Jun 14, 2023
ReFlow to Help Treat Hydrocephalus w/ Elsa Abruzzo & Mark Geiger of Anuncia Medical
- BRT S04 EP23 (186) 6-11-2023
What We Learned This Week
· Anuncia Medical has a Re-Flow product to help drain fluid from the brain, treats Hydrocephalus
· Hydrocephalus is a neurological disorder caused by an abnormal buildup of cerebrospinal fluid in the ventricles (cavities) deep within the brain. If left untreated, the brain could bleed or tumors. Blood in the CFS. Not uncommon for a patient to have to get repeated brain surgeries at a cost of $30-$40K each.
· Necessity is the mother of invention. A non-invasive medical device with a button on the back of your head which flushes the Catheter.
· Hydrocephalus Association has been advocates to help parents and patients and share the information needed. Now parents and patients can walk into the doctor’s office and ask if they’re a candidate for this type of product
Guest: Elsa Chi Abruzzo
RAC, FRAPS – President
Elsa Chi Abruzzo is a medical device executive, entrepreneur, and a founding member of Anuncia, Inc., Alcyone Therapeutics, Arthromeda, Inc. and Cygnus Regulatory. Elsa has a 30+ year successful product development, operations, regulatory, quality, and clinical track record in med tech Industries. Her experience includes leadership positions at Baxter, Cordis JNJ, CryoLife, Percutaneous Valve Technologies, AtriCure, InnerPulse, Merlin MD, Sapheon, and PTS Diagnostics. Elsa earned a BS in engineering from the University of Miami in Coral Gables, FL and is regulatory affairs certified and a Regulatory Affairs Professional Society Fellow, recognized for her leadership in Regulatory and Quality by MDDI.
https://anunciamedical.com/the-anuncia-story/#team
https://www.linkedin.com/in/elsachiabruzzo/
Mark Geiger – VP of Sales & Mktg
https://www.linkedin.com/in/mark-geiger-7809673/
Veteran in medical supplies industry with 29 years of Medical Device / BioTech Marketing & Sales experience. Also has 12 years of Marketing includes three years as Director of Marketing and part of the executive leadership team at the Medtronic Neurosurgery Business Unit in Goleta, California. The other eleven years of my career are in Medical Device Sales and Sales Management.
About Anuncia
Conceptualized in 2014 in collaboration with Boston Children’s Hospital and spun out of Alcyone Therapeutics in 2018, Anuncia’s patented portfolio of technologies are intended to provide peace-of-mind through innovation.
Our core ReFlow™ technology uses a simple finger depression of a soft silicone dome located under the patient’s scalp to produce a noninvasive, one-way flush of the patient’s own CSF directed toward the ReFlow™ catheter to restore or increase CSF flow through a non-flowing shunt and potentially avoid emergency surgery.
The name Anuncia comes from Panthera Uncia, the species name of the snow leopard. These animals live in mountainous regions of Asia and have been called by the World Wildlife Foundation “Guardians of the Headwaters” as they roam the headwater areas of the western basins.
The origin of the word hydrocephalus comes from the Greek hudrokephalon, from hudro ‘water’+ kephalē ‘head’. The snow leopard, or Guardian of the Headwaters, is a symbol of Anuncia’s dedication to improve daily quality of life for the millions of underserved patients with hydrocephalus and other CSF disorders, as well as their families, who suffer from the clinical, economic, and emotional burden of repeat revision brain surgery due to VP shunt occlusions.
Notes:
Anuncia Medical has a Re-Flow product to help drain fluid from the brain, treats Hydrocephalus
Hydrocephalus is a neurological disorder caused by an abnormal buildup of cerebrospinal fluid in the ventricles (cavities) deep within the brain.
The origin of the word Hydrocephalus comes from the Greek hudrokephalon, from hudro ‘water’+ kephalē ‘head’.
Seg 1
Create CFS daily, make 500 mL when you only need 200. When you have too much fluid this is hydrocephalus sis. To treat this you need to put a stunt in the head and the brain and a catheter tube to get flow regulation down the body.
Works on pressure remove CFS from the brain down the neck to the abdomen. The tube gets backed up it becomes occluded with tissue.
Annuncia has a product called the reflow mini. This is a GEN two device with a valve that can drain the stand. The current set up with the stunt usually last for two years and then a patient is back in the hospital for surgery again.
If left untreated, the brain could bleed or tumors. Blood in the CFS. Not uncommon for a patient to have to get repeated brain surgeries at a cost of $30-$40,000 each.
