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FDA PMA submitted for the RejuvenAir System - Jan 2026 SPRAY-CB pivotal trial hits primary endpoint $53M Series D closed, oversubscribed CE Mark secured in Europe 500+ Metered CryoSpray procedures performed FDA Breakthrough Device Designation granted FDA PMA submitted for the RejuvenAir System - Jan 2026 SPRAY-CB pivotal trial hits primary endpoint $53M Series D closed, oversubscribed CE Mark secured in Europe 500+ Metered CryoSpray procedures performed FDA Breakthrough Device Designation granted
Company Profile  /  Medical Devices  /  Interventional Pulmonology

CSA Medical.

The company treating chronic bronchitis with a metered spray of -196°C liquid nitrogen - freezing the damage so the airway can heal itself.

HQLexington, MA
Team~33 people
Total Funding$161M
StageSeries D
RejuvenAir by CSA Medical logo
CSA MEDICAL, INC. - MAKER OF THE REJUVENAIR SYSTEM. A CRYOSPRAY DEVICE COMPANY 131 HARTWELL AVE, LEXINGTON, MASSACHUSETTS.
-196°CCryospray Temp
210SPRAY-CB Patients
500+Procedures Done
$53MSeries D (2024)
The Dispatch

A Cold Cure for a Warm-Breathing Problem

Chronic bronchitis is one of medicine's stubborn conditions. Millions of people with COPD live with airways clogged by excess mucus and lined with damaged, cilia-worn tissue. For decades the standard answer has been the same: inhalers, steroids, and management of symptoms. CSA Medical, a modestly sized medical device company in Lexington, Massachusetts, took a different route - one that starts by making the airway very, very cold.

Its RejuvenAir System threads through a standard bronchoscope and delivers a precisely metered spray of liquid nitrogen onto the diseased lining of the airways. The cold destroys the damaged cilia and the mucus-producing goblet cells that drive chronic bronchitis. Crucially, it spares the extracellular matrix beneath - the biological scaffold the body uses to regrow a fresh, healthy layer of tissue. The company calls the result "airway rejuvenation." The clinical shorthand is airway remodeling. Either way, the ambition is the same: treat the cause, not just the cough.

How It Works

Four Steps, One Breath at a Time

1

Access

A physician guides the RejuvenAir catheter into the airways through a standard bronchoscope. No incision, often outpatient.

2

Metered Spray

A circumferential catheter delivers a dose-controlled cryospray of -196°C liquid nitrogen, tuned to airway diameter.

3

Destroy

Rapid freezing kills the damaged cilia and mucus-producing goblet cells while preserving the tissue matrix underneath.

4

Regrow

Healthy epithelial cells regrow on the preserved scaffold. No implant is left behind.

"The RejuvenAir System is designed to address the underlying cause of chronic bronchitis - the damaged cilia and mucus-producing goblet cells lining the airways - and enable a rejuvenative healing response."

- CSA Medical, describing the therapy's mechanism
The Business

What It Does, and For Whom

What it does. CSA Medical designs, builds, and sells spray cryotherapy systems - a capital console paired with single-use catheters. Its focus today is pulmonary: the RejuvenAir System for COPD patients with chronic bronchitis. The company's cryospray lineage began in the gastrointestinal tract with truFreeze, an endoscopic system cleared to ablate tissue in Barrett's esophagus that became the most widely used device of its kind with over 11,000 treatments before the GI business was divested to STERIS.

Who uses it. The direct customers are hospitals, interventional pulmonologists, and thoracic centers that perform bronchoscopy. The ultimate beneficiaries are COPD patients who have run out of good options. The pivotal SPRAY-CB trial enrolled 210 patients worldwide, and more than 500 Metered CryoSpray procedures have been performed to date.

The problem it solves. Chronic bronchitis has no device-based, disease-modifying therapy on the market. Patients cycle through medications that ease symptoms without addressing the mucus overproduction and airway damage at the root. RejuvenAir targets that root - and earned FDA Breakthrough Device Designation precisely because it addresses a large, underserved population.

The business model. It is a classic medtech razor-and-blade: sell or place the cryospray console, then generate recurring revenue from the disposable catheters used in each procedure. Growth is gated by regulatory approvals - a CE mark already secured in Europe, and a PMA filed with the FDA in January 2026 - and by adoption among pulmonologists.

