Developer docs
API playgroundTry for free, no card

Search company profiles

Anuncia Medical Inc.

Full company profile

uuid0000t9d

Namestring
Anuncia Medical Inc.
Legal namestring
Anuncia Inc.
Websiteurl
anunciainc.com
Company typeenum
Private
Founded yearint
2018
Descriptiontext

Anuncia Medical Inc. (legal entity Anuncia Inc.) is a Scottsdale, Arizona-based privately held neurotherapeutic medical device company founded in 2018 that develops products for cerebrospinal fluid (CSF) management in hydrocephalus patients. Its core offering is the FDA-cleared ReFlow™ System Mini, an integrated platform comprising the ReFlow™ Mini Flusher — an implantable device positioned under the scalp that, when pressed, sends a controlled flush of fluid toward the shunt ventricular catheter to dislodge blockages — and a companion ReFlow™ Ventricular Catheter with a proprietary relief membrane that opens under flush pressure to create an alternate CSF flow pathway. The company is expanding its portfolio with the ReFlow® External Ventricular Drains (EVD) Flusher, which received FDA Breakthrough Device Designation in March 2025 for use in neurocritical care.

The company sells its devices exclusively by or on the order of a physician as prescription-only medical devices in the United States, using a direct enterprise field-sales motion targeted at neurosurgeons and treating clinicians. End users are predominantly pediatric or over-60 hydrocephalus patients in whom a large share of shunts fail within the first two years, primarily from occlusion — the failure mode ReFlow is engineered to address non-invasively at home or in clinic, potentially avoiding repeat revision brain surgeries. Revenue is generated through one-time device sales per implantation; no pricing is publicly disclosed and no revenue figures have been released.

Anuncia operates with 11–50 employees and is led by CEO and President Elsa Chi Abruzzo, with a board including medical device industry figures. The company maintains partnerships with the Hydrocephalus Association and other professional associations, has received a Flinn Foundation Grant (March 2025), and signals active fundraising through an Investor Relations page. The global hydrocephalus market is projected to grow from $6.90B in 2020 to $10.17B by 2030 (4.0% CAGR), with North America currently the largest regional share — though Anuncia is currently US-only, leaving international expansion as future optionality.

Short descriptiontext

Anuncia Medical Inc. is a Scottsdale, Arizona-based medical device company that develops FDA-cleared ReFlow™ implantable and EVD flushing devices to non-invasively clear cerebrospinal fluid shunt occlusions in hydrocephalus patients, sold exclusively through US prescribing neurosurgeons.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersScottsdale, United States
HQ citystring
Scottsdale
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices1 record

Each record includes

City, Country, Type, Description, Source

Keyword5 values
hydrocephalus treatment devices, cerebrospinal fluid management, neurotherapeutic medical devices, shunt occlusion prevention, implantable CSF shunts
Industry1 code
1Neurosurgical Implants & Cranial/CMF (Cranial Plates, Dural Repair, Shunts)
CodeHLAHAEADPrimaryYes
NAICS code1 code
  • Surgical Appliance and Supplies Manufacturing339113
SIC code1 code
  • Surgical & Medical Instruments & Apparatus3841
Product category
Neurosurgical / Hydrocephalus Treatment Devices
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model1 record
1Medical Device Sales
TypeOne Time License
Description

Anuncia generates revenue through the sale of its FDA-cleared ReFlow™ System Mini and ReFlow™ Mini Flusher devices. These are prescription medical devices sold to hospitals and through physicians for implantation in hydrocephalus patients.

anunciamedical.com
Marketing channels8 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components5 values
Operations, Technology or R&D, Personnel, Marketing or Sales, Others
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Brand1 of 3 records shown
1ReFlow™ System Mini
Description

The only noninvasive way to attempt to restore, increase, or maintain CSF flow within a shunt system for patients with hydrocephalus.

anunciamedical.com
+2 more records
Core offering1 text field

Anuncia Medical develops, manufactures, and sells FDA-cleared, prescription-only ReFlow™ neurotherapeutic devices for cerebrospinal fluid (CSF) management in patients with hydrocephalus. The ReFlow™ System Mini pairs an implantable Mini Flusher placed under the scalp with a ReFlow™ Ventricular Catheter featuring a proprietary relief membrane, enabling non-invasive clearing of shunt occlusions to help avoid repeat revision brain surgeries.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 value
  • Large percentage of hydrocephalus shunts fail in first two years, mainly from occlusion
Product overview1 text field

