Vapotherm Files Prospectus for HI-VNI-Based Mask-Free Non-Invasive Respiratory Support Platform

Respiration is a fundamental physiological activity essential for sustaining life. With changes in the human living environment, worsening air pollution, and the prevalence of respiratory infectious diseases, the incidence of respiratory system diseases has risen sharply.

According to data published in a Lancet specialty journal in 2020, in 2017,Globally, it is estimated that544.9 million people(95% UI: 506.9 million–584.9 million) with chronic respiratory diseases, compared to 389.7 million in 1990Increased by 39.8%。Deaths from chronic respiratory diseases accounted for 7.0% of all-cause mortality,The third leading cause of global deaths in 2017, second only to cardiovascular diseases (31.8%) and tumors (17.1%).

Respiratory diseases primarily involve pathological changes in the trachea, bronchi, lungs, and thoracic cavity. Mild cases often present with cough, chest pain, and impaired breathing, while severe cases may lead to dyspnea, hypoxia, and even death from respiratory failure. Characterized by high incidence, high mortality, and substantial disease burden, respiratory diseases have become a global public health concern, particularly in the wake of the COVID-19 pandemic.

Ventilators have become another “lung” for patients, serving as an effective means of artificially replacing spontaneous ventilation. They are widely used in the management of respiratory failure caused by various etiologies, anesthetic respiratory management during major surgeries, respiratory support therapy, and emergency resuscitation, occupying a crucial position in modern medicine.

According to a report by Southwest Securities, the global market size for home non-invasive ventilators was $2.7 billion in 2020, with a compound annual growth rate (CAGR) of 12.2% from 2016 to 2020. It is projected that, driven by rising penetration rates in emerging markets such as China, the global home non-invasive ventilator market will reach $5.58 billion by 2025, representing a CAGR of 15.5%. Prior to the outbreak of the epidemic in China,The market size of China's ventilator industry (calculated at ex-factory prices) is approximately RMB 12 billion, with the demand for medical ventilators reaching 16,900 units, a year-on-year increase of 15.2%.

There are various types of ventilators, which can be classified into invasive and non-invasive ventilators based on their working principles.Invasive VentilatorCommonly applied inSevere Respiratory FailurePatient,Non-invasive ventilatorit can be administered via an oronasal mask, nasal mask, or full-face mask.Non-Invasive Positive Pressure Ventilation (NIPPV) Therapy, relievePatients with Mild-to-Moderate Respiratory FailureSymptoms.

In 2018, the FDA established a new regulation designatingPositioning High-Flow Nasal Insufflation (HI-VNI) as an Attractive Alternative to Non-Invasive Positive Pressure Ventilation (NIPPV). The patent for HI-VNI technology originates from Vapotherm, a respiratory device company named Vapotherm.

Vapotherm is a medical device company founded in 1999, headquartered in New Hampshire, USA. Vapotherm specializes in non-invasive technologies that provide respiratory support for patients with chronic or acute respiratory distress, and has developed a variety of system devices based on its proprietary HI-VNI technology for different scenarios and diseases.In 2018, Vapotherm went public on the New York Stock Exchange, with a market capitalization exceeding $1 billion.

Bill Niland is the founder and Chief Business Officer of Vapotherm, and a graduate of Rowan University in the United States. Bill is a serial entrepreneur in the healthcare sector, having successfully founded and exited four healthcare companies. In 2014, he joined Harpoon Medical as President and Chief Executive Officer, subsequently leading the company’s sale to Edwards Lifesciences for an upfront payment of $100 million and a total consideration of up to $250 million.

Bill has extensive experience in the healthcare sector.Over 25 Years of Experience, serving as CEO or board member of multiple companies including ReGelTec, Sonavex, and CoapTech,Holds 22 patents, including 12 in the field of medical devices。

Since its founding, Vapotherm’s high-flow nasal cannula therapy, enabled by its proprietary HI-VNI technology, hasAdopted by over 1,250 hospitals, serving more than 3 million patients. Beyond the United States, it has business operations in the United Kingdom, Brazil, Spain, Germany, Japan, and Indonesia.

For patients with respiratory distress (including hypoxia, hypercapnia, and dyspnea), non-invasive positive pressure ventilation (NIPPV) has long been a first-line therapy actively employed in clinical practice. As an alternative to invasive mechanical ventilation, NIPPV has achieved a qualitative leap in both patient comfort and clinical applicability. By utilizing oronasal masks, nasal masks, or full-face masks to deliver low-flow non-invasive positive pressure ventilation, NIPPV can reduce the rates of endotracheal intubation and mortality among patients.

In recent years, high-flow nasal cannula (HFNC) has become a more widely accepted tool than non-invasive positive pressure ventilation (NIPPV), demonstrating comparable efficacy to NIPPV in preventing reintubation and in preventing or resolving post-extubation acute respiratory distress.

Studies have shown that over 30% of patients cannot tolerate the pressure sensation from masks, leading to anxiety or discomfort. Based on technical research into NIPPV and HFNC, Vapotherm has combined these two technologies to develop a mask-free, high-flow nasal cannula therapy solution.Mask free-NIV。

 Respiratory Failure Treatment Source: Vapotherm Official Website

Mask-free NIV does not rely on traditional positive pressure ventilation; instead, it facilitates breathing by delivering heated and humidified air at high flow rates, a method known as HI-VNI.HI-VNI is an emerging oxygenation technology, also known as high-velocity nasal insufflation, which allows for the delivery of humidified and heated oxygen at flow rates of up to 40 L/min via specialized high-flow nasal cannulas.

