Across the Kidneyverse: December 5, 2023

This week: UPS, Organ Recovery Systems, IceCure, Calliditas, Outset, AHA, Evergreen, and AWAK

Welcome to Signals, where we explore the frontiers of healthcare technology, one [space] at a time. Stay optimistic and up to date about the future of this space — join the expedition!

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IN THIS ISSUE

• UPS and Organ Recovery Systems make the first-ever unattended kidney shipment in Mississippi.

• IceCure Medical shares new results from its ProSense study.

• Calliditas Therapeutics starts its Phase II trial for Alport syndrome.

• Outset Medical’s CMO shares more on the growing SNF dialysis opportunity.

• Heard at AHA: PREVENT equations predict long-term CVD risks.

• Evergreen Nephrology proposes "CKD stage 3-plus" group.

• AWAK Technologies earns its 2nd FDA Breakthrough designation.

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1. UPS and Organ Recovery Systems make the first-ever unattended kidney shipment.

UPS Express Critical, in collaboration with Kentucky Organ Donor Affiliates (KODA), has successfully shipped a kidney using a perfusion pump, entirely unattended by medical personnel, to the University of Mississippi Medical Center.

“Before, if you wanted to move a kidney on a pump, it had to be driven or you had to fly it on a chartered flight with a medical team,” said Brian Beam, UPS Express Critical manager.

This is a great story, especially given Brian’s personal connection to transplant. His father passed due to liver failure while we was on a waiting list.

Why it matters: This approach, leveraging Organ Recovery Systems technology, potentially reduces the need for chartered flights with medical teams.

EXPLORE FURTHER

• Learn more about innovations in organ transplantation.

• Read the 2020 Bloom Works Report on the US organ transplant system.

• Watch John Oliver’s recent coverage on Last Week Tonight

Meet Ricky, the 54-year old double transplant recipient. [Credit: UPS]

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2. IceCure Medical shares new results from its ProSense study

A new study demonstrated the effectiveness of the IceCure Medical system, a minimally invasive cryoablation technology, in treating small renal masses.

The study (n = 25 patients) showed a 92% disease-free survival rate and a remarkable 100% secondary local control rate for recurrent lesions.

Why it matters: This technology not only offers a high success rate but also allows most patients to be discharged the day after treatment, emphasizing its efficiency and patient-friendly approach.

EXPLORE FURTHER

• Read IceCure’s press release

• A 2020 post on IceCure’s success with kidney tumors

• This video details of how patients are treated with IceCure

Credit: IceCure

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3. Calliditas starts Phase II trial for Alport syndrome.

Calliditas Therapeutics has begun a Phase II trial for setanaxib, aimed at treating Alport syndrome, a rare genetic kidney disorder. The study (n = 20 patients) will assess the drug's safety and impact on kidney function over 24 weeks, focusing on patients with significant proteinuria despite existing RAS blocker treatments.

Setanaxib was investigated in a 24-week, phase 2 trial in 111 patients and has received orphan drug designation for the treatment of PBC in the United States and Europe.

Why it matters: Between 30K and 60K people in the US are estimated to have Alport syndrome, and current treatment options are limited.

EXPLORE FURTHER

• Read the press release

• Learn more about setanaxib

• More about genetic kidney diseases

Credit: Calliditas

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4. Outset Medical’s CMO shares more on the growing SNF dialysis opportunity.

Outset Medical’s CMO Michael Aragon, MD shared his perspective with McKnight's. He believes the increasing number of kidney patients needing dialysis presents a growing opportunity for skilled nursing facilities (SNFs) to improve care and operational control.

An estimated 85,000-plus dialysis patients are admitted to SNFs annually, a number that is projected to grow by 6% annually. Current dialysis solutions (i.e. outsourcing or transporting patients out to clinics) can leave a SNF with limited control of the care continuum, present a heavy logistical burden for staff and patients, and result in poor patient experience.