Anuncia Medical Inc. offers a unified portfolio of neurotherapeutic devices centered on the ReFlow™ brand for cerebrospinal fluid (CSF) management. The core offering consists of the ReFlow™ System Mini, which includes the ReFlow™ Mini Flusher (an implantable device implanted under the scalp that can be pressed to flush blockages from shunt systems) and the companion ReFlow™ Ventricular Catheter (with a relief membrane backup feature). These FDA-cleared devices work together as an integrated shunt system to prevent and clear occlusions without requiring repeat revision brain surgeries. The company is expanding its portfolio with FDA Breakthrough Device Designation for the ReFlow® External Ventricular Drains (EVD) Flusher for critical care applications.

Product and service3 records
1ReFlow™ System Mini
CategoryNeurosurgical implant system
Description

An FDA-cleared neurotherapeutic device offering the only noninvasive way to attempt to restore, increase, or maintain cerebrospinal fluid (CSF) flow within a shunt system. Designed to monitor, treat, and prevent shunt occlusions at-home or in-clinic for patients with hydrocephalus or conditions requiring CSF draining or shunting. Sold as a prescription medical device by or on the order of a physician in the United States.

2ReFlow™ Mini Flusher
CategoryImplantable neurosurgical device
Description

An implantable device placed under the patient's scalp as part of a shunt system; pressing it non-invasively sends a controlled flush of fluid toward the shunt ventricular catheter to push out blockages and open ventricular catheter flow holes. Indicated for patients with hydrocephalus or conditions requiring CSF draining or shunting, and intended for use by patients, caregivers, or clinicians to manage shunt occlusions without surgery.

3ReFlow™ Ventricular Catheter
CategoryNeurosurgical catheter component
Description

A ventricular catheter designed for use with the ReFlow Mini Flusher, featuring a relief membrane backup feature that can be opened by the flush to create an alternate pathway for CSF flow when blockages occur. Used in shunt systems for hydrocephalus patients.

Scale indicator1 record

Each record includes

Type, Value, Description, Source

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight6 records

Each record includes

Type, Description

Peers8 records
TypeDirect peer
Description

Integra LifeSciences (Codman Specialty Surgical) is a leading manufacturer of hydrocephalus shunts, EVDs, and intracranial pressure monitoring devices—the most direct competitor to Anuncia's ReFlow portfolio. Both serve the same neurosurgery call point with implantable CSF management devices.

TypeBroad incumbent
Description

Medtronic's Hydrocephalus Therapy business (formerly Codman, acquired 2014) is the global market leader in CSF shunts, valves, and EVDs. Medtronic's neurosurgery division directly competes with Anuncia across the same patient population and surgeon call point, with dramatically broader scale and distribution.

TypeDirect peer
Description

B. Braun's Aesculap division (via its partnership with Miethke) manufactures gravitational and programmable hydrocephalus valves and shunt systems. They compete head-to-head with Anuncia in the implantable CSF management market and have deep neurosurgeon relationships globally.

TypeDirect peer
Description

Sophysa (France) is a specialist manufacturer of programmable hydrocephalus valves, shunts, and intracranial pressure monitors. They are a focused niche competitor comparable to Anuncia in scale and product specificity, targeting the same neurosurgery customer base.

TypeDirect peer
Description

Spiegelberg (Germany) manufactures EVDs, ICP monitors, and CSF drainage systems used in neurosurgery and neurocritical care. They directly overlap with Anuncia's expanded ReFlow EVD Flusher product line.

TypeBroad incumbent
Description

Natus Medical provides neurology and neurosurgery-related devices and disposables, including products for hydrocephalus and CSF management. They are a broader incumbent with overlapping but non-identical product lines in the same neurosurgery market.

TypeEmerging player
Description

Mölnlycke has expanded into neurosurgical drapes and single-use neurosurgery devices. While not a direct CSF management peer, they participate in the same neurosurgery OR ecosystem where Anuncia's ReFlow devices are implanted.

TypeEmerging player
Description

Penumbra is a neurovascular device company with growing presence in the neurosurgery/neurocritical care market. While focused on stroke and thrombectomy, they participate in the same neurohospital call point as Anuncia's EVD Flusher extension.