Why It's Different

Not a Drug, Not an Implant

MECHANISM

Treats the cause

Most COPD therapy manages symptoms. RejuvenAir targets the damaged cells and mucus machinery that produce them.

DESIGN

Nothing left behind

Unlike valves or coils, the cryospray leaves no implant. It works, then gets out of the body's way.

PRECISION

Metered dosing

An energy-control algorithm and circumferential catheter tune the cryospray dose to each airway diameter.

PEDIGREE

Proven cryospray roots

The technology was refined for years in the esophagus before being re-engineered for the lungs.

The Landscape

Where It Fits in the Market

Interventional pulmonology is a crowded but young field. The alternatives to RejuvenAir range from everyday pharmacology to competing device approaches. This is an illustrative view of how these options position on invasiveness versus how directly they target the underlying tissue - not a clinical ranking.

Approaches to Airway Disease

ILLUSTRATIVE - "TARGETS UNDERLYING AIRWAY TISSUE" (RELATIVE, NOT A CLINICAL SCORE)
RejuvenAir Metered CryoSpray (CSA Medical)Tissue-directed
Bronchial Rheoplasty (RheOx)Tissue-directed
Targeted Lung Denervation (dNerva)Nerve-directed
Bronchial Thermoplasty (asthma)Muscle-directed
Inhaled Bronchodilators & SteroidsSymptom mgmt
The Money

Backed to Reach the Market

$53M
Series D · Sept 2024 · Oversubscribed
Co-led by TVM Capital Life Science & Yonjin Ventures.
Joined by SV Health Investors, Ascension Ventures, First Analysis, Blue Heron, and Intersouth Partners.
Total funding to date: ~$161M. Round earmarked to fund FDA PMA and U.S. commercialization.
The Record

A Slow-Then-Sudden Timeline

'17

truFreeze expands into Barrett's esophagus

FDA label expansions cover low- and high-grade dysplasia; cryospray proves itself in the GI tract.

'18

Early COPD signal

RejuvenAir Metered CryoSpray shows early promise in COPD patients with chronic bronchitis.

'20

Pivot to the lungs

The company centers on the pulmonary program after divesting its GI cryotherapy business to STERIS.

'24

Pivotal enrollment done + $53M raised

SPRAY-CB finishes enrolling 210 patients ahead of schedule; an oversubscribed Series D closes.

'26

FDA PMA submitted

Following positive SPRAY-CB results, CSA Medical files its Premarket Approval application with the FDA.

"First-of-its-kind, bronchoscopic, device-based therapy that targets diseased airway tissue in chronic bronchitis - with no implant left behind."

- How the company frames RejuvenAir's place in interventional pulmonology

The company is led by president and CEO Wendelin Maners, who joined CSA Medical in 2011 as VP of Emerging Therapies after roles at Boston Scientific and in healthcare investment banking. The leadership bench pairs clinical, regulatory, quality, and commercial expertise - the mix a device company needs to move from a pivotal trial to a market launch.

Questions

Frequently Asked

What does CSA Medical make?

CSA Medical develops spray cryotherapy medical devices. Its flagship product, the RejuvenAir System, delivers metered doses of -196°C liquid nitrogen through a bronchoscope to treat chronic bronchitis in COPD patients.

How does the RejuvenAir System work?

It sprays a controlled dose of liquid nitrogen onto damaged airway tissue, destroying diseased cilia and mucus-producing cells while preserving the extracellular matrix - which allows healthy airway cells to regrow.

Is RejuvenAir FDA approved?

As of January 2026, CSA Medical submitted a Premarket Approval (PMA) application to the FDA following positive pivotal SPRAY-CB trial results. It holds FDA Breakthrough Device Designation and a European CE mark, but full FDA approval was still pending review.

How much funding has CSA Medical raised?

The company has raised roughly $161M in total, including an oversubscribed $53M Series D in September 2024 co-led by TVM Capital Life Science and Yonjin Ventures.

Where is CSA Medical located?

CSA Medical is headquartered at 131 Hartwell Avenue, Lexington, Massachusetts, and employs about 33 people.

Go Deeper

Explore & Connect

Official channels, key coverage, and the clinical record behind the RejuvenAir System.

Profile compiled from public sources including CSA Medical / RejuvenAir communications, PR Newswire, and medtech trade press. Figures such as revenue are approximate. Regulatory status current as of the noted dates.