Dr. Aragon lists six potential benefits for SNF operators, including (i) census optimization; (ii) new revenue streams; (iii) reduced cost and risk; (iv) easier scheduling; (v) better continuity; and (vi) few readmissions.

Why it matters: Thanks to advancements in hemodialysis technology, SNFs can now establish their own dialysis programs in-house, creating new revenue streams while avoiding the drawbacks of off-site or third-party dialysis services.

EXPLORE FURTHER

• Learn more about 3 Outset studies shared at ASN last month

• Read the 2021 paper on self-care training using Tablo

• Read Dr. Allen Kaufman’s piece in MedCity News from last year

Credit: MedCity News

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5. Heard at AHA: PREVENT equations predict long-term risks of cardiovascular disease.

A group of experts introduced the PREVENT equations at the recent American Heart Association Scientific Sessions. The new risk calculator offers an enhanced method of predicting long-term absolute risk associated with cardiovascular-kidney-metabolic (CKM) syndrome.

These equations, developed using contemporary data of over 6 million adults, incorporate factors like heart failure, kidney function, and social determinants of health, aim to improve long-term risk assessment (10-yr and 30-yr) and intervention strategies for a diverse population starting at age 30.

"Longer-term estimates are important because short-term or 10-year risk in most young adults is still going to be low. We wanted to think more broadly and apply a life-course perspective," Dr. Sadiya Khan said. "Providing information on 30-year risk may reveal earlier opportunities for intervention and prevention efforts in younger people."

Why it matters: Compared with the existing calculator, the new version allows health professionals to evaluate younger people and look further into the future.

EXPLORE FURTHER

• Details were published in Circulation

• Find the PDF and image below here

Khan et al. (2023)

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6. Evergreen Nephrology suggests addition of ‘CKD stage 3-plus’ group to care models.

Researchers from Evergreen Nephrology suggest adding a new category, "CKD stage 3-plus," to better classify patients with stage 3 chronic kidney disease who have additional comorbidities indicating a higher risk of rapid progression.

This proposal aims to facilitate earlier and more effective intervention for a subset of patients whose condition may deteriorate quickly, despite their current classification suggesting relatively preserved kidney function. Evergreen’s VP of Strategic Operations, Austin Campbell, PhD, said:

“The general recommendation is for nephrologists to begin engagement at stage 4. The fundamental question that guides the study is, ‘Is that always early enough?’ Because it's known that some patients with CKD 3 actually end up progressing very rapidly.”

Why it matters: Introducing the 'CKD stage 3-plus' category could significantly refine care models, allowing for earlier and more targeted interventions.

EXPLORE FURTHER

• Read the full article here

• Learn more about Evergreen Nephrology

Credit: Evergreen on X

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7. AWAK earns FDA Breakthrough Device Designation for AI kidney disease tool.

AWAK’s AI-enabled kidney disease progression prediction model was developed in collaboration with Ever Fortune.AI (EFAI), a spin-off company from China Medical University Hospital (CMUH) based in Taiwan. This tool assesses the risk of chronic kidney disease progression and the need for renal replacement therapy over 1, 2, and 5-year periods.

The two companies entered in a strategic partnership in September 2021 to revolutionize the diagnosis, treatment, and management of kidney disease by building solutions using medical big data and artificial intelligence.

Why it matters: AWAK recently relocated its Chief Business Officer Mandar Gori to the US to pave the way for US market entry. This is their second Breakthrough Device Designation from the FDA.

EXPLORE FURTHER

• Read the press release

• Learn more about Ever Fortune AI

• Their first FDA breakthrough designation was for a PD device in 2019

Credit: AWAK

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QUESTION OF THE WEEK

This week I asked “Imagine you have $1 million to invest in kidney care today. Here's the catch: you have to invest it all at once. How do you spend it?”

PS — There’s still time to vote📥!

PPS — BONUS points if you tell us what technologies, care models, people or services you’d invest in below.

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