Market position
Strengths4 records

Each record includes

Headline, Details, Source

Weaknesses4 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks5 records

Each record includes

Headline, Details, Source

Key highlights7 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment2 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile1 record

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
No
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature3 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles10 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
Compliance2 records

Each record includes

Name, Class, Description

Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds3 records

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors1 record

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Anuncia Medical Inc.

Neurosurgical / Hydrocephalus Treatment Devicesanunciainc.com

Anuncia Medical Inc. is a Scottsdale, Arizona-based medical device company that develops FDA-cleared ReFlow™ implantable and EVD flushing devices to non-invasively clear cerebrospinal fluid shunt occlusions in hydrocephalus patients, sold exclusively through US prescribing neurosurgeons.

What Anuncia Medical Inc. does

Anuncia Medical Inc. (legal entity Anuncia Inc.) is a Scottsdale, Arizona-based privately held neurotherapeutic medical device company founded in 2018 that develops products for cerebrospinal fluid (CSF) management in hydrocephalus patients. Its core offering is the FDA-cleared ReFlow™ System Mini, an integrated platform comprising the ReFlow™ Mini Flusher — an implantable device positioned under the scalp that, when pressed, sends a controlled flush of fluid toward the shunt ventricular catheter to dislodge blockages — and a companion ReFlow™ Ventricular Catheter with a proprietary relief membrane that opens under flush pressure to create an alternate CSF flow pathway. The company is expanding its portfolio with the ReFlow® External Ventricular Drains (EVD) Flusher, which received FDA Breakthrough Device Designation in March 2025 for use in neurocritical care.

The company sells its devices exclusively by or on the order of a physician as prescription-only medical devices in the United States, using a direct enterprise field-sales motion targeted at neurosurgeons and treating clinicians. End users are predominantly pediatric or over-60 hydrocephalus patients in whom a large share of shunts fail within the first two years, primarily from occlusion — the failure mode ReFlow is engineered to address non-invasively at home or in clinic, potentially avoiding repeat revision brain surgeries. Revenue is generated through one-time device sales per implantation; no pricing is publicly disclosed and no revenue figures have been released.

Anuncia operates with 11–50 employees and is led by CEO and President Elsa Chi Abruzzo, with a board including medical device industry figures. The company maintains partnerships with the Hydrocephalus Association and other professional associations, has received a Flinn Foundation Grant (March 2025), and signals active fundraising through an Investor Relations page. The global hydrocephalus market is projected to grow from $6.90B in 2020 to $10.17B by 2030 (4.0% CAGR), with North America currently the largest regional share — though Anuncia is currently US-only, leaving international expansion as future optionality.

Anuncia Medical Inc. firmographics

Firmographics
Name
Anuncia Medical Inc.
Legal name
Anuncia Inc.
Website
https://anunciainc.com
Company type
Private
Founded year
2018
Operating status
Operating
Headcount range
11–50 employees
Short description
Anuncia Medical Inc. is a Scottsdale, Arizona-based medical device company that develops FDA-cleared ReFlow™ implantable and EVD flushing devices to non-invasively clear cerebrospinal fluid shunt occlusions in hydrocephalus patients, sold exclusively through US prescribing neurosurgeons.
Ownership category
akta.pro rank

Anuncia Medical Inc. industry classification

Industry
Product category
Neurosurgical / Hydrocephalus Treatment Devices
NAICS
Surgical Appliance and Supplies Manufacturing (339113)
SIC
Surgical & Medical Instruments & Apparatus (3841)
akta.pro primary industry
Neurosurgical Implants & Cranial/CMF (Cranial Plates, Dural Repair, Shunts) (HLAHAEAD)

Keywords

  • Hydrocephalus treatment devices
  • Cerebrospinal fluid management
  • Neurotherapeutic medical devices
  • Shunt occlusion prevention
  • Implantable CSF shunts

Where Anuncia Medical Inc. is headquartered

Location

Headquarters

HQ city
Scottsdale
HQ country
United States
HQ region
North America

Offices1 record

Markets served

Anuncia Medical Inc. business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Operations, Technology or R&D, Personnel, Marketing or Sales, Others

