perspective including characterizing the heterogeneity. We will utilize this scientific background work toward a data-centric approach to optimizing our intratumoral therapeutic platform.

 

Medgadget: Thanks so much for your time, PJ. Is there anything you think we should know about your company?

PJ: The core value that allows Alcyone to develop innovative technologies in neuroscience and oncology is our deep purpose to serve patients in need and clinicians who strive everyday help these patients. This singular purpose shared through-out the organization dictates our vision, mission, and strategy.

https://anunciamedical.com/wp-content/uploads/2021/12/Alcyone-Lifesciences.png 357 500 admin https://anunciamedical.com/wp-content/uploads/2021/12/anuncia_logo-800.png admin2019-05-07 02:55:542022-01-07 15:23:16Looking to the Future of Neuro Devices: Exclusive Interview with Alcyone Lifesciences CEO PJ Anand

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
info@anunciainc.com

SOURCE Anuncia, Inc.

https://anunciamedical.com/wp-content/uploads/2021/12/hyrdocephalus.jpg 250 350 admin https://anunciamedical.com/wp-content/uploads/2021/12/anuncia_logo-800.png admin2018-12-22 02:53:472022-03-31 07:30:30First-in-Human Use of ReFlow™ for Treatment of Hydrocephalus

Brain emergency averted at the push of a button

May 29, 2018

A Boston neurosurgeon recently avoided doing emergency brain surgery on a young patient just by pressing on a new device.

The Alivio ReFlow ventricular system was embedded beneath the scalp of the unidentified hydrocephalus patient.

Comprised of a subcutaneous “flusher” component and a ventricular catheter, the device has a “relief membrane” backup feature at the catheter’s proximal end. By pushing a button on the device, the first-in-human procedure cleared a clogged shunt that directs the flow of cerebrospinal fluid to the patient’s abdomen. The device received 510(k) clearance from FDA in 2017 as well as the CE Mark and is compatible with other manufacturers’ shunts.

Named for the Greek words hydro meaning water and cephalus meaning head, hydrocephalus is an abnormal accumulation of cerebrospinal fluid within brain cavities called ventricles. Part of each ventricle called the choroid plexus produces the fluid. Congenital hydrocephalus occurs in one or two per 1,000 live births, but the condition may also be acquired at any age.

About 50% of shunts in children fail during the first two years following implantation, usually due to blockages by tissue from the ventricles or choroid plexus, according to the Hydrocephalus Association. Such blockages can lead to emergency revision surgery, and many patients have had multiple revision surgeries, according to PJ Anand, founder and CEO of Anuncia, the maker of the Alivio system.

“It’s devastating. It’s debilitating to the patient. It’s debilitating to the families,” Anand said. “This device offers them an option for getting away from that emergency situation.”

Anuncia has been overwhelmed by the response from parents and patients to the news of the recent procedure. One patient even asked to have the device placed prophylactically, according to the CEO.

Anand spun off Anuncia from his other company, Alcyone Lifesciences, earlier this year to allow the new firm to focus on devices for hydrocephalus. Lowell, Massachusetts-based Anuncia recently began working with Cincinnati Children’s Hospital on developing a plate to keep a ventricular catheter in position. Anand would like his company to develop a drug to eliminate ventricular catheter blockages but is happy for now with Alivio.

“We’re hoping that this will result in much more innovation going forward,” he said.

https://anunciamedical.com/wp-content/uploads/2021/12/Anuncia-brain-device2.jpg 191 267 admin https://anunciamedical.com/wp-content/uploads/2021/12/anuncia_logo-800.png admin2018-05-29 02:54:152022-01-07 15:22:55Brain emergency averted at the push of a button

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 better 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

https://anunciamedical.com/wp-content/uploads/2021/12/anuncia_logo-800.png 202 810 admin https://anunciamedical.com/wp-content/uploads/2021/12/anuncia_logo-800.png admin2018-02-20 02:51:412022-03-31 07:36:13Alcyone Lifesciences Completes Spin-Off of Hydrocephalus Business, Anuncia

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The ReFlow Ventricular 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.

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