Currently, the FDA has approved an updated version of HI-VNI and introduced new classification regulations, designating HI-VNI as an attractive alternative to non-invasive positive pressure ventilation (NIPPV).

Vapotherm has developed a range of complementary products for various applications, centered around its Mask-free NIV product and HI-VNI technology.

The HVT 2.0 System includes the HVT 2.0 Mask-free NIV and a single-patient-use circuit.

HVT 2.0 is equipped with mask-free NIV, a mobile touchscreen, and associated components, enabling rapid startup within five minutes. Relevant data demonstrate that, compared to NIPPV, HVT 2.0 reduces patients’ ICU admission rates, improves ambulation during use, shortens hospital stays, and thereby lowers nursing care costs.

HVT 2.0 is suitable for both adults and children, with a flow range of 5–45 L/min and battery life supporting 30 days of continuous use.

Precision Flow System is the sole product launched under the updated HI-VNI technology portfolio. The system comprises the Precision Flow Mask free-NIV, patient circuits, and the Precision Flow Heliox helium-oxygen mixture delivery device.

This system’s steam humidification differs from conventional methods, utilizing specialized instruments to generate humidity through gas mixing.Medical-Grade Steam, maintains stable medical gas conditions by eliminating condensate, thereby preserving oxygen humidity and temperature. It also provides two flow ranges for use in neonates, children, and adults.Neonates: 1–8 L/min; Children/Adults: 5–40 L/min。

To ensure the device is suitable for emergency or critical care situations, the system also provides heliox delivery. As prescribed by physicians, Precision Flow Heliox accurately mixes helium and oxygen in precise proportions to alleviate respiratory distress. Precision Flow Heliox offers a flow range of 1–40 L/min, with an 80/20 heliox input (79% helium/21% oxygen), and an oxygen concentration adjustable from 21% to 100% in 1% increments.

Capital Accessories, including the Oxygen Assist Module (OAM), vapor delivery device, and Q50 air compressor, are auxiliary devices suitable for all scenarios.

OAM can automatically control FiO₂₂(Fraction of Inspired Oxygen) Assists medical staff in controlling SpO₂₂(SpO2) range to ensure patient SpO₂maintained at normal levels to avoid certain clinical consequences, such as retinopathy of prematurity (ROP), or lung injury and vasoconstriction in some critically ill adult populations.

The Q50 compressor can be conveniently mounted on the Precision Flow roll stand, minimizing additional space requirements and supporting the Precision Flow System in achieving care objectives.

Additionally, Vapotherm has developed a variety of disposable components, including ProSoft nasal cannulas and tracheostomy adapters, to supplyNebulized Drug Deliverytwo options (aerosol disposable patient circuit ADPC and aerosol adapter AAA-1) andNitric Oxide Delivery Methodsetc.

In March 2022, Vapotherm announced a strategic partnership with the artificial intelligence research institution Carnegie Mellon University. The collaboration aims to leverage Carnegie Mellon’s AI expertise to provide relevant training for Vapotherm employees and develop AI applications that deliver better care, improve quality of life, mitigate the impact of chronic respiratory diseases, and reduce healthcare costs for customers.

According to Vapotherm’s Q3 2022 financial report, total revenue for the third quarter was $13.5 million, representing a 4.4% increase from the second quarter of 2022. The integration of respiratory devices with helium, nebulized medications, and AI suggests that future ventilators may hold development potential beyond current expectations.

Overall Technological Level of China's Ventilator Industry Compared with International Advanced StandardsAt least a 20-year gap, leading domestic enterprises still employ “hot-wire” flow sensors at the inspiratory end of adult ventilators—a technology that has been phased out by mainstream international products—while high-tech models such as neonatal conventional and high-frequency ventilators remain a “blank” in the market.

Technological backwardness has kept domestic ventilators at the mid-to-low end of the market, with German and American industry giants monopolizing 80–90% of the high-end ventilator market in China. On the export front, although ventilator exports rose amid the COVID-19 pandemic, prior to 2020, the life support systems divisions of leading Chinese companies primarily exported anesthesia machines and ECG monitors, while ventilators saw dismal sales in the international market.

From the perspective of overall industry prospects, China’s per capita ventilator availability remains low compared with developed countries such as the United States, Germany, France, and the United Kingdom, with 57 ventilators per million people, indicating substantial room for growth in industry penetration.

Opportunities and Challenges Coexist: The Unprecedented Industry Boom Driven by the COVID-19 Pandemic Has Not Fundamentally Altered the Overall Technological Disadvantage of China’s Ventilator Sector, Which Continues to Face Severe and Pressing Tests and Challenges in the Normalized Market Competition of the Post-Pandemic Era.

Driven by market demand, China has pursued a dual-pronged technological development path: on one hand, introducing, assimilating, and building upon international technologies to catch up and advance; on the other, integrating domestic capabilities across the medical, computer software, and mechanical-electronic industries to make concerted efforts in overcoming key technical challenges. This approach has ultimately enabled technological leapfrogging and charted an advanced trajectory for domestically produced ventilators.