Revenue model

  1. Medical Device Sales: Anuncia generates revenue through the sale of its FDA-cleared ReFlow™ System Mini and ReFlow™ Mini Flusher devices. These are prescription medical devices sold to hospitals and through physicians for implantation in hydrocephalus patients.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels8 records

Anuncia Medical Inc. product offering

Product offering

Core offering

Anuncia Medical develops, manufactures, and sells FDA-cleared, prescription-only ReFlow™ neurotherapeutic devices for cerebrospinal fluid (CSF) management in patients with hydrocephalus. The ReFlow™ System Mini pairs an implantable Mini Flusher placed under the scalp with a ReFlow™ Ventricular Catheter featuring a proprietary relief membrane, enabling non-invasive clearing of shunt occlusions to help avoid repeat revision brain surgeries.

Product overview

Anuncia Medical Inc. offers a unified portfolio of neurotherapeutic devices centered on the ReFlow™ brand for cerebrospinal fluid (CSF) management. The core offering consists of the ReFlow™ System Mini, which includes the ReFlow™ Mini Flusher (an implantable device implanted under the scalp that can be pressed to flush blockages from shunt systems) and the companion ReFlow™ Ventricular Catheter (with a relief membrane backup feature). These FDA-cleared devices work together as an integrated shunt system to prevent and clear occlusions without requiring repeat revision brain surgeries. The company is expanding its portfolio with FDA Breakthrough Device Designation for the ReFlow® External Ventricular Drains (EVD) Flusher for critical care applications.

Differentiator

Problem solved

Functional benefit

Brands

  • ReFlow™ System Mini: The only noninvasive way to attempt to restore, increase, or maintain CSF flow within a shunt system for patients with hydrocephalus.
  • ReFlow™ Mini Flusher
  • ReFlow™ Ventricular Catheter

Products and services

  • ReFlow™ System Mini An FDA-cleared neurotherapeutic device offering the only noninvasive way to attempt to restore, increase, or maintain cerebrospinal fluid (CSF) flow within a shunt system. Designed to monitor, treat, and prevent shunt occlusions at-home or in-clinic for patients with hydrocephalus or conditions requiring CSF draining or shunting. Sold as a prescription medical device by or on the order of a physician in the United States.
  • ReFlow™ Mini Flusher An implantable device placed under the patient's scalp as part of a shunt system; pressing it non-invasively sends a controlled flush of fluid toward the shunt ventricular catheter to push out blockages and open ventricular catheter flow holes. Indicated for patients with hydrocephalus or conditions requiring CSF draining or shunting, and intended for use by patients, caregivers, or clinicians to manage shunt occlusions without surgery.
  • ReFlow™ Ventricular Catheter A ventricular catheter designed for use with the ReFlow Mini Flusher, featuring a relief membrane backup feature that can be opened by the flush to create an alternate pathway for CSF flow when blockages occur. Used in shunt systems for hydrocephalus patients.

Quantifiable outcome

  • Large percentage of hydrocephalus shunts fail in first two years, mainly from occlusion

Companies that use Anuncia Medical Inc.

Customer profile

Segments2 records

Ideal customer profiles1 record

Anuncia Medical Inc. technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature3 records

Anuncia Medical Inc. partnerships and signals

Strategic signal

Scale indicators1 record

Recent moves6 records

Expansion highlights6 records

Anuncia Medical Inc. competitors and assessment

Company assessment

Direct peers

  • Integra LifeSciences: Integra LifeSciences (Codman Specialty Surgical) is a leading manufacturer of hydrocephalus shunts, EVDs, and intracranial pressure monitoring devices—the most direct competitor to Anuncia's ReFlow portfolio. Both serve the same neurosurgery call point with implantable CSF management devices.
  • B. Braun (Aesculap / Miethke): B. Braun's Aesculap division (via its partnership with Miethke) manufactures gravitational and programmable hydrocephalus valves and shunt systems. They compete head-to-head with Anuncia in the implantable CSF management market and have deep neurosurgeon relationships globally.
  • Sophysa: Sophysa (France) is a specialist manufacturer of programmable hydrocephalus valves, shunts, and intracranial pressure monitors. They are a focused niche competitor comparable to Anuncia in scale and product specificity, targeting the same neurosurgery customer base.
  • Spiegelberg: Spiegelberg (Germany) manufactures EVDs, ICP monitors, and CSF drainage systems used in neurosurgery and neurocritical care. They directly overlap with Anuncia's expanded ReFlow EVD Flusher product line.