People who deal with this might have inclusions in the night which is common as you make more CFS as you sleep. Then you have to go to the hospital and get a neurosurgeon to treat you.
Necessity is the mother of invention. A non-invasive medical device with a button on the back of your head which flushes the Catheter.
They have lots of data published on the GEN one reflow. Seven patients, nine total in two years they flush the brain two times a day. In the last two years these patients have only needed one surgery first 13 surgeries prior.
Seg 2
Mark had a hydrocephalus office at 14 years old. You have to put a stent in, plumbing for the head. Marc has had five surgeries. This is why he got into the medical device business. Has a 32 year career working in metal goal devices and consulting. Originally started at med Tronic and in 2023 joined Anuncia.
Treat with surgery. Hydrocephalus is very scary for kids you wake up with a headache and the parents have to rush you to the hospital.
The reflow product is maintenance flushing with caregivers and neurosurgeon over seeing it.
They have to pass FDA test for clearance and safety. The product must be repeatable and consistent. You always start with pre-clinical tests. The product of a shunt system already existed so Anuncia can piggyback on the current system for faster FTA adoption.
Adding a novel component with a process, that used to be down in a hospital with a needle that was very invasive. Current data with their product shows safety.
Seg 3
Socrates Study, should be the standard of care. There may be a commercial use in the future. They have published peer review data which is the currency of the medical business, you need data.
They sell technically to the surgeons. How do you do this? You do the missionary work of business, you work trade shows and connections.
Currently Anuncia has 50 accounts. Typically takes 7 touches to get with doctors, and show them the clinical data.
Because of the Internet and widespread information data and stories are out there now for patients to read.
Emily Fudge the founder of the Hydrocephalus Association (https://www.hydroassoc.org/)
This association has been advocates to help parents and patients and share the information needed. Now parents and patients can walk into the doctor’s office and ask if they’re a candidate for this type of product
Hydrocephalus Assoc. Connect event that meets every two years, patients in patient groups involved learning about new treatments.
As a patient convention doctors and companies have to stay on top of the latest developments in the industry.
http://hcrn.org/ - Hydrocephalus Research Network
https://ishcsf.com/ - Hydrocephalus Society
Seg 4
Investors and pharmaceutical companies want to see data, they want to see adoption and sales and money. Business model for a non-CR, the reflow product is part of shunt care.
Anuncia sells to doctors and hospitals and then later expects to sell to home care.
In the reimbursement world of medicine - ICE 10 diagnostic related groups pay for care and also private insurance or Medicare pay too
Cost of $11,000 to $28,000 for care and a total of $40,000 for surgeries plus you have devices in surgery and anesthesia if you can avoid just one revision surgery you have the cost savings to health savings and avoiding infection issues.
Value-based payment model of hospitals, amount per patient hospital gets reimbursed. Hospitals do not make money on patients staying.
Need to get your studies published on the New England medical journal or the Lancette journal. Nancy has a breakthrough device designated FDA unique product which can get medical reimbursement.
Article on Anuncia: HERE
‘Anuncia Medical Inc. Announces Published Data with Promising Clinical Outcomes Using the ReFlow™ Ventricular System In-Line with Hydrocephalus Shunts’
Though limited, these recently published data, and others like them, suggest that use of the ReFlow device to maintain flow at home may also have potential benefits as a preventative treatment that could reduce revision surgeries. Anuncia received a U.S. Food and Drug Administration (FDA) "Breakthrough Device Designation" for this use and is working closely with the medical community and the FDA to design and conduct clinical trials to further evaluate this practice.
U.S. cases of hydrocephalus are 70,000, with 45,000 of them being children and 25,000 adults due to accidents or brain damage. Anuncia has other products to deal with CFS management
Count of 1 million patients in the US, usually seniors have brain or cranial pressure, which could be hydrocephalus. They have a gate imbalance, brain fog, memory issues and other health issues called NPH.
Typically the symptoms are mass because they’re similar to health Alzheimer’s or dementia. The annunciation aunt can eliminate symptoms in 6 to 12 months.
Pens study
These patients deal with over drainage. Gary Shafi, a hydrocephalus patient with 8 surgeries.
There are 30 million people worldwide who deal with hydrocephalus, and 20 million people dealing with NPH. This has a major addressable market.
** Thanks to Joan Kerber-Walker of AZ Bio for the intro to Stan.
AZ Bio & Life Sciences Innovation w/ Joan Koerber-Walker
- BRT S04 EP10 (172) 3-5-2023
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