Broad incumbents

  • Medtronic: Medtronic's Hydrocephalus Therapy business (formerly Codman, acquired 2014) is the global market leader in CSF shunts, valves, and EVDs. Medtronic's neurosurgery division directly competes with Anuncia across the same patient population and surgeon call point, with dramatically broader scale and distribution.
  • Natus Medical: Natus Medical provides neurology and neurosurgery-related devices and disposables, including products for hydrocephalus and CSF management. They are a broader incumbent with overlapping but non-identical product lines in the same neurosurgery market.

Emerging players

  • Mölnlycke Health Care (CSF / Neurosurgery): Mölnlycke has expanded into neurosurgical drapes and single-use neurosurgery devices. While not a direct CSF management peer, they participate in the same neurosurgery OR ecosystem where Anuncia's ReFlow devices are implanted.
  • Penumbra: Penumbra is a neurovascular device company with growing presence in the neurosurgery/neurocritical care market. While focused on stroke and thrombectomy, they participate in the same neurohospital call point as Anuncia's EVD Flusher extension.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

Anuncia Medical Inc. social profiles

Digital presence

Anuncia Medical Inc. compliance and trust

Trust signal

Compliance2 records

Anuncia Medical Inc. financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Anuncia Medical Inc. leadership team

Management profile

Number of profiles

Profiles10 records

Anuncia Medical Inc. funding detail

Funding detail

Funding overview

Funding rounds3 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Anuncia Medical Inc. M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Anuncia Medical Inc.

What does Anuncia Medical Inc. do?

Anuncia Medical develops, manufactures, and sells FDA-cleared, prescription-only ReFlow™ neurotherapeutic devices for cerebrospinal fluid (CSF) management in patients with hydrocephalus. The ReFlow™ System Mini pairs an implantable Mini Flusher placed under the scalp with a ReFlow™ Ventricular Catheter featuring a proprietary relief membrane, enabling non-invasive clearing of shunt occlusions to help avoid repeat revision brain surgeries.

Is Anuncia Medical Inc. a public or private company?

Anuncia Medical Inc. is a private company. It is classified as venture growth investor backed and is currently operating.

When was Anuncia Medical Inc. founded?

Anuncia Medical Inc. was founded in 2018. It employs 11 to 50 people.

Where is Anuncia Medical Inc. based?

Anuncia Medical Inc. is headquartered in Scottsdale, United States, in the North America region.

How does Anuncia Medical Inc. make money?

One revenue line is on record: medical Device Sales.

Who are Anuncia Medical Inc.'s main competitors?

Direct peers on record are Integra LifeSciences, B. Braun (Aesculap / Miethke), Sophysa and Spiegelberg. Broad incumbents are Medtronic and Natus Medical. Emerging players are Mölnlycke Health Care (CSF / Neurosurgery) and Penumbra.

Does Anuncia Medical Inc. have an API?

No public API is recorded for Anuncia Medical Inc..

What industry is Anuncia Medical Inc. in?

Anuncia Medical Inc.'s product category is Neurosurgical / Hydrocephalus Treatment Devices. Its primary akta.pro industry code is HLAHAEAD, Neurosurgical Implants & Cranial/CMF (Cranial Plates, Dural Repair, Shunts). Its NAICS code is 339113 and its SIC code is 3841.

Unlock the full company data

50 free credits on sign-up, no credit card required.

Contact sales
Live signals
openPR.comGlobal Factors Influencing the Rapid Evolution of the External Ventricular Drain MarketThe external ventricular drain (EVD) market is projected to reach $6.74 billion by 2030 with a compound annual growth rate of 6.1%, driven by rising neurological disorders and increased neurosurgical investments. In June 2023, Swiss medical technology firm Luciole Medical AG acquired German catheter and EVD kit provider Spiegelberg GmbH & Co. KG to strengthen its neurocritical care portfolio, combining product lines and distribution channels. In March 2025, US-based Anuncia Medical Inc. received FDA Breakthrough Device Designation for its ReFlow External Ventricular Drains, a novel device using a non-invasive manual flushing system to address brain swelling and elevated intracranial pressure.PR NewswireAnuncia Medical Inc. Announces Published Data with Promising Clinical Outcomes Using the ReFlow™ Ventricular System In-Line with Hydrocephalus ShuntsAnuncia Medical Inc. announced publication of clinical data in Pediatric Neurosurgery showing its FDA-cleared and CE-marked ReFlow Ventricular System reduced proximal shunt failures from 14 total events among 9 patients in the 2 years prior to implantation to only 1 failure in the 2-4 years following ReFlow implantation and use to maintain flow. The company also announced the launch of the smaller ReFlow System Mini Gen 2 in the U.S. next month, representing a next-generation iteration developed from over four years of clinical follow-up feedback. The ReFlow device allows neurosurgeons to non-invasively clear occluded ventricular catheters and potentially prevent blockages in hydrocephalus shunt systems.PR NewswireAnuncia Medical honored as participant in the 2022 Flinn Foundation Bioscience Entrepreneurship ProgramAnuncia Medical, Inc., a medtech startup developing neurotherapeutic devices for hydrocephalus treatment, was selected as one of seven Arizona early-stage bioscience companies to participate in the 2022 Flinn Foundation Bioscience Entrepreneurship Program. The company will receive $30,000 in non-dilutive funding, individualized plans from industry experts, and connections with Arizona bioscience leaders. Anuncia Medical is also preparing to submit its ReFlow System Mini to the US FDA for commercial approval later in 2022.PR NewswireAnuncia, Inc. Selects Scottsdale, Ariz. for New HQ to Further Develop Lifesaving MedtechAnuncia Inc., a therapeutic medical device company specializing in cerebrospinal fluid management, announced it is relocating its headquarters from Massachusetts to Scottsdale, Arizona at the SkySong innovation center — marking the company's first geographic expansion. The move positions Anuncia within the Greater Phoenix biomedical ecosystem and supports its plans to scale manufacturing and hire across engineering, clinical, manufacturing, and finance roles. The company, which holds FDA and CE Mark clearance for its ReFlow Ventricular System, also announced it is opening its next fundraising round to support growth.PR NewswireAnuncia Inc. Receives FDA "Breakthrough Device Designation" for ReFlow™ System MiniAnuncia Inc. received FDA Breakthrough Device Designation for its ReFlow™ System Mini, a device intended to treat CSF disorders like hydrocephalus by allowing noninvasive prophylactic flushing to prevent shunt blockages. This designation makes the product eligible for prioritized regulatory review and potential CMS reimbursement, addressing a market where up to half of intracranial shunts fail within two years. Preliminary studies indicate the technology can keep shunts patent beyond one year, potentially reducing emergency surgeries and healthcare costs.MedicaldesignandoutsourcingBrain emergency averted at the push of a buttonA Boston neurosurgeon successfully avoided emergency brain surgery on a hydrocephalus patient by using the Alivio ReFlow ventricular system, a device that cleared a clogged shunt directing cerebrospinal fluid. The first-in-human procedure demonstrates the device's potential to prevent complications associated with shunt failures, a prevalent issue in hydrocephalus patients. Anuncia, the company behind the device, has received significant positive feedback from parents and patients following this procedure.PR NewswireAnuncia Announces Successful First-in-Human Use of the Alivio ReFlow™ Ventricular System for Treatment of HydrocephalusAnuncia, Inc. announced the successful first-in-human implantation of its Alivio ReFlow™ Ventricular System for hydrocephalus treatment at Boston Children's Hospital on May 22, 2018. The novel device, which received FDA 510(k) clearance and EU CE Mark approval, provides neurosurgeons with a non-invasive option to restore cerebrospinal fluid flow by flushing blocked ventricular catheters, potentially avoiding emergency revision surgeries. The implantation marks a key milestone for the company as it begins commercialization of the technology, addressing a condition where at least 50 percent of shunt patients experience failures within two years.PR NewswireAlcyone Lifesciences Completes Spin-Off of Hydrocephalus Business, AnunciaAlcyone Lifesciences has completed the spin-off of its hydrocephalus business into a new independent company, Anuncia, Inc., based in Massachusetts. The separation comes immediately after Anuncia received US FDA 510(k) clearance and EU CE Mark approval for its ReFlow Ventricular System, enabling commercialization of the non-invasive shunt technology in both markets. The board-determined strategic rationale is to maximize focus and flexibility for each company to pursue growth opportunities and provide shareholders with more targeted investment options in their respective markets.